ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1499

Year-5 Follow-up of Belimumab Safety (mortality and Malignancies) in Patients with Systemic Lupus Erythematosus (SLE) Who Completed a Phase 4, 52-week, Randomized, Double-blind Placebo-controlled Safety Study

Saira Sheikh1, James Cheng-Chung Wei2, Dana Tegzova3, William Stohl4, Ricardo Acayaba de Toledo5, Tamara Mucenic6, Mauricio R. Abello Banfi7, Kathleen Maksimowicz-McKinnon8, Carlos Abud-Mendoza9, Sandra Navarra10, Mercedes García11, IGNACIO GARCÍA-DE LA TORRE12, Sofia Fernandes13, Julia HN Harris14, Abhishek Roy15, Jose Miyar Olaiz16, Paul WIlde17 and David A. Roth18, 1University of North Carolina at Chapel Hill, Chapel Hill, NC, 2Chung Shan Medical University Hospital, Department of Rheumatology, Taichung, Taiwan, 3Institute of Rheumatology, Prague, Czech Republic, 4University of Southern California Keck School of Medicine, Division of Rheumatology, Los Angeles, CA, 5Faculdade de Medicina de São José do Rio Preto, São José do Rio Preto, Service of Rheumatology of the Internal Medicine Department, São José do Rio Preto, Brazil, 6Hospital Moinhos de Vento, Porto Alegre, Brazil, 7Centro Integral de Reumatología del Caribe, Barranquilla, Colombia, 8Medical University of South Carolina, Charleston, SC, 9Hospital Central “Dr Ignacio Morones Prieto”, Unidad Regional de Reumatología y Osteoporosis, Hospital Central; Facultad de Medicina de la Universidad Autónoma de San Luis Potosí, San Luis Potosí, Mexico, 10University of Santo Tomas Hospital, Joint and Bone Center, Manila, Philippines, 11Hospital Interzonal General de Agudos José de San Martín, La Plata, Argentina, 12Universidad de Guadalajara/Hospital General de Occidente, Guadalajara, Mexico, 13GlaxoSmithKline, Stevenage, United Kingdom, 14GlaxoSmithKline, Immunology Biostatistics, Brentford, United Kingdom, 15GlaxoSmithKline, Bangalore, India, 16GlaxoSmithKline, Safety Evaluation and Risk Management, Brentford, United Kingdom, 17GlaxoSmithKline, Clinical Development, Brentford, United Kingdom, 18GlaxoSmithKline, Collegeville, PA

Meeting: ACR Convergence 2023

Keywords: , ,

Session Information

Date: Monday, November 13, 2023

Title: (1488–1512) SLE – Treatment Poster II

Session Type: Poster Session B

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

Background/Purpose: Belimumab (BEL) is an approved treatment for active SLE and LN, in addition to standard therapy (ST). Despite BEL clinical studies demonstrating a favorable benefit–risk profile, varying incidence rates of mortality and adverse events of special interest, including malignancies, require further evaluation. This study aimed to assess the long-term safety of BEL therapy in patients with SLE.

Methods: This was a Year-5 post-treatment follow-up of the Phase 4, double-blind, placebo (PBO)-controlled Belimumab Assessment of Safety in SLE (BASE) study (GSK Study BEL115467; NCT01705977).1 Overall, 4003 adults with active, autoantibody-positive SLE received BEL (10 mg/kg intravenously [IV]) or PBO, plus ST, for 48 weeks. Patients then entered a Year 2–5 follow-up period in which they received physician-directed ST. All patients were contacted annually by telephone, including patients who discontinued treatment in Year 1. Mortality and new primary malignancies (including nonmelanoma skin cancer) were the endpoints collected, and rates summarized. We present the final Year-5 follow-up data by treatment received during Year 1.

Results: Out of the Year-1 population, 77.0% (N=3081) were followed up through to Year 5 with a similar proportion of patients in each Year-1 treatment group. Baseline characteristics for the Year-5 follow-up population were similar to the Year-1 study population (N=4003). By the Year-5 follow-up, cumulatively 13.4% and 11.4% of patients in the BEL and PBO Year-1 treatment groups had received BEL as part of physician-directed care, respectively. Cumulative follow-up adjusted mortality rates were lower in the BEL vs PBO Year-1 treatment group by Years 2 to 5 (Year 5 BEL 0.61 vs PBO 0.96 per 100 patient-years; Table). Post hoc analyses of the Year 2–5 follow-up period showed that 96 patients (2.85%) died and the highest incidence of deaths by system organ class was infections and infestations (total 0.83%: BEL 0.83% and PBO 0.84%) and cardiac disorders (total 0.51%: BEL 0.29% and PBO 0.72%). Cumulative follow-up adjusted new primary malignancy patient incidence rates were lower in the BEL vs PBO Year-1 treatment group by Years 2 and 3, but similar by Years 4 and 5 (Year 5 BEL 0.40 vs PBO 0.38 per 100 patient-years; Table). Post hoc analyses of the Year 2–5 follow-up period showed that 46 patients (1.37%) developed new primary malignancies (BEL 1.42% and PBO 1.32%). The area most affected by neoplasm was the breast (total 0.36%: BEL 0.35% and PBO 0.36%).

Conclusion: The Year-5 follow-up results of BASE, the largest double-blind, placebo-controlled clinical trial in patients with SLE to date, support the safety of BEL therapy with no new BEL safety concerns identified in this analysis.

Funding: GSK

Reference
1 Sheikh SZ et al. Lancet Rheum 2020;3:e122–30

Supporting image 1

Table. Year 1 plus Years 2–5 post-treatment* follow-up mortality and new primary malignancy† rates by Year_1 study treatment.

*Patients in the post-treatment follow-up period were no longer receiving study treatment; †includes nonmelanoma skin cancer.

Disclosures: S. Sheikh: AstraZeneca, 2, Aurinia Pharmaceuticals Inc., 2, Biogen, 2, GSK, 1, 1, 2, Lilly USA, 2, Pfizer, 5; J. Wei: Abbvie, 2, 5, 6, Amgen, 5, AstraZeneca, 6, BMS, 2, 5, 6, Celgene, 2, Chugai, 2, 6, Eisai, 2, 6, Eli Lilly, 2, 5, 6, Gilead, 5, GSK, 2, 5, Janssen, 2, 5, 6, Novartis, 2, 5, Pfizer, 2, 5, 6, Sanofi-Aventis, 2, SUN pharma, 5, TSH Taiwan, 2, UCB pharma, 2, 5; D. Tegzova: None; W. Stohl: GSK, 5, Pfizer, 5; R. Acayaba de Toledo: AbbVie, 2, 5, 6, Celltrion, 6, Fresenius, 6, GSK, 5, Janssen, 2, 6, Novartis, 2, 5, 6, Pfizer, 5, UCB, 2; T. Mucenic: AbbVie, 6, BMS, 6, Eli Lilly, 5, Gilead, 6, GSK, 2, Janssen, 5, 6, Novartis, 6, Pfizer, 6, Roche, 5, UCB, 5; M. Abello Banfi: None; K. Maksimowicz-McKinnon: Chemocentryx, 5; C. Abud-Mendoza: GSK, 6, Lilly, 6, Pfizer, 6; S. Navarra: Astellas, 6, AstraZeneca, 6, Biogen, 2, Boehringer-Ingelheim, 2, GSK, 6, Novartis, 6, Pfizer, 6; M. García: GSK, 6, Janssen, 6, Pfizer, 6; I. GARCÍA-DE LA TORRE: None; S. Fernandes: GSK, 3, 12, Shareholder; J. Harris: GSK, 3, 11; A. Roy: GSK, 3; J. Olaiz: GSK, 3, 11; P. WIlde: GSK, 3, 11; D. Roth: GSK, 3, 12, Shareholder.

To cite this abstract in AMA style:

Sheikh S, Wei J, Tegzova D, Stohl W, Acayaba de Toledo R, Mucenic T, Abello Banfi M, Maksimowicz-McKinnon K, Abud-Mendoza C, Navarra S, García M, GARCÍA-DE LA TORRE I, Fernandes S, Harris J, Roy A, Olaiz J, WIlde P, Roth D. Year-5 Follow-up of Belimumab Safety (mortality and Malignancies) in Patients with Systemic Lupus Erythematosus (SLE) Who Completed a Phase 4, 52-week, Randomized, Double-blind Placebo-controlled Safety Study [abstract]. Arthritis Rheumatol. 2023; 75 (suppl 9). https://acrabstracts.org/abstract/year-5-follow-up-of-belimumab-safety-mortality-and-malignancies-in-patients-with-systemic-lupus-erythematosus-sle-who-completed-a-phase-4-52-week-randomized-double-blind-placebo-controlled-safe/. Accessed .

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