Richard Nowak, MD, and Director of Myasthenia Gravis Clinic at Yale University, discusses data from the MINT study for myasthenia gravis (MG).
MG is a chronic autoimmune neuromuscular disease characterized by weakness of the skeletal muscles. The condition results from a defect in the transmission of nerve impulses to muscles, which is due to the presence of antibodies against the acetylcholine receptor in the neuromuscular junction. The exact reason this occurs is not known. Weakness tends to increase during periods of activity and improve after periods of rest. Common symptoms include weakness of the muscles that control:
- Eye and eyelid
- Facial expressions
- Chewing
- Talking
- Swallowing
MINT Clinical Trial
The MINT clinical trial is a phase 3, randomized, double-blind, placebo-controlled, parallel-group trial evaluating the efficacy and safety of inebilizumab in adults with generalized MG (gMG). Inebilizumab is a B-cell-depleting monotherapy that binds to the cell surface of CD19+ B lymphocytes. It is currently approved for the treatment of neuromyelitis optica spectrum disorder (NMOSD).
The trial included 238 adults with gMG, 190 of which are acetylcholine receptor autoantibody-positive (AChR+) and 48 who are muscle-specific kinase autoantibody-positive (MuSK+). The study met its primary endpoint of statistically significant change from baseline in MG Activities of Daily Living (MG-ADL) score at week 26 with a score of -4.2 with inebilizumab and -2.2 for placebo.
Inebilizumab also illustrated significant change from baseline compared to placebo in secondary endpoints of Quantitative MG (QMG) score (inebilizumab: -4.8, placebo: -2.3), MG-ADL score in the AChR+ group (inebilizumab: -4.2, placebo: -2.4), QMG score in the AChR+ group (inebilizumab: -4.4, placebo: -2.0), and MG-ADL score in the MuSK+ group (inebilizumab: -3.9, placebo: -1.7)
Overall, patients being treated with inebilizumab demonstrated continued improvement through week 26. Patients who began the trial taking corticosteroids were tapered down starting at week 4 to 5 mg of prednisone per day by week 24. Additionally, safety results were consistent with the known profile.
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To learn more about MG and other rare autoimmune conditions, visit https://checkrare.com/diseases/autoimmune-auto-inflammatory-disorders/