The 15-year clinical study demonstrated that more than 80% of patients were still walking without assistance despite a mean MS disease duration of 22 years, and two-thirds of patients have not transitioned to secondary progressive MS.
Reportedly, the patients who remained in the study over a mean of 15 years showed a reduction in annualised relapse rate (ARR) from baseline as well as minimal increase in Expanded Disability Status Scale (EDSS). On average, the ARR in the ongoing cohort declined from 1.12 ± 0.82 to 0.25 ± 0.34 at the 15-year analysis. Additionally, the study reinforces the established long-term safety profile associated with Copaxone.
Teva said that the study represents the only prospective, open-label follow-up study designed to evaluate continuous immunomodulatory therapy in RRMS patients. The study, currently in its 19th year, was extended to 20 years based on the positive results seen thus far and the interest of the MS community in the long term outcomes of treatments for this life-long disease.
Moshe Manor, vice president of global branded products at Teva, said: “We are pleased to see that results from this study reinforce the long term efficacy and safety of Copaxone. The longest term study extension further demonstrates Teva’s investment in Copaxone and our ongoing commitment to improve the disease course of MS.”