The 2012 MS Year in Review including all my MS-Related posts written for HealthCentral is now available.

Needle-Free Injections: Reality In the Future?

Biologic drugs have been used to treat RA during the past ten years. and are typically used as second-line drugs for patients who do not respond to traditional DMARDs.  Some biologics are used as first-line drugs for select patients with moderately to severely active RA.  There are nine biologics which are used for the treatment of RA, with the first receiving FDA approval in 2001.  A tenth biologic drug, Xeljanz (tofacitinib), was approved in November 2012 and should hit the market soon.

Traditionally, RA patients may be prescribed treatment with one or more of the non-biologic DMARDs before receiving treatment with a biologic drug (which is considered more aggressive).  A recent meta-analysis of 70 studies involving drugs used for RA compared the effectiveness of various treatments and combination of treatments in preventing joint erosion caused by RA as seen on x-ray image.  One outcome of the analysis revealed that combination treatment with 2 DMARDs plus periodic steroid treatment may be as effective as a biologic agent plus methotrexate (Graudal, 2010).

Besides being very expensive, a drawback to the biologic medications has been that they are given as subcutaneous injection (shot under the skin) or intravenous (IV) infusion.  However, many patients who fear self-injections are able to learn to give themselves shots with appropriate training and support.

Read this post in its entirety:

DMARDs, Biologics for RA, and Needle-Free Injections

Cognitive Skills and Driving in MS

How do you know if you should or shouldn’t be driving?

Research has found that information processing and visuospatial skills are predictive of driving performance among persons with MS. Cognitive tests, specifically the Symbol Digit Modalities Test (SDMT) and the Spatial Recall Test (SPART 7/24), may be useful as screening methods for identifying the potential impact of cognitive impairment on driving (Schultheis, 2010).

However, Dr. Akinwuntan, a professor at Georgia Health Sciences University, says that the current practice is to administer 15 to 22 different tests that can last up to three hours and cost as much as $450 to patients with MS who need to be evaluated for driving appropriateness.

Read this post in its entirety:

New Study to Test Driving Ability and Cognitive Function in Multiple Sclerosis

Driving and MS

Studies indicate that automobile accidents involving drivers diagnosed with MS occur at a higher rate than those involving healthy drivers of the same age.  About three times higher, according to early research studies on the subject from Denmark (Lings, 2002) and New Jersey (Schultheis, 2002).

Although the majority of people with MS can drive safely, there are symptoms, such as vision problems, muscle weakness, or spasticity, which can make driving more difficult.  During an exacerbation, some people with MS may temporarily give up driving.  Others may lose their license if involved in a serious accident.

According to Dr. Akinwuntan in Augusta, Georgia, patients whose level of disability is low, scoring less than 2.5 on the Expanded Disability Status Scale (EDSS), “are relatively good drivers and those above 7 are not fit to drive.”  Of course, this is a wide generalization which may not apply to your personal situation.

Read this post in its entirety:

Safety, Driving, and Multiple Sclerosis

Tremors in MS

A study published in the open-access journal Tremor and Other Hyperkinetic Movements reviewed recent advancements in the understanding of tremors in MS.  The review explores the prevalence and clinical features of tremors in MS, including physical  cause of tremors, and treatment methods, including surgery and/or prescription medications.

Reviewers searched MEDLINE with the terms “multiple sclerosis” and “tremor,” published between January 1966 and May 2012.  My own search revealed articles dating back to 1958, and at least six additional relevant articles published since May 2012.


Prevalence of tremor in MS
Studies indicate that tremors are prevalent in 25% to 58% of the MS population.  Upper limb tremor was described in 58% of 100 randomly selected MS patients from an MS specialty clinic in London (potential for selection bias); 27% with minimal tremor, 16% with mild tremor, and 15% with moderate to severe tremor (Alusi, 2001).  In a community-based study of 200 MS patients in Olmsted County, Minnesota, tremor was noted in 25.5% of patients with severe tremor seen in only 3% of patients (Pittock, 2004).

Read this post in its entirety:

Tremor in Multiple Sclerosis: Prevalence, Cause and Treatment

"Walking on Rocks" and RA

Patients living with rheumatoid arthritis may experience symptoms which cannot be detected by just looking at their body.  Even squeezing and poking the tissues surrounding tender joints may not make swelling entirely obvious.  Doctors often have to trust that when we say, “ouch,” we really do mean it.

There have been times where one of my RA symptoms was the “walking on rocks” sensation in my feet.  Really quite unpleasant.  Some people might describe this sensation as walking on marbles or walking on pebbles.  Researchers at the University of Southampton aim to improve the health and mobility of RA patients who experience the “walking on marbles” pain. 

Last fall one of our health guides, V, asked, “Anyone else feel as though they are walking on rocks?”  Responses to her question reveal that this is truly a common complaint.

Investigators have developed new ways of using diagnostic ultrasound and MRI (magnetic resonance imaging) techniques to assess a patient’s feet, specially the area around the ball of the foot and toes.  Previously, it was thought that this pain was due to walking on joints which were directly affected by RA. 


Read this post in its entirety:

"Walking on Rocks": An Invisible Complication of RA

Carnival of MS Bloggers #129

Welcome to the Carnival of MS Bloggers, a bi-weekly compendium of thoughts and experiences shared by those living with multiple sclerosis.

Rediscovering One's Self

What's for Breakfast? Watercolour Hibiscus

by Linda of Bright Wings of Summer

Funny days

Warning: This post may use the words poo &bum, and cause outright laughter...

What did you have for breakfast? Sometimes my days are very boring, and not much happens.  Other days...

It started yesterday.  During a fab day out Christmas shopping with a girlfriend I developed a sore ankle - which I naturally ignored - never let a foot impediment get in the way of a good Girls Day Out!  Then later that night, exhausted, and with Hubby just getting home at 6.45, and no dinner on the table - I said - well lets just have waffles!  SO there were were at 8.00pm at night having waffles, and cream and maple syrup - for Dinner!! (At least they were sourdough, and have eggs in them... I won't mention the vast quantities of fat in the butter.  or cream. Not if you don't. )

Anyway - My sore ankle? is still sore... this morning I discovered it has a reduced range of motion.  So what? Well after a quick google check - don't you love google - it has ALL the answers!  I have spasticity in that left foot now it seems. Yucky yucky yuck poo bum.  (I DID warn you!)

So what?  Well I have MS (Multiple sclerosis) (If you don't know what that is go and google it.  Try wikipedia.  I'll wait)...

So - this is my First sign of progression since 2006,  I'm not happy 'bout that.  Which means today is now a designated "rest, stay cool, and no stress day"... Right... other than paying the bills, taking the framed art to the shop, returning a broken frame to K-Mart, and the FN (fortnight) grocery shop?  With a heat wave coming.  Well 30 is a heat wave for me...    Hmmm my list of things to do is huge, and now I need to make dr appointments, and think about treatment for spasticity -which means physio, or doing stretches myself, which will still take more time out of my day - groaning melodramatically -

why is life never simple?  

O.K. need to stop thinking about the list. It's making me stressed just thinking about it.  Right then - No lists. They are evil.  (Except when you read other peoples lists on Aimees List it Tuesday :-).

I Breathe. Nice thoughts. watching the birds enjoy the bird bath.  Oh, and see the cat watching them through the window - cute.  But  I know what he wants to do - go outside and eat them.  Don't think about the psycho teenager Alpha Male Cat who wants to go outside and hunt...or the fact that both the cat litter trays really, really do need freshening up... or the cat hair dust bunnies I know are there somewhere if I look... nope not looking.

Instead Look at the pretty flowers in the vege garden...without thinking of the fruit fly that have already stung the tomatoes, which requires a trip to Bunnings to buy fruit fly traps, or netting, or napalm... and definitely don't think about the 28 spotted lady beetle that you know is lurking on your eggplant leaves having a munch...

Thinking about munching...Hmmm getting hungry - time for breakfast.  At least we have bread (it's only just a little stale), and eggs, and milk (just enough for a coffee).. which I'll surely need if I am to be superwoman and figure out what I can do with the 2 wrinkled apples, and a sad lemon, I can see in the fruit bowl...  Nope can't be bothered with the eggs - there is just enough waffle batter left for 1 more - and THAT's what I had for breakfast!

It's Complicated 

by Kim of Doc, It Hurt When I Do This...

We cripples have learned a thing or two about the Laws of Physics.  For example, a body in motion stays in motion and a body at rest tends to keel over and plant itself face down on the sidewalk.  That’s one of the easy ones.  Gravity claims us all sooner or later, but it claims a cripple a little sooner than most.  We know that aging is the great leveler, we’re just waiting for our peers to catch up with us. We might need a cane or wheelchair in our fifties, but don’t we feel a bit smug whenever some able-bodied person scoots around us, frightened of his own inevitable decline?  That’s okay, we think, you just keep running, buddy, the day will come when you can’t run anymore. You go, Charlie. 


We cripples have also learned a thing or two about love. How spouses, for example, who love us very much, can entertain a twinge of disappointment when we cannot go for an impromptu walk around town, enjoy the rush of blood in our limbs and the air in our lungs, the quickening heartbeat, the children playing catch in the street and the sun slipping towards the horizon. It is an uncomfortable feeling, disappointment, it makes them feel that perhaps they are not good people for having such twinges. So they push it away.

But these small disappointments can accumulate over time. We are not aware of this, of course, though we do worry that it is being felt. We perform reality checks on an annual basis, we give our spouses opportunities to come clean.  But they reassure us, year after year, that it doesn’t matter, honey, I love you, I’m not going anywhere. And we believe them. We believe them because they dote on us, bring us coffee and cook our breakfast on Saturday mornings. They do all the housework and grocery shopping, open packages for us, chop the veggies for dinner. And they do not withhold affection, we get held and kissed and gazed at lovingly every day. So it must be true. It doesn’t matter. They love us. They aren’t going anywhere.

And yet we have doubts. We push those doubts away and tell ourselves they are of no consequence.  But they infiltrate our bliss in various ways; in my case, in a recurring nightmare. My husband and I are at some event in a large building with a stage. When the performance is over we head towards the exit along with everybody else. The crowd swirls around me and my husband is no longer at my side. I search for him, spot the back of his head a few yards away and push through the crowd in that direction. But I lose him. I cannot see him anywhere. My vision begins to darken and my legs weaken. I hobble along corridors through room after room and decide to head for an exit, he’s sure to be outside waiting for me. By the time I reach the door, the building is empty and I am alone. I step outside into the waning light, hysterical with grief, and peer at the narrow distances, past a now empty parking lot and across a barren landscape, and drag myself in the direction of home. Just before I go completely blind, I awake.

An MSer’s worst nightmare is not physical decline, it is abandonment. A couple of months ago, my husband of not quite two years, my partner for six, my doting, kind, funny, compassionate mate, informed me that he didn’t want to be married to me anymore because he resents my disease. I cannot be his activities companion. He feels like a coward about the future. He cannot be the husband I need and deserve.

It doesn’t matter, honey, I love you.  I’ll never leave you. Yes, he spoke those very words, year after year. Old reliable, he was. Like a 20th century car that gets an annual tune-up by its conscientious owner even though it never needs the points and plugs replaced. The fact that you cared enough to perform routine maintenance endeared you to it in a human kind of way. Unnecessary maintenance, but cute, very cute. I get a pat on the head for being so aware, so thoughtful, so painstakingly dedicated to taking nothing and no one for granted.

What isn’t cute is that annual reality check was never an invitation to placate me. I was not trolling for the lie, I was courting the truth, the whole truth, and nothing but the truth, so help me God. I’m funny that way.  I need to know even if it hurts. He knew that about me, knew that if he wanted out I would want to know about it. I told him that. Honey, if you ever decide that you don’t want to take the whole journey with me, I’ll understand. We’ve all got to follow the path we think will make us happy. And I meant it, every word.

Perhaps it was pride that held him back, or the prospect of getting bad press, I’ll never really know for sure.  Look, there goes that guy who dumped his disabled wife. What a putz. There are not a lot of ways to spin that kind of abandonment in a way that would make yourself a sympathetic character, goodness knows.  Judgments would be harsh, there is just no getting around that. It’s enough to hold a husband hostage in an unhappy marriage for months, even years. Keeping such a grave secret took its toll on him, and when he fessed up to me about his unhappiness, he wept deeply and often while I took in the news; I was at first incredulous, then defiant, bargaining for a delay in his decision until he sought therapy. Eventually, acceptance silenced me. I had just gotten the news that my marriage was dying and I had the grieving ahead of me, but for him it had died long ago and he was simply revisiting the grave with a heavy and regretful heart, only this time, he had brought me along. I had to leave.

He moved me back to my mother’s house where I had lived for twelve years before meeting him. I lay on my old full-sized bed and cried, feeling as though I had been punished and sent to my room without supper.  My mother had painted my old bedroom white after I’d moved in with him. And I suddenly felt as though I had never left that bed, that I’d been in a coma for five years, dreaming that I lived in another house with a husband, two dogs, three birds, a garden, lulled by the sweet strains of marital devotion, and now I had awakened back in my old bedroom, the white walls being the only proof of the passage of time.

A month has passed since the separation. I was sad, grieving, angry, bewildered for the first two weeks, but I’ve stopped crying now. I feel relief, I’m free. Liberated because I am no longer waiting for him, no longer feeling guilty for not being normal, no longer afraid that I’ll disappoint him. The worst has happened, I’ve been abandoned because of my disease.

But it is not the hardship that I feared it would be. I missed him for a while, for two weeks, but then I stopped, and that in itself troubled me. I realized how distant he had become for the whole previous year and how easily I had made excuses for him. He was tired, he worked two jobs and had other responsibilities besides. He was in a twelve-month rehab program and I figured I was there on a rain check for a year, I’d wait for him to finish it and then I’d get him back again. So I waited. I championed his progress, felt proud of him, in love with him, desirous and lonely, yes, but he was going through a tough time and I should try not to act too needy. I was very patient. I thought we were happy. I thought I was happy, but I wasn’t. And the fact that I stopped missing him so quickly saddened me, it meant the relationship had been over for me, too, and for quite a while. I simply hadn’t owned it.

I saw a therapist immediately, before I left my husband.  In my first session, I told my therapist that I was suffering from low self-esteem, that my self-worth was in the toilet. After all, I’d just gotten dumped out of a marriage because I was not whole. But by the end of the session, he told me a startling thing:  I possess very high self-esteem, I just think I don’t. We call that cognitive distortion.  

The distortion, it seems, came about when I got the bright idea to abandon my expectations. One should have expectations in a marriage, who doesn’t know that? Apparently, I don’t. I didn’t expect my husband to want to share activities with me, explore the depths of intimacy. I didn’t expect him to make plans with me for the future, be my health advocate in an emergency, I didn’t even expect him to want to be married to me forever.  Gratitude had displaced any reasonable demands I might have made. Gratitude so deeply ingrained that I felt I hadn’t the right to intone: “Please, sir, I want some more.” After all, I wasn’t a starving, abused orphan in a workhouse. I was well-fed and loved. What more could a middle-aged cripple want from a new husband?

And I had my own pride to contend with, my own fear of bad press. The odds were against us, so many women with a chronic disease or catastrophic illness are abandoned by their husbands. I didn’t want to become a cliché. Having expectations certainly wouldn’t tip the odds in my favor. And so I never protested when he wanted to stay overnight on his sailboat Friday nights, join a rock band, rehearse two days a week, and gig on the weekends. He had his freedom and I retreated to my office, seeking refuge in my online patient community of friends. There, I developed the intimacy my marriage lacked.

Now that I am single again, my friendships continue to nourish me, I still have the intimacy. And I’ve made plans to find my groove again as a writer, I’ve long neglected a book I started writing several years ago.  But what continues to haunt me is the notion of expectations. If I ever consider marriage again, I must bring to the table a list of expectations and a promise to myself that gratitude shall be reserved for acts of kindness only and never become the sole tenet of my marriage philosophy. The prospect of such a thing seems daunting right now, in fact, it upsets me to think about it.

The fact that it troubles me to imagine such a testament to self-worth means I have some healing to do yet.  And heal I shall.  My husband has given me a gift I would never have asked him for: I’ve gotten my whole self back, intact, for the most part. And I won’t squander it.  Not ever.


This concludes the 129th edition of the Carnival.  The next Carnival of MS Bloggers will be hosted here on December 20, 2012. Please remember to submit a post (via email) from your blog of which you are particularly proud, or which you simply want to share, by noon on Tuesday, December 18, 2012.

Comments for this post.

Just For Fun - Mnozil Brass

Mnozil Brass - The Competition

This took me back to music school years, and made me laugh. Love the variety of genres (and personalities) combined into a brilliant show of musical theatrics. Enjoy!

Oh, and how could you not love a performance which includes an Alphorn?

MS in America 2012 - Take the Survey

In five short days, the "Multiple Sclerosis in America 2012" survey (sponsored by HealthUnion, a creator of disease-specific communities) has received an impressive 1000 responses from people like you diagnosed with MS.

Take a moment to add your experience and opinions to the survey.  Results will be shared in January 2013 which the launch of a new MS website/community.

http://tinyurl.com/b7okhqk 

Carnival of MS Bloggers #128

Welcome to the Carnival of MS Bloggers, a bi-weekly compendium of thoughts and experiences shared by those living with multiple sclerosis.

Happy Thanksgiving

Thanksgiving Prayer 2012

from the life well lived blog

I was a bit surprised when J suggested maybe A was ready for some more adult prayers. When asked, she meant the more adult prayers where we tell God what we want or need. I was kind of taken aback. I haven’t prayed that way since hearing a Riverdale
Baptist high school soccer coach lead his team in prayer before playing us by asking God to grant them victory, and then leading them in a public confessional to try and explain why God had let them lose to us.

Somehow keeping my relationship with God one where I can simply be thankful for all I have been given seems more my speed. If my wife or kids ever ask for an older prayer, I suppose I could lead them in a “Pater Noster” or an “Our Father” with or without the “for thine is the kingdom...”

Until then, I will keep my prayers to what I know.

• I am thankful for every day spent with a family who love and forgive me.
• I am thankful for the resilience of mind and body my kids show daily.
• I am thankful for a home in which to be comfortable.
• I am thankful for the love of our three dogs and the riches they imply we have.
• I am thankful for a job on which I am still challenged to learn something new every day.
• I am thankful for friends always there in time of need.
• I am thankful for the advances in medical technology allowing me to even consider running a half marathon in a couple of weeks after seven and a half years of MS.
• I am thankful for every sunrise and sunset.
• For every beginning, middle and end I witness,

Thank you.
Amen.

"short" blocks (Sandy vs NYC )

by Lorraine of I'm a Scatterbrain

These are giant community compost bins; empty, they each weigh half a ton.
This is a little ways downtown from me... and on the river, so also three
"long" blocks away from me.

I realized the the MS society fitness thingys began at the start of October,
and this time I can't blame my laxness on their SHITTY web site.

Even so, these things run vaguely once a week, with no clear reason why some weeks are off, to it is a fucking pain in the ass to enter them all in Google Calendar. Yes, I love my abductors, total Stockholm Syndrome, and Google knows all my teensiest bits of data.

This is an example of my occasional yearning to have a smart job again,
I would like to make the MS web events be "google-calendar" accesible.

I thought I could go back to web-D when I was unable to tend bar because
of MS, I thought, well, I'll just teach myself the new web coding just like
I taught myself the old coding.

This photo (left) is by my downstairs neighbor, Eak the Geek.

The next day he, Jennifer Blowdryer
and I went to the Key Food to get food out of the giant dumpster (they couldn't give
it away in case it was rotten, but tons of it was frozen, anyway, I didn't want to eat, just see the spectacle). I would like to train myself out of saying wrong things, like "tons," or "a lot," but in this case it seems fitting?

He was away at law school and I wanted to get ahold of him for some co-op reason (I was on the board of directors, ha ha, back then), and HE the reason I first went on Facebook, because where ELSE could he be? ... Well, myspace wasn't quite dead yet.

J. B. and  I ended up being foul weather friends and having too much wine and going to see all the trashed areas in our tiny neighborhood.

The blackout here was from Monday to Saturday, and we were up and down the stairs
between our two apartments for silly projects like prying open an old boom box to add
batteries for radio or what...

what else??? there was so much nothing we did in the dark together.

Actually, I had more social life after the storm, in the dark, than any time since Charlie...

Charlie called me several times before the storm and after. He still calls me Hon and Babycat, which makes my spirits SOAR.

Not for long of course, and when my mood crashed it was very easy to brood in the darkness about a-a-a-all the bad things in life. Like Indian Point being not that far away, and right after Japan, no wonder I dwelt.

I told EVERYONE that I was nowhere near the storm, but today I put this on my brother's Fbook -- Hey T, this was nine "short" blocks from my place (don't tell Mom or Dad, BWAH ha ha ha)

This concludes the 128th edition of the Carnival.  The next Carnival of MS Bloggers will be hosted here on December 6, 2012. Please remember to submit a post (via email) from your blog of which you are particularly proud, or which you simply want to share, by noon on Tuesday, December 4, 2012.

Comments for this post.

Broken Bones and MS

A recent study confirms that patients with multiple sclerosis have an increased risk of fractures and broken bones.  Researchers analyzed hospital records and death certificates using an English national linked Hospital Episode Statistics (HES) database covering the population of England of about 50 million people during the years 1999-2010.

In this English study, patients with MS had an overall 99% increased risk of fracture as compared to the reference group (Ramagopalan, 2012).  This exceeds the results of previously published studies which investigated the risk of fracture in patients with MS.

Read this post in its entirety:
Increased Risk of Fracture in MS Patients

Leading a Double Life

Last week, I spent a few days discussing important health and patient issues with a group of inspiring patient leaders representing a wide variety of disease states and communities.  Although none of us had the same disease, we discovered that we had similarities and overlap in our experiences and philosophies.  

As we each contributed to the conversation, several of us would preface our responses with our own personal experiences or those we’ve observed in our communities.  I found myself frequently saying things such as:

• “As an MS blogger…”
• “Within the RA community, I see…” 
• “As a person living with chronic illness, I….”

On the trip home, I realize that not once did I say, “As a musician living with MS or RA, my experience is…”

Read this post in its entirety:
Arts in Health: My Dual Life as a Musician

Carnival of MS Bloggers #127

Welcome to the Carnival of MS Bloggers, a bi-weekly compendium of thoughts and experiences shared by those living with multiple sclerosis.

The Colors of MS

Use All Your Colors 

by Ashley of MS Run in US blog

Every day is a brand new day and an opportunity to make of it what we want.  Every day we’re faced with thousands of choices; what to wear, what to say, where to go, what to do, how to react, how much to spend, how much to save, when to indulge, when to restrict, how to love, etc.  Data suggests that adults make nearly 35,000 decisions every day.  The idea of it can be staggering and intimidating.

Recently a client shared with me a story about himself when he was young.  In less words then the story should be told, essentially as a youngster he waited years for his family to have enough money to purchase the 64 pack of crayons for art class.  Until then they were only able to afford the 8 pack of standard rainbow crayons.  A few years later after he had gotten his use out of the 64 pack of crayons he decided to pass them on to his younger sister.  Before giving them away he notice, upon inspection, that he had only used the standard 8 colors regularly.  He so highly valued the other crayons that he was “saving” them.  He realized though that he saved them so much he didn’t even use them!

From that day forward he developed a motto: “Use all your colors!”.  This is a motto he applies to all areas of his life, of which his colors are his abilities. Whether it be for work or pleasure he commits to using all of his colors/abilities.

Obviously this concept has to be applied within reason.  We can’t just use all the money we have in one day or we’d find ourselves in a bit of trouble by the time the bills came.  But what if we applied this to abilities that we do have in plenty: love, compassion, endurance, forgiveness, kindness, patience, humor, drive, integrity…  These are all things that are given to us in immeasurable amounts.  There is no end to the amount of forgiveness we posses.  There is not limit to our kindness.  We impose our own limits on these attributes.

What if for today and beyond we don’t limit our abilities to do these things? What if we forgive until we can’t forgive anymore, and then we forgive more?

Remember as you go throughout your day that you have a box full of colorful qualities that you can use to brighten your world.  Use your colors.  And when you’re tired of coloring your world, color some more.

“Happiness is like jam.  You can’t spread it without getting some on yourself.” -Unknown

Escaping the "Red Zone" of MS

by Caroline of The Girl With MS

Sometimes this is not very easy to do, keeping your clothes on, with MS.  Summer months are brutal and just hiding out by the AC doesn't cut it for most folks. Planning ahead with cooling devices is best but sometimes we simply wake up in the "red zone", inflamed and sensitive, a red flag for a relapse.

When I'm in the Red Zone the first thing done is to rate the shade of red. Am I getting a little pink or have I fried myself?

And then ask myself why?

• What did I do yesterday?
• What did I eat?
• What was the temperature?
• How did I sleep?
• What's on my agenda today?

What can I do now to move into the "Blue Zone"?

Hanging by water is a great option. Pools, rivers, lakes, oceans provide instant relief from warmer temperatures. But not all of us have this opportunity nor can we often remove our clothes to cool off so improvise we must.

Quick tips:

• Cool shower. Even Luke warm is fine. Just hop in the shower for instant cool down.
• Wet bandanna around cooling points: neck, wrists, ankles
• Ice water, drink it, pour it on your head, pour it down your shirt!
• Wet shirt, cool off body. Huge help in the Sahara when my guides
  put my shirt in the crocodile infested waters so I could cool off. They
  don't have ice on safari in Tanzania, FYI.
• Juice it! With Cooling, anti inflammatory and detoxing foods such as cucumber, apple, pineapple, etc.
• Visualize the Blue Zone:

Ahhhhh....feeling cooler already. Now, not to mess it up.

That means to watch diet and activities all day:

• Cooling foods
• Activities by AC
• Water, hydration
• Reduce stress and get those items checked off to-do list
• Have fun brainstorming on some new projects
• Find balance
• Be at peace
• Mellow in the "Green Zone"

So, How do you deal when you're in the Red Zone?

This concludes the 127th edition of the Carnival.  The next Carnival of MS Bloggers will be hosted here on November 22, 2012. Please remember to submit a post (via email) from your blog of which you are particularly proud, or which you simply want to share, by noon on Tuesday, November 20, 2012.

Comments for this post.

Sharing Pictures from the Big Day

Just a few images from the wedding which our fabulous photographer captured. It's so hard to pick favorites out of the over 1000 pictures which were taken. I think I've narrowed it down to around 400 so far? Enjoy.

Welcome New MS Bloggers

Life isn't sugarcoated - this is it - 

Loving the Changes -

MS Survival Guide -

Stumbling in Flats -

The directory of the MS blogging community can now be found on this page.

Carnival of MS Bloggers #126

Welcome to the Carnival of MS Bloggers, a bi-weekly compendium of thoughts and experiences shared by those living with multiple sclerosis.

Happy Belated Carnival
from the Newly Married Lady

Rob and Lisa

(a few select photos from the big day)

Pregnancy and MS – Reducing Risk of Relapse After Delivery

by Dr. Yumi of Universal Balance Consultations

OK, here’s Part II of my article on reducing the risk of relapse after delivery. Remember in Part I, we talked about how much your risk increases after delivery, and how
important rest is to recover properly and avoid relapse. We also included some tips to make sure you get that rest.

PART II
Nourish your body for post-delivery recovery

Next is diet. I can’t stress the importance of proper diet enough. Not only will you be providing nourishment for yourself (and the baby if you’re breast-feeding,) a nutrient rich diet with some selected items will actually speed your healing process. And by recovering and strengthening the body, you’ll be reducing your chances of relapse.

“So what foods are best to nourish, and promote healing and strength after delivery?”
As soon as you get home from the hospital, you should make a big pot of Recovery Soup. It should have the following ingredients:

• Lamb, pork kidney or carp (one or more)
• White spring onion or white scallion, (the white parts are especially important)
• Ginger (freshly crushed or cut into thin slices is best)
• Dong quai (Angelica sinensis)

After that, just add more of your favorite vegetables, salt to taste and maybe some light seasoning. But you don’t want to use any type of spicy ‘hot’ seasoning, (chili pepper, cayenne pepper, and the like.)

There are other herbal supplements you can use to recover and nourish if you’re interested. But the Recovery Soup will make a great base to start from. I recommend you have a bowl or two each day for at least one month after delivery, or as long as you’re breast-feeding.

For the remainder of your diet during this period, you want to be eating as many nutrient rich foods as you can, which means include fruits and vegetables in all your meals. Also, stay away from fatty meats and junk food. I shouldn’t have to say here to avoid buckets of
greasy fried chicken and value meals from the local fast food joint. But I will. Avoid them!

These should be a very last resort; so maybe suggesting specific dishes you’d like to your friends in the cooking rotation would be a good idea. (See Part I) You want to strike a balance between healthy and tasty.

With the combination of rest and a nutritious diet, you should be well on your way to recovering from your delivery, and thereby reducing the chances of your symptoms flaring up. If you’re not interested in the diet, then the best thing to do is to just rest as much as possible after delivery. And avoid exerting yourself at least for a month or two. This will allow your body to heal. But I highly recommend you supplement with your diet.

Great, now you know how to regain your strength and avoid relapses. But you may still be wondering what it is that makes you more prone to relapses just after delivery.

What’s the deal with pregnancy and relapses?


According to oriental medicine theory, the kidneys are a major energy center, and govern the brain, back, spinal cord, bones, and bone marrow. The kidneys also store prenatal energy and control birth, growth, maturation and sexuality, so they’re one of the main organs that support pregnancy.

MS patients have lesions in the brain and/or spinal cord, which means your kidneys are probably already weak. (The kidneys could be the original problem, or they could have been weakened by some other imbalance.) Nevertheless, pregnancy, delivery, breast-feeding, sleep deprivation, overexertion, or any kind of mental stress, further burden
the kidneys.

When the kidneys are weak and overtaxed, the risk of relapse increases.
You’re particularly at risk if you’re breast-feeding because your body is still weak from the delivery, and your kidneys are providing nourishment for both you and the baby. This especially drains your kidney energy, so you might want to consider switching to formula after a month or two. However long you breast-feed, though, be sure to have the Recovery Soup for the duration.

You just don’t want to take unnecessary chances. Everything about your pregnancy and delivery is putting a strain on your kidneys. So it’s important in the first few months after delivery to properly heal and allow your body and kidney energy to strengthen.

All right, so now we know what’s going on with your kidneys and why women with MS are more prone to relapses. We’ve also learned how we can avoid those relapses. By following the guidelines I’ve presented, you can rest easier knowing you’re taking appropriate steps to maintain your health.

I hope this information has been useful to you and will help keep your own pregnancy episode-free. Especially if you have MS, you need to take good care of yourself, so you can in turn take care of that precious little person who’s just come into your life.

I’ve enjoyed presenting this info here and look forward to discussing further MS topics with you. Thanks for your time.

Dr. Yumi Izumisato

This concludes the 126th edition of the Carnival.  The next Carnival of MS Bloggers will be hosted here on November 8, 2012. Please remember to submit a post (via email) from your blog of which you are particularly proud, or which you simply want to share, by noon on Tuesday, November 6, 2012.

Thank you.

Comments for this post.

Today's Lucky Numbers

Today's date is 10-11-12.

On its own that's pretty cool.

But knowing that it's only

9 days until our wedding is even better.

10.11.12 + 9 = 10.20.2012

Carnival of MS Bloggers #125

Welcome to the Carnival of MS Bloggers, a bi-weekly compendium of thoughts and experiences shared by those living with multiple sclerosis.

Synchronicity and Balance

Today's Lucky Numbers

by Lisa of Brass and Ivory: Life with MS and RA

Today's date is 10-11-12.

On its own that's pretty cool.

But knowing that it's only

9 days until our wedding is even better.

10.11.12 + 9 = 10.20.2012

Synchronicity 

by Mary of Travelogue for the Universe

Synchronicity

is

Timing

on Steroids.

Another Concept

referred to  by

Edgar Cayce

and other mystics

and dreamers.

Do you ever

open a book and find

it is exactly where you wanted to be?

Do you ever get somewhere and find something

you needed and yet were not looking for it?

Do you ever paint a picture,

wondering

What is it that

you are trying to say,

and when you are done,

You see the results,

so obvious,

a perfect result,

then you show another person

and they are affected,

with the emotion you had,

brush in hand, struggling to find the right

colors, strokes, tempo,

and you see the message as a thread

between you and another person,

and you see how special it is

that this whole experience even happened

as it was meant to be,

The Timing felt so right,

That is

Synchronicity.

A love/hate relationship with tablets.

by Alison of Beauty and meaning in a broken world

7 things that I hate about putting my medications for the week into my pill box:
1. It takes a long time.
2. It reminds me that I have a lot of medical problems.
3. There are too many tablets and the lids hardly close.
4. There is a lot to remember and keep track of. Do I need a refill? Will I get it on time?
5. They are small and fiddly and I keep dropping them.
6. They make me dizzy, unfocussed and unable to have more than 1 glass of wine.
7. They remind me that I have MS.

5 things I love about my tablets:
1. They cheer me up.
2. They reduce my pain.
3. They make it managable to go out in public.
4. They let me sleep at night.
5. They help me survive.

This concludes the 125th edition of the Carnival.  The next Carnival of MS Bloggers will be hosted here on October 25, 2012. Please remember to submit a post (via email) from your blog of which you are particularly proud, or which you simply want to share, by noon on Tuesday, October 23, 2012.

Thank you.

Comments for this post.

Welcome New MS Bloggers

• A Life Derailed with MS - Amanda 
• My Fab Life with MS - Teresa 
• Alemtuzumab and Me - Sian
• MS Open Mic - Estizer 
• Multiple Stupidness - Eddie 
• Stumbling in Flats -

The directory of the MS blogging community can now be found on this page.

Former bloggers turned business persons, check them out:

• Universal Balance Consultations - Mark

Carnival of MS Bloggers #124

Welcome to the Carnival of MS Bloggers, a bi-weekly compendium of thoughts and experiences shared by those living with multiple sclerosis.

MS Hug, Montel Williams, and Massage

MS Hug

by Estizer of MS Open Mic

 I read a blurb in the NMSS Magazine that stated African Americans with MS are less likely to use any of the disease modifying drugs than people of other races. That got my attention although I do think its a matter of personal choice,I choose to do drugs! I set out to find the nearest African American support group to check this out. That was 1.5 hours away in Philadelphia.  Like any other group I’ve come upon, I talked more than anyone in the room. Except this one guy, he was pretty cool. I brought up the article and as it stated most of the people in the room were not on medication. But what the article failed to address was how many people in the room had insurance or co-pay issues.  As I looked around the table I was far more concerned with the level of obesity and a host of other health issues that must only complicate MS.

Everyone went around the table and talked about what bothered them last month and then it was the cool guys turn)At first he had a burning pain in his leg JUST LIKE MONTEL but when Montel said it I thought it was totally BOGUS DUDE and he just wanted to smoke some weed, but now I believed him! (Sorry Montel) Next the cool guy said he had an MS Hug and EVERYBODY in the room was like “oh yeah, oh yeah…they’re the worse right? Hahaha, oh yeah” EVERYBODY except ME! All of the sudden I felt like I forgot to put my drawers on. I just sat really quiet so nobody noticed.

Now… how cool was I when two years later I felt an intense tightening around my chest, along with a pain and burning sensation. I clutched my chest… awashed in fear! This was it! Did I go to the emergency room? Because these were all the signs of a heart attack. I DID NOT. Why you ask? Because this was an MS HUG like the cool guy at the support group had described…just like it…right…everybody said so, right?

Montel Williams Interview on Larry King

by Eddie at Multiple Stupidness

Montel Tells

When I first became ill, I scoured the internet for information on MS. Of course, this included YouTube, and there are probably hundreds of videos there concerning MS. Some are informational, some are testimonials and some are interviews or excerpts from programmes. Some are depressing and misleading, some are interesting and informative, and some are absolutely inspirational.

One of my favourites is the interview on Larry King Live of Montel Williams. I hadn't heard of him before I saw the interview, but he is an American talk show host who himself has been diagnosed with MS. As I watched it, it was wonderful not only because here was a man describing very, very similar symptoms to my own, but he was able to express things about MS that I felt, but had never been able to adequately verbalise.

An example of this is the injection I take every other day. I hate taking my injection. I hate it! Why? It doesn't hurt particularly. It's take less than five minutes, and I don't really suffer side effects from the betaferon like I did in the beginning. So why do I hate taking it? Montel Williams explains it beautifully, and very quickly I started directing people to these videos if they really wanted a clear, articulate expression of what MS is like and, because my illness felt so similar to his, a little of what my experience is like.

[Please go to Eddie's blog to view the videos.]

Massage Benefits MS

by Caroline of the Girl with MS

Many folks have asked about the benefits of massage for folks with MS.

Bottom line, I prefer spending my money and health on massage than on many of the Western "medicines" created for MS. Which don't seem to be true medicine. They are drugs that cover up the symptoms. So how do we reduce the symptoms and treat MS proactively?

Massage!

Among other ways to live healthy including nutrition, exercise, and spiritual well being, massage is a great physical way to remove toxins from our bodies. Whatever caused our MS or whatever exacerbates it, the one thing we can do is keep our body as clean as possible.

Now this is not always easy. Trust me! Coffee, tobacco, alcohol, artificial sweeteners, fake foods, artificial or fake anything can send MS into a tizzy.

The goal always is to reduce these toxins and increase MS beneficial foods, such as cooling mung beans and detoxing apples.

One thing we can do to remove toxins is to have a massage. And what a treat it is!

Massage seems to help in several areas: spasticity, pain, fatigue, poor circulation, and mental wellness...ahhhh....

The National MS Society has good information about massage and bodywork therapies click here. Here is the NMSS summary of how massage effects (or not) the course of MS.

"Massage and the underlying disease of MS:

While massage can be helpful in relieving stress and inducing relaxation, it has no effect on the course of MS. A 1998 study investigated the effect of massage in people with MS on:

• relief of anxiety and depression 
• improvement in mood, self-esteem and body image 
• increased ambulation and improved physical and social functioning. 

The study used self-reports by the participants and found that, at the end of a five-week period, physical and social activity had improved in the people receiving massage. Those in the massage group also reported a decrease in depression. There was, however, no improvement in grip strength and only marginal improvement in ambulation." 

So, keep up the massage and add some strength training or yoga to keep those muscles strong!

Lance Armstrong's LIVESTRONG.com talks about the benefits of massage on pain in MS sufferers. By reducing pain, massage can help folks become more mobile. Less pain = more movement. Folks withnMS don't want to be in bed. Sometimes we don't have much choice.

Massage & Bodyworks Magazine has done their research with regards to MS and massage presenting us with one of the most comprehensive yet simple to digest articles summarizing MS, the disease, along with the benefits of massage.

"For the MS patient, a well-being approach for addressing body, mind, and spirit is essential to combating the effects of the disease. Helpful self-care can include a daily routine of tai chi or yoga, meditation, and attention to diet." 

They get it. They get the disease and seem to understand what we need to feel better.

Many therapists, especially in the Northwest where prevalence is higher, jphave numerous MS clients. Crowell is one of them:

"With her extensive MS experience, Crowell says she has learned the importance of balance between releasing spasticity and maintaining enough tone for the client to function. “If you relax someone with MS too much, they can’t walk when they get off the table. They use the spasticity to keep them erect.” By implementing a reflex response technique, she reduces spasms without decreasing tone. The client is better able to maintain standing balance, and for those who are not ambulatory, core stability is increased so they can sit better. “One of the things people tend to lose is control. You are working with refining the amount of contraction they use with a given movement."

Wow! This is some great stuff. A must read for all with multiple sclerosis.

The American Academy of Neurology talks about the most common massage techniques used for reducing pain in MS patients:

• Craniosacral massage: Light pressure is applied to the head, neck, and spine to ease tension and compression. This type of massage is not appropriate for people with conditions that could be affected by intracranial pressure changes, such as acute aneurysm, cerebral hemorrhage, or hydrocephaly. 
• Lymphatic massage: Light, rhythmic strokes are used to improve the flow of lymph (a colorless fluid that helps fight infection and disease) and get rid of waste throughout the body. Lymphatic massage is often used to reduce post-surgical swelling and to help heal sports-related injuries. 
• Myofascial release: Pressure and body positioning are used to loosen and stretch the muscles, fascia (connective tissue), and related structures. Both physical therapists and massage therapists who are appropriately trained use this technique.
• Reflexology: Specialized thumb and finger techniques are applied to reflex points in the hands and/or feet. 
• Shiatsu: Gentle finger and hand pressure are applied to specific points on the body to relieve pain. 
• Swedish massage: A variety of strokes and light-pressure techniques are used to enhance blood flow, remove waste products from tissues, stretch ligaments and tendons, and ease physical and emotional tension. 
• Trigger point massage: Pressure is applied to trigger points (tender areas where the muscles have been damaged or where tension accumulates) to alleviate muscle spasms and pain. 

One of my favorites? Lymphatic massage...you can feel the toxins being squeegeed out of you! But I love them all. In fact, I'm off to get one now! What's your experience? Pro massage or toss it?

This concludes the 124th edition of the Carnival.  The next Carnival of MS Bloggers will be hosted here on October 11, 2012. Please remember to submit a post (via email) from your blog of which you are particularly proud, or which you simply want to share, by noon on Tuesday, October 9, 2012.

Thank you.

Comments for this post.

Cognitive Reframing and Stress Reduction

When faced with stress, effective coping skills are your way to staying above the fray.  Stress itself is not necessarily bad.  But an individual's perception and respond to a stressful event is very important.

General stress management techniques include: eating a balanced healthy diet; keeping physically, socially and intellectually active; taking prescribed medications as directed; getting adequate amounts of sleep; and resting if fatigued.  Strive for cardiovascular health.

Maintain a sense of humor and positive attitude.  Be aware of lifestyle habits that can negatively impact your physical and mental health.  Take advantage of cognitive and/or physical aids and strategies when needed.  Cognitive reframing can be one of the most effective stress management techniques available.

Read this post in its entirety:

Stress and MS: Cognitive Reframing and Stress Reduction

Stress and MS: The Mind-Body Connection

Stress is not an inherently bad thing, however if you have MS, you know that it can have negative effects. For years, the connection between stress and MS has been accepted by neurologists, neuropsychologists, and patients alike.  I agree that acute stress seems to aggravate my MS symptoms.

Saturday morning, I attended an MS Women’s Breakfast sponsored by the local chapter of the National MS Society.  The guest speaker was Mary Elizabeth Quig, Ph.D., clinical neuropsychologist at Georgetown University MS Center and founding partner at Neuropsychology Associates of Fairfax.  The title of her presentation was “Dames who Reframe.”

Dr. Quig began her presentation discussing neuropsychology, stress, and psychoneuroimmunology (PNI).  Psychoneuroimmunology takes an interdisciplinary approach to the study of the interaction between mental processes, the nervous system, and the immune system.  It offers a scientific study of the Mind-Body connection.

Read this post in its entirety:

Stress and MS: The Mind-Body Connection

Carnival of MS Bloggers #123

Welcome to the Carnival of MS Bloggers, a bi-weekly compendium of thoughts and experiences shared by those living with multiple sclerosis.

FDA Approves MS Pill, MS Inconvenience, 
and Anti-inflammatory Foods to Help MS

FDA approves oral drug, Aubagio (teriflunomide), for treatment of Relapsing MS 

from Lisa Emrich of Brass and Ivory: Life with MS and RA 

Late Wednesday afternoon, the FDA announced that Aubagio (teriflunomide) has been approved for adults with relapsing forms of MS.  Click through to the original blog post to find the FDA announcement, a Reuters news report, abstracts for 12 academic studies published between 2006 and 2012 regarding teriflunomide and oral medications in development for MS, and the Genzyme press release regarding the FDA approval of Aubagio (teriflunomide).

GRRRRR!! 

from Stax of Multiple Sclerosis & Me

i hate being sick; having MS!!

that's all; no funny stories, no lamenting or feeling sorry for myself. i just hate it; it's a pain in my ass and a big inconvenience.

What to eat with MS? 

from The Girl With MS 

Nutrition will allow you to Thrive with MS! Anyone with MS should know what cooling foods are and how they affect the body and the disease.

My research began over ten years ago. Three different Chinese medicine doctors diagnosed me as being kidney yen deficient. While investigating what these doctors were telling me, I found that many of the symptoms for this 5,000 year old Chinese disease were shockingly similar to that of modern day MS and many autoimmune diseases for that matter.

When asked about the cause the Chinese doctors all responded with "Western diet and lifestyle". The Western diet contains many processed and falsely seasoned foods not to mention excess fat. Western people are known to skip meals, eat on the hoof and gorge on salte, fat and sweets with no care about their bodies.

According to Chiness Medicine there are different kinds of food: cool, neutral and heating. Depending upon our makeup and health dictates which foods are best. For an inflamed person with MS the cooling foods are desired.

(FYI - Chinese Medicine offers much more than discussed here where it's been crudely simplified. Resources linked below)

So what foods cool off the body and help my MS?


Some obvious food such as cucumbers come to mind. Apples, bananas, citrus, clams and many more. But what about sushi? Have you ever eaten the eel? Unagi? One summer there was a heat wave in Japan and a subsequent shortage of Unagi due to its cooking effect on the body.

Imagine using foods to cool off and saving that electricity bill!

Information about cooling foods and nutrition for MS has grown significantly these
past ten years. Here are some places to check out:

A good primer on Chinese Medicine and food classifications

Spreadsheet of foods by class from DocStock

Heating vs Cooling Foods. A review

Food as Medicine - a look into Chinese Medicine. (downloadable PDF)

Chinese Food Pyramid for Dogs and More

Nutrition will allow you to Thrive with MS!

This concludes the 123rd edition of the Carnival.  The next Carnival of MS Bloggers will be hosted here on September 27, 2012. Please remember to submit a post (via email) from your blog of which you are particularly proud, or which you simply want to share, by noon on Tuesday, September 25, 2012.

Thank you.

Comments for this post.

FDA approves oral drug, Aubagio (teriflunomide), for treatment of Relapsing MS

Late Wednesday afternoon, the FDA announced that Aubagio (teriflunomide) has been approved for adults with relapsing forms of MS.  Below you will find the FDA announcement, a Reuters news report, abstracts for 12 academic studies published between 2006 and 2012 regarding teriflunomide and oral medications in development for MS, and the Genzyme press release regarding the FDA approval of Aubagio (teriflunomide).

As I am the type of researcher/reader who likes to have easy access to complete information in one place.  I thought that you might appreciate the following collection of abstracts/links.  Many of the studies are open access (meaning you do not have to pay for access) and downloadable.  I have a few pdf copies of ones which are not open access, published in the Multiple Sclerosis Journal.

Scroll down to the bottom of this post to read Genzyme's announcement which includes the introduction of their MS One to One™ program.  Update: Aubagio will be priced at $45,000

**********

FDA approves new multiple sclerosis treatment Aubagio

September 12, 2012 – The U.S. Food and Drug Administration today approved Aubagio (teriflunomide), a once-a-day tablet for the treatment of adults with relapsing forms of multiple sclerosis (MS).

“In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Multiple sclerosis can impair movement, sensation, and thinking, so it is important to have a variety of treatment options available to patients.”

MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs at least twice as frequently in women as in men. For most people with MS, episodes of worsening function (relapses) are initially followed by recovery periods (remissions). Over time, recovery periods may be incomplete, leading to progressive decline.

The most common side effects of Aubagio experienced by patients in clinical trials include diarrhea, abnormal liver tests, nausea, and hair loss.

The drug contains a Boxed Warning to alert prescribers and patients to the risk of liver problems, including death, and a risk of birth defects. Physicians should do blood tests to check liver function before a patient starts taking Aubagio and periodically during treatment.

Also included in the Boxed Warning is an alert noting that, based on animal studies, the drug may cause fetal harm. For this reason, Aubagio is labeled as Pregnancy Category X, which means women of childbearing age must have a negative pregnancy test before starting the drug and use effective birth control during treatment.

Aubagio will be dispensed with a patient Medication Guide that provides important instructions on its use and drug safety information.

Aubagio is made by Bridgewater, N.J.-based Sanofi Aventis.

**********

Sanofi's MS pill Aubagio gets FDA greenlight

(Reuters) – September 12, 2012 – Sanofi's multiple sclerosis pill, Aubagio, is set to reach the U.S. market, after the Food and Drug Administration gave a green light on Wednesday.

Aubagio is one of the two multiple sclerosis treatments the French drugmaker is relying on to return to growth after the loss of several blockbuster drugs to generic rivals.

"In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo," Russell Katz, director of the Division of Neurology Products at the FDA, said in a statement posted on the drug regulator's website.

The European regulator is expected to give its response on Aubagio in the first quarter of 2013.

Compared with older therapies for MS, Aubagio has the advantage of being an oral drug.

But it has produced less impressive results in clinical tests than other oral treatments and has failed to show it was better than Merck's Rebif, a commonly used injectable drug for MS, although Aubagio has milder side effects.

Analysts expect the drug could find favor among newly diagnosed patients, since around 35 percent to 40 percent of MS patients prefer to take no medication rather than face unwanted side effects.

MS pills Gilenya by Novartis and Biogen Idec Inc's BG-12 are seen dominating a market that JPMorgan analysts predict growing to $14 billion in 2015 from $9.6 billion last year.

Aubagio is seen grabbing a much smaller chunk of this market, reaching modest sales of $353 million in the United States and five major European countries by 2020, according to business intelligence firm Datamonitor.

Multiple sclerosis, which has no cure, affects 2.5 million people worldwide. It is a chronic, often disabling disease that attacks the central nervous system and can lead to numbness, paralysis and loss of vision.

In addition to Aubagio, Sanofi has filed MS injectable drug Lemtrada with regulators.

Despite a recent setback at the FDA, when the regulator asked Sanofi to refile its marketing application for the drug, Lemtrada could be launched in 2013 if it wins approval.

**********

Miller AE, O'Connor P, et al. Pre-specified subgroup analyses of a placebo-controlled phase III trial (TEMSO) of oral teriflunomide in relapsing multiple sclerosis.  Mult Scler. 2012 Jun 21. [Epub ahead of print]

BACKGROUND: The Teriflunomide Multiple Sclerosis Oral (TEMSO) trial, a randomized, double-blind, placebo-controlled phase III study, demonstrated that teriflunomide significantly reduced annualized relapse rate (ARR), disease progression and magnetic resonance imaging (MRI) activity, with a favorable safety profile in relapsing multiple sclerosis (RMS) patients.Objective:The purpose of this study was to report the effects of teriflunomide on ARR and disability progression in pre-specified subgroups.
METHODS: RMS patients (n=1088) were randomized to placebo or teriflunomide, 7 mg or 14 mg, once daily, for 108 weeks. Subgroup analyses were performed for ARR and disability progression by baseline demographics (gender, race, age), disease characteristics (Expanded Disability Status Scale (EDSS) strata, relapse history, multiple sclerosis (MS) subtype), MRI parameters (gadolinium-enhancing lesions, total lesion volume) and prior use of MS drugs. A generalized estimating equation method and Cox regression model were used to assess consistency of the treatment effect across subgroups, utilizing a treatment-by-subgroup interaction test for each factor separately.

RESULTS: Reductions in ARR and disability progression were consistent across subgroups in favor of teriflunomide, with no treatment-by-subgroup interaction test reaching statistical significance.

CONCLUSION: The positive effects of teriflunomide were demonstrated consistently across subgroups in TEMSO.

**********

Freedman MS, Wolinsky JS, et al. Teriflunomide added to interferon-β in relapsing multiple sclerosis: a randomized phase II trial. Neurology. 2012 Jun 5;78(23):1877-85. Epub 2012 May 23.

OBJECTIVE: To evaluate teriflunomide as add-on therapy to ongoing stable-dosed interferon-β (IFNβ) in patients with relapsing forms of multiple sclerosis (RMS).
METHODS: A total of 118 patients with RMS were randomly assigned 1:1:1 to receive oral placebo or teriflunomide, 7 or 14 mg, once daily for 24 weeks; 86 patients entered the 24-week extension. The primary objective was to evaluate safety; secondary objectives were to evaluate the effects of treatment on disease activity assessed by MRI and relapse rate.

RESULTS: Teriflunomide was well tolerated with a low and similar incidence of treatment-emergent adverse events (TEAEs) across the 3 groups; TEAEs led to treatment discontinuation of 4.9%, 8.1%, and 7.9% of patients in the placebo, 7-mg, and 14-mg groups, respectively. The number of gadolinium-enhancing T1 (T1-Gd) lesions was reduced in both teriflunomide groups, with relative risk reductions (RRRs) of 84.6% (p = 0.0005) and 82.8% (p < 0.0001) for 7 and 14 mg, respectively, compared with IFNβ alone at 48 weeks. T1-Gd lesion volume was also reduced in the 7-mg group (RRR 72.1%, p = 0.1104) and 14-mg group (RRR 70.6%, p = 0.0154). A trend toward dose-dependent reduction in annualized relapse rate was also noted (RRRs 32.6% [p = 0.4355] and 57.9% [p = 0.1005] for 7 and 14 mg, respectively).

CONCLUSION: Teriflunomide as add-on therapy to IFNβ had acceptable safety and tolerability and reduced MRI disease activity compared with IFNβ alone.

Classification of evidence: This study provides Class II evidence that teriflunomide, 7 and 14 mg, added to IFNβ, is safe. The T1-Gd lesion burden was significantly reduced with both teriflunomide doses.

**********

Confavreux C, Li DK, et al. Long-term follow-up of a phase 2 study of oral teriflunomide in relapsing multiple sclerosis: safety and efficacy results up to 8.5 years. Mult Scler. 2012 Sep;18(9):1278-1289. Epub 2012 Feb 3.

BACKGROUND: Teriflunomide, an oral disease-modifying therapy in development for patients with relapsing forms of multiple sclerosis (RMS), was well tolerated and effective in reducing magnetic resonance imaging (MRI) lesions in 179 RMS patients in a phase 2 36-week, placebo-controlled study.

METHODS: A total of 147 patients who completed the core study entered an open-label extension. Teriflunomide patients continued their assigned dose, and placebo patients were re-allocated to teriflunomide, 7 mg/day or 14 mg/day. An interim analysis was performed at a cut-off on January 8 2010.

RESULTS: The mean and median duration of study treatment, including both the core and extension phase, from baseline to the interim cut-off, was 5.6 years (standard deviation: 2.7 years) and 7.1 years (range: 0.05-8.5 years), respectively. Of 147 patients, 62 (42.2%) discontinued (19% due to treatment-emergent adverse events (TEAEs)). The most common TEAEs were mild infections, fatigue, sensory disturbances and diarrhoea. No serious opportunistic infections occurred, with no discontinuations due to infection. Asymptomatic alanine aminotransferase increases (≤3× upper limit of normal (ULN)) were common (7 mg, 64.2%; 14 mg, 62.1%); increases >3×ULN were similar across groups (7 mg, 12.3%; 14 mg, 12.1%). Mild decreases in neutrophil counts occurred; none led to discontinuation. The incidence of malignancies was comparable to that of the general population, and cases were not reminiscent of those observed in immunocompromised patients. Annualised relapse rates remained low, minimal disability progression was observed, with a dose-dependent benefit with teriflunomide 14 mg for several MRI parameters.

CONCLUSION: Teriflunomide had a favourable safety profile for up to 8.5 years.

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Killestein J, Rudick RA, Polman CH. Oral treatment for multiple sclerosis. Lancet Neurol. 2011 Nov;10(11):1026-34.

BACKGROUND: The armamentarium for the treatment of relapsing-remitting multiple sclerosis (RRMS) is increasing rapidly. Several oral treatments have shown benefit and will generate much interest because of the convenience of such administration. However, availability of convenient oral drugs will not necessarily translate into clinical effectiveness and safety. Here, we provide an interim report about the mechanisms of action, and efficacy and safety results that have been reported since January, 2010, for five new oral drugs. Additionally, we draw attention to issues that neurologists and patients will encounter when considering the use of new oral drugs.
RECENT DEVELOPMENTS: Positive results have been reported for five new oral drugs for RRMS--fingolimod, cladribine, teriflunomide, laquinimod, and dimethyl fumarate--in phase 3 studies; a few new oral drugs are likely to be approved for RRMS soon.

WHERE NEXT?: Emerging oral treatments are ushering in a new era in the treatment of MS, providing not only new treatment options but also new challenges. Since data for some of the new drugs have not been reported in peer-reviewed journals yet and safety profiles are not yet fully developed, opinions about the use of these new oral drugs in practice are preliminary and tentative. Practice will evolve with time as information and experience accumulates. Of importance will be results from comparator trials, information about management of patients with breakthrough disease, results from long-term safety studies, and results of studies to assess the potential for neuroprotective effects of the new drugs.

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O'Connor P, Wolinsky JS, et al. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med. 2011 Oct 6;365(14):1293-303.

BACKGROUND: Teriflunomide is a new oral disease-modifying therapy for relapsing forms of multiple sclerosis.

METHODS: We concluded a randomized trial involving 1088 patients with multiple sclerosis, 18 to 55 years of age, with a score of 0 to 5.5 on the Expanded Disability Status Scale and at least one relapse in the previous year or at least two relapses in the previous 2 years. Patients were randomly assigned (in a 1:1:1 ratio) to placebo, 7 mg of teriflunomide, or 14 mg of teriflunomide once daily for 108 weeks. The primary end point was the annualized relapse rate, and the key secondary end point was confirmed progression of disability for at least 12 weeks.

RESULTS: Teriflunomide reduced the annualized relapse rate (0.54 for placebo vs. 0.37 for teriflunomide at either 7 or 14 mg), with relative risk reductions of 31.2% and 31.5%, respectively (P=0.001 for both comparisons with placebo). The proportion of patients with confirmed disability progression was 27.3% with placebo, 21.7% with teriflunomide at 7 mg (P = 0.08), and 20.2% with teriflunomide at 14 mg (P = 0.03). Both teriflunomide doses were superior to placebo on a range of end points measured by
magnetic resonance imaging (MRI). Diarrhea, nausea, and hair thinning were more
common with teriflunomide than with placebo. The incidence of elevated alanine
aminotransferase levels (≥1 times the upper limit of the normal range) was higher
with teriflunomide at 7 mg and 14 mg (54.0% and 57.3%, respectively) than with
placebo (35.9%); the incidence of levels that were at least 3 times the upper limit of
the normal range was similar in the lower- and higher-dose teriflunomide groups
and the placebo group (6.3%, 6.7%, and 6.7%, respectively). Serious infections were
reported in 1.6%, 2.5%, and 2.2% of patients in the three groups, respectively. No
deaths occurred.

CONCLUSIONS: Teriflunomide significantly reduced relapse rates, disability progression (at the higher dose), and MRI evidence of disease activity, as compared with placebo.

(Funded by Sanofi-Aventis; TEMSO ClinicalTrials.gov number, NCT00134563.).

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Nicholas R, Giannetti P, et al. Development of oral immunomodulatory agents in the management of multiple sclerosis. Drug Des Devel Ther. 2011;5:255-74. Epub 2011 May 10.

Abstract: The emergence of oral disease-modifying therapies in multiple sclerosis (MS) will have a significant impact on the evolving scenario of immunomodulatory treatments in MS where current therapies are all injectable. Reducing relapses in trials translates for individuals with MS into a therapeutic aim of stopping future events. Thus the possible absence of any perceived benefits to the individual together with the long disease course, variable outcome, and a younger age group affected in MS makes side effects the major issue. The use of disease-modifying therapies as a whole needs to be placed in the context of a widening therapeutic indication where the use of these therapies is being justified at an increasingly early stage and in pre-MS syndromes such as clinically isolated and radiologically isolated syndromes where no fixed disability is likely to have accumulated. The five oral therapies discussed (cladribine, fingolimod, laquinimod, BG-12, and teriflunomide) have just completed Phase III studies and some have just been licensed. New oral drugs for MS need to be placed within this evolving marketplace where ease of delivery together with efficacy and side effects needs to be balanced against the known issues but also the known long-term safety of standard injectables.

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Krieger S. Multiple sclerosis therapeutic pipeline: opportunities and challenges. Mt Sinai J Med. 2011 Mar-Apr;78(2):192-206. doi: 10.1002/msj.20241.

Abstract: The year 2010 marked the beginning of the era of oral medications for the treatment of multiple sclerosis, with the approval of dalfampridine to improve walking and fingolimod as the first oral disease-modifying agent. This review provides an overview of these and other emerging therapies, with an emphasis on the opportunities for new treatment paradigms they have the potential to offer, followed by a discussion of the challenges they will pose in the new era of multiple sclerosis management. Therapeutics in late-stage development for MS include non-selective immunosupressants, targeted immune-modulators, and monoclonal antibodies. Oral agents including cladribine, teriflunomide, laquinimod, and dimethyl fumarate, as well as monoclonal antibodies alemtuzumab, daclizumab, and rituximab are considered. Potential side effects and adverse event monitoring, including opportunistic infections, emergent malignancies, and other systemic consequences of immunosuppression are discussed in a unified section. Challenges of optimally staging, sequencing, and combining treatments in the expanding multiple sclerosis armamentarium are discussed. This review emphasizes the multifactorial decision making that these new therapeutics will warrant in terms of patient selection and personalization/individualization of therapy, and the increasingly interdisciplinary approach that will be necessitated by the new generation of agents.

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Jadidi-Niaragh F, Mirshafiey A. Therapeutic approach to multiple sclerosis by novel oral drug. Recent Pat Inflamm Allergy Drug Discov. 2011 Jan;5(1):66-80.

Abstract: Multiple sclerosis (MS) is a chronic inflammatory autoimmune disease of the central nervous system and the most common cause of neurological disability in young adults, along with a considerable clinical and pathological heterogeneity. Since, current therapies appear to be modest in the magnitude of their treatment effects, particularly in the progressive phase of this disease, thus novel promising therapeutic strategies might open a light horizon in approaching to an efficient treatment in MS. In this review, we will discuss about relevant patents and novel designed immunosuppressive and anti-inflammatory oral drugs promising for treatment of multiple sclerosis.

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Palmer AM. Teriflunomide, an inhibitor of dihydroorotate dehydrogenase for the potential oral treatment of multiple sclerosis. Curr Opin Investig Drugs. 2010 Nov;11(11):1313-23.

Abstract: Teriflunomide, being developed as a potential oral treatment for multiple sclerosis (MS) by sanofi-aventis, is the active metabolite of the rheumatoid arthritis drug leflunomide. Both teriflunomide and leflunomide are inhibitors of the mitochondrial enzyme dihydroorotate dehydrogenase, which is critically involved in pyrimidine synthesis. The production of activated T-cells largely depends on de novo pyrimidine synthesis, and thus pyrimidine depletion is thought to result in the inhibition of immune cell proliferation. Therapeutic efficacy of teriflunomide has been demonstrated in vivo in an experimental autoimmune encephalomyelitis model of MS using Dark Agouti rats. In a phase II, randomized, double-blind, placebo-controlled clinical trial of patients with relapsing-remitting MS, treatment with teriflunomide reduced the number of active lesions in the brain and preliminary evidence indicated a slowing in the development of disability. Recently reported data from the phase III TEMSO clinical trial support these initial findings. Compared with current therapies, teriflunomide has the advantage of oral administration. Thus, if good efficacy is demonstrated, teriflunomide may have a role to play in the future treatment of MS.

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Barten LJ, Allington DR, et al. New approaches in the management of multiple sclerosis. Drug Des Devel Ther. 2010 Nov 24;4:343-66.

Abstract: Multiple sclerosis (MS) is a central nervous system chronic inflammatory disease that is characterized by an extensive and complex immune response. Scientific advances have occurred in immunology, pathophysiology, and diagnostic and clinical assessment tools, and recent discovery of unique therapeutic targets has spurred numerous Phase II and Phase III clinical trials. Reductions in MS relapse rates and improvements in T₂ or gadolinium-enhancing lesion burdens have been reported from Phase III trials that include fingolimod, alemtuzumab, cladribine, and rituximab. Promising Phase II trial data exist for teriflunomide, daclizumab, laquinimod, and fumarate. The optimism created by these favorable findings must be tempered with evaluation of the adverse effect profile produced by these new agents. Given the discovery of progressive multifocal leukoencephalopathy with the use of natalizumab, ongoing vigilance for rare and life-threatening reactions due to new agents should be paramount. Patients with MS often experience difficulty with ambulation, spasticity, and cognition. Recent clinical trial data from two Phase III dalfampridine-SR trials indicate certain patients receive benefits in ambulation. This article provides an overview of data from clinical trials of newer agents of potential benefit in MS.

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Warnke C, Meyer zu Hörst G, et al. Review of teriflunomide and its potential in the treatment of multiple sclerosis. Neuropsychiatr Dis Treat. 2009;5:333-40. Epub 2009 Jun 10.

Abstract: In the light of new cases of progressive multifocal leukoencephalopathy and induced autoimmunity in multiple sclerosis (MS) patients who received treatment with upcoming disease-modifying immunosuppressant drugs with a highly specific mode of action such as natalizumab, rituximab, or alemtuzumab, alternative oral treatment options for a subgroup of less severely affected MS patients are a major focus of drug development. These agents are currently investigated in phase III clinical trials and some of them are characterized by a favorable safety profile. With an emphasis on teriflunomide, the active metabolite of an immunosuppressant approved for the treatment of rheumatoid arthritis since 1998, a number of oral treatment options for patients with MS are discussed.

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O'Connor PW, Li D, et al. A Phase II study of the safety and efficacy of teriflunomide in multiple sclerosis with relapses. Neurology. 2006 Mar 28;66(6):894-900.

BACKGROUND: Teriflunomide, a dihydro-orotate dehydrogenase inhibitor, has immunomodulatory effects, including the ability to suppress experimental allergic encephalomyelitis. In this randomized, double-blind, placebo-controlled Phase II study, the authors examined the safety and efficacy of oral teriflunomide in multiple sclerosis (MS) with relapses.

METHODS: Patients (n = 179) with relapsing-remitting MS (n = 157) or secondary progressive MS with relapses (n = 22) were randomized to receive placebo, teriflunomide 7 mg/day, or teriflunomide 14 mg/day for 36 weeks. MRI brain scans were performed every 6 weeks. The primary endpoint was the number of combined unique active lesions per MRI scan. Secondary endpoints included MRI-defined disease burden, relapse frequency, and disability increase.

RESULTS: The median number of combined unique active lesions per scan was 0.5, 0.2, and 0.3 in the placebo, teriflunomide 7 mg/day (p < 0.03 vs placebo), and teriflunomide 14 mg/day (p < 0.01 vs placebo) groups during the 36-week double-blind treatment phase. Teriflunomide-treated patients also had significantly fewer T1 enhancing lesions per scan, new or enlarging T2 lesions per scan, and new T2 lesions. Patients receiving teriflunomide 14 mg/day had significantly reduced T2 disease burden. Teriflunomide treatment resulted in trends toward a lower annualized relapse rate and fewer relapsing patients (14 mg/day only) vs placebo. Significantly fewer patients receiving teriflunomide 14 mg/day vs placebo demonstrated disability increase. Treatment was well tolerated; numbers of adverse events and serious adverse events were similar in all treatment groups.

CONCLUSION: Oral teriflunomide was effective in reducing MRI lesions and was well tolerated in patients with relapsing multiple sclerosis.

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FDA Approves Genzyme’s AUBAGIO® (teriflunomide),

a Once-Daily, Oral Treatment for Relapsing Multiple Sclerosis

CAMBRIDGE, Mass. – September 12, 2012 – Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that the U.S. Food and Drug Administration (FDA) has approved AUBAGIO® (teriflunomide) as a new once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis (MS). AUBAGIO has shown significant efficacy across key measures of MS disease activity, including reducing relapses, slowing the progression of physical disability, and reducing the number of brain lesions as detected by MRI.

“We are very excited to introduce AUBAGIO as a new treatment option that can make a difference in the lives of people with multiple sclerosis,” said David Meeker, President and CEO, Genzyme. “The approval of our first MS therapy represents an important milestone for Genzyme and underscores our commitment to long-term leadership and partnership in the MS community.”

The FDA approval was based on efficacy data from the TEMSO (TEriflunomide Multiple Sclerosis Oral) trial. In the Phase III TEMSO trial, AUBAGIO 14 mg significantly reduced the annualized relapse rate (p=0.0005) and the time to disability progression (p=0.0279) at two years versus placebo in patients with relapsing forms of multiple sclerosis. AUBAGIO 7 mg significantly reduced the annualized relapse rate (p=0.0002) in the trial.

“Many people living with MS struggle with the additional burden of injectable therapies administered daily to weekly,” said Dr. Aaron E. Miller, Medical Director, The Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Mount Sinai Medical Center. “The FDA’s approval of AUBAGIO, a new oral treatment option, is an encouraging advancement for the MS community and may be a valuable treatment for people living with this often debilitating disease.”

The ongoing AUBAGIO clinical development program, involving more than 5,000 patients in 36 countries, is amongst the largest of any MS therapy. Some patients in extension trials have been treated for up to 10 years.

“We are greatly encouraged to see a new oral therapeutic option become available to people living with MS,” said Dr. Timothy Coetzee, Chief Research Officer at the National MS Society. “With collaborative research underway around the world today, this is an extremely hopeful time for anyone who is diagnosed with MS.”

The AUBAGIO label includes a boxed warning citing the risk of hepatotoxicity and, teratogenicity (based on animal data).

In MS clinical studies with AUBAGIO, the incidence of serious adverse events were similar among AUBAGIO and placebo-treated patients. The most common adverse events associated with AUBAGIO in MS patients included increased ALT levels, alopecia, diarrhea, influenza, nausea and paresthesia.

The labeling for AUBAGIO was also informed by the estimated 2.1 million years of patient exposure globally since the launch of leflunomide, which is indicated in the U.S. for the treatment of rheumatoid arthritis. Teriflunomide is the principal active metabolite of leflunomide. Severe liver injury including fatal liver failure has been reported in patients treated with leflunomide.

Please click here for full Prescribing Information for once-daily oral AUBAGIO (teriflunomide), including boxed warning and contraindications, for treatment of Relapsing Multiple Sclerosis.

The AUBAGIO clinical development program in MS also included the recently reported TOWER study. TOWER assessed the efficacy and safety of once-daily, oral AUBAGIO in patients with relapsing forms of multiple sclerosis (MS). In the study, patients receiving teriflunomide 14 mg had a statistically significant reduction in annualized relapse rate and risk of disability progression. In addition, a significant reduction in annualized relapse rate was observed in patients treated with teriflunomide 7 mg compared to placebo. Adverse events observed in the trial were consistent with previous clinical trials with teriflunomide in MS. Analysis of the full TOWER data is ongoing and results will be presented at a forthcoming scientific meeting.

AUBAGIO is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for AUBAGIO is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system (CNS).

As part of its commitment to MS patients, Genzyme has developed the MS One to One™ program. MS One to One provides information about multiple sclerosis, AUBAGIO and other relevant resources and is available and staffed by dedicated MS nurses and highly trained representatives who can provide support for individuals living with MS, their health care providers, family and loved ones. For more information about these support services, call the MS One to One line at 1-855-MSOne2One (1-855-676-6326) Monday through Friday, from 8:30 a.m. to 8:00 p.m. ET. Information and support are also available at www.MSOnetoOne.com.

Marketing applications for AUBAGIO are under review by the European Medicines Agency (EMA) and other regulatory authorities.

Learn more at www.genzyme.com.

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UPDATED: Sanofi snags FDA OK for oral MS drug Aubagio, prices at $45K

September 12, 2012 | By John Carroll

Sanofi ($SNY) won a badly needed FDA approval Wednesday for its oral multiple sclerosis drug Aubagio (teriflunomide). And soon after the news hit a representative for Sanofi subsidiary Genzyme said that the MS treatment will be priced at $45,000 a year, angling in to grab market share.

"The price of Copaxone is 7% more," the rep added. "The price of Avonex is 8% more and the price of Gilenya is 28% more than the price of Aubagio." The new treatment was filed for approval by Sanofi's biologics arm, Genzyme, which will now handle the marketing.

"In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo," commended Dr. Russell Katz, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "Multiple sclerosis can impair movement, sensation, and thinking, so it is important to have a variety of treatment options available to patients."

"We'll stack up quite well with what's out there," David Meeker, the CEO at Genzyme, tells FierceBiotech. All of the drugs available carry warnings about significant side effects. And the injectables on the market present an added burden for the population that oral drugs can eliminate.

"I do predict movement," he added about the patients and physicians considering treatment regimens. "There's going to be a significantly increased willingness to try new things." And after Lemtrada makes it through the approval process on MS, where it's given a good shot at an approval, the Genzyme MS franchise will grow. "These new drugs will be highly complementary, providing meaningful choices."

For Sanofi, the agency's approval marks a key win after a lengthy drought of new approvals. In the next step, Sanofi will work to steal a march on Biogen Idec ($BIIB), which has won the spotlight on MS with its experimental MS drug BG-12. The Aubagio program, which was transferred over to its biologics arm Genzyme as it seeks an OK on Lemtrada as well, failed to beat out the injectable Rebif. The key challenge here, though, will be Aubagio's ability to gain market share among new oral therapies. But some analysts aren't hopeful that the newly approved treatment can come close to blockbuster status.

"We doubt the drug will seriously affect Gilenya or Tysabri, where prescriptions are largely driven by efficacy," Berenberg Bank's Alastair Campbell told Bloomberg. Datamonitor assessed peak sales at just a little above $350 million for the top global commercial markets, according to a report from Reuters.

The approval will bolster CEO Chris Viehbacher as he continues to push a big shakeup on the R&D side of the business. But it may not be welcomed by the company's French employees, who are staging a strike today to protest deep cuts anticipated for the European side of the operation.

R&D hasn't always been easy at Sanofi. Weeks after Genzyme filed its application for Lemtrada as a new treatment for multiple sclerosis, regulators handed the NDA back, telling the biologics arm of Sanofi that it needs to complete a rewrite before they can properly assess it. But the Aubagio sign-off follows an important approval for its cancer division. Just days ago Sanofi got its first green light for Zaltrap, a cancer drug developed with Regeneron ($REGN). It's a second-line approval, in a market already dominated by Roche's ($RHHBY) Avastin and Bristol-Myers Squibb's ($BMY) Erbitux. But it's a step forward after a couple of oncology setbacks--and a first step toward hundreds of millions in sales.