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Background <p>Generalized myasthenia gravis (gMG) is an autoimmune disease characterized by fluctuating muscle weakness. The MG Impairment Index (MGII) incorporates patients’ perspectives (22 items) and physician evaluation (6 items) of impairment. We evaluated the effect of rozanolixizumab using the MGII in the randomized, double-blind, placebo-controlled, Phase 3 MycarinG study.</p> Methods <p>Adult patients with gMG were randomized 1:1:1 to once-weekly rozanolixizumab 7&#xa0;mg/kg, 10&#xa0;mg/kg or placebo for 6&#xa0;weeks. MGII assessment was optional. Exploratory MGII analyses included change from baseline (CFB) to Day 43 in total score and ocular/generalized subscores; higher scores reflect greater impairment. Post hoc analyses included responder rates (≥ 5.5-point improvement) and achievement of patient-acceptable symptom state (PASS; ≤ 10 points, patient-reported items only).</p> Results <p>Overall, 200 patients received rozanolixizumab 7&#xa0;mg/kg (n = 66), 10&#xa0;mg/kg (n = 67) or placebo (n = 67). The MGII was completed by 144/200 (72.0%) patients. Mean CFB in MGII total score was greater in the rozanolixizumab groups versus placebo; mean CFB in ocular and generalized subscores was consistent with the total score. At Day 43, 57.1%, 83.3% and 40.4% of patients, respectively, were responders, and 30.8%, 39.2% and 7.7%, respectively, achieved MGII PASS. Responsiveness correlations between MGII total score CFB and MG-ADL anchor at Day 43 demonstrated a Spearman’s correlation coefficient of 0.5991 (p &lt; 0.0001).</p> Conclusion <p>These findings further support efficacy analyses from MycarinG to highlight the benefit of rozanolixizumab in patients with gMG and demonstrate the utility of the MGII in evaluating patient-relevant symptoms following treatment.</p> Trial registration <p>NCT03971422 (registered May 29, 2019).</p>

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Measuring the effect of rozanolixizumab using the Myasthenia Gravis Impairment Index: analyses from the randomized phase 3 MycarinG study

  • 期刊论文

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  • 发表日期：

    2025年11月8日

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  • Carolina Barnett-Tapia,
  • Elena Cortés Vicente,
  • Robert M. Pascuzzi,
  • Kimiaki Utsugisawa,
  • Jos Bloemers,
  • Fiona Grimson,
  • Thaïs Tarancón,
  • Vera Bril

摘要

Background

Generalized myasthenia gravis (gMG) is an autoimmune disease characterized by fluctuating muscle weakness. The MG Impairment Index (MGII) incorporates patients’ perspectives (22 items) and physician evaluation (6 items) of impairment. We evaluated the effect of rozanolixizumab using the MGII in the randomized, double-blind, placebo-controlled, Phase 3 MycarinG study.

Methods

Adult patients with gMG were randomized 1:1:1 to once-weekly rozanolixizumab 7 mg/kg, 10 mg/kg or placebo for 6 weeks. MGII assessment was optional. Exploratory MGII analyses included change from baseline (CFB) to Day 43 in total score and ocular/generalized subscores; higher scores reflect greater impairment. Post hoc analyses included responder rates (≥ 5.5-point improvement) and achievement of patient-acceptable symptom state (PASS; ≤ 10 points, patient-reported items only).

Results

Overall, 200 patients received rozanolixizumab 7 mg/kg (n = 66), 10 mg/kg (n = 67) or placebo (n = 67). The MGII was completed by 144/200 (72.0%) patients. Mean CFB in MGII total score was greater in the rozanolixizumab groups versus placebo; mean CFB in ocular and generalized subscores was consistent with the total score. At Day 43, 57.1%, 83.3% and 40.4% of patients, respectively, were responders, and 30.8%, 39.2% and 7.7%, respectively, achieved MGII PASS. Responsiveness correlations between MGII total score CFB and MG-ADL anchor at Day 43 demonstrated a Spearman’s correlation coefficient of 0.5991 (p < 0.0001).

Conclusion

These findings further support efficacy analyses from MycarinG to highlight the benefit of rozanolixizumab in patients with gMG and demonstrate the utility of the MGII in evaluating patient-relevant symptoms following treatment.

Trial registration

NCT03971422 (registered May 29, 2019).