AI Article Synopsis
- The study aims to compare the effectiveness of belimumab versus anifrolumab in treating systemic lupus erythematosus (SLE) to guide treatment decisions.
- By analyzing data from eight randomized trials using a method called multilevel network meta-regression, researchers assessed the SLE Responder Index (SRI)-4 response after 52 weeks of treatment.
- Results indicate that both medications show similar effectiveness, with belimumab appearing slightly more effective, but the uncertainty in results leaves open the possibility of either treatment being more beneficial for specific patient groups.
Article Abstract
Objective: To generate comparative efficacy evidence of belimumab versus anifrolumab in SLE that can inform treatment practices.
Methods: The SLE Responder Index (SRI)-4 response at 52 weeks of belimumab versus anifrolumab was evaluated with an indirect treatment comparison. The evidence base consisted of randomised trials that were compiled through a systemic literature review.A feasibility assessment was performed to comprehensively compare the eligible trials and to determine the most appropriate indirect treatment comparison analysis method. A multilevel network meta-regression (ML-NMR) was implemented that adjusted for differences across trials in four baseline characteristics: SLE Disease Activity Index-2K, anti-double-stranded DNA antibody positive, low complement (C)3 and low C4. Additional analyses were conducted to explore if the results were robust to different sets of baseline characteristics included for adjustment, alternative adjustment methods and changes to the trials included in the evidence base.
Results: The ML-NMR included eight trials: five belimumab trials (BLISS-52, BLISS-76, NEA, BLISS-SC, EMBRACE) and three anifrolumab trials (MUSE, TULIP-1, TULIP-2). Belimumab and anifrolumab were comparable in terms of SRI-4 response (OR (95% credible interval), 1.04 (0.74-1.45)), with the direction of the point estimate slightly favouring belimumab. Belimumab had a 0.58 probability of being the more effective treatment. The results were highly consistent across all analysis scenarios.
Conclusions: Our results suggest that the SRI-4 response of belimumab and anifrolumab are similar at 52 weeks in the general SLE population, but the level of uncertainty around the point estimate means we cannot rule out the possibility of a clinically meaningful benefit for either treatment. It remains to be seen if specific groups of patients could derive a greater benefit from anifrolumab or from belimumab, and there is certainly an unmet need to identify robust predictors towards more personalised selection of available biological agents in SLE.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10186457 | PMC |
| http://dx.doi.org/10.1136/lupus-2023-000907 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Renal response status to predict long-term renal survival in patients with lupus nephritis: results from the Toronto Lupus Cohort.
Lupus Sci Med
November 2024
Value Evidence and Outcomes, GSK, Collegeville, Pennsylvania, USA.
Objective: To evaluate modified versions of the Belimumab International Study in Lupus Nephritis (BLISS-LN) belimumab study primary efficacy renal response (mPERR) and complete renal response (mCRR) criteria (excluding mandatory corticosteroid tapering) as predictors of real-world, long-term renal outcomes among patients with lupus nephritis (LN).
Methods: This retrospective, observational study (GSK Study 212866) used deidentified data between 1970 and 2015 from the University of Toronto Lupus Cohort from adults diagnosed with systemic lupus erythematosus and biopsy-proven Class III±V, IV±V or V LN. At 24 months postbiopsy, patients were retrospectively indexed as responders/non-responders based on mPERR (estimated glomerular filtration rate (eGFR) ≤20% below biopsy value/≥60 mL/min/1.
Belimumab 10 years later: how drug positioning has changed.
Immunol Res
December 2024
Lupus Clinic, Rheumatology Unit, Department of Clinical, Internal, Anesthesiological and Cardiovascular Sciences, Sapienza University of Rome, Viale del Policlinico 155, 00161, Rome, Italy.
We analysed the change in the positioning of belimumab (BLM) in systemic lupus erythematosus (SLE) treatment in the first decade of real-life use, by providing data about patients treated by this biological drug in the Sapienza Lupus Cohort. We evaluated SLE patients treated by BLM according to the current clinical practice. Data of each patient were collected, focusing on previous and concomitant treatments.
View Article and Find Full Text PDFExtrapolation of the Efficacy and Pharmacokinetics of Belimumab to Support its Use in Children with Lupus Nephritis.
Clin Pharmacokinet
September 2024
GSK, R&D, Collegeville, PA, USA.
Background And Objective: Lupus nephritis (LN), a severe manifestation of systemic lupus erythematosus, has greater severity in children versus adults. Belimumab is approved for systemic lupus erythematosus treatment in patients aged ≥ 5 years, and for active LN in adults in the European Union, China, Japan and Latin America, and patients aged ≥ 5 years in the USA. Low prevalence of paediatric active LN makes conducting a clinical study within a reasonable period unfeasible.
View Article and Find Full Text PDFAttainment of remission and low disease activity after treatment with belimumab in patients with systemic lupus erythematosus: a post-hoc analysis of pooled data from five randomised clinical trials.
Lancet 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 PDFEfficacy and safety of sequential therapy with subcutaneous belimumab and one cycle of rituximab in patients with systemic lupus erythematosus: the phase 3, randomised, placebo-controlled BLISS-BELIEVE study.
Ann 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.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!