Wan-Chen Shen1,2, Chia-Hwa Lee3,4,5, El-Wui Loh6, An-Tsz Hsieh7,8, Lawrence Chen9, Ka-Wai Tam6,10,11,12. 1. Department of Pharmacy, Taipei Medical University-Shuang Ho Hospital, New Taipei City, Taiwan. 2. College of Pharmacy, Taipei Medical University, Taipei, Taiwan. 3. School of Medical Laboratory Science and Biotechnology, College of Medical Science and Technology, Taipei Medical University, Taipei, Taiwan. 4. Comprehensive Cancer Center of Taipei Medical University, Taipei, Taiwan. 5. Department of Laboratory Medicine, Taipei Medical University-Shuang Ho Hospital, Taipei, Taiwan. 6. Center for Evidence-Based Health Care, Department of Medical Research, Taipei Medical University-Shuang Ho Hospital, New Taipei City, Taiwan. 7. Division of Endocrinology & Metabolism, Department of Internal Medicine, Taipei Medical University-Shuang Ho Hospital, New Taipei City, Taiwan. 8. Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. 9. Lake Erie College of Osteopathic Medicine, Bradenton, Florida. 10. Division of General Surgery, Department of Surgery, Taipei Medical University-Shuang Ho Hospital, New Taipei City, Taiwan. 11. Department of Surgery, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. 12. Cochrane Taiwan, Taipei Medical University, Taipei, Taiwan.
Abstract
STUDY OBJECTIVE: To investigate the efficacy and safety of rituximab in patients with Graves' orbitopathy (GO). DESIGN: Systematic review and meta-analysis of four randomized controlled trials. PATIENTS: A total of 293 patients with GO who received rituximab or control (either glucocorticoids, the established first-line therapy [three trials], or saline [one trial]). MEASUREMENTS AND RESULTS: Relevant studies published before February 2018 were identified from the PubMed, EMBASE, Cochrane Library, and Scopus databases and the ClinicalTrials.gov registry. Individual effect sizes were standardized, and a meta-analysis was conducted to calculate the pooled effect size by using a random-effects model. Treatment efficacy was assessed by measuring the following outcomes: clinical activity score (CAS), sight visual acuity reduction (NOSPECS) score, proptosis, diplopia, changes in eye volume, quality of life, and adverse events. In the four included trials, 113 patients in the rituximab group and 108 patients in the control group were evaluated. Compared with the control group, CAS (weighted mean difference 0.57, 95% confidence interval 0.25-0.89) was significantly reduced at 24 weeks in the rituximab group. Compared with the control group, considerable proptosis reduction was also observed in the rituximab group; however, the difference was not significant. The proportion of adverse events in the rituximab group was not significantly higher than that in the glucocorticoid control group, but one of the included trials indicated that the rituximab group had more serious adverse events than the saline control group. CONCLUSION: Rituximab is a relatively safe and viable treatment that is superior to glucocorticoids or saline for patients with moderate to severe GO. However, the incidence of serious adverse events was disparate among the included trials. Additional studies involving a larger sample size and investigating the optimal rituximab dosage, frequency, and method of administration are warranted.
STUDY OBJECTIVE: To investigate the efficacy and safety of rituximab in patients with Graves' orbitopathy (GO). DESIGN: Systematic review and meta-analysis of four randomized controlled trials. PATIENTS: A total of 293 patients with GO who received rituximab or control (either glucocorticoids, the established first-line therapy [three trials], or saline [one trial]). MEASUREMENTS AND RESULTS: Relevant studies published before February 2018 were identified from the PubMed, EMBASE, Cochrane Library, and Scopus databases and the ClinicalTrials.gov registry. Individual effect sizes were standardized, and a meta-analysis was conducted to calculate the pooled effect size by using a random-effects model. Treatment efficacy was assessed by measuring the following outcomes: clinical activity score (CAS), sight visual acuity reduction (NOSPECS) score, proptosis, diplopia, changes in eye volume, quality of life, and adverse events. In the four included trials, 113 patients in the rituximab group and 108 patients in the control group were evaluated. Compared with the control group, CAS (weighted mean difference 0.57, 95% confidence interval 0.25-0.89) was significantly reduced at 24 weeks in the rituximab group. Compared with the control group, considerable proptosis reduction was also observed in the rituximab group; however, the difference was not significant. The proportion of adverse events in the rituximab group was not significantly higher than that in the glucocorticoid control group, but one of the included trials indicated that the rituximab group had more serious adverse events than the saline control group. CONCLUSION:Rituximab is a relatively safe and viable treatment that is superior to glucocorticoids or saline for patients with moderate to severe GO. However, the incidence of serious adverse events was disparate among the included trials. Additional studies involving a larger sample size and investigating the optimal rituximab dosage, frequency, and method of administration are warranted.
Authors: Vardaan Gupta; Christine L Hammond; Elisa Roztocil; Mithra O Gonzalez; Steven E Feldon; Collynn F Woeller Journal: Surv Ophthalmol Date: 2021-09-04 Impact factor: 6.197