Uplizna Shows Sustained Benefit in AChR+ Generalized Myasthenia Gravis
KEY TAKEAWAYS
- Uplizna treatment was associated with functional and clinical improvements in AChR+ gMG at 52 weeks.
- Sustained B-cell depletion and low immunogenicity were observed over the treatment period.
New data from the phase 3 MINT trial (NCT04524273) show that Uplizna (inebilizumab-cdon; Amgen, Thousand Oaks, CA) was associated with improvements in disease-related function and clinical severity in adults with acetylcholine receptor antibody-positive (AChR+) generalized myasthenia gravis (gMG) through 52 weeks, extending the benefit seen in earlier results. The findings, presented at the 2026 Muscular Dystrophy Association Clinical and Scientific Conference, suggest that B-cell depletion with Uplizna may provide durable disease control over 1 year for individuals with AChR+ gMG.
The randomized, placebo-controlled MINT trial enrolled 238 adults with gMG, including 190 who were AChR+. Participants in the AChR+ cohort were randomized 1:1 to 300 mg intravenous (IV) Uplizna or placebo on days 1, 15, and 183 of a 52-week controlled period that also included a protocol-specified steroid taper. Efficacy was assessed by change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores at week 52. Researchers also evaluated pharmacodynamic effects through CD20+ B-cell counts and assessed anti-drug antibody prevalence.
Key Findings
- MG-ADL improvement favored Uplizna over placebo, with an adjusted treatment difference of -2.8 (95% CI, -3.9 to -1.7; nominal P<.001).
- QMG scores also favored Uplizna, with an adjusted difference of -4.3 vs placebo (95% CI, -5.9 to -2.8; nominal P<.001).
- CD20+ B-cell counts decreased 93.3% from baseline 2 weeks after the first Uplizna dose and remained suppressed throughout the treatment period.
- Anti-drug antibodies were detected in 4.2% of the Uplizna group and 2.1% of the placebo group.
Sources
Nowak, R, Utsugisawa K, Benatar M, et al. Myasthenia Gravis Inebilizumab Trial (MINT): efficacy and pharmacodynamics in AChR+ cohort (week 52). Poster presented at: 2026 MDA Clinical and Scientific Conference; March 8–11, 2026; Orlando, FL.