Background/Purpose: Mucocutaneous manifestations affect >80% of patients (pts) with SLE and can contribute to their poor quality of life through unwanted attention, self-consciousness, emotional symptoms, and functional decline.^1,2 There is emerging evidence that belimumab (BEL), in addition to standard therapy (ST), improves mucocutaneous manifestations of SLE.³ This large, integrated analysis further explored the effects of BEL on SLE disease activity within specific manifestations in the mucocutaneous system and vasculitis.

Methods: This post hoc analysis pooled data from five, Phase 3, randomized, placebo-controlled BEL trials (GSK Studies BLISS-76, BLISS-52, BLISS-NEA, BLISS-SC, and EMBRACE). Adults with SLE and a SELENA-SLEDAI score of either ≥8 (BLISS-NEA, BLISS-SC, EMBRACE) or ≥6 (BLISS-52, BLISS-76), with no selection or exclusion for any specific type of skin or vasculitic lesion at screening, were randomized to either BEL (10 mg/kg/month intravenously or 200 mg/week subcutaneously) or placebo (PBO), plus ST. The effect of BEL vs PBO on disease activity within the mucocutaneous organ system and vasculitis was measured every four weeks in the modified intention-to-treat population using items from both the SELENA-SLEDAI and the BILAG indices. Treatment differences in item resolution at Week 52 in pts with the item present at baseline (BL) were analyzed using Fisher’s exact test, provided there were at least 20 pts per arm with the item present at BL.

Results: Of 3086 included pts (BEL, n=1869; PBO, n=1217), 94.4% were female, mean (standard deviation) age was 37.0 (11.6) years (Table 1). Most pts had mucocutaneous manifestations at BL (SELENA-SLEDAI, 85.0%; BILAG [category A or B, moderate or severe activity]: 59.6%) (Table 1). At Week 52, significantly more BEL than PBO pts experienced improvements in SELENA-SLEDAI (59.4% vs 49.2%; treatment difference vs PBO 10.3%; p< 0.0001) and BILAG (54.1% vs 43.1%; treatment difference vs PBO 11.0%; p< 0.0001) mucocutaneous domains. Significant treatment differences were found in favor of BEL at Week 52 for four SELENA-SLEDAI items (vasculitis, rash, alopecia, and mucosal ulcers) and nine BILAG items (mild maculopapular eruption, localized active discoid lesions, mild alopecia, small mucosal ulceration, malar erythema, subcutaneous nodules, swollen fingers, major cutaneous vasculitis [including ulcers], and minor cutaneous vasculitis). For SELENA-SLEDAI, the largest BEL vs PBO treatment difference (25.4%) was for the vasculitis item (p<0.0001) and for BILAG; the largest BEL vs PBO treatment difference (34.1%) was for the major cutaneous vasculitis item (p=0.0039; Table 2).

Conclusion: Compared with ST alone, pts with SLE treated with BEL plus ST experienced significant improvements in specific manifestations of the mucocutaneous organ systems and vasculitis. This large integrated analysis of five Phase 3 clinical trials supports the efficacy of BEL in common mucocutaneous manifestations of SLE.Funding: GSKReferences¹Justiz Vaillant AA, et al. In: StatPearls. Treasure Island (FL): StatPearls Publishing. 2022²Yan D, et al. Lupus Sci Med. 2021;8: e000444³Tanaka Y, et al. Mod Rheumatol. 2020;30:313–20

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/belimumab-effects-on-skin-in-patients-with-systemic-lupus-erythematosus-a-pooled-post-hoc-analysis-of-five-phase-3-randomized-placebo-controlled-clinical-trials/