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Efficacy and safety of rituximab on lung and skin involvement in systemic sclerosis: a systematic review and metaanalysis

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Abstract

Objective

To evaluate the efficacy and safety of rituximab (RTX), an antiB cell monoclonal antibody, on lung and skin involvement in systemic sclerosis (SSc).

Methods

All literature published in Embase and Medline before September 2019 were comprehensively searched. Two independent reviewers selected eligible studies, extracted relevant data, and assessed the quality of the included studies. We only considered randomized, controlled trials (RCTs), cohort studies, and case-control studies that compared RTX with a placebo, other immunosuppressive agents, or corticosteroids. All analyses were performed using RevMan (version 5.3).

Results

A total of 8 studies (3 RCTs and 5 cohort studies) met our inclusion criteria. The pooled analysis showed a significant improvement of modified Rodnan skin score in the RTX group only in the cohort studies (mean difference [SD] − 3.31 [− 4.95, − 1.68]; I2 = 82%). As to the PFT, the RTX group showed a significant improvement in the forced vital capacity only in 3 RCTs (mean difference [SD] 6.59 [3.51, 9.68]; I2 = 0%). Additionally, the RTX group demonstrated a statistically significant improvement in the diffuse capacity of carbon monoxide only in the cohort studies (mean difference [SD] 7.42 [1.08, 13.76]; I2 = 97%). There were no significant differences in the AEs of the RTX and control groups.

Conclusions

RTX may be effective for lung and skin involvement in SSc, with no serious AEs. However, further studies with high quality and a large sample size are necessary to firmly establish the efficacy and safety of the use of RTX with SSc patients.

Key Points

• RTX may be an alternative treatment for cutaneous and pulmonary manifestations in patients with SSc with a favorable safety profile.

• However, further studies with a high quality and large sample size are necessary to firmly establish its efficacy and safety.

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Author information

Authors and Affiliations

  1. Division of Rheumatology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, 8th floor, Asadang Building, 2 Wanglang Road, Bangkok Noi, Bangkok, 10700, Thailand

    Sasimon Borrirukwisitsak & Wanrachada Katchamart

  2. Internal Medicine Center, Siriraj Piyamaharajkarun Hospital, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand

    Pongchirat Tantayakom

Authors
  1. Sasimon Borrirukwisitsak
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  3. Wanrachada Katchamart
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Contributions

All authors contributed to the study conception and design. Sasimon Borrirukwisitsak performed the literature search. All authors performed study selection, data abstraction, and data analysis. The first draft of the manuscript was written by Sasimon Borrirukwisitsak and all authors commented on previous versions of the manuscript. Wanruchada Katchamart critically revised the work. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Wanrachada Katchamart.

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Ethics approval

This is a systematic review and metaanalysis that complies with a “Research with Exemption” category. The Siriraj Institutional Review Broad has confirmed that no ethical approval is required [Protocol number 210/2562 (Exempt), Date of Proof: April 2, 2019].

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Not applicable.

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Not applicable.

Code Availability

Review Manager software (version 5.3).

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Borrirukwisitsak, S., Tantayakom, P. & Katchamart, W. Efficacy and safety of rituximab on lung and skin involvement in systemic sclerosis: a systematic review and metaanalysis. Clin Rheumatol 40, 2779–2789 (2021). https://doi.org/10.1007/s10067-020-05542-1

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  • DOI: https://doi.org/10.1007/s10067-020-05542-1

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