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Archive for ‘MS Research News

Aug 19 2014 Plegridy: Just Approved. Interferon Every 2 weeks.

A new form of interferon beta-1a  (the active ingredient in Avonex and Rebif) is now available in a pegylated form.  A tail was added to the interferon molecule so injection under skin can be given only once every 2 weeks.

In the ADVANCE Trial,  512 patients received 125 micrograms of Plegridy and 500 patients received placebo every 14 days under the skin over 48 weeks.   MS attacks (annualized relapse rate) dropped by 36%.    Risk of disability progression was reduced by 38%.  Sixty-seven percent less new or enlarging T2 lesions and 86% less contrast-enhancing T1 lesions.

Risks of Plegridy are similar to other interferons and can include injection site reactions, flu-like symptoms, liver injury, depression and allergic reactions.  Plegridy comes in a single-dose prefilled pen or prefilled syringe.

May 7 2014 Straight from Philly: American Academy of Neurology Meeting News

American Academy of Neurology meeting in Philadelphia  just wrapped up.   Here’s some new information presented at the meeting.

1.  Estriol, a pregnancy hormone, was studied in addition to Copaxone.  During the last trimester of pregnancy, estriol levels increase and relapses decrease.  In a double-blind trial of 164 multiple sclerosis patients, relapses decreased 47% over one year on estriol and Copaxone compared to placebo and Copaxone (p=0.0326).  However,  relapses dropped only 32% at 2 years which was not statistically significant (p=0.015).  No significant impact on MRI imaging was seen at 2 years.

2. Alfacalcidol, synthetic compound with similarities to Vitamin D, reduced fatigue compared to placebo in a study of 158 MS patients.  More patients on Alfacalcidol remained relapse-free.

3.  B cells are a type of lymphocyte (white blood cell) that play a role in MS disease.  Data was presented on ofatumumab injected under the skin.  This antibody therapy knocks out B cells by attached to a B-cell marker CD20.  Significant impacts were seen on MRI activity based on doses studied.  Risks included injection-related reactions, low potassium and one patient had a cytokine release syndrome.

4.  The gut plays an important role in the body’s immune system.   Researchers found that MS patients have a higher levels of methnobrevibacter in stool samples.  This bowel bug is not a bacteria, but considered an archaea.  Methane breathing test might eventually be useful in multiple sclerosis.

5.  Melatonin can help with sleep, but what about a role in MS?  High relapse rates are associated with low melatonin levels in urine.  Melatonin may have positive effects on immune cells (IL-17 cells) by making them less inflammatory.

6.  Men with MS:  How’s your testosterone level?  40% of men are deficient in a study of multiple sclerosis patients, early in the disease course.

Jan 29 2014 Copaxone 40 mg 3 Times a Week FDA-Approved

Tired of daily Copaxone 20 mg injections for multiple sclerosis?  A new option is now available.  FDA just approved 40 mg dose three times a week.

The GALA trial studied Copaxone 40 mg (double dose) three times a week vs. placebo in 1404 patients.  Copaxone 40 mg three times a week reduced new relapses 34% and reduced MRI activity with contrast 45%.  Safety of Copaxone 40 mg appears comparable to 20 mg dose.  In fact, a lower amount of immediate post-injection reactions were seen in the GALA 40 mg trial.  Previous studies had demonstrated a 29% reduction of relapses with Copaxone 20 mg daily.

If interested in switching to 40 mg three times a week, discuss with your healthcare provider.

Jan 1 2014 8 New Expectations in 2014 for MS.

1.  More People on Oral MS Treatments.  The uptake is growing quickly and safety information accumulating.  Gilenya, Aubagio and Tecfidera are providing new highly effective options for patients.  See our ORAL Treatment Chart for download/printing.

2. Copaxone 40 mg three times a week.  Likely USA approval end of January.  Large majority of patients on Copaxone will reduce their frequency of injections to only three times a week from 20 mg injected daily.  Less shots and better for the skin.

3. Generic MS treatment.  Possible FDA-approval of generic versions of Copaxone in May.  A lot of uncertainty if the generic versions of Copaxone will be truly equivalent IF approved.  Unclear how the health insurance companies will react.

4. Plegridy.  Interferon beta-1a injected under the skin (subcutaneously) every 2 weeks.  In a one-year clinical trial, peginterferon  demonstrated  a drop in relapses of 36% for every two-week injections compared to placebo and reduced the likelihood of disability progression by 38%.  Read more.

5. Lemtrada Appeal.  During this past week, the FDA denied approval of Lemtrada.  This annual infusion therapy had demonstrated a reduction in new relapses by 49-55% in two clinical trials.  Recently, Lemtrada was approved for use in Europe, Canada and Australia.  Genzyme will appeal the decision. Read more about the FDA’s decision.

6. Improved Vitamin D Levels.  More studies have demonstrated adequate Vitamin D levels are associated with less risk of relapses, less disability and less MRI activity. Aim for 50 to 100 nmol/L.  Talk to your healthcare provider.

7. More Global Patient Advocacy. People living with multiple sclerosis around the globe are becoming more informed about their treatment options and their disease including MRI results.  Advocacy groups are providing patient support and fundraising to find a cure for multiple sclerosis.  The internet including TWITTER have made newsworthy information about MS instantaneously global.

8. Human Remyelination Studies Proceed.  Early stages of experimental antibody therapies, including anti-Lingo-1,  anti-SEMA4D and rHIgM22, will continue to try to stimulate new myelin formation.

Share Your Story on www.ICanWithMS.org!

This website, just launched by Dr. Barry Singer,  gives voice to those living with MS.  MS cannot stop the spirit of those living with the disease. Submit your own post or read the other inspiring posts. Send your Tweets or Instagrams directly to the site using #ICanWithMS. The website is a collage of video, pictures, tweets and instagrams.  Don’t Let MS Define You!

Dec 30 2013 Lemtrada Not Approved

FDA has taken the position that the Lemtrada clinical trials were not adequate and well-controlled.  Patients in the trial were assigned to alemtuzumab (Lemtrada) infusions or Rebif injections.  Patients did not receive placebo infusions or placebo injections so the FDA was concerned that knowing which treatment a person was receiving would bias the result.  Due to infusion reactions with Lemtrada and interferon side effects, a trial where patients were truly blinded would have been very difficult.  Nonetheless,  that FDA stated that one or more additional active comparator clinical trials would need to be performed for approval.  Lemtrada has recently been approved in Europe, Canada and Australia.

Read Genzyme Press Release.

Dr. Barry Singer just launched:  www.ICanWithMS.org.  Tell your MS story.  Visit website to explore or post videos, pictures, and text.  Tweet or Instagram to #ICanWithMS.

Dec 26 2013 Is Your MS Treatment Working?

Many people with multiple sclerosis take their disease-modifying treatment with good response; they experience  infrequent relapses and no progression in disability.  Other people seem less responsive to a particular treatment and can have worsening disability. A new article analyzed and combined studies (called meta-analysis) to determine which factors predict  a good or poor response to interferon treatment.

Overall, early new MRI activity predicted worse outcome on interferon beta treatments.  For example, two or more T2 white matter MRI lesions on a scan at one year on medication predicted an increase risk in disability.  Two or more active T1 contrast MRI lesions on interferon also increased risk of disability and further attacks.  Another predictor of disability 15-16 years later was two or more relapses during the first two years of interferon treatment.

Fortunately, most people living with relapsing MS have good MRI and relapse control to their individual treatment.  This article highlights people at higher risk for being poor responders to treatment.  The article did not examine what would happen if these patients switched therapy.  However, it’s important to discuss alternative treatment options with your healthcare provider if not responding well to treatment due to new MRI activity and breakthough relapses.

Article: Dobson R, Rudick RA, Turner B, et al. Assessing treatment response to interferon-beta: Is there a role for MRI? Neurology 2014;82:1-7.

LEARN MORE ABOUT YOUR MRI

Nov 13 2013 FDA Advisory Committee Voted on Lemtrada.

The FDA Advisory Committee met today and voted  on specific questions regarding Lemtrada (alemtuzumab).  The committee had concerns about the studies not being well-controlled since patients were randomized to either Rebif or Lemtrada, but knew which medication they were taking (non-blinded).  However, by a vote of 12 to 6, the committee voted that the trials did demonstrate substantial evidence of effectiveness.  In addition, the panel supported that the benefits of Lemtrada outweighed the risks.  The committee was not in favor of first-line use.  The final ruling will be by the FDA after reviewing the committee’s input.   The MS Center for Innovations in Care at Missouri Baptist Medical Center is a site for the CARE-MS II Trial of alemtuzumab.     

Lemtrada is an antibody treatment that is given in the vein over 5 consequetive days the first year and 3 days the second year.  The medicine causes a loss of T and B cell immune cells that are involved the immune attack associated with multiple sclerosis.

In the CARE-MS I Trial, 581 early, active relapsing-remitting patients, who had received no prior MS therapy, were randomized to Rebif or alemtuzumab treatment. Compared to those MS patients on Rebif, those individuals on alemtuzumab had 55% less relapses.  A low percentage of patients had worsening disability on both treatments without a significant difference between Rebif and Alemtuzumab (11% and 8% respectively worsened).

In the CARE-MS II Trial,  Alemtuzumab (Lemtrada) IV treatment dropped new relapses by half (49%) compared to Rebif in a 2 year trial.   People with MS treated with alemtuzumab also were 42%  less likely to progress in disability than on Rebif and have less MRI activity.

The most common side effects of Lemtrada are infusion associated reactions, infections (upper respiratory tract and urinary tract),  and low white blood counts. Serious autoimmune conditions can occur such as low platelets (bleeding risks),  thyroid disease and kidney disease.

 

Oct 27 2013 Sequencing: Why it matters to You.

Switching MS treatments?   Important to understand the impact of your current treatment on your immune system as beginning your new treatment.   A major concern is a potential increase risk of serious infection if the time interval too short.   As more medications become available,  the impact of the sequence in which these meds are used is very important.  Many multiple sclerosis medications affect the immune system differently.  Some medications can impact your immune system for up to 2 months after discontinuing treatment. 

Neurologist often allow for a period of time between treatments, perhaps 2 weeks to 3 months.  There are no set rules on how long to wait.   Evidence is based partially on clinical trials.  If treatment held for 2-3 months,  some neurologist give IV steroids for 1-2 days monthly while off treatment.   Some medications can be removed from the body through washout procedures.  Bottom Line: Understand the plan if you are “sequencing” from one treatment to another.

 

Oct 12 2013 Global MS Meeting ECTRIMS 2013 Highlights

Comi presented follow-up on 699 MS patients followed on MS treatment for 8 years.  New MRI activity and relapses predict disability risk.

Over 5 year BENEFIT study,  low vitamin D increased risk of new MRI activity and brain atrophy (shrinkage).  In addition, low vitamin D increased the risk of disability progression. Best to get vitamin level greater than 50.

Aubagio  (teriflunomide) 14 mg decreased the likelihood of a 2nd MS attack by 43% and reduced new enhancing MRI activity by 59%.   The 7 mg dose was less effective with 37% less likelihood of a 2nd attack and 21% less contrast MRI activity.

Why is MS rare in HIV+ people?  Gold presented results from United Kingdom database of 55 million people between 1999 to 2001.  Out of the greater than 21,000 HIV+ patients, only 7 also had MS.  Greater than 18 people with both diseases would have been expected.  Could be that anti-viral therapy for HIV helps MS?   Trial beginning with MRI scans for raltegravir.

Farez presented an Argentinian study on salt intake in 122 people with MS.  Greater than 2 grams/day of salt (calculated from random urine sodium measurements) was associated with more MRI activity and more relapses.  Sodium blood levels appeared unrelated.

Smoking increases the risk of developing MS.  Men who smoke a pack per day for 16 years have three times the risk.  Quit smoking for 10 years and risk declines.

TOFINGO Trial results examined the timing of switching patients from Tysabri to Gilenya.  78-82% of patients were JC virus positive.   If patients waited 8 weeks to start Gilenya after the last Tysabri infusion, 75% of people were free of contrast T1 brain acitivity.  For 12 week and 16 week washouts, 61.3% and 47.5% of people were free of contrast MRI lesions respectively.

Sep 17 2013 Just Approved: Lemtrada Available Soon in Europe

The European Commission has granted marketing authorization for Lemtrada and Genzyme plans to launch Lemtrada (alemtuzumab) soon. Lemtrada is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis  with active disease defined by clinical or imaging features. Lemtrada is an antibody treatment that is given in the vein over 5 days the first year and 3 days the second year.

In the CARE-MS I Trial, 581 early, active relapsing-remitting patients, who had received no prior MS therapy, were randomized to Rebif or alemtuzumab treatment. Compared to those MS patients on Rebif, those individuals on alemtuzumab had 55% less relapses.  A low percentage of patients had worsening disability on both treatments without a significant difference between Rebif and Alemtuzumab (11% and 8% respectively worsened).

In the CARE-MS II Trial,  Alemtuzumab (Lemtrada) IV treatment dropped new relapses by half (49.4%) compared to Rebif in a 2 year trial.   People with MS treated with alemtuzumab also were 42%  less likely to progress in disability than on Rebif and have less MRI activity.

The most common side effects of Lemtrada are infusion associated reactions, infections (upper respiratory tract and urinary tract),  and low white blood counts. Serious autoimmune conditions can occur such as low platelets (bleeding risks) and thyroid disease. A comprehensive plan will support early detection and management of these autoimmune diseases.

The FDA is currently reviewing Lemtrada for US approval, potentially by the end of 2013.  The MS Center for Innovations in Care has been a CARE-MS II Trial site.