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Abstract Number: 2604

The Effect of Subcutaneous Belimumab on Corticosteroid Use in Patients with Systemic Lupus Erythematosus (SLE): A Phase 3, Randomized, Placebo-Controlled Study

Ronald F van Vollenhoven1, April Thompson2, Bonnie Pobiner2, Joe Eastman2, Anne Hammer2, James Groark3 and Damon Bass3, 1Amsterdam Rheumatology and Immunology Center, Amsterdam, Netherlands, 2GSK Research Triangle Park, Research Triangle Park, NC, 3GSK Collegeville, Collegeville, PA

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: belimumab, corticosteroids, prednisolone, prednisone, steroids and systemic lupus erythematosus (SLE)

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Session Information

Date: Tuesday, November 7, 2017

Session Title: Systemic Lupus Erythematosus – Clinical Aspects and Treatment Poster III: Therapeutics and Clinical Trial Design

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

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.


Disclosure: R. F. van Vollenhoven, AbbVie, Astra Zeneca, Biotest, Bristol-Myers Squibb, Celgene, Crescendo, GSK, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, UCB and Vertex (less than $10,000 each), 5,AbbVie, Amgen, Bristol-Myers Squibb, GSK, Pfizer, Roche and UCB, 2; A. Thompson, GSK, 1,GSK, 3; B. Pobiner, GSK, 1,GSK, 3; J. Eastman, GSK, 1,GSK, 3; A. Hammer, GSK, 1,GSK, 3; J. Groark, GSK, 1,GSK, 3; D. Bass, GSK, 1,GSK, 3.

To cite this abstract in AMA style:

van Vollenhoven RF, Thompson A, Pobiner B, Eastman J, Hammer A, Groark J, Bass D. The Effect of Subcutaneous Belimumab on Corticosteroid Use in Patients with Systemic Lupus Erythematosus (SLE): A Phase 3, Randomized, Placebo-Controlled Study [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). 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/. Accessed May 25, 2022.
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