A phase 3 study demonstrates reduction in time to first relapse with treatment.
Neuromyelitis optica spectrum disorder (NMOSD) is a relapsing autoimmune disease that often leads to disability. Satralizumab, a monoclonal antibody that antagonizes interleukin-6 (IL6), was investigated in this phase 3, randomized, double-blind, placebo-controlled, company-sponsored study. Investigators enrolled 83 patients with NMOSD to receive satralizumab or placebo subcutaneously at baseline, 2 weeks, and every 4 weeks thereafter. The double-blind period was planned until the occurrence of 26 protocol-defined relapses.
Relapses occurred in 8 (20%) of 41 satralizumab recipients and 18 (43%) of 42 placebo recipients. Relapses were reduced by 62% (hazard ratio, 0.38). At 48 weeks, 89% on satralizumab and 66% on placebo were relapse-free. I…
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)