Belimumab efficacy in mucocutaneous manifestations of systemic lupus erythematosus: a large post hoc analysis of five phase III clinical trials.

ABSTRACT:

Objective

To determine the efficacy of belimumab on mucocutaneous manifestations of SLE in a large integrative analysis.

Methods

Using data from five phase III clinical trials (BLISS-52; BLISS-76; BLISS-NEA; EMBRACE; BLISS-SC; N = 3086), we investigated the effect of belimumab vs. placebo on top of standard therapy on inducing improvement in mucocutaneous BILAG (mcBILAG) and mucocutaneous SLE Disease Activity Index 2000 (mcSLEDAI-2K), and on preventing mcBILAG flares. We employed logistic and Cox regression analysis, adjusting for trial variance.

Results

Belimumab was superior to placebo in inducing mcBILAG (week-52 OR: 1.29; 95% CI: 1.07-1.57; P = 0.008) and mcSLEDAI-2K (week-52 OR: 1.37; 95% CI: 1.16-1.62; P< 0.001) improvement, as well as in inducing sustained (≥2

SUBMITTER: Grosso G 

PROVIDER: S-EPMC12212913 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature