Abstract: Objective To investigate the clinical efficacy of tocilizumab(TCZ)in the treatment of moderate-to-severe thyroid-associated ophthalmopathy(TAO)with steroid resistance or intolerance. Methods Relevant clinical studies on tocilizumab for moderate-to-severe TAO with steroid resistance or intolerance were retrieved from the following Chinese and English databases: CNKI, CBM, Wanfang Data, VIP, PubMed, Web of Science, Embase, and Cochrane Library. The retrieval period was from the establishment of each database to April 11, 2024. Evaluation indicators included clinical activity score(CAS), exophthalmos, thyroid-stimulating immunoglobulin(TSI)or thyroid-stimulating hormone receptor antibody(TRAb), and adverse reactions. The quality of included randomized controlled trials(RCTs)was assessed using the Jadad scale, while the quality of non-randomized controlled trials was evaluated with the Minors scale. After data extraction, meta-analysis was performed using Stata 18.0 software. For continuous variables, the combined effect size was expressed as standardized mean difference(SMD)with 95% confidence interval(CI). For count data, the rate with 95%CI was used. Results A total of 1 RCT, 1 retrospective cohort study, and 8 before-after self-controlled trials were included, involving 194 subjects. The meta-analysis results showed that tocilizumab significantly reduced CAS ［SMD=-4.99, 95%CI(-6.30, -3.67), P<0.05］, decreased exophthalmos ［SMD=-0.81, 95%CI(-1.35, -0.27), P<0.05］, and lowered TSI/TRAb ［SMD=-0.86, 95%CI(-1.17, -0.55), P<0.05］. The incidence of adverse reactions was 0.35［95%CI(0.20, 0.51), P<0.05］, with most being mild to moderate and severe adverse reactions being rare. Conclusion Tocilizumab has a good therapeutic effect and favorable tolerance in the treatment of moderate-to-severe TAO with steroid resistance or intolerance.

Key words: Tocilizumab, Thyroid associated ophthalmopathy, Graves Ophthalmopathy, Therapeutic effect, Meta-analysis