Uplizna Safe and Effective for Adults Aged ≥50 Years with AQP4+ NMOSD

People aged ≥50 years with aquaporin-4 antibody positive (AQP4+) neuromyelitis optica spectrum disorder (NMOSD) who were treated with Uplizna (inebilizumab-cdon; Amgen, Dublin, Ireland) showed a reduced risk of attack compared with those receiving placebo, according to results of a post-hoc analysis of the N-MOmentum clinical trial (NCT02200770). The results were presented at the American Committees for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2024.

N-MOmentum was a multicenter, double-blind, randomized, placebo-controlled phase 2/3 clinical trial evaluating the safety and efficacy of Uplizna as a treatment for patients with NMOSD. The trial included a total of 213 AQP4+ participants, 65 (30.5%) of which were aged ≥50 years, while 148 (69.6%) were aged <50 years. The study included a randomized controlled period (RCP) and an open-label period (OLP). In the post-hoc analyses, the outcomes of the older and younger participants were compared in terms of Expanded Disability Status Scale (EDSS) worsening, annualized hospitalization rates, and the occurrence of adverse events (AEs), among others.

During the RCP:

• The hazard ratio (HR) for risk of attack for participants aged ≥50 years who received Uplizna compared with those receiving placebo was 0.27 (95% CI, .07 to .97; P=.05).
• Participants aged <50 years who received Uplizna showed an HR for risk of attack of 0.21 (95% CI, .10 to .42; P<.0001).
• EDSS worsening was significantly different between the participants aged ≥50 years and those aged <50 years: (.56 odds ratio [OR], [95% CI, .14 to 2.30] vs .33 OR [95% CI, .13 to .82])

For the OLP:

• The HR for annualized attack rate (AAR) in participants who received Uplizna was .08 (95% CI, .04 to .14) for those aged ≥50 years and .11 (95% CI, .08 to .16) in those aged <50 years, which is not a statistically significant difference.
• In contrast to the RCP, in the OLP, EDSS worsening was not significantly different between participants aged ≥50 years and those aged <50 years: (.68 [95% CI, .20 to 2.28] vs .86 [95%, .30 to 2.43])
• NMOSD-related annualized hospitalization rate was .16 (95% CI; .06 to .42) in participants aged ≥50 years and .13 (95% CI, .08 to .22) in participants aged <50 years.

Overall, the results of the post hoc analysis suggest that Uplizna is safe and effective as a treatment for participants with AQP4-IgG+ NMOSD who are aged ≥50 years.

The study authors are affiliated with Michigan Institute of Neurological Disorders (MIND), the Mayo Clinic, University of San Diego Health, the Cleveland Clinic, Duke University, the Max Delbrück Center for Molecular Medicine, Charité Universitätsmedizin, Fukushima Medical University, the Southern Tohoku Research Institute for Neuroscience, the Pontifical Catholic University of Rio Grande do Sul (PUCRS), Amgen, and the University of California, San Francisco Weill Institute for Neurosciences.