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Efficacy of rituximab versus tacrolimus in difficult-to-treat steroid-sensitive nephrotic syndrome: an open-label pilot randomized controlled trial
- Source :
- Pediatric Nephrology. December, 2022, Vol. 37 Issue 12, p3117, 10 p.
- Publication Year :
- 2022
-
Abstract
- Background Rituximab and tacrolimus are therapies reserved for patients with frequently relapsing or steroid-dependent nephrotic syndrome who have failed conventional steroid-sparing agents. Given their toxicities, demonstrating non-inferiority of rituximab to tacrolimus may enable choice between these medications. Methods This investigator-initiated, single-center, open-label, pilot randomized controlled trial examined the non-inferiority of two doses of intravenous (IV) rituximab given one-week apart to oral therapy with tacrolimus (1:1 allocation), in maintaining sustained remission over 12 months follow-up, in patients with difficult-to-treat steroid-sensitive nephrotic syndrome, defined as frequently relapsing or steroid-dependent disease that had failed [greater than or equal to] 2 steroid-sparing strategies. Secondary outcomes included frequency of relapses, proportion with frequent relapses, time to relapse and frequent relapses, and adverse events (CTRI/2018/11/016342). Results Baseline characteristics were comparable for 41 patients randomized to receive rituximab (n = 21) or tacrolimus (n = 20). While 55% of patients in each limb were in sustained remission at 1 year, non-inferiority of rituximab to tacrolimus was not demonstrated (mean difference 0%; 95% CI - 30.8%, 30.8%; non-inferiority limit - 20%; P = 0.50). Frequent relapses were more common in patients administered rituximab compared to tacrolimus (risk difference 30%, 95% CI 7.0, 53.0, P = 0.023). Both groups showed similar reductions in relapse rates and prednisolone use. Common adverse events were infusion-related with rituximab and gastrointestinal symptoms with tacrolimus. Conclusions Therapy with rituximab was not shown to be non-inferior to 12-months treatment with tacrolimus in maintaining remission in patients with difficult-to-treat steroid-sensitive nephrotic syndrome. Frequent relapses were more common with rituximab. While effective, both agents require close monitoring for adverse events. Graphical abstract A higher resolution version of the Graphical abstract is available as Supplementary information.<br />Author(s): Georgie Mathew [sup.1] , Aditi Sinha [sup.1] , Aijaz Ahmed [sup.1] , Neetu Grewal [sup.1] , Priyanka Khandelwal [sup.1] , Pankaj Hari [sup.1] , Arvind Bagga [sup.1] Author Affiliations: [...]
Details
- Language :
- English
- ISSN :
- 0931041X
- Volume :
- 37
- Issue :
- 12
- Database :
- Gale General OneFile
- Journal :
- Pediatric Nephrology
- Publication Type :
- Academic Journal
- Accession number :
- edsgcl.723704094
- Full Text :
- https://doi.org/10.1007/s00467-022-05475-8