Belimumab Provides Benefit in Cutaneous Lupus Erythematosus, With or Without SLE

Shivani Garg, MD, MS

Use of belimumab significantly improved cutaneous lupus erythematosus (CLE) whether or not patients also had systemic lupus erythematosus (SLE), according to new data presented at American College of Rheumatology (ACR) Convergence 2022.

A systematic review and meta-analysis of more than 6 published studies, results of the study suggest use of belimumab was associated with a strong cutaneous clinical response ranging from 44-55%, with a 50% lower flare risk over 1 year of treatment, regardless of whether or not patients had SLE.

“Our study is the first meta-analysis of belimumab’s efficacy in CLE and highlights that it is an effective adjunct therapy for patients with CLE as a primary manifestation of SLE,” said Shivani Garg, MD, MS, assistant professor at the University of Wisconsin School of Medicine and Public Health, in a statement from the ACR. “The study also highlights that belimumab can take at least 20 weeks to achieve a sustained clinical response in patients with CLE, so it should not be prematurely discontinued in these patients.”

A B-cell inhibitor, belimumab has been the subject of numerous recent research efforts to further expand the existing knowledge base surrounding inhibition of B-cell activation in patients with rheumatic disease. Approved for use in patients with SLE, the current study was launched by Garg and colleagues from the University of Wisconsin with the intent of exploring the effects of the agent in those with CLE, with or without SLE.

With this in mind, Garg and colleagues designed their research endeavor as a systematic review and meta-analysis to examine the efficacy of belimumab and time to response in patients with CLE through a comprehensive literature search for observational and interventional belimumab studies published in the Medline, Embase, CINAHL, and Web of Science databases. For the purpose of analysis, investigators used the Newcastle Ottawa Scale and Cochrane Collaboration Risk Assessment tools to rate the quality of observational and interventional studies.

The primary outcome of interest, which was examined using random effects modeling, was clinical response at 52 weeks among users compared with nonusers. A clinical response was defined as a decrease in the cutaneous domain from a baseline BILAG A or B score, to a BILAG score of B-E. Investigators pointed out plans to calculate pooled odds ratio for each consecutive 4-week observation interval to trend clinical response time and the time to achieve sustained response in CLE with or without SLE after starting belimumab.

From their search, investigators identified 745 abstracts for manual review. Of these, 13 met the inclusion criteria. From this group, investigators identified 6 blinded interventional studies providing details with cutaneous response in patients with SLE or CLE for inclusion in their analyses. Upon analysis, results indicate the odds of experiencing a clinical response at 52 weeks in the belimumab arm was 44% greater compared to those not reporting use of the B-cell inhibitor (OR, 1.44 [95% CI, 1.20-1.74]; P <.001, I2=0%). When assessing timing and duration of response, results indicated clinical response was first observed after 20 weeks of treatment with belimumab, sustained thereafter, and peaked at 1 year.

Further analysis indicated belimumab users had a 49% lower risk of severe cutaneous flares compared to nonusers (OR, 0.51 [95% CI, 0.31-0.84]; P <.001, I²=0%). Investigators pointed out 70% of interventional studies included in their analyses had a low risk of bias and no heterogeneity was observed among these studies.

This study, “Significant Improvement in Cutaneous Lupus Erythematosus with or Without Systemic Lupus Erythematosus with Belimumab Use – a Systematic Review and Meta-Analysis,” was presented at ACR Convergence 22.