Safety and efficacy of adding voclosporin to standard treatment of lupus nephritis in adult patients: a meta-analysis and time-to-event analysis of randomized controlled trials

Theodor Bilharz Research Institute

Bibliographic Information

Authors: Sayed M.S.; Murad M.R.; Kareem H.N.; Belabaci Z.; Abdelhamid M.T.; Humade S.H.; Abdullah L.; Abdulazeem H.

Journal: International Urology and Nephrology

Publisher: Springer Science and Business Media B.V.

Publication Date: 1 April 2026

Volume / Issue: Volume 58 / Issue 9

Pages: 3747–3758

ISSN: 3011623

DOI: 10.1007/s11255-026-05058-8

Scopus: View on Scopus

PubMed: 41922881

Document Type: Review

Authors and Affiliations

Sayed M.S., Faculty of Medicine, Beni-Suef University, Beni Suef, 62511, Egypt; Murad M.R., Faculty of Medicine, Al-Azahar University, Cairo, Egypt, Medical Research Group of Egypt (MRGE), Negida Academy, Arlington, MA, United States; Kareem H.N., Nursing College, Al-Qadisiyah University, Al-Diwaniya, Iraq; Belabaci Z., Faculty of Medicine, Djillali Liabes University, Sidi Bel Abbes, Algeria; Abdelhamid M.T., Theodor Bilharz Research Institute, Giza, Egypt; Humade S.H., Nursing College, Al-Mustaqbal University, Babil, Hillah, 51001, Iraq; Abdullah L., Pharmacology and toxicology department, Faculty of pharmacy, IUST, Ghabageb, Syrian Arab Republic; Abdulazeem H., Epidemiology, TUM School of Medicine and Health, Technical University of Munich, Munich, 80809, Germany

Abstract

Background: Lupus Nephritis (LN) is one of the most common complications of systemic lupus erythematosus. Recent primary studies have stated the superiority of adding voclosporin to standard treatment regimens in reducing proteinuria in LN patients. In this meta-analysis, we evaluate the safety and efficacy of combining voclosporin in patients with LN. Methods: We searched PubMed, Embase, Scopus, and Web of Science on February 25, 2025, to identify randomized controlled trials (RCTs) that compared the use of voclosporin with standard treatment versus placebo. The Cochrane ROB 2.0 tool was used to assess the quality of the included studies. Cumulative hazard ratio (HR) and risk ratio (RR) with their corresponding 95% confidence intervals (CI) were calculated using R and RevMan software. Results: 770 patients with LN were included in the three RCTs, with a mean age of 33.01(SD, 9.94) years. Voclosporin significantly achieved a higher reduction of the urine protein-to-creatinine ratio (UPCR) below 50% of its baseline value [HR: 1.97, 95% CI 1.66 to 2.35, log-rank p < 0.001], and below 0.5 g/g [HR: 1.84, 95% CI 1.43 to 2.37, log-rank p < 0.001] compared to placebo. There were higher complete and partial response rates at 6 months and 12 months in the voclosporin group, respectively. The overall adverse events and treatment-related serious adverse events significantly increased in the voclosporin group, which increases the clinical concerns of using voclosporin in LN patients. Conclusion: This analysis highlights the superior efficacy outcomes of voclosporin in inducing LN remission and reducing proteinuria. However, the risk of adverse effects was higher when voclosporin was used. Larger primary studies are needed to explore its exact safety profile. © The Author(s), under exclusive licence to Springer Nature B.V. 2026.

Keywords

Calcineurin inhibitors; Lupus nephritis; Time-to-event analysis; Voclosporin; corticosteroid; adult; clinical outcome; data extraction; disease activity; disease duration; drug efficacy; drug safety; estimated glomerular filtration rate; follow up; gastrointestinal disease; human; kidney function; lupus erythematosus nephritis; medical research; meta analysis; Newcastle-Ottawa scale; outcome assessment; protein creatinine ratio; protein urine level; quality control; randomized controlled trial (topic); Review

Citation Information

Scopus Citations: 1

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