Rituxumab for Sjorgen’s – pro
Rituximab is not FDA approved for Sjorgen’s Syndrome (JS). Two large RCTs did not meet their primary endpoint, several beneficial clinical effects of treatment have been shown; Patients with systemic involvement may benefit most from treatment..The recent metanalysis by Zheng: ” it can significantly enhance the ESSPRI score and pain VAS score in patients. However, it does not have a notable impact on glandular function. The occurrence of adverse effects was like that of the control group. Given the scarcity of research, the findings may be influenced by bias, and a substantial quantity of rigorous investigations is required to validate them.”
Medical necessity is not well supported.
Chen YH, Wang XY, Jin X, Yang Z, Xu J. Rituximab Therapy for Primary Sjögren’s Syndrome. Front Pharmacol. 2021 Sep 2;12:731122. doi: 10.3389/fphar.2021.731122. PMID: 34539411; PMCID: PMC8445329.
St Clair EW, Levesque MC, Prak ET, Vivino FB, Alappatt CJ, Spychala ME, Wedgwood J, McNamara J, Moser Sivils KL, Fisher L, Cohen P; Autoimmunity Centers of Excellence. Rituximab therapy for primary Sjögren’s syndrome: an open-label clinical trial and mechanistic analysis. Arthritis Rheum. 2013 Apr;65(4):1097-106. doi: 10.1002/art.37850. PMID: 23334994; PMCID: PMC3618621.
Onorina Berardicurti et al, Long-term safety of rituximab in primary Sjögren’s syndrome: the experience of a single centre. The Journal of Rheumatology October 2021, jrheum.210441; DOI: https://doi.org/10.3899/jrheum.210441
Xiao Zheng et al, Meta-analysis of the efficacy and safety of rituximab in the treatment of primary Sjögren’s syndrome. SYSTEMATIC REVIEW article Front. Immunol., 23 June 2025