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Abstract Number: 1295

Belimumab Reduces Severe Flares in Systemic Lupus Erythematosus Across Multiple Patient Subgroups: Results of a Large Integrated Analysis

Michelle Petri1, Norma Lynn Fox2, Mathew Gibb3, Tania Gonzalez-Rivera2, Anne Hammer2, Holly Quasny4, Ronald van Vollenhoven5 and David Roth2, 1Johns Hopkins University School of Medicine, Baltimore, MD, 2GlaxoSmithKline, Collegeville, PA, 3Veramed Ltd., Twickenham, United Kingdom, 4GlaxoSmithKline, Research Triangle Park, NC, 5Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Center, Amsterdam Rheumatology Center, Amsterdam, Netherlands

Meeting: ACR Convergence 2021

Keywords: Disease Activity, Systemic lupus erythematosus (SLE)

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Session Information

Date: Monday, November 8, 2021

Session Title: SLE – Diagnosis, Manifestations, & Outcomes Poster III: Outcomes (1257–1303)

Session Type: Poster Session C

Session Time: 8:30AM-10:30AM

Background/Purpose: Belimumab (BEL) is a disease-modifying systemic lupus erythematosus (SLE) treatment that inhibits B-lymphocyte stimulator. BEL has demonstrated a consistent efficacy profile across 4 pivotal Phase 3 trials1-4 and has improved renal outcomes in active LN and reduced SLE organ damage progression5,6. In 2011, BEL became the first biologic approved for SLE treatment in the USA7 with additional approvals in >70 countries. Severe flares in SLE are linked to poor long-term outcomes and increased healthcare resource utilization8. BEL has been shown to decrease severe flare risk2; however, data are lacking for specific patient (pt) subgroups. This analysis evaluated the role of BEL in preventing severe flares across a large pooled population as well as by subgroups.

Methods: The B­elimumab Summary of Lupus Efficacy (Be-SLE) analysis assessed data from 5 double-blind, placebo (PBO)-controlled BEL studies: BLISS-76, BLISS-52, BLISS-NEA, BLISS-SC, and EMBRACE. Data from pts receiving BEL (10 mg/kg intravenously or 200 mg subcutaneously) were compared with PBO; both groups received also standard therapy (ST). Data were collected every 4 weeks from baseline until Week 52. Severe flare was defined using the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLE Disease Activity Index (SLEDAI) flare index. The number of pts and time to first severe flare (days) were determined for both groups. Time to first severe flare was evaluated by the following subgroups: SLE International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index (SDI) score, disease duration, anti-double stranded deoxyribonucleic acid (dsDNA), serum levels of C3 and C4 proteins, steroid use, and immunosuppressant use. Hazard ratios (HR) for severe flare risk between groups were calculated using Cox proportional hazards model, adjusted for study and baseline SELENA-SLEDAI score.

Results: The analysis included 1869 pts receiving BEL and 1217 pts receiving PBO. Mean age (~37 years) and percentage of females (~94%) were similar between treatment groups. Over 52 weeks, 13.8% (n=258) of pts receiving BEL had severe flares versus 22.2% (n=270) of pts receiving PBO. BEL yielded a 39% reduction in the risk of severe flares versus PBO (HR: 0.61; 95% confidence interval [CI]: 0.51, 0.72). BEL also consistently reduced the risk of severe flares versus PBO across various pt subgroups (Figure); risk reductions appeared greater in pts with anti-dsDNA+ and ≥C3/C4, or SDI=0.

Conclusion: Pts receiving BEL had a reduced risk of severe flares versus pts receiving PBO. Some subgroups had greater risk reduction; these pts in particular may benefit from BEL. These results reinforce the advantage of BEL in ST in the treatment of SLE.

Funding: GSK

References:

1Navarra SV, et al. Lancet 2011;377(9767):721–31

2Furie RA, et al. Arthritis Rheum 2011;63(12):3918–30

3Zhang F, et al. Ann Rheum Dis 2018;77(3):355–63

4Stohl W, et al. Arthritis Rheum 2017;69(5):1016–27

5Urowitz MB et al. Ann Rheum Dis 2019;78(3):372–9

6Furie R, et al. N Engl J Med. 2020;383(12):1117-1128.

7GlaxoSmithKline. Benlysta Prescribing Information 2021

8Garris C et al. J Med Econ. 2013;16(5):667–77

Figure: Risk of severe flares HR for BEL versus PBO for various pt characteristic subgroups AM, antimalarial; ISA, immunosuppressant The orange box denotes the 95% CI for the overall (intention-to-treat) HR


Disclosures: M. Petri, Alexion, 1, Amgen, 1, Astrazeneca, 1, 5, Aurinia, 5, 6, Eli Lilly, 5, Emergent Biosolutions, 1, Exagen, 5, Gilead Biosciences, 2, GSK, 1, 5, IQVIA, 1, Idorsia Pharmaceuticals, 2, Janssen, 1, 5, Merck EMD Serono, 1, Momenta Pharmaceuticals, 2, PPD Development, 1, Sanofi, 2, Thermofisher, 5, UCB Pharmaceuticals, 2; N. Fox, GlaxoSmithKline, 3, 8, 11; M. Gibb, GlaxoSmithKline, 2; T. Gonzalez-Rivera, GlaxoSmithKline, 3, 8, 11; A. Hammer, GlaxoSmithKline, 3, 8, 11; H. Quasny, GlaxoSmithKline, 3, 8, 11; R. van Vollenhoven, Bristol Myers Squibb, 2, 5, Eli Lilly, 5, UCB, 2, 5, 6, Pfizer, 2, 6, 12, Support for educational programs; institutional grants, Roche, 12, Support for educational programs; institutional grants, Janssen, 2, 6, AbbVie, 2, 6, AstraZeneca, 2, Biotest, 2, GlaxoSmithKline, 2, 6, Biogen, 2, Galapagos, 2, 6, Gilead, 2, Sanofi, 2, Servier, 2, Vielabio, 2; D. Roth, GlaxoSmithKline, 3, 8, 11.

To cite this abstract in AMA style:

Petri M, Fox N, Gibb M, Gonzalez-Rivera T, Hammer A, Quasny H, van Vollenhoven R, Roth D. Belimumab Reduces Severe Flares in Systemic Lupus Erythematosus Across Multiple Patient Subgroups: Results of a Large Integrated Analysis [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/belimumab-reduces-severe-flares-in-systemic-lupus-erythematosus-across-multiple-patient-subgroups-results-of-a-large-integrated-analysis/. Accessed January 27, 2023.
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