Future Plans and Clinical Promise of Inebilizumab in Myasthenia Gravis: Richard Nowak, MD, MS

WATCH TIME: 5 minutes

"We're super excited based on the top-line results demonstrating efficacy and safety... More information to come, but this is probably the largest MG registrational trial, which is extremely important for the future of inebilizumab in treating myasthenia gravis."

In late September, Amgen announced positive data from the phase 3 MINT trial (NCT04524273) evaluating inebilizumab (Uplizna), an FDA-approved treatment for neuromyelitis optica spectrum disorder (NMOSD), in patients with generalized myasthenia gravis (gMG). The study included 238 patients with gMG who were randomly assigned 1:1 to either intravenous inebilizumab 300 mg (n = 119) or placebo (n = 119) for a 12-month period.

At the conclusion of the double-blind period, results showed a statistically significant change from baseline on the primary end point of Myasthenia Gravis-Activities of Daily Living (MG-ADL), with treated patients showing changes of –4.2 vs –1.9 for those on placebo (P <.0001). In addition to showing a treatment effect, the study was also notable in that it included the most patients with muscle-specific tyrosine kinase antibody positive gMG (n = 48) recorded in a therapeutic trial. Coming into the study, patients had an MG-ADL score of 6 or greater and a Quantitative Myasthenia Gravis score of 11 or greater.

These data, along with an additional assessment of efficacy, durability of response, and safety, were subsequently presented at the 2024 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting, held October 15-18, in Savannah, Georgia. During the meeting, NeurologyLive^® sat down with study investigator Richard Nowak, MD, MS, to discuss the promising trial results, particularly in patients with acetylcholine receptor (AChR) and MuSK antibody-positive gMG. Nowak, director of the myasthenia gravis clinic at Yale University, provided commentary on some of the subanalyses of the study, as well as the future direction of the treatment. He noted that while there is excitement, there is a need for further analysis and long-term data collection.

Click here for more AANEM 2024 coverage.

REFERENCE
1. Amgen Conference Call to Discuss New Topline Data in Inflammation and Rare Disease. News release. Amgen. September 24, 2024. Accessed October 24, 2024. https://amgen2.rev.vbrick.com/#/videos/750c4b9d-5c91-4634-8906-a16b53f346bf.