Background/Purpose: Reduced corticosteroid use is considered a key goal in SLE treatment. This concept of ‘steroid-sparing’, seen with intravenous (IV) belimumab based on cumulative steroid use over 52 weeks¹, was investigated in patients with SLE treated with subcutaneous (SC) belimumab.

Methods: This was a Phase 3, multicenter, double-blind, 52-week study (112341/NCT01484496) in adult patients with active SLE (SELENA-SLEDAI score ≥8). Patients were randomized (2:1) to weekly belimumab 200 mg SC or placebo, plus standard care (SoC). The primary endpoint was SLE Responder Index response rate at Week 52²; efficacy and safety data have been published³. Here, the effects on corticosteroid use (prednisone equivalent) are reported, evaluating multiple pre-specified measures including the proportion of patients (>7.5 mg/day at baseline) with a ≥25% reduction from baseline to ≤7.5 mg/day during Weeks 40–52 (key secondary endpoint).

Results: Baseline corticosteroid use was comparable between groups (belimumab, 481 [86.5%]; placebo, 241 [86.1%]), with most patients receiving >7.5 mg/day (60.2%). A numerically greater proportion of patients with baseline dose >7.5 mg/day in the belimumab group had a dose reduction of ≥25% to ≤7.5 mg/day during Weeks 40–52 compared with patients receiving placebo (belimumab, 18.2%; placebo, 11.9%; OR [95% CI] 1.65 [0.95, 2.84]; p=0.0732). Fewer patients in the belimumab group versus the placebo group required ≥50% increase (min ≥5 mg/day) in dose during Weeks 40–52 (Week 52: belimumab, 4.9%; placebo, 7.9%; OR [95% CI] 0.56 [0.31, 1.02]; p=0.0574) or any increase in corticosteroid from Weeks 20–28 and 36–52 (Week 52: belimumab, 8.1%; placebo, 13.2%; OR [95% CI] 0.55 [0.34, 0.87]; p=0.0117). The percentage of patients with ≥50% reduction in corticosteroid dose by Week 52 was similar in the belimumab (range: 0.2–15.2%) and placebo (range: 0–14.1%) groups. A small number of patients in each group required an increase (≥50%, min ≥5 mg/day) in dose from baseline (range: belimumab 2.7–5.2%; placebo, 1.4–8.6%). Mean (SD) cumulative corticosteroid dose at Week 52 was 3933.8 mg (3660.76) in the belimumab group and 4567.3 mg (5981.53) in the placebo group; the median (IQR) was the same in both groups (3650.0 [1825–5475]; p=0.4299). Median (IQR) corticosteroid dose at baseline was 10 mg/day (IQR 5–15) in both groups; no meaningful change occurred in either group by Week 52. Mean dose at baseline was 10.8 mg/day and 11.2 mg/day in the belimumab and placebo groups, with mean changes at Week 52 of -1.76 mg and -0.03 mg, respectively. Adverse events incidence (≥1) was similar (belimumab, 80.8%; placebo 84.3%).

Conclusion: SC belimumab decreased the need for raising corticosteroid dose during the study. Other outcomes showed trends towards a corticosteroid-sparing effect of belimumab, consistent with IV studies of belimumab.^1,4

References: ¹van Vollenhoven RF. Arthritis Rheum. 2016;68(9):2184-92; ²Furie RA et al. Arthritis Rheum. 2009;61(9):1143-51; ³Stohl W et al. Arthritis Rheum. 2017;69:1016-27; ⁴Tanaka Y et al. Lupus Sci Med. 2017;4(Suppl 1):A45-6.

Study funded/conducted by GSK. Editorial assistance: Sam Halliwell, PhD, Fishawack Indicia Ltd, funded by GSK.

« Back to 2017 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/the-effect-of-subcutaneous-belimumab-on-corticosteroid-use-in-patients-with-systemic-lupus-erythematosus-sle-a-phase-3-randomized-placebo-controlled-study/