Subcutaneous belimumab
Authors:
M. Skácelová
Authors‘ workplace:
III. interní klinika – nefrologická, revmatologická a endokrinologická LF UP a FN, Olomouc
Published in:
Čes. Revmatol., 33, 2025, No. 1, p. 25-31.
Category:
Úvodník
Overview
The use of biologic agents has expanded treatment options for patients with active forms of systemic lupus erythematosus (SLE) who show an inadequate response to standard immunosuppressive therapies. One such agent is belimumab, a fully human recombinant IgG1λ monoclonal antibody that inhibits the binding of soluble B-lymphocyte stimulator (BLyS) to B cells. Belimumab is currently available in two formulations: as an intravenous infusion and, more recently, as a pre-filled syringe for subcutaneous administration.
Keywords:
Systemic lupus erythematosus – biologic therapy – subcutaneous administration – belimumab
Sources
- Horák P, Skácelová M, Schubertová M. Život ohrožující projevy systémového lupusu a antifosfolipidového syndromu ve vnitřním lékařství. Vnitř. Lék. 2018; 64(2): 136–145.
- Danchenko N, Satia JA, Anthony MS. Epidemiology of systemic lupus erythematosus: a comparison of worldwide disease burden. Lupus 2006; 15(5): 308–318.
- Fanouriakis A, Kostopoulou M, Andersen J, et al. EULAR recommendations for the management of systemic lupus erythematosus: 2023 update. Ann Rheum Dis. 2024; 83: 15–29.
- Kidney Disease: Improving Global Outcomes (KDIGO) Lupus Nephritis Work Group. KDIGO 2024 Clinical Practice Guideline for the Management of Lupus Nephritis. Kidney Int. 2024; 105(1S): S1–S69.
- Horák P. Principy léčby SLE dle aktualizovaných doporučení EULAR 2023 – komentář. Čes. Revmatol. 2024; 32(3): 107–115.
- www.sukl.cz
- Stohl W, Schwarting A, Okada M, Scheinberg M, Doria A, Hammer AE, et al. Efficacy and safety of subcutaneous belimumab in systemic lupus erythematosus: a fifty-two-week randomized, double-blind, placebo-controlled study. Arthritis Rheumatol. 2017; 69(5): 1016–1027.
- Cai WW, Fiscella M, Chen C, Zhong ZJ, Freimuth WW, Subich DC. Bioavailability, pharmacokinetics, and safety of belimumab administered subcutaneously in healthy subjects. Clin Pharmacol Drug Dev. 2013; 2(4): 349–357.
- Shida Y, Takahashi N, Sakamoto T, Ino H, Endo A, Hirama T. The pharmacokinetics and safety profiles of belimumab after single subcutaneous and intravenous doses in healthy Japanese volunteers. J Clin Pharm Ther. 2014; 39(1): 97–101.
- Meng X, Wang Q, Wu S, Pu D, Zhang A, Fang S, et al. Pharmacokinetics and safety of intravenous and subcutaneous auto-injector single-dose belimumab in healthy Chinese volunteers: a phase 1, randomized, open-label study. Rheumatol Ther. 2021; 8(4): 1711–1724.
- Yapa SW, Roth D, Gordon D, Struemper H. Comparison of intravenous and subcutaneous exposure supporting dose selection of subcutaneous belimumab systemic lupus erythematosus Phase 3 program. Lupus 2016; 25(13): 1448–1455.
- Furie RA, Petri MA, Wallace DJ, Ginzler EM, Merrill JT, Stohl W, et al. Novel evidence‐based systemic lupus erythematosus responder index. Arthritis Rheum. 2009; 61: 1143–1151.
- Doria A, Bass D, Schwarting A, Hammer A, Gordon D, Scheinberg M, et al. A 6-month open-label extension study of the safety and efficacy of subcutaneous belimumab in patients with systemic lupus erythematosus. Lupus 2018; 27(9): 1489–1498.
- Ramachandran S, Parks D, Kurtinecz M, Roth DA, AlfonsoCristancho R. An indirect comparison of intravenous and subcutaneous belimumab efficacy in patients with SLE and high disease activity. J Comp Eff Res. 2018; 7(6): 581–593.
- Lee YH, Song GG. Comparative efficacy and safety of intravenous or subcutaneous belimumab in combination with standard therapy in patients with active systemic lupus erythematosus: a Bayesian network meta-analysis of randomized controlled trials. Lupus 2018; 27(1): 112–119.
- Parodis I, Girard-Guyonvarc’h C, Arnaud L, Distler O, Domján A, van den Ende CHM, et al. EULAR recommendations for the non-pharmacological management of systemic lupus erythematosus and systemic sclerosis. Ann Rheum Dis. 2024; 83(6): 720–729.
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