Systematic Review and Meta-Analysis of the Efficacy and Safety Profile of Belimumab in Combination with Standard Therapy for Adults with Systemic Lupus Erythematosus
Introduction: Systemic lupus erythematosus (SLE) is a multi-system autoimmune disorder marked by pathogenic autoantibodies, resulting in considerable morbidity and mortality. Despite existing diverse treatment regimens, the need for more effective therapies persists. Recent advancements include mono...
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Faculty of Medicine, Universitas Airlangga
2025-01-01
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| Series: | Current Internal Medicine Research and Practice Surabaya Journal |
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| Online Access: | https://e-journal.unair.ac.id/CIMRJ/article/view/66383 |
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| author | Mochamad Rangga Alif Dharmawan Maftuchah Rochmanti Awalia Citrawati Dyah Kencono Wungu |
| author_facet | Mochamad Rangga Alif Dharmawan Maftuchah Rochmanti Awalia Citrawati Dyah Kencono Wungu |
| author_sort | Mochamad Rangga Alif Dharmawan |
| collection | DOAJ |
| description | Introduction: Systemic lupus erythematosus (SLE) is a multi-system autoimmune disorder marked by pathogenic autoantibodies, resulting in considerable morbidity and mortality. Despite existing diverse treatment regimens, the need for more effective therapies persists. Recent advancements include monoclonal antibodies, such as belimumab, which can inhibit receptors tied to SLE’s pathogenesis. This meta-analysis aimed to evaluate the efficacy and safety of combining belimumab and standard therapy compared to placebo in SLE patients, utilizing as many indicators as possible to comprehensively assess the former's potential.
Methods: This study adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and the Cochrane Handbook for Systematic Reviews of Interventions. A thorough literature search was performed across various databases, including PubMed, ScienceDirect, ProQuest, and grey literature sources such as MedRxiv and BioRxiv. The data underwent statistical analysis, with I²<50% indicating low heterogeneity and p<0.05 denoting statistical significance.
Results: The literature search yielded seven records for analysis in this study. All the selected studies were multicenter, phase III/IV, randomized clinical trials published between 2011 and 2019. The selected studies' risk of bias was assessed using Cochrane’s Risk of Bias (RoB) 2 tool. The results indicated that belimumab and standard therapy significantly improved disease activity, reduced flare occurrences—particularly severe flares, lowered corticosteroid dosage, and enhanced key biomarkers compared to placebo. The safety profile was favorable, with significantly minimal side effects, infections, and mortality risks.
Conclusion: Belimumab combined with standard therapy demonstrates promising efficacy and safety for SLE treatment, suggesting its potential for broader adoption in clinical practice.
Highlights:
• This systematic review and meta-analysis provide a thorough and complete analysis of multiple indicators regarding the efficacy and safety of belimumab in the treatment of systemic lupus erythematosus (SLE), which have never been reviewed before.
• The findings of this study may lead to broader acceptance and adoption of belimumab as the standard treatment for SLE. |
| format | Article |
| id | doaj-art-69c85fcf734f4636b51548ddfb6934e7 |
| institution | DOAJ |
| issn | 2721-544X |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Faculty of Medicine, Universitas Airlangga |
| record_format | Article |
| series | Current Internal Medicine Research and Practice Surabaya Journal |
| spelling | doaj-art-69c85fcf734f4636b51548ddfb6934e72025-08-20T03:01:26ZengFaculty of Medicine, Universitas AirlanggaCurrent Internal Medicine Research and Practice Surabaya Journal2721-544X2025-01-0161546410.20473/cimrj.v6i1.6638364551Systematic Review and Meta-Analysis of the Efficacy and Safety Profile of Belimumab in Combination with Standard Therapy for Adults with Systemic Lupus ErythematosusMochamad Rangga Alif Dharmawan0https://orcid.org/0009-0005-3988-2930Maftuchah Rochmanti1https://orcid.org/0000-0002-9222-9376Awalia2https://orcid.org/0000-0002-4232-384XCitrawati Dyah Kencono Wungu3https://orcid.org/0000-0001-5180-957XMedical Study Program, Faculty of Medicine, Universitas Airlangga, Surabaya, IndonesiaDepartment of Anatomy, Histology, and Pharmacology, Faculty of Medicine, Universitas Airlangga, Surabaya, IndonesiaDivision of Rheumatology, Department of Internal Medicine, Dr. Soetomo General Academic Hospital; Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia; Indonesian Society of Internal MedicineDepartment of Physiology and Biochemistry, Faculty of Medicine, Universitas Airlangga, Surabaya, IndonesiaIntroduction: Systemic lupus erythematosus (SLE) is a multi-system autoimmune disorder marked by pathogenic autoantibodies, resulting in considerable morbidity and mortality. Despite existing diverse treatment regimens, the need for more effective therapies persists. Recent advancements include monoclonal antibodies, such as belimumab, which can inhibit receptors tied to SLE’s pathogenesis. This meta-analysis aimed to evaluate the efficacy and safety of combining belimumab and standard therapy compared to placebo in SLE patients, utilizing as many indicators as possible to comprehensively assess the former's potential. Methods: This study adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and the Cochrane Handbook for Systematic Reviews of Interventions. A thorough literature search was performed across various databases, including PubMed, ScienceDirect, ProQuest, and grey literature sources such as MedRxiv and BioRxiv. The data underwent statistical analysis, with I²<50% indicating low heterogeneity and p<0.05 denoting statistical significance. Results: The literature search yielded seven records for analysis in this study. All the selected studies were multicenter, phase III/IV, randomized clinical trials published between 2011 and 2019. The selected studies' risk of bias was assessed using Cochrane’s Risk of Bias (RoB) 2 tool. The results indicated that belimumab and standard therapy significantly improved disease activity, reduced flare occurrences—particularly severe flares, lowered corticosteroid dosage, and enhanced key biomarkers compared to placebo. The safety profile was favorable, with significantly minimal side effects, infections, and mortality risks. Conclusion: Belimumab combined with standard therapy demonstrates promising efficacy and safety for SLE treatment, suggesting its potential for broader adoption in clinical practice. Highlights: • This systematic review and meta-analysis provide a thorough and complete analysis of multiple indicators regarding the efficacy and safety of belimumab in the treatment of systemic lupus erythematosus (SLE), which have never been reviewed before. • The findings of this study may lead to broader acceptance and adoption of belimumab as the standard treatment for SLE.https://e-journal.unair.ac.id/CIMRJ/article/view/66383systemic lupus erythematosusbelimumabplaceboefficacy and safetydisease |
| spellingShingle | Mochamad Rangga Alif Dharmawan Maftuchah Rochmanti Awalia Citrawati Dyah Kencono Wungu Systematic Review and Meta-Analysis of the Efficacy and Safety Profile of Belimumab in Combination with Standard Therapy for Adults with Systemic Lupus Erythematosus Current Internal Medicine Research and Practice Surabaya Journal systemic lupus erythematosus belimumab placebo efficacy and safety disease |
| title | Systematic Review and Meta-Analysis of the Efficacy and Safety Profile of Belimumab in Combination with Standard Therapy for Adults with Systemic Lupus Erythematosus |
| title_full | Systematic Review and Meta-Analysis of the Efficacy and Safety Profile of Belimumab in Combination with Standard Therapy for Adults with Systemic Lupus Erythematosus |
| title_fullStr | Systematic Review and Meta-Analysis of the Efficacy and Safety Profile of Belimumab in Combination with Standard Therapy for Adults with Systemic Lupus Erythematosus |
| title_full_unstemmed | Systematic Review and Meta-Analysis of the Efficacy and Safety Profile of Belimumab in Combination with Standard Therapy for Adults with Systemic Lupus Erythematosus |
| title_short | Systematic Review and Meta-Analysis of the Efficacy and Safety Profile of Belimumab in Combination with Standard Therapy for Adults with Systemic Lupus Erythematosus |
| title_sort | systematic review and meta analysis of the efficacy and safety profile of belimumab in combination with standard therapy for adults with systemic lupus erythematosus |
| topic | systemic lupus erythematosus belimumab placebo efficacy and safety disease |
| url | https://e-journal.unair.ac.id/CIMRJ/article/view/66383 |
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