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Belimumab efficacious in cutaneous lupus erythematosus

Presented by
Dr Daniel Montes, University of Wisconsin, WI, USA
ACR 2022
A meta-analysis found 44% increased odds of clinical response and an overall response rate of 55% in belimumab users with cutaneous lupus erythematosus. Furthermore, the likelihood of cutaneous flaring was reduced by 49%.

“As you may know, cutaneous lupus is the most common manifestation of systemic lupus and delays in treatment or inadequate control lead to alopecia, scarring, and permanent pigmentary changes,” Dr Daniel Montes (University of Wisconsin, WI, USA) stated as background [1]. He further explained that although belimumab is already approved for systemic lupus erythematosus, knowledge gaps remain.

The presented meta-analysis was undertaken to gain insights into the efficacy of the B-cell activation inhibitor belimumab concerning predominant cutaneous manifestations of lupus and time to therapy response. The primary endpoint looked at clinical response concerning the cutaneous domain of the British Isles Lupus Assessment Group score (BILAG) in patients with or without belimumab. It was defined as a change from BILAG A/B at baseline to BILAG B-E after 52 weeks. “Additionally, we calculated a pooled odds ratio (OR) at each 4-week consecutive interval across 52 weeks to trend the time to clinical response in belimumab users,” Dr Montes informed. Based on the PRISMA guidelines, 13 studies were included in the meta-analysis, 6 of them randomised controlled trials.

After 1 year, the likelihood of clinical response in those on belimumab was 44% greater than in non-users (OR 1.44; P<0.0001), while the overall response rate was 55% when also observational studies were comprised. “We noted that the first significant clinical response in belimumab users was at week 20, and this was sustained to week 52, where the peak response was seen,” Dr Montes underlined. The OR of having a cutaneous flare was 0.51 (P=0.007), reflecting about half the probability of a flare for belimumab users.

“Our study found that belimumab is an effective biological therapy for patients with cutaneous lupus with or without systemic disease, but it can take up to 20 weeks to achieve a clinically significant response. Thus, belimumab should not be prematurely discontinued,” Dr Montes concluded.


    1. Montes D. Significant improvement in cutaneous lupus erythematosus with or without systemic lupus erythematosus with belimumab use – a systematic review and meta-analysis. 0348, ACR Convergence 2022, 10–14 November, Philadelphia, USA.

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