Fresh evaluations stemming from the phase 3 MINT study of inebilizumab (Uplizna, developed by Amgen) in generalized myasthenia gravis (gMG) revealed sustained clinical progress among participants testing positive for anti-muscle-specific kinase antibodies (MuSK+) through 52 weeks. The data further indicated that the therapeutic advantages remained consistent regardless of how long individuals had experienced the condition.
Amgen unveiled these findings during the 2026 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting and MGFA Scientific Session, which took place this week in Orlando, Florida.
Findings in the MuSK+ Patient Group
The MINT trial enrolled 48 participants with MuSK+ gMG, randomly assigning them in equal proportions to receive either 300 mg intravenous inebilizumab or a placebo over a 26-week controlled period. During this phase, patients systematically tapered their steroid use to 5 mg per day or less by week 24.
Out of these participants, 46 transitioned into a subsequent 26-week open-label phase where all received inebilizumab, with 44 completing this extension. At the study’s outset, Myasthenia Gravis-Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores showed no significant differences between the two initial groups.
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Treatment Effectiveness Across Diagnostic Timelines
A separate analysis explored whether inebilizumab’s performance fluctuated based on the duration since gMG diagnosis, categorizing the trial’s 238 participants into three groups: those diagnosed less than 1 year, 1 to fewer than 4 years, or 4 or more years prior to their first dose.
By week 26, the average improvement in MG-ADL scores from baseline was consistently greater among those receiving inebilizumab compared to placebo across all three patient categories.
For individuals who continued inebilizumab treatment, both MG-ADL and QMG scores further declined from their starting points by week 52, registering reductions of -5.6 on MG-ADL and -6.1 on QMG.
As Richard Nowak, MD, MS, the MINT trial’s principal investigator and director of the Yale Myasthenia Gravis Clinic at Yale University, and his team concluded, “In this descriptive analysis, inebilizumab demonstrated ongoing improvement in MG-ADL and QMG scores compared to baseline irrespective of initial randomization.”
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Transitioning from Trial Data to Medical Practice
The FDA granted approval for inebilizumab in December 2025 for treating both AChR+ and MuSK+ gMG, based on the MINT trial’s primary 26-week outcomes. During this period, the drug achieved a 4.2-point reduction in MG-ADL scores compared to 2.2 points with placebo, and a 4.8-point reduction in QMG scores versus 2.3 points.
A preplanned study published in August 2026 in JAMA Neurology demonstrated that inebilizumab also lowered the frequency of disease flare-ups and the need for rescue treatments through week 26, with 16% of treated patients experiencing exacerbations compared to 35% on placebo.
Among AChR+ participants observed until week 52, the positive trend persisted, with MG-ADL scores improving by -5.7 compared to -2.3 for those diagnosed less than 1 year earlier, -5.0 versus -2.7 for those diagnosed 1 to fewer than 4 years prior, and -4.0 compared to -1.5 for those diagnosed 4 or more years ago. Similar advantages for inebilizumab were observed in QMG scores across all groups. These updates were shared at the 2026 AANEM Annual Meeting and MGFA Scientific Session, held from September 29 to October 2, 2026, in Orlando, FL, and published online in JAMA Neurology in August 2026.
