MINT
Trial question
What is the role of inebilizumab, a monoclonal antobody targetting CD19-positive B cells, in patients with AChR antibody-positive or MuSK antibody-positive generalized myasthenia gravis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
61.0% female
39.0% male
N = 236
236 patients (144 female, 92 male).
Inclusion criteria: adult patients with AChR antibody-positive or MuSK antibody-positive generalized myasthenia gravis.
Key exclusion criteria: receipt of cyclosporine, tacrolimus, methotrexate in the past 4 weeks; current use of corticosteroids, acetylcholinesterase inhibitors, azathioprine, or mycophenolate mofetil.
Interventions
N=119 inebilizumab (intravenous dose of 300 mg administered on days 1 and 15 for all and additionally on day 183 for patients who were AChR antibody-positive for 52 weeks or 26 weeks for those who were MuSK antibody-positive).
N=117 placebo (matching placebo for 52 weeks for participants who were AChR antibody-positive or 26 weeks for those who were MuSK antibody-positive).
Primary outcome
Least-squares mean reduction in Myasthenia Gravis Activities of Daily Living scale score at week 26, overall population
4.2 points
2.2 points
4.2 points
3.2 points
2.1 points
1.1 points
0.0 points
Inebilizumab
Placebo
Significant
increase ▲
Significantly greater reduction in least-squares mean Myasthenia Gravis Activities of Daily Living scale score at week 26, overall population (4.2 points vs. 2.2 points; MD 1.9, 95% CI 1 to 2.9).
Secondary outcomes
Significantly greater reduction in least-squares mean Quantitative Myasthenia Gravis scale score at week 26, overall population (4.8 points vs. 2.3 points; MD 2.5, 95% CI 1.2 to 3.8).
Significantly greater reduction in least-squares mean Myasthenia Gravis Activities of Daily Living scale score at week 26, AChR antibody-positive population (4.2 points vs. 2.4 points; MD 1.8, 95% CI 0.7 to 2.9).
Significantly greater reduction in least-squares mean Quantitative Myasthenia Gravis scale score at week 26, AChR antibody-positive population (4.4 points vs. 2 points; MD 2.5, 95% CI 1 to 3.9).
Safety outcomes
No significant difference in at least one adverse and serious adverse event.
Conclusion
In adult patients with AChR antibody-positive or MuSK antibody-positive generalized myasthenia gravis, inebilizumab was superior to placebo with respect to a least-squares mean reduction in Myasthenia Gravis Activities of Daily Living scale score at week 26, overall population.
Reference
Richard J Nowak, Michael Benatar, Emma Ciafaloni et al. A Phase 3 Trial of Inebilizumab in Generalized Myasthenia Gravis. N Engl J Med. 2025 Apr 8. Online ahead of print.
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