Evaluation of belimumab treatment in patients with systemic lupus erythematosus in a clinical practice setting: Results from a 24-month OBSErve study in Argentina

Babini, Alejandra; A, Cappuccio; Caprarulo, Cesar; Casado, Gustavo; Eimon, Alicia; Figueredo, H; García, Mercedes; Magri, Sebastián; Mannucci, Pier Mannuccio; Rodriguez, Séverine; Pons-Éstel, Bernardo A; Velozo, E.; Iglesias-Rodriguez, Melitza; Streger, G

doi:10.1177/0961203320947814

Cited by 19 publications

(20 citation statements)

References 27 publications

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“…The present study identified trials published up to 2020, excluding potentially relevant studies published later. One publication from July 2020 reported results from the 24-month Argentina OBSErve study of 81 patients with SLE showing that belimumab treatment leads to clinical improvement and reductions in corticosteroid dose, consistent with the findings presented here [ 42 ]. Similar results were also reported in a recently published post hoc pooled analysis of real-world data from six OBSErve studies [ 43 ], most of which were included in our evaluation.…”

Section: Discussionsupporting

confidence: 87%

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

et al. 2022

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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.

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Section: Discussionsupporting

confidence: 87%

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

et al. 2022

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“…This was a post hoc pooled analysis (GSK study 206351) of patient-level data pooled from the six retrospective, observational cohort OBSErve studies from 97 study centers based in Argentina (GSK study 201282), Canada (GSK study 117300), Germany (GSK study 117214), Spain (GSK study 200883), Switzerland (GSK study 201232), and the USA (GSK study 117295) [ 11 – 17 ]. Follow-up times varied between the original studies (OBSErve Canada, Germany, Spain, and Switzerland: 6 months; OBSErve Argentina and USA: up to 24 months), for the current analysis, patient data collected at belimumab start (index date, between September 2012 and March 2016) and at 6 months after index, or at time of discontinuation, were analyzed, because this was the longest duration of follow-up time for which all countries could contribute data (Supplementary Fig.…”

Section: Methodsmentioning

confidence: 99%

Real-World Effectiveness of Belimumab in the Treatment of Systemic Lupus Erythematosus: Pooled Analysis of Multi-Country Data from the OBSErve Studies

et al. 2020

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Introduction The real-world effectiveness of belimumab for systemic lupus erythematosus (SLE) in six countries was evaluated in the OBSErve program. The aim of this post hoc analysis (GSK study 206351) was to pool individual patient OBSErve data to further evaluate the effectiveness of belimumab in a large sample of patients with SLE. Methods OBSErve (Argentina, Canada, Germany, Spain, Switzerland, and the USA) enrolled adults ≥ 18 years of age with SLE, who were prescribed belimumab as part of standard therapy (index: date of belimumab initiation). Endpoints (month 6 vs. index) included physician-assessed overall clinical response to belimumab in the overall population (primary) and high disease activity subgroups (secondary; patients with a SLEDAI-2K/SELENA-SLEDAI score ≥ 10 or patients with high anti-dsDNA or low complement at index); other secondary endpoints included changes in glucocorticosteroid (GCS) use and changes in disease activity. Factors associated with physician-assessed overall clinical response were also evaluated. Results In total, 830 patients were included in the overall population (mean [standard deviation (SD)] age: 41.9 [12.57] years; female: 89.3%; 60.4% from the USA). Nearly half (48.1%) of belimumab-treated patients experienced a ≥ 50% physician-assessed improvement in their overall manifestations, and 13% achieved a near normalization of their condition (equal to ≥ 80% improvement). Initiating belimumab while on high-dose (> 7.5 mg/day) GCS use was associated with ≥ 50% clinical improvement at month 6 (OR: 1.9, p = 0.003). Most (78.1%; n = 518/663) patients were able to reduce or discontinue their oral GCS dose after 6 months of belimumab, with a mean (SD) change of − 8.5 (10.74) mg/day prednisone-equivalent. The mean (SD) change from belimumab initiation in disease activity score (SLEDAI-2K/SELENA-SLEDAI) was − 5.7 (4.5; n = 344). Conclusions Belimumab improves clinical manifestations of SLE and is associated with GCS dose reductions in a real-world clinical setting, supporting the real-world effectiveness of belimumab for SLE. Electronic Supplementary Material The online version of this article (10.1007/s40744-020-00243-2) contains supplementary material, which is available to authorized users.

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“…Characteristics of included studies. A total of seven RCTs (11)(12)(13)(14)(15)(16)(17) and 19 case series (18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34)(35)(36) were included in the analysis, including 6,832 patients with SLE. The details of the aforementioned studies are presented in Tables I and II.…”

Section: Resultsmentioning

confidence: 99%

Efficacy and safety of belimumab in the treatment of systemic lupus erythematosus: A meta‑analysis

Zhang

Liu

et al. 2022

World Acad Sci J

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The present meta-analysis aimed to systematically review the efficacy and safety of belimumab (BLM) therapy for patients with active and autoantibody-positive systemic lupus erythematosus (SLE) treated with standard of care (SOC). To evaluate the efficacy and safety of BLM plus SOC treatment in patients with active SLE, eligible studies were retrieved from the Web of Science, The Cochrane Library, PubMed and Embase online databases up to July, 2021. Review Manager (version 5.3) and STATA 16.0 software were used to analyze the extracted data from the included studies. A total of seven randomized controlled trials (RCTs) and 19 case series, with 4,235 and 2,597 patients with SLE, respectively were analyzed. In the RCTs, there were more SLE responder index (SRI-4) responders in the BLM group compared with the control group [52.8 vs. 41.6%; relative risk (RR), 1.27; 95% confidence interval (95% CI), 1.18-1.37); P<0.00001]. In addition, compared with the placebo group, more patients in the BLM group achieved a ≥4-point reduction in the Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index score (RR, 1.26; 95% CI, 1.15-1.38; P<0.00001). Furthermore, treatment with BLM was found to significantly decrease the risk of severe disease exacerbations (flares) compared with the control group (RR, 0.72; 95% CI, 0.63-0.81; P<0.00001). Additionally, the corticosteroid dosage was reduced by ≥25 or 50% to ≤7.5 mg/day during weeks 40-52 in more patients in the BLM group compared with the control group (RR, 1.44; 95% CI, 1.17-1.76; P= 0.0005). However, no differences were observed in the RR of adverse events (AEs) and severe AEs between both groups (RR, 1.00; 95% CI, 0.97-1.02; P= 0.84; and RR, 0.80; 95% CI, 0.62-1.03; P= 0.08, respectively). In the case series studies, the total remission rate was 60.5% (95% CI, 52.1-68.3%; P= 0.015). In addition, treatment with BLM significantly decreased the use of corticosteroids (mean deviation, -8.73; 95% CI, -11.07 to -6.39; P<0.00001). Overall, the results of the present meta-analysis demonstrated that BLM therapy provided significant clinical efficacy and it was well-tolerated by patients with active SLE. More importantly, treatment with BLM may reduce the use of glucocorticoids.

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Evaluation of belimumab treatment in patients with systemic lupus erythematosus in a clinical practice setting: Results from a 24-month OBSErve study in Argentina

Cited by 19 publications

References 27 publications

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

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

Real-World Effectiveness of Belimumab in the Treatment of Systemic Lupus Erythematosus: Pooled Analysis of Multi-Country Data from the OBSErve Studies

Efficacy and safety of belimumab in the treatment of systemic lupus erythematosus: A meta‑analysis

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