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Background: Belimumab (BEL) is an approved systemic lupus erythematosus (SLE) treatment. Despite BEL clinical studies demonstrating a favourable benefit–risk profile, varying incidence rates of mortality and adverse events of special interest, including malignancies, require further evaluation.
Objectives: To assess long-term safety following BEL therapy.
Methods: This was a Year (Yr)-4 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 IV) or PBO, plus standard therapy (ST), for 48 weeks. Patients (pts) then entered a Yr 2–5 follow-up period in which they received physician-directed ST. All pts were contacted annually by telephone, including pts who discontinued treatment. Mortality and new malignancies (including nonmelanoma skin cancer) were the endpoints collected, and rates summarised. We present Yr-4 follow-up data by Yr-1 treatment received.
Results: Baseline characteristics for the Yr-4 follow-up population (N=3204) were similar to the Yr-1 double-blind study population (N=4003). By the Yr-4 follow-up, cumulatively 12.7% and 11.0% of pts in the BEL and PBO Yr-1 groups had received BEL as part of physician-directed care, respectively (data not shown). As shown in the
Yr 1 plus Yrs 2–4 post-treatment* follow-up mortality and new primary malignancy rates by Yr-1 study treatment
| Pts with events per yr, n (%) | Pt incidence rate per 100 pt-yrs | |||||
|---|---|---|---|---|---|---|
| (Cumulative rate, %) | ||||||
| BEL | PBO | Total | BEL | PBO | Total | |
| Yr-1 (as-treated) population | N=2002 | N=2001 | N=4003 | |||
| Deaths | 13 (0.65) | 22 (1.10) | 35 (0.87) | 0.66 (0.65) | 1.11 (1.10) | 0.87 |
| New primary malignancies† | 9 (0.45) | 10 (0.50) | 19 (0.47) | 0.45 | 0.50 | 0.47 |
| Yr-2 (as-treated in Yr-1) population | N=1695 | N=1670 | N=3365 | |||
| Deaths | 9 (0.53) | 21 (1.26) | 30 (0.89) | 0.60 (1.10) | 1.18 (2.15) | 0.89 (1.62) |
| New primary malignancies | 3 (0.18) | 7 (0.42) | 10 (0.30) | 0.34 (0.60) | 0.48 (0.85) | 0.41 (0.72) |
| Yr-3 (as-treated in Yr-1) population | N=1659 | N=1630 | N=3289 | |||
| Deaths | 9 (0.54) | 17 (1.04) | 26 (0.79) | 0.58 (1.55) | 1.14 (3.00) | 0.86 (2.27) |
| New primary malignancies, n (%) | 7 (0.42) | 9 (0.55) | 16 (0.49) | 0.37 (0.95) | 0.49 (1.25) | 0.43 (1.10) |
| Yr-4 (as-treated in Yr-1) population | N=1622 | N=1582 | N=3204 | |||
| Deaths by MedDRA SOC | 14 (0.86) | 13 (0.82) | 27 (0.84) | 0.65 (2.25) | 1.07 (3.65) | 0.86 (2.95) |
| Infections/infestations | 4 (0.25) | 5 (0.32) | 9 (0.28) | |||
| Cardiac disorders | 2 (0.12) | 1 (0.06) | 3 (0.09) | |||
| General disorders/ administration site conditions | 2 (0.12) | 2 (0.13) | 4 (0.12) | |||
| Respiratory/thoracic/ mediastinal disorders | 2 (0.12) | 1 (0.06) | 3 (0.09) | |||
| Nervous system disorders | 2 (0.12) | 1 (0.06) | 3 (0.09) | |||
| Other‡ | 2 (0.12) | 3 (0.18) | 5 (0.15) | |||
| New primary malignancies | 10 (0.62) | 5 (0.32) | 15 (0.47) | 0.43 (1.45) | 0.44 (1.45) | 0.43 (1.45) |
*Pts in the post-treatment follow-up period are no longer receiving study treatment. †Includes nonmelanoma skin cancer.
‡Contains 1 event for 5 distinct pts of each of renal/urinary disorders, and neoplasms (BEL); musculoskeletal/connective tissue disorders, injury/poisoning/procedural complications, and vascular disorders (PBO).
MedDRA, Medical Dictionary for Regulatory Activities; SOC, system organ class
Conclusion: Post-treatment Yr-4 follow-up results in BASE, the largest double-blind trial in pts with SLE to date, support the safety of BEL therapy, with no new BEL safety concerns identified in this analysis.
REFERENCES:
[1]Sheikh SZ, et al . Lancet Rheumatol 2020;3:e122–30
Acknowledgements: This analysis was funded by GlaxoSmithKline (GSK). Medical writing support was provided by Lulu Hill, MPharmacol, Fishawack Indicia Ltd. UK, part of Fishawack Health, and was funded by GSK.
Disclosure of Interests: Saira Sheikh Consultant of: GSK, Grant/research support from: Pfizer, Morton Scheinberg Consultant of: GSK, Pfizer, Alnylam, AbbVie, PTC Therapeutics, James Cheng-Chung Wei Consultant of: TSH Biopharm, AbbVie, BMS, Celgene, Chugai, Eisai, Janssen, Novartis, Pfizer, Sanofi-Aventis, and UCB Pharma, Grant/research support from: AbbVie, Amgen, Astellas, BMS, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, Sun and UCB Pharma, Dana Tegzová: None declared, William Stohl Consultant of: GSK, Grant/research support from: GSK, Pfizer, Gilead, RICARDO ACAYABA DE TOLEDO Speakers bureau: AbbVie, Janssen, UCB, Novartis, Celltrion, Consultant of: AbbVie, Janssen, Novartis, UCB, Grant/research support from: Pfizer, AbbVie, Novartis, GSK, Tamara Mucenic Speakers bureau: Novartis, Janssen, BMS, AbbVie, Pfizer, Roche, Grant/research support from: GSK, Janssen, Roche, Eli Lilly, Gilead, UCB, Mauricio R Abello Banfi: None declared, Kathleen Maksimowicz-McKinnon Grant/research support from: Chemocentryx, Carlos Abud-Mendoza Speakers bureau: GSK, Lilly, Pfizer, Sandra Navarra Speakers bureau: Pfizer, Novartis, Johnson & Johnson, Consultant of: Biogen, Boehringer Ingelheim, Grant/research support from: Astellas, Mercedes García Speakers bureau: GSK, Janssen, Pfizer, Ignacio Garcia-De La Torre: None declared, Andrew Liu Shareholder of: GSK, Employee of: GSK, Abhishek Roy Employee of: GSK, Paul Wilde Shareholder of: GSK, Employee of: GSK, Sofia Fernandes Shareholder of: GSK, Employee of: GSK, Julia Harris Shareholder of: GSK, Employee of: GSK, David Roth Shareholder of: GSK, Employee of: GSK