ACR Meeting Abstracts

ACR Meeting Abstracts

  • Home
  • Meetings Archive
    • ACR Convergence 2022
    • ACR Convergence 2021
    • ACR Convergence 2020
    • 2020 ACR/ARP PRSYM
    • 2019 ACR/ARP Annual Meeting
    • 2018 ACR/ARHP Annual Meeting
    • 2017-2009 Meetings
    • Download Abstracts
  • Keyword Index
  • Advanced Search
  • Your Favorites
    • Favorites
    • Login
    • View and print all favorites
    • Clear all your favorites
  • Meeting Resource Center

Abstract Number: 1302

Year-3 Observational Follow-up of Belimumab Safety (Mortality and Malignancies) in Patients with SLE Who Completed a Phase 4, 52-Week, Randomized, Double-Blind Placebo-Controlled Safety Study

Saira Sheikh1, Cheng-Chung Wei2, Dana Tegzova3, William Stohl4, Ricardo Acayaba de Toledo5, Tamara Mucenic6, Mauricio Abello Banfi7, Kathleen Maksimowicz-McKinnon8, Carlos Abud-Mendoza9, Sandra Navarra10, Mercedes Garcia11, Ignacio Garcia-De La Torre12, Regina Kurrasch13, Sofia Fernandes14, Julia Harris15, Saima Muzaffar14, Norma Lynn Fox13, Andrew Liu16, Holly Quasny17 and David Roth13, 1University of North Carolina Thurston Arthritis Research Center, and Department of Medicine, Division of Rheumatology, Allergy and Immunology, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, 2Institute of Medicine, Chung Shan Medical University; Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan (Republic of China), 3Institute of Rheumatology, Prague, Czech Republic, 4University of Southern California Keck School of Medicine, Los Angeles, CA, 5Faculdade de Medicina de São José do Rio Preto, São José do Rio Preto, Brazil, 6Hospital Moinhos de Vento, Porto Alegre, Brazil, 7Centro Integral de Reumatología del Caribe, Barranquilla, Colombia, 8Henry Ford Hospital, Wayne State University, Detroit, MI, 9Hospital Central “Dr Ignacio Morones Prieto”, Unidad Regional de Reumatología y Osteoporosis, Hospital Central and Facultad de Medicina de la Universidad Autónoma de San Luis Potosí, San Luis Potosí, Mexico, 10University of Santo Tomas Hospital, Manila, Philippines, 11Hospital Interzonal General de Agudos José de San Martín, La Plata, Argentina, 12Centro de Estudios de Investigación Básica y Clínica, S.C., Guadalajara, Mexico, 13GlaxoSmithKline, Collegeville, PA, 14GlaxoSmithKline, Stevenage, Hertfordshire, United Kingdom, 15GlaxoSmithKline, Uxbridge, United Kingdom, 16GlaxoSmithKline, Brentford, United Kingdom, 17GlaxoSmithKline, Research Triangle Park, NC

Meeting: ACR Convergence 2021

Keywords: belimumab, Malignancy, Mortality, Safety, Systemic lupus erythematosus (SLE)

  • Tweet
  • Email
  • Print
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 recombinant IgG1λ monoclonal antibody that is approved for treatment of systemic lupus erythematosus (SLE). Although clinical studies of BEL have demonstrated a favorable benefit–risk profile, varying incidence rates of mortality and adverse events of special interest, including malignancies, warrant further consideration. The Belimumab Assessment of Safety in SLE (BASE) placebo- (PBO)-controlled trial was conducted to assess long-term safety following BEL exposure.1

Methods: This was a post-treatment follow-up of the Phase 4, double-blind BASE study (GSK Study BEL115467; NCT01705977).1 A total of 4003 adults with active, autoantibody positive SLE received BEL (10 mg/kg IV) or PBO, plus standard therapy (ST) for 48 weeks. Following the treatment period, patients 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 during the study. Mortality and new primary malignancies (including nonmelanoma skin cancer [NMSC]) were the only endpoints collected and rates were summarised. We present the data for the Year-3 follow-up by treatment received during the 52-week double-blind treatment period (Year 1).

Results: Baseline characteristics at the start of the 52-week treatment for the Year-3 follow-up population (N=3266) were similar to those of the Year-1 double-blind study population (N=4003). By the Year-3 follow-up, cumulatively 12.0% and 10.9% of patients in the original BEL and PBO Year-1 treatment groups had received BEL as part of physician-directed care, respectively. In total (for both treatment groups), crude mortality rates were similar across Year 1 (0.87%), Year 2 (0.89%), and Year 3 (0.80%), whilst crude malignancy rates for Year 3 (0.52%) were numerically higher than Year 2 (0.30%), but similar to Year 1 (0.47%) (Table 1). Mortality and malignancy rates were lower in the BEL versus PBO Year-1 treatment group. Cumulative rates are shown in Table 2.

Conclusion: Post-treatment follow-up results in Year 3 from BASE, the largest study of patients with SLE to date, provide continued support for the safety profile of BEL and remained consistent with the Year-2 follow-up data. No new safety concerns for BEL were identified in patients with active, autoantibody-positive SLE receiving ST.

Funding: GSK

References:
1Sheikh SZ, et al. Lancet Rheum 2020 (ePub ahead of print) doi.org/10.1016/S2665-9913(20)30355-6

Table 1. Year_1, Year_2 and Year_3 post-treatment* follow-up mortality and new primary malignancy rates by study treatment during Year 1

Table 2. Cumulative deaths and new primary malignancies by follow-up year


Disclosures: S. Sheikh, Pfizer, 5, GlaxoSmithKline, 2, 5; C. Wei, Abbvie, 2, 5, Amgen, 5, Astellas, 5, BMS, 2, 5, Celgene, 2, 5, Eli Lilly, 5, Gilead, 5, Janssen, 2, 5, Novartis, 2, 5, UCB, 2, 5, TSH Biopharm, 2, Chugai, 2, Eisai, 2, Pfizer, 2, Sanofi-Aventis, 2, Sun, 5; D. Tegzova, None; W. Stohl, Gilead, 5, Pfizer, 5, GlaxoSmithKline, 2, 5; R. Acayaba de Toledo, Pfizer, 5, AbbVie, 2, 5, 6, Novartis, 2, 5, 6, GSK, 5, UCB, 2, 5, 6, Roche, 5, 6, Janssen, 5, 6; T. Mucenic, GSK, 5, Janssen, 5, 6, Roche, 5, 6, Eli Lilly, 5, Gilead, 5, UCB, 5, Novartis, 6, BMS, 6, AbbVie, 6, Pfizer, 6; M. Abello Banfi, None; K. Maksimowicz-McKinnon, Chemocentryx, 1; C. Abud-Mendoza, Lilly, 6, GlaxoSmithKline, 6, Pfizer, 6; S. Navarra, Biogen, 2, Boehringer Ingelheim, 6, Pfizer, 6, Novartis, 6, Johnson & Johnson, 6; M. Garcia, GSK, 6, Janssen, 6, Pfizer, 6; I. Garcia-De La Torre, None; R. Kurrasch, GlaxoSmithKline, 3, 8, 11; S. Fernandes, GlaxoSmithKline, 3, 8, 11; J. Harris, GlaxoSmithKline, 3, 8, 11; S. Muzaffar, GlaxoSmithKline, 3, 8, 11; N. Fox, GlaxoSmithKline, 3, 8, 11; A. Liu, GlaxoSmithKline, 3, 8, 11; H. Quasny, GlaxoSmithKline, 3, 8, 11; D. Roth, GlaxoSmithKline, 3, 8, 11.

To cite this abstract in AMA style:

Sheikh S, Wei C, Tegzova D, Stohl W, Acayaba de Toledo R, Mucenic T, Abello Banfi M, Maksimowicz-McKinnon K, Abud-Mendoza C, Navarra S, Garcia M, Garcia-De La Torre I, Kurrasch R, Fernandes S, Harris J, Muzaffar S, Fox N, Liu A, Quasny H, Roth D. Year-3 Observational Follow-up of Belimumab Safety (Mortality and Malignancies) in Patients with SLE Who Completed a Phase 4, 52-Week, Randomized, Double-Blind Placebo-Controlled Safety Study [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/year-3-observational-follow-up-of-belimumab-safety-mortality-and-malignancies-in-patients-with-sle-who-completed-a-phase-4-52-week-randomized-double-blind-placebo-controlled-safety-study/. Accessed March 23, 2023.
  • Tweet
  • Email
  • Print

« Back to ACR Convergence 2021

ACR Meeting Abstracts - https://acrabstracts.org/abstract/year-3-observational-follow-up-of-belimumab-safety-mortality-and-malignancies-in-patients-with-sle-who-completed-a-phase-4-52-week-randomized-double-blind-placebo-controlled-safety-study/

Advanced Search

Your Favorites

You can save and print a list of your favorite abstracts during your browser session by clicking the “Favorite” button at the bottom of any abstract. View your favorites »

ACR Pediatric Rheumatology Symposium 2020

© COPYRIGHT 2023 AMERICAN COLLEGE OF RHEUMATOLOGY

Wiley

  • Home
  • Meetings Archive
  • Advanced Search
  • Meeting Resource Center
  • Online Journal
  • Privacy Policy
  • Permissions Policies
  • Cookie Preferences