The clinical research director at the UCSF Multiple Sclerosis Center shared his perspective on the recent FDA approval of inebilizumab (Uplizna; Viela Bio) for NMOSD.
“With the B cell-depleting antibodies we don’t have those same concerns [of serious bacterial infections]—B cell depletion may be associated with some increased risk of infection, but we really didn’t see that much in the N-Mo[mentum] trial, and we haven’t really seen that with ocrelizumab or rituximab either.”
With the recent FDA approval of inebilizumab (Uplizna; Viela Bio) marking just the second such approval for those with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody-positive, the need to understand its use and safety is paramount for clinicians who are expected to have their initial experiences with the agent once it is available.
In order to ascertain more about the intravenous agent and how it compares to the other available treatment, eculizumab (Soliris; Alexion), NeurologyLive reached out to Bruce Cree, MD, PhD, MAS, clinical research director, UCSF Multiple Sclerosis Center, and professor of clinical neurology, UCSF Weill Institute for Neurosciences. Cree was the lead investigator for the largest ever monotherapy study in this patient population—the N-Momentum study (NCT02200770) of inebilizumab, which served as its basis for approval.
In this interview, Cree shared insight into how these agents compare along a number of lines, from their mechanisms of action to their safety profiles. He also offered further perspective on the FDA label warnings for inebilizumab and the observations of the N-Momentum study.
FDA Approves New Therapy for Rare Disease Affecting Optic Nerve, Spinal Cord. News release. FDA. June 11, 2020. Accessed June 19, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-new-therapy-rare-disease-affecting-optic-nerve-spinal-cord