Phase 3 MINT Analysis Finds Lower Exacerbation and Rescue Therapy Risk With Inebilizumab in gMG

A prespecified analysis of the phase 3 Myasthenia Gravis Inebilizumab Trial (MINT), published online in JAMA Neurology, found that inebilizumab reduced generalized myasthenia gravis (gMG) exacerbations and rescue therapy use versus placebo among adults with anti–acetylcholine receptor antibody–positive (AChR+) or anti–muscle-specific kinase antibody–positive (MuSK+) disease who underwent a protocol-specified corticosteroid taper.

MINT enrolled 238 adults across 81 academic and nonacademic sites in 18 countries. Participants were randomized 1:1 to intravenous inebilizumab 300mg or placebo. Those taking more than 5mg/day of corticosteroids began tapering at week 4 toward 5mg/day or less by week 24. Exacerbations included rescue therapy use, myasthenic crisis, or prespecified significant symptomatic worsening; rescue therapy comprised intravenous immunoglobulin or plasma exchange.

By week 26, exacerbations occurred in 16.0% of inebilizumab recipients and 35.0% of placebo recipients. Rescue therapy was used by 8.4% and 23.9%, respectively. Exacerbation hazards also favored inebilizumab in the combined group at week 26, the AChR+ group at week 52 and the MuSK+ group at week 26.

The annualized exacerbation rate through week 26 was 0.40 with inebilizumab and 1.17 with placebo, a rate difference of –0.77. All reported P values were nominal; multiplicity and hierarchical testing were not performed for the exacerbation end point. Additional limitations included a lack of standardization for rescue therapy use, partial reliance on investigator discretion, and an exacerbation definition broader than myasthenic crisis alone. The protocol-specified steroid taper also may differ from clinical practice.

Only 3 participants had myasthenic crisis with rescue therapy by week 26, and none had crisis independent of rescue therapy or significant symptomatic worsening; the authors said further study may be warranted.

Source: Nowak RJ, Utsugisawa K, Benatar M, et al. JAMA Neurol. Published online August 10, 2026. doi:10.1001/jamaneurol.2026.2558