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News|Articles|October 3, 2026
Nipocalimab’s Safety Profile Slightly Favored Over Other Myasthenia Gravis Therapies, Indirect Comparison Shows
Author(s)Marco Meglio
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Key Takeaways
- Bayesian indirect comparisons in AChR+ gMG leveraged placebo-controlled trials to evaluate nipocalimab safety versus FcRn blockers, C5 inhibitors, IVIg, and rituximab using odds ratios and credible intervals.
- Overall AE odds were broadly similar between nipocalimab and most comparators, with the most favorable probability signal observed versus rozanolixizumab 10 mg.
A new Bayesian network meta-analysis found nipocalimab's serious adverse event rates compared favorably with other gMG therapies, while overall adverse event rates were comparable.
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A new indirect treatment comparison found that nipocalimab's rate of serious adverse events compared favorably with several approved and off-label therapies for generalized myasthenia gravis (gMG), while rates of any adverse event were broadly comparable across treatments. Researchers presented the Bayesian network meta-analysis at the
Multiple add-on therapies are used in gMG, including neonatal Fc receptor (FcRn) blockers, C5 complement inhibitors, and off-label treatments such as intravenous immunoglobulin (IVIg) and rituximab, but no head-to-head randomized trials exist comparing them directly. Nipocalimab previously demonstrated a favorable safety profile compared with placebo plus standard of care in the phase 3 VIVACITY-MG3 trial (NCT04951622) among seropositive and seronegative adults with gMG.1,2
The investigators set out to indirectly compare nipocalimab's safety, specifically any adverse event (AE) and any serious adverse event (SAE), against approved FcRn blockers (efgartigimod and rozanolixizumab), C5 complement inhibitors (ravulizumab, zilucoplan, and eculizumab), and the off-label therapies IVIg and rituximab.
A feasibility assessment informed the analysis's methodological choices, and a Bayesian network meta-analysis was conducted within the anti-acetylcholine receptor antibody-positive (AChR+) population to ensure comparability across eligible trials, drawing on placebo-controlled data from VIVACITY-MG3 (nipocalimab), RAISE (zilucoplan), CHAMPION-MG (ravulizumab), REGAIN (eculizumab), ADAPT and ADAPT-SC (efgartigimod), MycaringG (rozanolixizumab), BeatMG and RINOMAX (rituximab), and a 2025 IVIg trial. Base-case analyses included trials with similar follow-up duration, and sensitivity analyses included all trials regardless of duration; results from the 2 approaches were consistent.
Outcomes were reported as odds ratios (ORs) with 95% credible intervals (CrIs) and the probability that the OR was less than 1, favoring nipocalimab, interpreted using a framework for assessing network meta-analysis results.1,3
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Against FcRn blockers and C5 inhibitors, nipocalimab's AE profile was comparable across most comparisons (probability of OR less than 1 ranging from 16.7% to 83.8%), including efgartigimod (OR, 1.76; 95% CrI, 0.56-5.73), eculizumab (OR, 1.61; 95% CrI, 0.40-6.72), zilucoplan (OR, 0.88; 95% CrI, 0.22-3.62), and ravulizumab (OR, 0.83; 95% CrI, 0.28-2.52). The exception was rozanolixizumab 10 mg, where nipocalimab appeared likely favorable (OR, 0.49; 95% CrI, 0.15-1.65; probability of OR less than 1, 87.5%).
Compared with the off-label therapies, AE rates were similarly comparable: the probability of lower AE odds with nipocalimab was 50.1% versus rituximab (OR, 1.00; 95% CrI, 0.16-6.42) and 54.3% versus IVIg (OR, 0.92; 95% CrI, 0.22-3.89).1
For SAEs, nipocalimab's results were comparable only with eculizumab (probability of OR less than 1, 73.4%) and efgartigimod (77.8%); results were likely favorable against rozanolixizumab 7 mg (90.5%), efgartigimod PH20 SC (91.1%), rozanolixizumab 10 mg (95.9%), zilucoplan (97.0%), and ravulizumab (OR, 0.15; 95% CrI, 0.03-0.66; probability of OR less than 1, 99.4%).
Versus the off-label therapies, SAE results also favored nipocalimab, with a 96.4% probability of lower odds versus rituximab and 96.0% versus IVIg.
The investigators cautioned that the evidence network is sparse, with most comparisons informed by data from a single clinical trial per comparator, and that heterogeneity in study populations and designs across the component trials could introduce bias. “Based on ITCs, AE rates were comparable, while SAE results favored nipocalimab when compared with alternative gMG therapies,” concluded Saiju Jacob, MD, professor at the University of Birmingham and consultant neurologist at University Hospitals Birmingham NHS Foundation Trust, and colleagues.
REFERENCES
1. Jacob S, Hutton B, Van Sanden S, Denee T, Karmous W, Diels J, Gandhi K, Paoli CJ, Hashim M, Gilhus NE. Indirect comparison of nipocalimab safety versus neonatal Fc receptor blockers, C5 complement inhibitors, rituximab and intravenous immunoglobulin in generalized myasthenia gravis. Presented at: 2026 AANEM Annual Meeting and MGFA Scientific Session; September 29-October 2, 2026; Orlando, FL.
2. Antozzi C, et al. Nipocalimab in adults with generalised myasthenia gravis (Vivacity-MG3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2025;24(2):106-116.
3. Cope S, Jansen JP. Quantitative summaries of treatment effect estimates obtained with network meta-analysis of survival curves to inform decision-making. BMC Med Res Methodol. 2013;13:147. doi:10.1186/1471-2288-13-147
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