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

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...

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Autores principales: Huang, Shirley P., Snedecor, Sonya J., Nanji, Sakina, Lloyd, Emily, Bell, Christopher F.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9314515/
https://www.ncbi.nlm.nih.gov/pubmed/35596922
http://dx.doi.org/10.1007/s40744-022-00454-9
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author Huang, Shirley P.
Snedecor, Sonya J.
Nanji, Sakina
Lloyd, Emily
Bell, Christopher F.
author_facet Huang, Shirley P.
Snedecor, Sonya J.
Nanji, Sakina
Lloyd, Emily
Bell, Christopher F.
author_sort Huang, Shirley P.
collection PubMed
description 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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spelling pubmed-93145152022-07-27 Real-World Effectiveness of Belimumab in Systemic Lupus Erythematosus: A Systematic Literature Review Huang, Shirley P. Snedecor, Sonya J. Nanji, Sakina Lloyd, Emily Bell, Christopher F. Rheumatol Ther Review 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. Springer Healthcare 2022-05-21 /pmc/articles/PMC9314515/ /pubmed/35596922 http://dx.doi.org/10.1007/s40744-022-00454-9 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Review
Huang, Shirley P.
Snedecor, Sonya J.
Nanji, Sakina
Lloyd, Emily
Bell, Christopher F.
Real-World Effectiveness of Belimumab in Systemic Lupus Erythematosus: A Systematic Literature Review
title Real-World Effectiveness of Belimumab in Systemic Lupus Erythematosus: A Systematic Literature Review
title_full Real-World Effectiveness of Belimumab in Systemic Lupus Erythematosus: A Systematic Literature Review
title_fullStr Real-World Effectiveness of Belimumab in Systemic Lupus Erythematosus: A Systematic Literature Review
title_full_unstemmed Real-World Effectiveness of Belimumab in Systemic Lupus Erythematosus: A Systematic Literature Review
title_short Real-World Effectiveness of Belimumab in Systemic Lupus Erythematosus: A Systematic Literature Review
title_sort real-world effectiveness of belimumab in systemic lupus erythematosus: a systematic literature review
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9314515/
https://www.ncbi.nlm.nih.gov/pubmed/35596922
http://dx.doi.org/10.1007/s40744-022-00454-9
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