Belimumab effective for cutaneous lupus erythematosus, regardless of SLE, after 20 weeks
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PHILADELPHIA — Belimumab demonstrated a strong clinical response and significantly reduced flare risk for patients with cutaneous lupus erythematosus, with or without systemic lupus erythematosus, after 20 weeks, said a presenter here.
“Belimumab [(Benlysta, GlaxoSmithKline)] is one of only four FDA-approved medications for lupus,” Shivani Garg, MD, MS, assistant professor at the University of Wisconsin School of Medicine and Public Health, said during an ACR Convergence 2022 press conference. “However, the role of Benlysta in cutaneous lupus, or in cutaneous-predominant manifestations of lupus, remains unclear, and the time to response after starting therapy in cutaneous lupus is unknown.
“Such gaps can limit a critical medication’s use for cutaneous manifestations of lupus, and can also lead to premature discontinuation of medication, thinking that the medication is not working while it might be just taking its time to show response,” she added.
To assess the efficacy of belimumab as well as the time to response after initiating belimumab in patients with CLE, with or without SLE, Garg and colleagues performed a comprehensive search for MeSH headings and keywords — including lupus, cutaneous, discoid and belimumab — in Medline, Embase, CINAHL and Web of Science.
Their meta-analysis identified six blinded interventional studies in which belimumab was compared to standard of care — such as conventional DMARDs or prednisone plus hydroxychloroquine — assessing the cutaneous response in patients with SLE or CLE. These studies were homogenous with a low risk of bias.
The primary outcome of the study was clinical response at 52 weeks among belimumab users vs. non-users, with a clinical response defined as a reduction in skin manifestations from a baseline British Isles Lupus Assessment Group (BILAG) score of A or B to a BILAG score of B to E.
According to study results, the likelihood of clinical response at 52 weeks for belimumab users were 44% higher vs. non-users (OR = 1.44; 95% CI 1.2-1.74). Additionally, belimumab users exhibited a 49% lower risk for severe cutaneous flares vs. non-users (OR = 0.51; 95% CI, 0.31-0.84).
“Our study uniquely identified that Benlysta can take up to 20 weeks to achieve clinically significant response in patients with cutaneous predominant manifestations, and that the medication should not be prematurely discontinued,” Garg said.
“This study will inform practice and guide clinicians to discuss treatment options and expectations with patients starting Benlysta to avoid premature discontinuation of therapy in the absence of early benefits,” she added. “Our study strongly supports the inclusion of Benlysta in the existing treatment paradigm for cutaneous predominant manifestations of lupus to improve outcomes and quality of life.”
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Garg S. Abstract 348. Presented at: ACR Convergence 2022; Nov. 11-14, 2022; Philadelphia (hybrid meeting).
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