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
Recommended Citation
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, Lynn 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. Arthritis and Rheumatology 2021; 73(SUPPL 9):2696-2699.
Document Type
Conference Proceeding
Publication Date
9-1-2021
Publication Title
Arthritis and Rheumatology
Keywords
autoantibody, belimumab, endogenous compound, placebo, adult, cancer patient, clinical trial, conference abstract, controlled study, crude mortality rate, double blind procedure, drug safety, drug therapy, female, follow up, human, major clinical study, male, mortality, non melanoma skin cancer, phase 4 clinical trial, physician, primary tumor, randomized controlled trial, systemic lupus erythematosus, telephone
Abstract
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. (Figure Presented).
Volume
73
Issue
SUPPL 9
First Page
2696
Last Page
2699
