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Long-term safety and efficacy of belimumab in Japanese patients with SLE: A 7-year open-label continuation study.
- Source :
-
Modern Rheumatology . Jan2023, Vol. 33 Issue 1, p122-133. 12p. - Publication Year :
- 2023
-
Abstract
- Objectives: Evaluate long-term safety, tolerability, and efficacy of belimumab in Japanese patients with systemic lupus erythematosus (SLE). Methods: This was a subgroup analysis of Japanese patients who completed studies BEL113750 or BEL112341 and were enrolled in a Phase 3, open-label extension study (BEL114333; NCT01597622). Eligible patients received intravenous belimumab 10 mg/kg every 28 days for ≤7 years. Primary endpoint: safety and tolerability. Secondary endpoints included SLE Responder Index (SRI)-4 response rate, SRI-4 components, severe SLE flare, and use of corticosteroids/other SLE-related treatments. Analyses were based on observed data from first belimumab dose received in either parent or current study through to study end. Results: Of 71 Japanese patients enrolled, 69.0% completed the study. Overall, 98.6% patients had adverse events (AEs); 32.4% had serious AEs. The proportion of SRI-4 responders increased progressively (Year 1, Week 24: 40.9% [27/66]; Year 7, Week 48: 84.6% [11/13]) as did the proportion of Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index responders. The proportion of patients with no worsening in PGA (91.2–100.0%) and no new organ damage (92.6–100.0%) remained stable over time. Severe SLE flare was experienced by 11.3% (8/71) of patients. Corticosteroid and immunosuppressant use decreased over time. Conclusions: Favourable safety profile and treatment responses with belimumab were maintained for ≤7 years in Japanese patients with SLE. [ABSTRACT FROM AUTHOR]
- Subjects :
- *JAPANESE people
*BELIMUMAB
*SYSTEMIC lupus erythematosus
*LUPUS erythematosus
Subjects
Details
- Language :
- English
- ISSN :
- 14397595
- Volume :
- 33
- Issue :
- 1
- Database :
- Academic Search Index
- Journal :
- Modern Rheumatology
- Publication Type :
- Academic Journal
- Accession number :
- 162419533
- Full Text :
- https://doi.org/10.1093/mr/roab125