MS Blog

As we start 2011 together, it’s a great time to recommit to helping yourself and those close to you.  Got a plan?   Exercise is a great start!   Sign up for a class, buy a yoga tape, or join a gym.  If your legs are weak, consider a recumbent bike or focus on arms with weights.   The more you do, the stronger you will be.   Shake up your diet, if needed.  Skip the fried food and roll out the fresh fruits and vegetables.  Drink more water and ditch the sweetened soda.  Follow through on stop smoking.

You be the model for your friends and families.  The payoff will be great!

The  two-year ALLEGRO clinical trial was conducted at 139 sites in 24 countries and enrolled 1,106 MS patients. Patients were randomized to receive a once-daily oral dose of 0.6 mg laquinimod or placebo.   Treatment with laquinimod resulted in less confirmed relapses than placebo.  Treatment with laquinimod rather than placebo resulted in less likelihood of having confirmed disability progression and MRI active lesions. 

A second clinical study, BRAVO, is a two-year,  multi-center, randomized, double-blind, placebo-controlled study designed to compare a once-daily oral dose of 0.6 mg laquinimod and oral placebo plus another comparison group on Avonex .  BRAVO enrolled 1,332 patients at 154 sites in the U.S, Europe, Israel and South Africa.  BRAVO study results are expected in the third quarter of 2011.  Submission to the FDA is planned after the results of BRAVO study are obtained.

Check out this NEW VIDEO  of  real people living with multiple sclerosis who describe how they successfully handle the disease.  While watching the new MS Center video, you will also get at sense of how we focus on each multiple sclerosis patient as an individual with specific goals and needs.  The MS Center for Innovations in Care is a designated National Multiple Sclerosis Society Affiliated Center for Comprehensive Care.

CLICK HERE to forward to the MS Center Video.

A Swedish study confirmed that the risk of getting MS goes up if you have been exposed to the Epstein-Barr virus (which causes mononucleosis, “mono”) .  Smoking  and low vitamin D blood levels further increase your risk of developing MS.  People born with certain genetic types are particularly at risk if exposed to Epstein-Barr virus or smoke.  Although you can’t change your genes, you can reduce the risk of developing MS if you stop smoking for greater than five years.

The TEMSO trial randomly assigned 365 patients to 7 mg oral teriflunomide daily, 358 patients to 14 mg oral terflunomide daily, and 366 patients to placebo (no treatment).  The MS patients had less relapses on treatment than on placebo (31.5% less relapses on the 14 mg dose and 31.2% on the 7 mg dose).  Patients on terflunomide 14 mg were 30% less likely to progress in disability than on placebo.  The low dose reduced the risk of worsening disability by 23.7%, but was not statistically significant.  The number of active lesions with contrast (on T1 scan) was 80% lower on the higher dose and 57% lower on the lower dose.  Side effects and risks seen included diarrhea, nausea, hair thinning, and liver blood test abnomalities.  Of 11 pregnancies, 10 patients had either miscarriages or elective abortions and 1 healthy baby born.  Another Phase III trial studying the experimental medication teriflunomide is still enrolling patients.   To read more on this other teriflunomide trial.

Treatments in earlier stages of development (Phase II trials) had mixed results.  The high dose of oral frategrast, which works like Tysabri, was effective in reducing MRI activity on the high dose (900 or 1200 mg twice a day).  However,  the 27% reduction of relapses on frategrast compared to placebo was not statistically significant.  The antibody therapy ocrelizumab, which focuses on the immune B cells, reduced relapses 80% on 600 mg dose and 73% on 2000 mg dose.   The therapy was also very powerful in reducing new MRI activity.  The biggest concern with the therapy was that one of the 55 patients assigned to the 2000 mg dose died in the 12th week of the trial due to a severe inflammatory reaction with widespread clotting in the blood.  A similar antibody, ofatumumab, reduced MRI activity with contrast greater than 99%.  Out of the 26 ofatumumab-treated patients, 2 people had infusion reaction including hives and cough.

Controversy regarding CCSVI continues!  Dr. Claudio Baracchini of Padua, Italy studied patients with the first attack of MS (with lesions on their MRI consistent with MS).  In a study of 50 MS patients and 50 healthy matched control subjects, only 16% of MS patients had blocked veins on ultrasound per Dr. Zamboni’s CCSVI criteria.  Of  the 8 MS patients that had CCSVI by ultrasound, seven patients were injected with dye (venography) and none had blockages.  Dr. Baracchini, who has been doing neck vessel ultrasounds for 20 years, stated that there was no evidence of vein blockages causing MS.  Fireworks followed when another doctor, unknown to me, stated that greater than 90% of his patients have vein blockages on venography.  My understanding is that the results from CCSVI screening depend on the quality of the ultrasound machine, how the study is performed, and who interprets the results.  For example, veins collapse when compressed too hard with the ultrasound probe or the person is placed certain positions.

With over 5000 researchers and doctors in Gothenburg, Sweden sharing their contributions,  the ECTRIMS meeting was a very important place to learn about and critically review the latest advances in MS.

Gilenya ( also known as fingolimod, FTY720) was just FDA-approved for the treatment of relapsing forms of MS to reduce the number of relapses and delay the development of disability.  Gilenya is taken as a once-day 0.5 mg capsule and will be available for prescribing on Oct. 4, 2010.

Compared to both placebo and Avonex in two trials, Gilenya reduced relapses over half (52% less than Avonex, 54% less than placebo).  Gilenya also lowered the likelihood of worsening disability by 30% compared to placebo.  New MRI lesions were decreased significantly compared to placebo (new or enlarging T2 lesions were reduced 74% and T1 contrast enchancing lesions reduced 82% on Gilenya).

Because of the risk of slow heart rate the first six hours on Gilenya, monitoring of blood pressure and heart rate are important the first six hours after the first dose.  The infusion center at Missouri Baptist Medical Center is set-up to provide this outpatient monitoring for our patients.  Baseline EKG’s are recommended for certain patients.

Serious infections can occur.  Patients will need a white blood count in the past 6 months prior to starting Gilenya (fingolimod).  Two deaths have occurred from herpes infections (chicken pox and viral encephalitis) in patients in the fingolimod studies (over 3600 patients in Phase III clinical trials).  In both cases, the individuals were on higher dose of fingolimod (1.25 mg) and received high dose steroids.  If you have not had chicken pox or not sure, let your healthcare provider know to you can be tested and/or vaccinated prior to treatment.

Swelling in the back of the eye (macular edema) can occur, especially in diabetics or people with uveitis.  Retina eye exam will be done prior to starting Gilenya and 3-4 months on treatment.  Liver blood tests can be high on fingolimod.  Baseline liver blood test is recommended prior to starting treatment.  Mild breathing test abnormalities were seen in the trials but no tests required on treatment unless breathing problems develop.  Elevation of blood pressure can occur.  Because of potential risk to the fetus if becoming pregnant of Gilenya, the recommendation is to use effective contraception on treatment and 2 months following stopping Gilenya.

An announcement today was made that the investigational once-daily oral teriflunomide reduced relapses compared to placebo in 1088 patients with relapsing MS in the TEMSO trial.  Patients were randomized to 7 mg, 14 mg or placebo.  Other positive findings were seen on both clinical and MRI results.  The safety was apparently in line with previous clinical experience.  The number of patients dropping out of  the trial due to side effects or other problems was similar between the teriflunomide and placebo groups. Study findings will be presented at the ECTRIMS meeting in Sweden on Oct 15, 2010.

Recruiting now for the investigational drug teriflunomide in the TOWER study.

Cladribine Tablets is an experimental treatment that has been studied in relapsing forms of multiple sclerosis.  The FDA has granted a priority review which means a decision for FDA approval could occur with 6 months.  EMD Serono announced that a decision on this oral therapy is expected in the last quarter of the year in 2010.

Now Enrolling.

Clinical research study in St. Louis for an investigational drug for multiple sclerosis.

Find out more details.

Today, we completed a 10K (6.2 mile) military-style obstacle course to raise money for the Gateway Chapter of the National MS Society. Thanks to all our supporters who propelled us to the top fundraising team! We climbed walls, swung on ropes across mud pits, and crawled through mud-filled tunnels. And then the giant mud slide!

Great news for those living with MS!  The FDA advisory committee reviewed Gilenya (fingolimod, FTY720) today.  The 25 members of the committee all found that the clinical trials had demonstrated substantial effectiveness of Gilenya and safety data justifies approval.  The vast majority on the committee also voted to allow use of the drug as a first option rather than restrict it only as a second option.  Monitoring recommended for slow heart rate risk with first dose.  Swelling in the back of eye (macular edema) and potential lung function evaluations were supported by the committee members.

The MS Center for Innovations in Care was the only center in St. Louis to participate in the relapsing remitting trials TRANSFORMS and FREEDOMS 2 for FTY720.