Abstract
BackgroundTripterygium glycosides (TG) has been used to treat a spectrum of inflammatory and autoimmune diseases. Our preliminary studies have shown that TG is effective in the treatment of active Graves’ ophthalmopathy (GO).ObjectiveWe aimed to compare the efficacy and tolerability of TG with intravenous methylprednisolone (iv.MP) in patients with active moderate-to-severe GO.MethodsThis study was an observer-masked, single-centre, block-randomised trial. Patients with active moderate-to-severe GO were randomly assigned to receive iv.MP (500 mg once per week for 6 weeks followed by 250 mg per week for 6 weeks) or with TG (20 mg tablet three times per day for 24 weeks). The primary endpoints were the overall response rate and the patients’ quality of life at 12 and 24 weeks.ResultsIn this study, 161 patients were enrolled and randomised from 2015 to 2019. A total of 79 were randomly assigned to receive iv.MP and 82 to receive TG. A greater overall response rate was found in the TG group compared with the iv.MP group at week 24 (90.2% vs 68.4%, P = 0.000). Similarly, the patients’ quality of life of the TG group showed a significantly higher response than the iv.MP group at week 24 (89.02% vs 72.15%, P = 0.001). The TG therapy showed a better CAS response than the iv.MP (91.5% vs 70.9% improved, P < 0.05), and up to 91.2% of patients were inactive. Also, the TG group showed a significantly higher improved rate of diplopia, proptosis, visual acuity, soft tissue involved and the decrease of eye muscle motility than the iv.MP group at week 24. Significantly more patients in the iv.MP group than the TG group experienced adverse events.ConclusionCompared with iv.MP treatment, TG therapy is more effective and safer for patients with active moderate to severe GO.
Highlights
Graves’ orbitopathy (GO) is an inflammatory autoimmune disorder of the orbit which is associated with autoimmune thyroid disease, especially Graves’ disease [1]
A total of 200 patients with active moderate to severe Graves’ ophthalmopathy (GO) were eligible to participate in the study
Dysthyroid optic neuropathy was not registered in patients in the Tripterygium glycosides (TG) group, whereas it occurred early in five patients in the iv.MP group between weeks 8 and 12
Summary
Graves’ orbitopathy (GO) is an inflammatory autoimmune disorder of the orbit which is associated with autoimmune thyroid disease, especially Graves’ disease [1]. TG provides a strong immunosuppressive effect, strongly inhibited activated T-cells or B-cells, but with a weak action on resting cells and without causing serious damages to the normal immune system [14, 15, 16, 17, 18, 19, 20, 21, 22]. These encouraging findings showed promise for TG in the treatment of several inflammatory autoimmune conditions in which activated leukocytes play a pivotal role in the inflammatory and autoimmune response. Conclusion: Compared with iv.MP treatment, TG therapy is more effective and safer for patients with active moderate to severe GO
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
