Efficacy and safety of pharmacological treatment for Sjögren's disease: a network meta-analysis.

BACKGROUND

Sjögren's disease (SjD) is an autoimmune disease characterized by symptoms such as dry mouth and dry eyes, with potential involvement of multiple organ systems. We aimed to evaluate the efficacy and safety of oral pharmacotherapy for SjD through a network meta-analysis (NMA).

METHODS

PubMed, Embase, Cochrane Library, and Web of Science were searched for randomized controlled trials (RCTs) up to 9 January 2025. The Cochrane Risk of Bias Tool 2.0 was used to estimate the quality of the studies. Bayesian NMA was implemented utilizing the GEMTC package in R (version 4.5.0) to compare the results. Effect sizes were reported as mean differences (MD) or risk ratios (RR) with 95% credible intervals (CrI). Statistical significance was set at P < 0.05. Funnel plots were generated utilizing Stata 18.0 to evaluate publication bias.

RESULTS

We included 27 RCTs involving 2261 participants. Compared to the placebo (PBO) group, iscalimab (MD = -3.4, 95% CrI:-5.2,-1.6), dazodalibep (MD = -2.2, 95% CrI:-3.86,-0.53), iguratimod (MD = -1.85, 95% CrI:-2.63,-1.07), remibrutinib (MD = -2.86, 95% CrI:-4.92, -0.8), leflunomide + hydroxychloroquine (MD = -4.31, 95% CrI: -7.66, -0.94), ianalumab (MD = -1.85, 95% CrI: -3.64, -0.06), and filgotinib (MD = -1.2, 95% CrI: -1.55, -0.85) significantly reduced the European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) score. Additionally, no marked distinctions were detected between oral pharmacotherapy and PBO in the EULAR Sjögren's Syndrome Patient-Reported Index (ESSPRI) score, adverse events, or serious adverse events.

CONCLUSION

Compared to PBO, iscalimab, dazodalibep, iguratimod, remibrutinib, leflunomide + hydroxychloroquine, ianalumab, and filgotinib significantly reduced the ESSDAI score, with no distinctions in the ESSPRI score. No significant differences in safety profiles were fond between any drugs and PBO.