Belimumab May Reduce Glucocorticoid Use in Systemic Lupus Erythematosus

Belimumab was found to be effective in reducing the use of glucocorticoids among individuals with systemic lupus erythematosus (SLE), according to research recently presented at the American College of Rheumatology (ACR) Convergence 2021, held November 3-10, 2021.

This study included data from 5 double-blind, placebo-controlled studies of belimumab in SLE:  BLISS-76 (ClinicalTrials.gov Identifier: NCT00410384), BLISS-52 (NCT00424476), BLISS-NEA (NCT01345253), BLISS-SC (NCT01484496), and EMBRACE (NCT01632241). A total of 1869 participants received belimumab 200 mg subcutaneously or 10 mg/kg intravenously and 1217 received placebo. The majority of study participants (94.4%) were women, with a median age of 36 years (range, 18-77). Data were collected every 4 weeks between baseline and week 52. Glucocorticoid tapering was performed at the discretion of the investigator, with tapering recommended for patients responding well to treatment. A reduction in glucocorticoid use of at least 25% from baseline to no greater than 7.5 mg/d by week 52 was a shared endpoint in the 5 studies. A logistic regression model was used to calculate odds ratios (OR) for changes in glucocorticoid dose, with covariates including study, treatment, baseline dose, and SLE severity.

Glucocorticoids were administered at baseline to 88.2% (n=1648; mean baseline dosage 12.3 mg/d) of those in the belimumab group and 88.7% (n=1079; mean baseline dosage 12.2 mg/d) of those in the placebo group. Among the belimumab group, 16.9% (n=202) achieved a reduction in glucocorticoid use of at least 25% to no greater than 7.5 mg/d at weeks 40 through 52 compared with 11.9% (n=91) of those in the placebo group (OR 1.52; 95% CI, 1.16-1.99; P =.0024).

At the end of the study period, a decrease in glucocorticoid use was observed in 33.9% of the belimumab group vs 27.4% of the placebo group (OR 1.41; 95% CI, 1.18-1.70; P =.0002). The investigators report that an increase in glucocorticoid use was experienced by 11.1% and 16.2% of the belimumab and placebo groups, respectively (OR 0.65; 95% CI, 0.52-0.81; P =.0001). Statistically significant differences were reported for both increased glucocorticoid dose by week 12 and decreased glucocorticoid dose by week 24. The mean cumulative glucocorticoid dose over 1 year was 4495±4018.8 mg for the belimumab group and 5096±5641.6 mg for placebo (P =.024).

The study authors conclude that “[belimumab] was associated with significantly greater reductions in [glucocorticoid] dose from baseline, and a lower cumulative [glucocorticoid] dose over 1 year versus [placebo].” Furthermore, these reductions “occurred early in the 52-week treatment period despite no forced taper in the original studies.”

Disclosure: This clinical trial was supported by and some authors are employees of GlaxoSmithKline. Please see the original reference for a full list of authors’ disclosures.

Reference

Costenbader K, Abe Y, Arnaud L, et al. Reduction in glucocorticoid use in patients with systemic lupus erythematosus treated with belimumab: a large pooled analysis of 5 placebo-controlled studies. Presentation at ACR Convergence 2021; November 3-10, 2021. Abstract 1283.