Overviewing the N-MOmentum Trial of Inebilizumab for NMOSD: Bruce Cree, MD, PhD, MAS, FAAN
The clinical research director of the UCSF Multiple Sclerosis Center provided an overview of the phase 2/3 N-Momentum study assessing the efficacy of inebilizumab in patients with neuromyelitis optica spectrum disorder. [WATCH TIME: 5 minutes]
WATCH TIME: 5 minutes
"The trial was successful, it showed that with [inebilizumab] treatment, there was a substantial delay between the time entry into the study and the time of first clinical attack."
Inebilizumab (Uplizna; Amgen), an FDA-approved anti-CD19 B-cell-depleting antibody, demonstrated efficacy and safety among patients with neuromyelitis optica spectrum disorder (NMOSD) in the phase 2/3 N-MOmentum trial (NCT02200770). Newly published in The Lancet Neurology, end-of-study analysis of the study, which included the randomized controlled period and open-label extension period, revealed the continued and sustained clinical benefits of long-term treatment with inebilizumab in this patient population.1 In this trial, adults with NMOSD were randomly assigned 3:1 to receive intravenous inebilizumab 300 mg (n = 174) or placebo (n = 56) on days 1 and 15 of the randomized period which lasted up to 197 days.
Conducted by lead author Bruce Cree, MD, PhD, MAS, FAAN, and colleagues, the primary end point of the randomized period was the time to onset of adjudicated NMOSD attack on or before day 197. Patients who had an adjudicated attack, completed 197 days of the trial, or were in the randomized controlled period when enrollment stopped were allowed to enter an open-label period where they either switched to inebilizumab from placebo (n = 51) or continued treatment with inebilizumab (n = 165). All participants subsequently received inebilizumab every 6 months for a minimum of 2 years. The end-of-study analysis end points were time to adjudicated attack and annualized attack rate as well as safety outcomes.
In the analysis, adjudicated NMOSD attacks (n = 63) occurred in 21% of treated patients (n = 225) and 63% of attacks occurred in 15% of treated patients in 1-year of treatment. Among those who had an adjudicated attack on inebilizumab, 36 (77%) out of 47 patients were subsequently attack-free at the end of 4 years. In terms of safety, 92% of treated patients had at least 1 treatment-emergent adverse event, the most frequent of which were urinary tract infection, nasopharyngitis, and arthralgia. In a recent interview, Cree, the clinical research director of the UCSF Multiple Sclerosis Center, sat down with NeurologyLive® to further discuss the findings regarding the primary end point as well as the secondary end points of end-of-study analysis and how the design of the study minimized the exposure of participants to placebo.
