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Randomized study of adjunctive belimumab in participants with generalized myasthenia gravis.

Publication ,  Journal Article
Hewett, K; Sanders, DB; Grove, RA; Broderick, CL; Rudo, TJ; Bassiri, A; Zvartau-Hind, M; Bril, V; BEL115123 Study Group,
Published in: Neurology
April 17, 2018

OBJECTIVE: To investigate the efficacy and safety of belimumab, a fully human immunoglobulin G1λ monoclonal antibody against B-lymphocyte stimulator, in participants with generalized myasthenia gravis (MG) who remained symptomatic despite standard of care (SoC) therapy. METHODS: Eligible participants with MG were randomized 1:1 to receive IV belimumab 10 mg/kg or placebo in this phase II, placebo-controlled, multicenter, double-blind study (NCT01480596; BEL115123). Participants received SoC therapies throughout the 24-week treatment phase and 12-week follow-up period. The primary efficacy endpoint was mean change from baseline in the Quantitative Myasthenia Gravis (QMG) scale at week 24; safety assessments included the frequency and severity of adverse events (AEs) and serious AEs. RESULTS: Forty participants were randomized (placebo n = 22; belimumab n = 18). The mean change in QMG score from baseline at week 24 was not significantly different for belimumab vs placebo (p = 0.256). There were no statistically significant differences between treatment groups for secondary endpoints, including the MG Composite and MG-Activity of Daily Living scores. Acetylcholine receptor antibody levels decreased over time in both treatment groups. No unexpected AEs were identified and occurrence was similar in the belimumab (78%) and placebo (91%) groups. One participant receiving placebo died (severe sepsis) during the treatment phase. CONCLUSIONS: The primary endpoint was not met for belimumab in participants with generalized MG receiving SoC. There was no significant difference in mean change in the QMG score at week 24 for belimumab vs placebo. The safety profile of belimumab was consistent with previous systemic lupus erythematosus studies. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for participants with generalized MG, belimumab did not significantly improve QMG score compared with placebo.

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Published In

Neurology

DOI

EISSN

1526-632X

Publication Date

April 17, 2018

Volume

90

Issue

16

Start / End Page

e1425 / e1434

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Time Factors
  • Receptors, Cholinergic
  • Receptor Protein-Tyrosine Kinases
  • Neurology & Neurosurgery
  • Myasthenia Gravis
  • Middle Aged
  • Male
  • International Cooperation
  • Immunosuppressive Agents
 

Citation

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Hewett, K., Sanders, D. B., Grove, R. A., Broderick, C. L., Rudo, T. J., Bassiri, A., … BEL115123 Study Group, . (2018). Randomized study of adjunctive belimumab in participants with generalized myasthenia gravis. Neurology, 90(16), e1425–e1434. https://doi.org/10.1212/WNL.0000000000005323
Hewett, Karen, Donald B. Sanders, Richard A. Grove, Christine L. Broderick, Todd J. Rudo, Ashlyn Bassiri, Marina Zvartau-Hind, Vera Bril, and Vera BEL115123 Study Group. “Randomized study of adjunctive belimumab in participants with generalized myasthenia gravis.Neurology 90, no. 16 (April 17, 2018): e1425–34. https://doi.org/10.1212/WNL.0000000000005323.
Hewett K, Sanders DB, Grove RA, Broderick CL, Rudo TJ, Bassiri A, et al. Randomized study of adjunctive belimumab in participants with generalized myasthenia gravis. Neurology. 2018 Apr 17;90(16):e1425–34.
Hewett, Karen, et al. “Randomized study of adjunctive belimumab in participants with generalized myasthenia gravis.Neurology, vol. 90, no. 16, Apr. 2018, pp. e1425–34. Pubmed, doi:10.1212/WNL.0000000000005323.
Hewett K, Sanders DB, Grove RA, Broderick CL, Rudo TJ, Bassiri A, Zvartau-Hind M, Bril V, BEL115123 Study Group. Randomized study of adjunctive belimumab in participants with generalized myasthenia gravis. Neurology. 2018 Apr 17;90(16):e1425–e1434.

Published In

Neurology

DOI

EISSN

1526-632X

Publication Date

April 17, 2018

Volume

90

Issue

16

Start / End Page

e1425 / e1434

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Time Factors
  • Receptors, Cholinergic
  • Receptor Protein-Tyrosine Kinases
  • Neurology & Neurosurgery
  • Myasthenia Gravis
  • Middle Aged
  • Male
  • International Cooperation
  • Immunosuppressive Agents