ArticleNeurology and therapy2026
Rapid Serum IgG Reduction as a Potential Indicator of Short-Term Clinical Improvement in AChR-Ab-Positive Generalized Myasthenia Gravis: A Post Hoc Analysis of a Phase III Batoclimab Trial.
Article in Neurology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05039190 (A Multicenter, Randomized, Double-blind, Placebo-controlled, Seamless and Group Sequential Phase 2/3 Study to Evaluate the Efficacy and Safety of HBM9161), which is not on this map. Not yet cited in PubMed.
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A Multicenter, Randomized, Double-blind, Placebo-controlled, Seamless and Group Sequential Phase 2/3 Study to Evaluate the Efficacy and Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis
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Abstract
introductionGeneralized myasthenia gravis (gMG) is an autoimmune disorder often associated with anti-acetylcholine receptor antibodies (AChR-Abs). Identifying short-term predictors or indicators of clinical improvement is crucial for optimizing treatment strategies.
methodsThis post hoc analysis utilized data from a phase III, multicenter randomized controlled trial enrolling 65 patients with AChR-Ab-positive gMG across 27 centers in China. We evaluated serum immunoglobulin G (IgG) as a potential short-term indicator of clinical improvement in patients treated with batoclimab. Clinical severity was evaluated using the Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scales. Spearman correlation analyses, mixed-effects models, and multivariate analyses were performed to assess relations between biomarker changes and symptom improvement.
resultsWithin-patient Spearman correlation showed significant associations between reductions in IgG or AChR-Ab levels and symptom improvement (ΔIgG vs. MG-ADL change: r = 0.372, p < 0.001; ΔIgG vs. QMG change: r = 0.492, p < 0.001). Mixed-effects modeling indicated that an 80% reduction in IgG corresponded to a 59% probability of MG-ADL improvement by ≥ 3 points and a 77% probability of QMG improvement by ≥ 3 points. High baseline body mass index (BMI) was identified as an independent risk factor for slower IgG decline.
conclusionBatoclimab rapidly reduced IgG and pathogenic AChR-Ab levels, leading to improved clinical outcomes in patients with gMG. The reduction rate in total IgG may serve as a valuable short-term indicator of clinical response in patients with AChR-Ab-positive gMG following neonatal fragment crystallizable receptor antagonist therapy.
trial registrationClinicalTrials.gov Identifier NCT05039190.
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