Patients with cutaneous lupus erythematosus (CLE) have lesser risk for severe flares, greater clinical response rates, and sustained clinical response after at least 20 weeks following belimumab treatment compared with nonusers, according to study findings published in Arthritis Care & Research (Hoboken).
Belimumab is a monoclonal antibody approved by the US Food and Drug Administration (FDA) to treat moderate to severe systemic lupus erythematosus (SLE), by inhibiting B-cell activation.
Time-to-response for the treatment of CLE with belimumab is unknown, potentially resulting in the premature discontinuation of effective treatment.
Researchers at the University of Wisconsin School of Medicine conducted a systematic review and meta-analysis to analyze the clinical response time following treatment with belimumab in patients with CLE with and without SLE.
Researchers comprehensively searched Embase, Medline, CINAHL, clinicaltrials.gov, and the Web of Science databases in September 2021 and January 2022. They identified 747 potential studies published between January 1997 and January 2022, of which 14 were eligible in the review. Six high-quality randomized controlled trials (RCTs) that compared belimumab users with nonusers were also included.
Patients with CLE who received treatment with belimumab achieved a 44% higher clinical response rate compared with nonusers (pooled odds ratio [OR], 1.44; 95% CI, 1.20-1.74; P <.001).
It took 20 weeks after initiating treatment with belimumab for patients with CLE to achieve sustained clinical response through 1 year (OR, 1.35; 95% CI, 1.01-1.81; P =.04). Included studies used the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) and the British Isles Lupus Assessment Group Index (BILAG) to assess clinical response to belimumab.
In addition, the researchers observed that patients with CLE receiving treatment with belimumab experienced a 49% lower risk for severe cutaneous flares compared with those who were not receiving treatment with belimumab (pooled OR, 0.51; 95% CI, 0.31-0.84; P =.007)
Study limitations included the fact that only 1 study analyzed the response time of belimumab for CLE in those without SLE; heterogeneity in study reporting; inability to analyze clinical response after week 52; lack of analysis on the effect of belimumab on different CLE subtypes; and the poor quality of all observational studies in terms of risk of bias.
“This study highlights that belimumab can take at least 20 weeks to achieve a sustained clinical response in patients with CLE with SLE; thus, it should not be prematurely discontinued in such patients,” the study authors noted.
Kneeland R, Montes D, Endo J, Shields B, Bartels CM, Garg S. Improvement in cutaneous lupus erythematosus after 20 weeks of belimumab use – A systematic review and meta-analysis. Arthritis Care Res (Hoboken). Published online November 10, 2022. doi:10.1002/acr.25058