Real-World Effectiveness of Belimumab in Systemic Lupus Erythematosus: A Systematic Literature Review

Abstract

Introduction Belimumab is a recombinant human monoclonal antibody that binds to soluble B-lymphocyte stimulator and inhibits its biological activity. Since receiving approvals for the treatment of systemic lupus erythematosus (SLE), several observational studies have investigated the effectiveness of belimumab in the real-world setting. This study reports a systematic review and meta-analysis of the literature to evaluate the real-world effectiveness of belimumab for the treatment of SLE. Methods A literature search following PRISMA Guidelines and limited to studies in English was performed (2014−2020) to identify relevant studies reporting effectiveness outcomes of belimumab in patients with SLE. A modified version of the Newcastle–Ottawa Scale was used to assess study quality. Outcomes, including SLE Disease Activity Index (SLEDAI) score, prednisone-equivalent use, and SLE flare were pooled and analyzed using statistical aggregation methods. Results The literature search identified 514 articles for initial review. Of these, 17 articles were suitable for data extraction and summary. Baseline characteristics of patients in real-world studies were generally similar to those of relevant clinical trials, including age, sex, disease duration, SLEDAI score, and prednisone-equivalent use. Real-world use of belimumab was associated with reductions in SLEDAI score (mean baseline score to month 6: 10.1–4.4; 57% reduction), prednisone-equivalent dosing (mean baseline dose to month 6: 12.1 mg/day to 6.9 mg/day; 43% reduction), and flare frequency (12 months prior to belimumab to 12 months after belimumab: 1.15–0.39 mean flares per patient per year; 66% reduction). Long-term data (up to 2 years post-treatment initiation) for SLEDAI score and prednisone-equivalent dose indicated that improvements in both outcomes continue over time among patients remaining on therapy. Conclusions In the real-world setting, observed outcomes with belimumab for the treatment of SLE are consistent with those reported from randomized clinical trials. Improvements persist long-term for SLEDAI activity and prednisone-equivalent use with belimumab. Supplementary Information The online version contains supplementary material available at 10.1007/s40744-022-00454-9.

Clinical response trajectories and drug persistence in systemic lupus erythematosus patients on belimumab treatment: A real-life, multicentre observational study

“…In an earlier practice-based study, we demonstrated good tolerability and a significant decline in disease activity in SLE patients under belimumab treatment, irrespective of the baseline serological status ( 12 ). Likewise, a number of other cohorts from different settings and regions of the world have evaluated the use of belimumab in adult SLE patients ( 7 , 13 ), focusing primarily on the frequency and predictors of treatment response including disease duration, baseline disease activity, type of manifestations and pre-existing organ damage ( 14 – 18 ).…”

Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Properties of Rozibafusp Alfa, a Bispecific Inhibitor of BAFF and ICOSL: Analyses of Phase I Clinical Trials

“…In the phase Ia, first-in-human, SAD study (NCT02618967), healthy subjects (N = 65; age 18-65 years) were randomized at a 3:1 ratio to receive a single subcutaneous (s.c.) dose of rozibafusp alfa (7,21,70,140,210,420, or 700 mg) or placebo, with a 15-week follow-up period.…”

“…3 Biologic treatment for SLE by single target inhibition of the BAFF pathway (belimumab) was approved in 2011 and has demonstrated efficacy in clinical trials and in real world settings. [4][5][6][7] More recently, inhibition of interactions between ICOS and ICOSL, as shown in early clinical trials with the anti-ICOSL antibody AMG 557, have demonstrated potential efficacy for the treatment of SLE. 8,9 There are no approved therapies that target BAFF and ICOSL simultaneously.…”

Steroid-sparing effect of belimumab: results from a retrospective observational study of real-world data

“…15 In their systematic review and meta-analysis, Huang et al demonstrated the overall effectiveness of belimumab in SLE in the real-world context, including a reduction of corticosteroid dose. 16 While previous research has evaluated data from randomised trials, retrospective claims and prospective chart reviews, the present study is unique in that it brings the perspective of community rheumatologists by leveraging real-world data from a large US rheumatology network. It seeks to evaluate patterns of OCS use before and during treatment with belimumab.…”