Improvement in Cutaneous Lupus Erythematosus After Twenty Weeks of Belimumab Use: A Systematic Review and Meta‐Analysis

Abstract

Objective Cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE), can be debilitating and cause psychological distress. Belimumab, a monoclonal antibody that inhibits B cell activation, is a Federal Drug Administration–approved SLE medication, but less is known on its use in CLE. Moreover, the time to response after starting belimumab in CLE is unknown, which may lead to premature discontinuation in the absence of early perceivable benefits. Thus, the objectives of this meta‐analysis were to examine the efficacy of belimumab, as well as the time to response after starting belimumab in patients with CLE with or without SLE. Methods A comprehensive literature search was performed to include studies that examined clinical response in patients with CLE with or without SLE receiving belimumab. A clinical response at 52 weeks in belimumab users versus nonusers was summarized in a random‐effects model. Additionally, we calculated the pooled odds ratio (OR) for each consecutive 4‐week observation interval to identify time to a clinical response in CLE with or without SLE after starting belimumab. Results Among 747 screened studies, 14 were included. The pooled odds of clinical response at 52 weeks in belimumab users were 44% higher compared to nonusers (OR 1.44 [95% confidence interval (95% CI) 1.20–1.74], I2 = 0%). A clinical response was first noted after 20 weeks of starting belimumab (OR 1.35 [95% CI 1.01–1.81], I2 = 0%), with a sustained clinical response through 1 year. Conclusion The findings support belimumab as an effective therapy for CLE with SLE. Likewise, the findings inform patient counseling regarding estimates of 20 weeks to achieve a response.

Rapid response of refractory subacute cutaneous lupus after single dose anifrolumab

“…6 Belimumab, a monoclonal antibody that inhibits B cell survival factor B-lymphocyte stimulator, has only shown modest improvement in CLE and may take several months of treatment to show a clinical response. 7 Here, we showcase the clinical utility of anifrolumab in SCLE, and offer it as promising therapeutic option for patients who have failed belimumab, which is also supported by several case series. 3 , 4 , 5 Additionally, its rapid efficacy can prevent the irreversible damage associated with longstanding CLE including dyspigmentation and scarring which negatively impacts emotions and functioning of patients.…”

Efficacy and safety of belimumab therapy for patients with lupus nephritis: A meta‐analysis and a propensity score‐matched case–control study

“…27 No safety signals were observed with regard to initiating or continuing belimumab treatment in patients with SLE or LN. 26,28 In this study, we found that treatment with belimumab was associated with a 27% reduction in the risk of serious TEAEs compared to placebo. In the belimumab group, the incidences of infectious TEAEs and death were not increased.…”

“…The safety of belimumab therapy in patients with LN is a major concern 27 . No safety signals were observed with regard to initiating or continuing belimumab treatment in patients with SLE or LN 26,28 . In this study, we found that treatment with belimumab was associated with a 27% reduction in the risk of serious TEAEs compared to placebo.…”

EULAR recommendations for the management of systemic lupus erythematosus: 2023 update

“…A small retrospective study in 73 patients with refractory CLE to first-line therapy found similar response rates (~65%) between MTX and mycophenolate 48. Anifrolumab and belimumab have both shown efficacy in mucocutaneous manifestations of SLE,49 50 although only anifrolumab has used the Cutaneous Lupus Area and Severity Index in its clinical programme, whereas belimumab has reported responses according to the general instruments SLEDAI and BILAG (hence, the designation B in the Grading of Recommendation, despite positive RCT data). Importantly, the list of recommended drugs is indicative and other treatments may be considered as second-line or third-line options, including dapsone, retinoids, CNI, AZA, CYC and RTX, ideally in collaboration with dermatologists experienced in the treatment of CLE.…”