Richard J. Nowak, MD, Director of the Myasthenia Gravis Clinic at Yale University, discusses positive data from the MINT clinical trial evaluating Uplizna (inebilizumab-cdon) in adults with generalized myasthenia gravis (gMG).
MG is a chronic autoimmune neuromuscular disease characterized by weakness of the skeletal muscles. Common symptoms include weakness of the muscles that control the eye and eyelid, facial expressions, chewing, talking, and swallowing. Weakness tends to increase during periods of activity and improve after periods of rest. The condition is due to the presence of antibodies against acetylcholine. The exact reason this occurs is not known.
MINT Clinical Trial
The MINT study (NCT04524273) is a phase 3, randomized, double-blind, placebo-controlled, parallel-group clinical trial evaluating the safety and efficacy of inebilizumab in adults with gMG. Inebilizumab is an anti-CD-19 antibody that causes targeted and sustained depletion of CD19+ B cells that contribute to underlying disease progression.
The trial enrolled 238 patients with gMG, with 190 patients who are acetylcholine receptor autoantibody-positive (AChR+), and 48 who are muscle-specific kinase autoantibody-positive (MuSK+). The primary endpoint of this study is change from baseline in MG Activities of Daily Life (MG-ADL) score at week 26 in the combined population.
Results demonstrated a durable efficacy over the 52-week period in patients with AChR+ gMG with two doses per year after initial loading dose. Among the AChR+ population treated with inebilizumab, 72.3% had a 3 point or greater improvement in MG-ADL score, compared to 45.2% in the placebo group. Change from baseline in Quantitative MG score was also greater for patients treated with inebilizumab compared to placebo, with 69.2% of AChR+ patients improving by 3 or more points, compared to 41.8% in the placebo group.
Sustained efficacy was also observed with protocol-specified steroid taper. Starting at week4, all patients reduced prednisone use to 5 mg per day by week 24. Additionally, no new safety signals were identified. The most common adverse events were infusion-related reactions, nasopharyngitis, and urinary tract infections.
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To learn more about MG and other rare autoimmune conditions, visit https://checkrare.com/diseases/autoimmune-and-auto-inflammatory-disorders/