Abstract
Objective: This systematic review presents the treatment efficacy of anifrolumab, belimumab and rituximab in nonrenal Systemic Lupus Erythematosus using the main endpoints.
Methods: A search was done using Embase, Medline, PubMed and Web of Science for the mentioned biologics targeting SLE after 1 Jan 2019. A manual search was done with ClinicalTrials.gov for trials, and search engines for literature reviews.
Results: For anifrolumab, all trials reached their end point except TULIP-1 (OR=1.16, [95% CI 0.77,1.76]). Meanwhile, most trials for belimumab did not reach a response, with its only randomised controlled trial (RCT) not reaching its endpoint OR=1.40 CI [0.92,2.11]. The only trial with rituximab included 125 patients; 48 achieved remission after one cycle and 61 after 2 cycles.
Conclusion: The review displays evidence on the positive efficacy of anifrolumab, a varied and safe effect for
belimumab and a good effect for rituximab. No trial revealed worsening by a biologic, which is a positive effect.
References
Nie Y, Zhao L, Zhang X. B Cell aberrance in lupus: the ringleader and the solution. Clin Rev Allergy Immunol. 2022;62(2):301-323. Available from: https://doi.org/10.1007/s12016-020-08820-7
Pappas-Taffer L, González-Rivera T, Werth VP. Cutaneous Lupus. Springer eBooks. 2022:25-52.
Chatham WW, Furie R, Saxena A, et al. Long-term safety and efficacy of anifrolumab in adults with systemic lupus erythematosus: results of a phase 2 open-label extension study. Arthritis Rheumatol. 2021;73(5):816-825. Available from: https://doi.org/10.1002/art.41598
Hassan SU, Md Yusof MY, Emery P, Dass S, Vital EM. Biologic sequencing in systemic lupus erythematosus: after secondary non-response to rituximab, switching to humanised anti-cd20 agent is more effective than belimumab. Front Med 2020;27(7):498. Available from: https://doi.org/10.3389/fmed.2020.00498
Furie RA, Morand EF, Bruce IN, et al. Type I interferon inhibitor anifrolumab in active systemic lupus erythematosus (TULIP-1): a randomised, controlled, phase 3 trial. Lancet Rheumatol 2019;1(4):e208–e219. Available from: https://doi.org/10.1016/S2665-9913(19)30076-1
Morand EF, Furie R, Tanaka Y, et al. Trial of anifrolumab in active systemic lupus erythematosus. NEJM 2020;382(3):211–21. Available from: https://doi.org/10.1056/NEJMoa1912196
Ginzler E, Guedes Barbosa LS, D’Cruz D, et al. EMBRACE: Phase 3/4, randomized, 52-week study of belimumab efficacy and safety in patients of black African ancestry with systemic lupus erythematosus. Arthritis Rheumatol 2021;74(1):112-123. Available from: https://doi.org/10.1002/art.41900
SLICC/ACR Damage Index. reference.medscape.com. 2020. Available from: https://reference.medscape.com/calculator/336/slicc-acr-damageindex (accessed 8 May 2024)
Kalunian KC, Furie R, Morand EF, et al. A randomized, placebo controlled phase III extension trial of the long-term safety and tolerability of anifrolumab in active systemic lupus erythematosus. Arthritis Rheumatol 2023;75(2):253-265. Available from: https://doi.org/10.1002/art.42392
Laccarino L, Saccon F, Mathieu A, et al. Effectiveness and safety of belimumab in patients with active systemic lupus erythematosus: Results from a large, nationwide, multicentric study. Annals of the Rheumatic Diseases 2019;78(Supplement 2): 778-779. Available from: https://doi.org/10.1136/annrheumdis-2019-eular.3635
van Vollenhoven RF, Navarra SV, Levy RA, et al. Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension. Rheumatology (Oxford) 2020;59(2):281–91. Available from: https://doi.org/10.1093/rheumatology/kez279
Shipa M, Embleton-Thirsk A, Parvaz M, et al. Effectiveness of belimumab after rituximab in systemic lupus erythematosus. Ann Intern Med 2021;174(12):1647–57. Available from: https://doi.org/10.7326/M21-2078