Compared with high-dose interferon, relapses were reduced by 47%, disability by 40%, and new lesions after 3 months by >95%.
For this multicenter, randomized, double-blind, placebo-controlled, manufacturer-sponsored, phase III study of the investigational drug ocrelizumab (see also NEJM JW Neurol Mar 2017 and N Engl J Med 2017; 376:280), investigators recruited 1656 patients with relapsing multiple sclerosis (MS) and recent disease activity. Two independent but similar trials (OPERA I and OPERA II) were pooled for analysis. Patients received either ocrelizumab (two 300-mg doses separated by 2 weeks, followed by one 600-mg dose every 6 months) or thrice-weekly interferon β-1a (IFN).
During the 96-week trial period, the annualized relapse rate was reduced by 47% with ocrelizumab versus IFN. Confirmed disability worsening was reduced by 40%. No evidence of disease ac…
Reviewing Author
DisclosuresConsultant/Advisory BoardAlexion Pharmaceuticals; Amgen; Astoria; Biogen; Bristol Myers Squibb; Celltrion; Genentech; Hoffmann-La Roche; Genzyme; EMD Serono; Immpact-Bio; Immunic Therapeutics; Kyverna; Lundbeck; Novartis; Sandoz; TG Therapeutics
Grant/Research SupportNational Institutes of Health; National Multiple Sclerosis Society; U.S. Department of Defense
Leadership Positions in Professional SocietiesConsortium of Multiple Sclerosis Centers (Treasurer)
DisclosuresConsultant/Advisory BoardAlexion Pharmaceuticals; Amgen; Astoria; Biogen; Bristol Myers Squibb; Celltrion; Genentech; Hoffmann-La Roche; Genzyme; EMD Serono; Immpact-Bio; Immunic Therapeutics; Kyverna; Lundbeck; Novartis; Sandoz; TG Therapeutics
Grant/Research SupportNational Institutes of Health; National Multiple Sclerosis Society; U.S. Department of Defense
Leadership Positions in Professional SocietiesConsortium of Multiple Sclerosis Centers (Treasurer)