Inebilizumab Effective and Safe for Neuromyelitis Optica Spectrum Disorder After Only 1 Clinical Attack 

Inebilizumab (Uplizna; Horizon Therapeutics, Deerfield, IL) is an approved treatment of neuromyelitis optica spectrum disorder (NMOSD) with seropositivity for antibodies to aquaporin 4 (AQP4). This treatment has proven efficacy for decreasing frequency and severity of clinical attacks as well as preventing disability, hospitalization, and new lesion formation on MRI.  

A new post hoc analysis of data from the phase 3 N-MOmentum trial (NCT02200770) has shown efficacy and safety are present regardless of whether a person was treated after a first single attack or after multiple attacks. Among those who had experienced only 1 attack (n=37), 4.2% (1/24) treated with inebilizumab experienced a second attack compared with 23.1% (3/13) of those treated with placebo. In participants who had more than 1 attack before joining the trial, 12.4% (17/137) treated with inebilizumab had another attack while on treatment vs 48.7% (19/39) of those treated with placebo.

Bruce Cree, MD, PhD, MAS, George A. Zimmermann professor in multiple sclerosis and clinical research director at the UCSF Multiple Sclerosis Center, neurologist, and lead investigator on the N-MOmentum trial noted, "NMO attacks can be devastating, resulting in blindness, which may become permanent, or affecting the spinal cord, resulting in paralysis. Early initiation of treatment to prevent attacks whenever possible is essential. Knowing that inebilizumab is safe and effective after 1 or more attacks enables clinicians to do so."  
 
Dr. Cree continued, "Newly approved treatments for NMO (ie, eculizumab, inebilizumab, and satralizumab) were launched either just prior to, or during, the pandemic--which greatly disrupted medical education. As a result, many clinicians may still be using older, off-label treatments (eg, mycophenolate mofetil or rituximab) even in those with newly diagnosed NMO. In my personal opinion, everyone who treats NMO needs to be familiar with, and explain to their patients, new, approved treatments for NMOSD, including the different routes and frequency of administration, unique adverse event profiles, and distinct mechanisms of action.

Additionally, separately presented data demonstrated improvements in pain scores after treatment with inebilizumab. The new analysis builds on those findings by showing a durable, long-term benefit in managing pain, with year-over-year improvements from baseline (average of 6.57 points after 1 year, 7.08 after 2 years, and 7.96 after 3 years) as measured by the 36-item short-form survey body pain subscore (SF36-BPS).

Treatment-emergent adverse events among those enrolled after their first attack were consistent with pivotal trial outcomes.

The data are being presented at the American Academy of Neurology (AAN) 2022 Annual Meeting in Seattle, WA, April 2-7 and virtually April 24-26.