Efficacy of Nipocalimab, a Novel Neonatal Fragment Crystallizable Receptor Blocker, as Measured Using Quantitative Myasthenia Gravis Assessment: Findings from the Phase 3 Placebo-controlled Vivacity-MG3 Study
Sindhu Ramchandren1, Maria Ait-Tihyaty2, Ibrahim Turkoz1, Kavita Gandhi3, Richard Nowak4
1Janssen Research & Development, LLC, Titusville, NJ, USA, 2Janssen Global Medical Affairs, Raritan, NJ, USA, 3Janssen Global Market Access, Raritan, NJ, USA, 4Department of Neurology, Yale University School of Medicine, New Haven, CT, USA
Objective:
To assess efficacy of nipocalimab using Quantitative Myasthenia Gravis (QMG) in patients with generalized myasthenia gravis (gMG).
Background:
There remains an unmet need for effective treatments providing meaningful symptom control in gMG. Patients treated with nipocalimab+standard-of-care (SoC) achieved significant improvement in mean MG-Activities of Daily Living score from baseline over weeks 22 to 24 compared with placebo+SoC in the 24-week double-blind, phase-3 Vivacity-MG3 study (NCT04951622).
Design/Methods:
Mean changes in QMG total score were compared between nipocalimab+SoC (nipocalimab) and placebo+SoC (placebo). A negative change in score indicates improvement. The proportion of patients achieving improvement of QMG ≥3 points (QMG-3), and sustaining QMG-3 improvement, and the proportion of time spent with QMG-3 improvement were examined for nipocalimab and placebo groups.
Results:
Nipocalimab demonstrated statistically significant improvement in QMG total score vs placebo over weeks 22 and 24; least-square (LS) mean change (SE): –4.9(0.50) vs –2.0(0.50); difference= –2.81(0.710); p<.001. Mean differences between groups was observed as early as the first post-baseline assessment (week 2): LS-mean change (SE): –3.6(0.36) vs –0.6(0.355); difference of –3.1(0.51); p<.001 favored nipocalimab. Earliest week (mean [SD]) QMG-3 improvements were 3.8(3.88) for nipocalimab vs 7.5(6.33) weeks for placebo. Within 8 weeks of treatment initiation, 89 (nipocalimab:71.4%[55/77]; placebo:44.7%[34/76]) patients achieved QMG-3 improvement; p<.001. Of 63 patients with sustained QMG-3 improvement for ≥8 weeks, significantly greater proportion were from the nipocalimab (55.8%[43/77] vs 26.3%[20/76]; p<.001) placebo group. Patients receiving nipocalimab were over four times more likely to sustain QMG-3 improvement for ≥16 weeks (Odds Ratio [95%CI]: 4.31[1.93, 9.66]) and for ≥20 weeks (Odds Ratio [95%CI]: 4.53[1.93, 10.62]). Significantly more patients from nipocalimab vs placebo (36.4% vs 10.5%; p<0.001) group spent >75% of study duration with QMG-3 improvement.
Conclusions:
These results indicate that nipocalimab, a novel FcRn blocker, demonstrated disease control in patients with gMG, as evidenced by significant improvements in QMG scores.
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