Thursday, August 6, 2015

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.

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].

Tuesday, 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?

Tuesday, July 28, 2015

What is Better: Endurance Training or Resistance Training?

Physical activity is an important part of staying healthy. Not only do we, as people living with MS, need to maximize cardiovascular health, we also need to maintain muscle strength and flexibility. However, multiple sclerosis is often associated with reduced physical fitness and lower quality of life.

Before I began riding the exercise bike regularly last fall, I would get winded much more easily. My heart and lungs were not functioning at their full capacity and I realized that I needed to do something about it. Although I really started riding the bike to improve my osteoarthritic knees, doing so helped me to get my heart pumping and to work up a sweat.

Over these past several months, I’ve noticed that both my strength and endurance have improved. I definitely feel better, physically and mentally.

Endurance training vs resistance training
Both options are good! People with MS are able to improve their physical fitness, including aerobic capacity and muscle strength, with either a combination of endurance and resistance training or endurance training alone, according to a recent study. Both forms of exercise used in the study reduced fatigue and improved quality of life for MS patients, especially in the areas of general health, mental health, vitality, and social functioning.

Trial participants (n=60; 44 female, 16 male) were randomized into one of two groups: the combined workout group (CWG) or the endurance workout group (EWG). MS patients completed a physician-supervised training program that lasted three months and consisted of two moderate-intensity training sessions per week, each of which was 40 minutes long. The CWG group exercised 20 minutes on a bicycle ergometer, followed by 20 minutes of resistance training. The EWG group focused on endurance exercise for the full 40 minutes. Twenty-three patients dropped out of the trial due to lack of time, long distance to training location, new workplace, or exacerbation.

Read this post in its entirety:
Which Type of Exercise is Better for People with MS?

(photo credit: pippalou)

Tuesday, July 21, 2015

How common is musculoskeletal pain in MS?

How common is musculoskeletal pain in MS?

A recent study investigated the severity and prevalence of musculoskeletal pain in MS patients in the Mazandaran Province of north Iran. Among 115 participants (76.5 percent female; mean age 30.4±5.8 years; mean disease duration 26.3±24.3 months), 87.8 percent were experiencing pain at the time of the study.

Lower limb pain, especially in the knees, is most common.

The most common locations for musculoskeletal pain reported were the knee (in 55.7 percent of study participants), wrist (43.5 percent), and neck (41.7 percent). In the 12 months prior to the study, significant numbers of the participants experienced chronic upper limb pain (60.9 percent), lower limb pain (64.3 percent), and backache (46.1 percent).

Upper back and neck pain are common in early stages of the disease.

MS patients reported mild to moderate pain, with more than half (53.9 percent) reporting that musculoskeletal pain had interfered with daily functioning, at least for a time. Upper back and neck pain were more common in patients who’d had MS for a shorter period of time, while knee pain was more common in patients with MS for a longer period of time.

Five times more women with MS have upper back pain.

Women experienced higher prevalence of shoulder, upper back, and ankle pain. The risk of upper back pain was 5.16 times higher in women than men, while ankle pain was 2.19 times higher. There was no significant gender difference in neck, wrist, back, hip, or knee pain.

Read this post in its entirety:
Majority of MS Patients Report Knee Pain

(photo credit: aleks)

(photo credit: aleks)
(photo credit: aleks)

Thursday, July 16, 2015

Treatment for MS-Related Itching

Pruritus in MS can be tricky to treat. If the itching is mild, treatment is usually unnecessary and the symptom often goes away on its own. If the itching is severe, prolonged, or disrupts your daily life, talk to your doctor about possible treatments.

Since itchiness associated with MS is neurologic in origin, cortisone cream and other topical treatments are rarely helpful. There are some medications, however, which may be useful in diminishing the itch, including anticonvulsants (e.g. gabapentin, carbamazepine, phenytoin), antidepressants (e.g. amitriptyline, paroxetine, mirtazapine), and the antihistamine hydroxyzine (Atarax).

It is tempting to scratch the itch, but resist the urge because scratching may actually increase the feeling of itchiness. Scratching too hard can also cause problems such as broken or damaged skin that bleeds or becomes infected. And if the skin is itchy, but also numb, then you might cause a lot of damage before you realize it.

Instead, you may want to experiment with applying ice or cold packs to temporarily relieve the itching. Cold seems to override the itchiness and “confuse” the already mixed up nerve signals. Never apply ice directly to skin (always wrap in a towel or washcloth) and never leave ice on one area for more than 15-20 minutes at a time.

Read this post in its entirety:
How Can I Fix This Crazy MS Itchiness?

(photo credit: "Ice Sculpture" by Andy Rogers is licensed under CC BY-SA 2.0

See also: Itchiness as an MS Symptom

Itchiness as an MS Symptom

When pruritus occurs as a symptom of multiple sclerosis, it is similar to other neurologic sensations - pins and needles, burning, stabbing, or tearing pain - known as dysesthesias. The itching with MS is often paroxysmal (coming on suddenly with great intensity) but temporary in nature and lasting anywhere from a couple of seconds to minutes. It can even seem to get worse the more you scratch.

Heat triggers pruritus for some people with MS and for others, it seems to be related to movement or tactile stimulation. For some reason, the itching often occurs at night with an intensity that has the power to wake you up from sleep.

Other causes of MS-related itching may include temporary skin irritation following injections, allergic reaction to medication, or side-effect of medication. In clinical trials, one of the common side effects of the oral medication dimethyl fumarate (Tecfidera) was flushing, followed by the sensation of heat or itching.

Read this post in its entirety:
MS Signs vs Symptoms: What is Pruritus?

(Photo credit: "Scratching her head" by Tambako is licensed under CC BY-ND 2.0

See also: Treatment for MS-Related Itching