Efficacy and safety of tocilizumab in the treatment of Graves' orbitopathy: a systematic review and meta-analysis.

PURPOSE: This meta-analysis aimed to explore the safety and efficacy of tocilizumab (TCZ) for moderate to severe steroid-resistant active Graves' orbitopathy (GO).

DESIGN

Systematic review and meta-analysis of 1 randomized controlled trial and 6 cohort studies.

MATERIALS AND

METHODS

We searched Pubmed, EMBASE and The Cochrane Library for relevant studies published before June 1, 2022. The primary outcome indicator was the change in clinical activity score (CAS). Secondary outcome indicators were a reduction in proptosis and correction of diplopia. Random effects models were used for all analytical models. The mean difference (MD) and standardized mean difference (SMD) of the combined effect sizes of these outcome indicators were calculated for continuous variables. The odds ratio (OR) of the combined effect size of these outcome indicators was calculated for the dichotomous variables. The study was registered with PROSPERO, CRD 42,022,381,596.

RESULT: Seven studies (n = 161) were included in the meta-analysis. The analysis showed that treatment of moderate to severe steroid-resistant active GO patients with TCZ resulted in improvements in CAS [SMD 4.25, 95% CI(2.94, 5.57), P < 0.00001], proptosis [MD 2.13, 95% CI (1.45, 2.80), P < 0.00001] and diplopia [OR 6.00, 95% CI(2.93, 12.30), P < 0.00001].

CONCLUSION

Our results strongly suggest that the use of TCZ for the treatment of patients with moderate to severe GO is very beneficial in reducing CAS, improving proptosis, and correcting diplopia. However, the incidence of serious adverse events varied among the included studies. Future randomized controlled trials (RCT) are necessary for further exploration.

CLINICAL TRIAL NUMBER: Not applicable.

PROSPERO: CRD42022381596.