Inebilizumab Provides Long-Term Freedom From Relapse for Neuromyelitis Optica Spectrum Disorder

Inebilizumab (Uplizna; Horizon Therapeutics, Deerfield, IL), an antiCD19 B cell depleteing antibody is approved by Food and Drug Administration for treatment of antiaquaporin-4 antibody positive (antiAQP4⁺) neuromyelitis optica spectrum disorder (NMOSD). In clinical trials, inebilizumab lowered the relapse rate for antiAQP4⁺ NMOSD, and long-term data of treatment over a 4-year open-label period is now available and shows that significant reduction of relapses has been maintained. 

Of individuals who received inebilizumab during the double-blind portion of the clinical trial (NCT02200770), 88% (n=165) remained relapse free over the 4-year open-label extension. Of those who initially began treatment with placebo for 28 weeks and then had inebilizumab, 83% were relapse free. Compared with baseline relapse rates, long-term treatment with inebilizumab provided a sustained reduction in relapse.

“The goal of the open-label extension period was to better understand the long-term administration of Uplizna beyond the 28-week time frame that was originally studied in the randomized controlled period of the trial,” said Bruce Cree, MD, PhD, MAS, professor of clinical neurology at the University of California San Francisco Weill Institute for Neurosciences and primary study investigator. “These data are important because they provide further evidence that Uplizna can safely be used by NMOSD patients for an extended period of time, for at least four years, and that the medicine provides a sustained effect on attack risk.”

“For people living with NMOSD, attacks can cause devastating and often permanent disability, including blindness and paralysis,” said Quinn Dinh, vice president, medical affairs, Horizon. “Having a treatment that can be administered twice a year after the initial doses and that has supportive long-term data, is an important advancement for the NMOSD community.”

In the phase 2/3 clinical trial, the double-blind period last 28 weeks after which participants could enter the open-label extension during with they received 300 mg infusions of inebilizumab every 6 months and had follow-up appointments at weeks 2, 4, 13, 26 and 39 and every 26 weeks afterward.

These data were presented at the virtual 2021 American Academy of Neurology (AAN) Virtual Annual Meeting April 17-22, 2021.