Belimumab is a novel add-on therapy that has been approved for patients with active and antibody-mediated systemic lupus erythematosus. It is a monoclonal antibody that decreases the activation of B-cells and consequently decreases antibodies' production. Recently, the US Food and Drug Administration approved subcutaneous belimumab for patients who have received training on using it. Subcutaneous belimumab can be administered using either a prefilled syringe or an auto-injector device. Weekly subcutaneous belimumab seems to be as effective as monthly intravenous belimumab with a similar safety margin. In this article, we reviewed the literature on subcutaneous belimumab focusing on safety and patients' experiences and satisfaction. Overall, subcutaneous belimumab appears to be preferred over intravenous belimumab for a number of reasons. However, more studies are still required to prove these findings.
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http://dx.doi.org/10.2147/PPA.S147163 | DOI Listing |
Immunol Lett
December 2024
Lupus Clinic, Rheumatology, Dipartimento di Scienze Cliniche Internistiche Anestesiologiche e Cardiovascolari, Sapienza Università di Roma, Viale del Policlinico 155 00161 Rome, Italy.
Systemic lupus erythematosus (SLE) is characterized by B cell dysregulation and expansion of atypical B cells that may correlate with disease manifestations and activity. This study investigated the impact of subcutaneous (sc) Belimumab (BLM) on the peripheral B cell compartment and on the functional properties of CD21, T-bet and CD11c atypical B cells, in 21 active SLE patients over a 12-month period. At baseline, active SLE patients displayed reduced unswitched IgM memory B cells and expansion of atypical B cells, compared to healthy donors and to SLE patients in remission.
View Article and Find Full Text PDFBr J Clin Pharmacol
September 2024
GSK, Stevenage, Hertfordshire, UK.
Aims: The pharmacokinetics (PK) of belimumab, a human immunoglobulin G1λ (IgG1λ) monoclonal antibody treatment for systemic lupus erythematosus (SLE), have been well reported. Clinical PK data in healthy participants and patients with SLE from Mainland China suggest lower-than-expected belimumab exposure. This study assessed inter-regional differences in belimumab exposure and efficacy via the exposure-response relationship to inform any dose-adjustment requirements.
View Article and Find Full Text PDFLancet Rheumatol
November 2024
Department of Rheumatology, Royal Prince Alfred Hospital Sydney, The University of Sydney School of Public Health, Sydney, NSW, Australia.
Background: Disease remission or low disease activity are key treatment targets for patients with systemic lupus erythematosus (SLE). Pivotal trials of belimumab were conducted before the introduction of these targets. In this study, we aimed to pool data across trials to assess attainment of remission and low disease activity in a large, racially and culturally diverse patient population with SLE.
View Article and Find Full Text PDFAnn Rheum Dis
October 2024
Department of Nephrology, Leiden University Medical Center, Leiden, The Netherlands.
Objectives: Disease activity control in patients with systemic lupus erythematosus (SLE) with corticosteroid and immunosuppressant withdrawal is a treatment goal. We evaluated whether this could be attained with sequential subcutaneous belimumab (BEL) and one cycle of rituximab (RTX).
Methods: In this phase 3, double-blind BLISS-BELIEVE trial (GSK Study 205646), patients with active SLE initiating subcutaneous BEL 200 mg/week for 52 weeks were randomised to intravenous placebo (BEL/PBO) or intravenous RTX 1000 mg (BEL/RTX) at weeks 4 and 6 while stopping concomitant immunosuppressants/tapering corticosteroids; standard therapy for 104 weeks (BEL/ST; reference arm) was included.
Clin Exp Rheumatol
July 2024
Lupus Clinic, Division of Rheumatology, Department of Internal Clinical Sciences, Anaesthesiologic and Cardiovascular Sciences, Sapienza University of Rome, Italy.
Objectives: To assess the efficacy of subcutaneous (sc) belimumab (BLM) by the application of SLE-DAS in a monocentric SLE cohort.
Methods: We evaluated SLE patients treated with sc BLM from March 2019. Disease activity has been assessed by SLEDAI-2k, SLE-DAS and PGA (Physician Global Assessment) in all the established time-points [baseline (T0), after 1 (T1), 3 (T3), 6 (T6) and 12 (T12) months].
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