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P721 Effect of thalidomide on clinical remission in adult with refractory crohn disease, a multicentre, randomised, double-blind clinical trial

X. Peng*1, M. Zhi1, Q. Cao2, P. Hu1, X. Gao1

1The sixth hospital affiliated to sun yat-sen university, Gastroenterology dept., Guangzhou, China, 2Run run shaw hospital affiliated of zhejiang university, Gastroenterology dept., Hangzhou, China

Background

With the development of biological agents, the treatment of Crohn's disease (CD) have improved significantly. However, there are quite a part of CD patients for the treatment of biological agents is invalid or loss in the process of treatment response. Several clinical studies have small sample have evaluated the efficacy and safety of thalidomide in adult with Refractory CD, but the object of study is only limited in children and adolescents.

Methods

Patients were recruited in 2 Inflammatory bowel disease centres in China between August 2016 and October 2018. Adult aged 18 to 50 years were eligible for enrolment if they had active Refractory CD (after failure of steroids, Immunosuppressive drug or biological agent). Thalidomide,100 mg per day, or placebo once daily for 8 weeks. In an open-label extension, non-responders to placebo received thalidomide for an additional 8 weeks. All responders continued to receive thalidomide for an additional minimum 48 weeks. To determine whether thalidomide is effective in inducing remission in refractory CD.

Results

25 patients were randomised to thalidomide and 25 to placebo. There were no significant difference between the two groups baseline. Clinical remission was achieved by significantly more patients treated with thalidomide (17/25 [68.0%] vs. 4/25 [16.6%], p < 0.01). The change in CRP were also more significantly in thalidomide than placebo(9.38 ± 20.6 mg/l vs. −5.08 ± 23.66, p = 0.01). Forty-seven patients who continue to receiving thalidomide after 8 week randomised, 57/5%(27/47) of them achieved clinical remission, and 9 patients had mucosal healing. Overall, 51.8%(14/27) patients maintain remission at 48th week, 2 patients remain mucosal healing. In the whole treatment process, there were 47 cases adverse drug reactions. The three most common kinds of adverse reactions were drowsiness, dermatitis and constipation. There were six patients had numbness symptoms, and four in them had abnormal electromyography.

Conclusion

In adult with refractory Crohn’s disease, thalidomide compared with placebo resulted in improved clinical remission at 8 weeks of treatment. Thalidomide can induced and maintenance clinical remission and mucosal healing in refractory Crohn Disease. Although the incidence of adverse drug reactions was relatively high during the treatment of thalidomide, most of them were mild and well tolerated. Thalidomide can be useful and safely in the treatment with refractory Crohn Disease.