Novartis Obtained MS Rights to Ofatumumab

What is ofatumumab?

Ofatumumab is a B-cell depleting monoclonal antibody therapy that targets CD20+ B-cells. Multiple sclerosis is known to be affected by T-cell activity, but is increasingly understood to be connected to B-cell activity in the immune system. B-cells are lymphocytes produced in the bone marrow.

B-cell depleting therapies and MS

Each of the investigational therapies that target CD20+ B-cells are cytotoxic, meaning that they bind to CD20 receptors on the cell surface and cause the cell to self-destruct. The rapid depletion of these specific B-cells is proving to be an effective treatment for MS.

Ofatumumab (Arzerra), a fully human MAB, has been studied in a small Phase IIa clinical trial involving 38 patients with relapsing-remitting MS. Results from the trial showed that intravenous ofatumumab (at each of three different doses being tested, given by infusions separated by two weeks) reduced total number of new brain lesions by up to 90% in 4-12 weeks. Compared to placebo, ofatumumab did not increase serious adverse events; however two patients in the 300-mg dosage group dropped out of the study because of adverse events. In light of these positive results, ofatumumab should be ready to move into Phase 3 trials.

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Novartis to Pay GSK $1B+ for Ofatumumab to Treat MS

Drug Assistance Programs You Should Know

Managing a chronic disease, such as rheumatoid arthritis, can be made more difficult if you are unable to afford your medications or health insurance premiums.

Copay assistance programs help patients who cannot afford to pay for prescribed medications despite insurance coverage. Frequently, drug manufacturers are able to provide financial help directly which should be your first resource to explore. To access manufacturer-sponsored programs, visit the brand website for the RA drug which you have been prescribed.

For patients who do not quality for manufacturer programs (perhaps due to insurance coverage through government programs such as Medicare), the following non-profit organizations offer additional help paying for medications. Some of these programs even offer financial help with insurance premiums and transportation costs to obtain treatment.

In general, to participate in these programs, the patient must have valid medical insurance that covers the prescribed medication, which in turn must be included on the program formulary; and the patient must meet annual household income criteria established by each program. One program included below offers help with generic medications regardless of insurance coverage.

Good Days from CDF

• Good Days, formerly known as the Chronic Disease Fund, provides direct financial assistance to RA patients prescribed one of the following biologic drugs: Cimzia, Humira, or Remicade. To participate with Good Days, patients must remain fully compliant with their medication.
• Good Days offers a Premium Assistance Program that helps patients find, and pay for, appropriate health insurance coverage.
• The Good Days Travel Concierge Program offers transportation services for pre-approved medical appointments to obtain treatment. If needed, the program may also arrange and cover lodging. Additional travel expenses, such as parking, fuel and meals, are covered.

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Six Assistance Programs RA Patients Need to Know

How to Take As Needed Medications

What does “as needed” mean?
Medications that are taken “as needed” are used only when necessary to treat a specific situation or symptom, such as pain, the common cold, allergies, constipation, anxiety, or fatigue. Some of these medications might be prescribed for you by a doctor while others can be purchased “over the counter” at your local pharmacy.

“Pro re nata” is a Latin phrase that means in the circumstances or as the circumstance arises. In medicine, pro re nata is abbreviated as p.r.n or PRN and means taken as needed or as the situation arises.

PRN medications are taken every once in a while to treat certain symptoms.

It is important to know what medications can be taken “as needed” and which ones must be taken regardless of how you feel. I take medications for low thyroid function, high cholesterol, and depression, each of which must be taken daily even if I feel great. This is non-negotiable. The list of medications I have on hand to be taken as needed is much longer and help me manage spasticity, nerve pain, anxiety, insomnia, and fatigue.

Can gabapentin or baclofen be taken “as needed”?
When I was first prescribed gabapentin and baclofen, I started them slowly, at a low dose, and titrated up to an effective dose which was taken daily on a regular schedule. Over the years, the amount of these medications I’ve needed to take has varied. At one point, I was taking 600mg of gabapentin three times daily to combat severe nerve pain. But now, I only take an occasional 300mg dose when mild nerve pain reaches the annoying or distracting stage. "As needed."

While I currently take baclofen each evening before bed, I also keep a prescription of diazepam (Valium) on hand for when the spasms get unbearable and when baclofen doesn’t sufficiently reduce the discomfort (ie, when massaging or stretching a knotted muscle causes intense crying).

Take medicines safely.
If you use PRN medications that are taken “only as needed,” it is important that you know exactly how these medications should be used. Discuss with your doctor his/her instructions regarding how frequently the medication can be used and what dosage you should use or not exceed.

Be aware that some of your PRN medications may be used instead of one of your other meds rather than in addition to. And, some medications may have similar ingredients and should not be used together. Ask your pharmacist if you ever have questions regarding medications (prescribed or OTC) to make sure that you take your medicines safely.


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Using "As Needed" Drugs with MS

(photo credit: Damian Gadal)

10 Lessons I’ve Learned Since Being Diagnosed with MS

1. Be patient with yourself and others. Just like a baby isn’t born with the skills to run, jump, or do calculus, you are not suddenly equipped with all the knowledge and skills you need to handle every challenge caused by multiple sclerosis (MS). It takes time to grow and mature into living a good life with chronic illness, but doing so becomes easier more quickly if you don’t try to do it alone.

2. Don’t expect others to know what you need, what you are thinking, or what you are experiencing unless you share that information and are willing to talk about it openly and honestly. Communication is a vital component of life; use it to your advantage as you continue to improve your communication skills.

3. Doctors are ultimately our partners, not our gods or slaves. If you want to “be fixed” by medical professionals, it won’t happen. If you want to dictate every bit of your medical care, without allowing for an open dialogue (see #2), you will not receive the best care. Find a doctor with whom you can develop a good working relationship. Be honest with your doctor, and yourself, and trust that he/she is there to help you. If you cannot have this type of doctor-patient relationship, it is your responsibility to find a doctor with whom you can partner.

4. Be prepared to learn more than you ever wanted to know about health and the human body. While you are educating yourself, so that you can truly participate in your own care (see #3), stay curious about how the body works. Stay on top of the latest understandings about multiple sclerosis symptoms, causes, treatments, research, etc. Don’t become obsessed, but do become empowered with knowledge.

5. Seek the ‘silver lining’ in difficult circumstances. Maintaining a positive outlook is important for staying motivated to take care of yourself in all aspects of life. It can be too easy to live in despair, or to feel dwarfed by the barrage of challenges MS may throw at you. As long as you can hang onto a kernel of light, you can feed that light and watch it grow and shower your life with unexpected blessings.

6. MS may change your life, but it doesn’t change who you are down deep. Watching your hopes and dreams for the future effectively dissolve in front of your eyes is god-awful painful - don’t let anybody tell you otherwise - but you are much more than what you do (professionally). This is one lesson that I have to remind myself over and over again - each time I feel sad about having been on the verge of “making it” when MS intruded and changed the roadmap of my life. But most importantly, continue to have dreams.

7. Just as it’s okay to cry and get angry, it’s also okay to smile and feel happy. The most important thing (it seems to me) is to acknowledge your emotions, honor them, and to allow yourself to feel them fully. The more you allow positive emotions to flow, the greater they grow and thrive. The more you honor your own negative emotions, the more quickly they dissipate into smoke and float away.

8. A sign of strength is the willingness to ask for and accept help. You do not need to face challenges alone. As you practice to develop and improve your communication skills (see #2), it is important to allow others to contribute what they can to your overall well-being. Someday you will be rewarded with the opportunity to help someone else which you will see can be a blessing to both parties involved.

9. Life is less embarrassing than you think. Whether you are reluctant to have people visit because you haven’t cleaned your home to an artificial, perfect standard, or you pee your pants in a public bathroom and need to deal with wet clothing, moving beyond the embarrassment and getting on with enjoying life is vastly more important than closing yourself off from others physically or emotionally.

10. Focus on what you CAN do today to make life better for yourself. No matter what your challenges, there are endless possibilities and actions you can take to improve your circumstances. Somedays, I have to move away from struggling to stay alert to “get work done” - a CAN’T situation - to focusing on listening to my body and giving it what it may need today which is a 2 o’clock nap and cuddle with a soft, fuzzy kitty cat - definitely a CAN DO situation.

What lessons have you learned since being diagnosed with MS or any other chronic disease? Share in the comments and you may end up completing #8!

This post originally appeared on HealthCentral.

(photo credit: deathtothestockphoto.com)

Exercise is Good for Mental Health and Brain Volume

Two unrelated open-access studies, published recently online, emphasize how exercise may benefit people living with multiple sclerosis. One study demonstrated that physical activity is associated with increased brain volume and the other showed that increased physical activity is associated with improved mental health and higher quality of life for MS patients.

Physical activity and brain volume

In a recent study published in Behavioural Neurology, a team of researchers from the University of Illinois at Urbana-Champaign identified an association between increased physical activity and higher volumes of brain tissue as measured by MRI scan in people with MS.

Physical activity was measured by an accelerometer worn for 7 consecutive days with data categorized by time spent in sedentary behavior, light physical activity, and moderate-to-vigorous physical activity. Data collected on days where the participant failed to wear the device for ≥ 10 hours without periods of inactivity exceeding 60 minutes (indicative of noncompliance) were excluded from the analysis.

Results from the study, involving 39 people with MS (30 female, 9 male; age 48.7 ± 9.6; disease duration 10.3 ± 8.5; EDSS 4.5 ± 2.5; and 77% with relapsing-remitting MS disease course), provide the first evidence that moderate-to-vigorous physical activity is associated, not only with volumes of whole brain gray and white matter but also, with deep gray matter structures that are involved in motor and cognitive functions in MS.¹

In other words, moderate-to-vigorous physical activity (MVPA) seems to protect against brain atrophy in people with MS, including areas of the brain connected to motor and cognitive functions. No associations were found between sedentary behavior and light physical activity with MRI outcomes.

Authors conclude that this study “supports the possibility that enhancing physical activity, specifically MVPA, could contribute to brain health in people with MS [which is] important considering brain volume is correlated with disability status and cognitive impairment in MS.”

Physical activity and mental health

Read this post in its entirety:
Exercise and Physical Activity Have Multiple Benefits for People with MS

Maximize Your Treatment Value

1. Choose medication that fits your lifestyle and priorities.
With 13 disease-modifying therapies available, MS patients and neurologists in the US have more options than ever to slow down progression of the disease. Before choosing a medication, it is important to evaluate the benefits and risks of each option to determine which one(s) more closely matches your personal needs, priorities, and concerns. Don’t forget to factor in your lifestyle preferences as you will only gain the greatest benefit from a treatment plan if you are able to follow it as directed.

2. Use medication as directed.
With each new medication you are prescribed, it is important to understand how the drug should be taken (what time of day/week/month to take it, with food or without, and for how long); potential side effects and what to do if you experience them; what to do if you miss a dose; and are there certain foods, alcohol, dietary supplements, or other medications to avoid while taking the prescribed medication. For each MS medication, there are patient guides available that explain some of this information, but don’t be shy about asking your doctor and/or pharmacist for more information.

3. Keep a symptom, medication and side-effect diary.
Especially important when you are first getting into the habit of using a new medication is to keep track of how you are using the medication, including any problems you experience. Many MS drug manufacturers provide physical diaries and/or smart device apps that help make this task easier. With your first MS drug, patients are encouraged to document where they gave themselves injections and rotate injection sites appropriately. With careful documentation, you can look back on your notes to look for patterns that may help you improve the way you use medication.

4. Take advantage of drug company programs.
Drug companies that manufacture disease-modifying therapies for MS typically offer programs to patients. These programs range from on-call nurses who answer your questions, free print or electronic materials, and financial assistance to help pay for treatment, to local programs where patients can learn more about treatment options, ask trained medical professionals questions, and socialize with other patients. Taking advantage of these programs is one way that you can become a more educated and equipped patient to make informed treatment decisions.

5. Keep your doctors informed as well.
Always tell your doctors/nurses/healthcare professionals what medications, OTC drugs, and dietary supplements you are using. Keep an updated list in your purse or wallet which can be easily accessed and shared. If you see multiple doctors, schedule time with your primary care doctor or a clinical pharmacist to take a big picture look at your health needs and to optimize your treatment plan(s). Also tell your doctor if you are pregnant, breastfeeding, or intend to become pregnant in the near future; use alcohol or tobacco; have other health conditions; have food or other allergies, or follow a restricted diet.

Read this post in its entirety:
Five Ways to Get the Most Out of Your MS Medication

(photo credit: deathtothestockphoto.com)

FDA Warns of PML in Patients Taking Gilenya (fingolimod)

The FDA warns that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking fingolimod (Gilenya, Novartis) for multiple sclerosis.

“These are the first cases of PML reported in patients taking Gilenya who had not been previously treated with an immunosuppressant drug for MS or any other medical condition,” said an FDA statement released yesterday. “As a result, information about these recent cases is being added to the drug label.”

Gilenya is an immunomodulator shown to benefit patients with relapsing forms of MS. Immunomodulators alter the immune system to reduce inflammation.

Two recent cases of PML in patients taking Gilenya WITHOUT prior exposure to immunosuppressant drugs:
Case #1: A 49-year-old patient with a five year history of MS developed probable PML after taking Gilenya for approximately four years. The patient had previously been treated with interferon beta-1a (Rebif) for 10 months in addition to short-term corticosteroids for relapse, before and during Gilenya treatment. During a routine MRI, new lesions considered atypical for MS and compatible with PML were detected. The patient with probable PML did not have clinical signs or symptoms suggestive of PML, and was diagnosed based on MRI findings and JC virus detected in the cerebrospinal fluid (CSF).

Case #2: A 54-year-old patient with a 13-14 year history of MS developed PML after taking Gilenya for approximately two and a half years. The patient had previously been treated with interferon beta-1b (Betaseron) for approximately 11 years. The patient had also been treated with mesalazine for ulcerative colitis for the last four years. The patient was hospitalized with suspected PML after developing new symptoms, including walking instability, clumsiness, inattention, somnolence and mental sluggishness. At that time, a brain MRI was suggestive of PML, and JC virus DNA was detected in the CSF. The patient was diagnosed with definite PML based on characteristic symptoms, MRI findings, and JC virus in the CSF.

Update: On August 17, 2015, Novartis was informed of a third MS patient taking Gilenya (who had not previously used Tysabri) who developed PML. This patient has a history of colorectal cancer treated with chemotherapy and radiation treatment, as well as Crohn's disease, and Novartis says they are currently in "active discussions with external advisors to review details of this case and the role of various risk factors contributing to the development of PML."

Two prior cases of PML in patients taking Gilenya WITH prior exposure to immunosuppressant drugs:
Case #1: In April 2012, Novartis reported a case of PML in a patient receiving Gilenya who had previously been treated for more than three years with natalizumab (Tysabri, Biogen) before switching to fingolimod. Tysabri exposure in patients who test positive for antibodies to the JC virus is a known risk factor for the development of PML.

Case #2: In August 2013, the FDA reported that a patient developed PML after taking Gilenya for eight months. However, PML could not be conclusively linked to Gilenya because the patient had been treated with: 1) an immunosuppressant drug (azathioprine) prior to starting Gilenya, and 2) multiple courses of intravenous corticosteroids, which can weaken the immune system, before and during Gilenya treatment.

What is PML?
Progressive multifocal leukoencephalopathy (PML) is a rare and serious brain infection caused by the John Cunningham (JC) virus. The JC virus is a common virus that is harmless in most people but can cause PML in some patients who have weakened immune systems, including those taking immunosuppressant drugs. Symptoms of PML are diverse and may include progressive weakness on one side of the body; clumsiness; vision problems; confusion, and changes in thinking, personality, memory and orientation. The progression of deficits can lead to severe disability or death. A magnetic resonance imaging (MRI) scan may find lesions in the brain before these symptoms develop.

What should I do about PML if I take Gilenya?

• Seek medical attention immediately if you experience symptoms that concern you, such as:
- new or worsening weakness
- trouble using your arms or legs
- changes in thinking, eyesight, strength, or balance
• Do not stop taking Gilenya without first talking to your health care professional.
• Read the Medication Guide you receive with your Gilenya prescription.
• Discuss any questions or concerns about Gilenya and the risk of PML with your health care professional.

Healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

Source:
FDA Drug Safety Communication: FDA warns about cases of rare brain infection with MS drug Gilenya (fingolimod) in two patients with no prior exposure to immunosuppressant drugs [August 4, 2015].

Do You Take Medications As Prescribed?

In a recent TEDxTalk in Basel, Switzerland, Silja Chouquet, a healthcare consultant and personal friend of mine, discussed the complexity of prescribed medications, why people don’t take their medication, and what we should do about it. Silja is passionate about the role that healthcare companies, including pharma, can play in moving beyond the pill to helping patients become more ‘compliant’ or better yet, empowered.

"If we could develop something to get people to take the medicine we prescribe them, it would have a greater benefit to society than any new drug we could develop." -Chouquet.



Read this post in its entirety:
Compliant, Complacent, or Condemned: Which Type of Patient Are You?