Incidence of COVID-19 in the Phase 3 Myasthenia Gravis Inebilizumab Trial (MINT) Randomized Controlled Period

Topic:

Clinical Trials

Poster Number: 210 M

Author(s):

Richard Nowak, Yale School of Medicine, Kimiaki Utsugisawa, Hanamaki General Hospital, Michael Benatar, University of Miami, Emma Ciafaloni, MD, FAAN, University of Rochester Medical Center, Rochester, NY, USA, M. Isabel Leite, University of Oxford, John Vissing, MD, Neurology at the University of Copenhagen, Qing Li, Amgen Inc., Fengming Tang, PhD, Amgen Inc., Catherine Najem, Amgen Inc., Sue Cheng, MD, Amgen Inc., James F. Howard Jr., MD, University of North Carolina

BACKGROUND
B-cell-depleting therapies have the potential to lessen humoral responses. It is unclear whether this leads to a higher risk of Coronavirus Disease 2019 (COVID-19) incidence.

OBJECTIVE
This post-hoc analysis of the Myasthenia Gravis Inebilizumab Trial (MINT) examined whether inebilizumab treatment is associated with an increased risk of COVID-19 infection in participants with generalized Myasthenia Gravis (gMG).

METHODS
MINT (NCT04524273) was a phase 3 study which evaluated the efficacy and safety of inebilizumab in adult patients with gMG. First participant was enrolled August 30, 2020, after COVID-19 was initially reported (December 2019) and before the first vaccine received approval (December 2020). Participants were given 300mg of intravenous inebilizumab or placebo on RCP Day-1, Day-15, and Day-183 (AChR+ only). Descriptive statistics/analysis completed.

RESULTS
A total of 238 participants were randomized (placebo 119, inebilizumab 119). Considering the timeline of trial enrollment and vaccine availability, 4 (3.4%) placebo-treated participants and 9 (7.6%) inebilizumab-treated participants received a COVID-19 vaccine on/after the 1st dose. COVID-19 infection was reported in 19 (16.0%) placebo-treated and in 21 (17.7%) inebilizumab-treated participants during the RCP. Most infections were in participants <65 years of age (100% placebo, 90.5% inebilizumab). Most of the reported infections were Grade 1 [placebo: 8/19 (42.1%); inebilizumab: 10/21 (47.6%)] or Grade 2 [placebo: 8/19 (42.1%); inebilizumab: 8/21 (38.1%)]. COVID-19 related hospitalizations occurred in 4 placebo-treated participants and 4 inebilizumab-treated participants with a mean ± SD hospitalization length of 10.8±8.8 days and 22.8±25.9 days, respectively. CONCLUSION Inebilizumab treatment did not increase the incidence of COVID-19 in participants with gMG.