Multiple Sclerosis (MS) Copaxone 15 year study data released in Jerusalem

The longest study to date of MS Copaxone infections, a 15 yr study in Jerusalem, was made public in February of 2010. The study data was published in the Multiple Sclerosis journal and chronicles the longest ever uninterrupted evaluation of Multiple Sclerosis Copaxone treatment involving relapsing-remitting multiple sclerosis patients to date. The decade and a half clinical study showed that over 80 percent of participants were still able to walk without help, even though they had MS for about 22 years. Furthermore, about 66% did not proceed to develop secondary-progressive MS. The ARR, or Annualized Relapse Rate, was also reduced.  For those that remained on the MS Copaxone therapy for the duration of the study, the ARR declined from 1.12 to .25 by the end of the trial.  The margin of error for ARR was plus or minus 0.82 and 0.34 respectively.

Manufacturer Teva Pharmaceutical Industries pleased with MS Copaxone study results

Teva Pharmaceuticals emphasized the demonstration of long term and continuous use of the Multiple Sclerosis Copaxone regimen and stated that company is committed to further investment in treating MS, Copaxone follow-up trials, and improving the benefit to risk profile of the treatment drug.

This study exhibits the only prospective, open-label follow-up study developed to take a hard look at extended immunomodulatory therapy in RRMS patients. And it is not over yet.  The study, which is currently in its twentieth and final year, was extended based on the positive results shown so far and the keen interest of the MS community in the long term outcomes of therapies for this lifetime affliction.

The Study

The Multiple Sclerosis Copaxone started in 1991 and tracked 100 patients on MS Copaxone injections continuously for the period.  For those interested in researching the details for themselves, it is named “Continuous Long-Term Immunomodulatory Therapy in Relapsing Multiple Sclerosis: Results from the 15-Year Analysis of the U.S. Prospective Open-label Study of Glatiramer Acetate.”  It followed the Teva’s Phase 3 trials of Copaxone.  The EDDS scores were documented every 6 months.  57 percent of participants either improved their EDDS or, at minimum, stabilized them.  And sixty five percent never went on to develop Secondary-Progressive MS.

The most common side effects are redness, swelling or lumps and itching at the site of injections. This is similar to other injection-type MS drugs. Some patients also experienced rash, flushing, chest pain, and shortness of breath.  Full hardcopy trial results can be obtained by contacting the manufacturer, Teva. The contact information can be obtained at the Copaxone website or on inserts available with the drug packaging.