Efficacy and safety of thalidomide in the treatment of 29 refractory Crohn's disease patients

Abstract

Objective To evaluate the efficacy and safety of thalidomide (100 to 200mg per day) in the treatment of adult refractory Crohn's disease (CD). Methods From July 2008 to February 2013, 29 refractory CD patients were enrolled in thalidomide (100 to 200 mg per day)cohort study. The clinical activity was evaluated by simplified CD activity index. Patients in clinical remission underwent colon endoscope examination, and mucosal healing was assessed by simple endoscopic score for Crohn's disease (SES-CD). Adverse reactions (ADR) were also observed. Results Among the 29 CD patients, 23 males and six females, the baseline of 19 patients (65.5%) were in clinical active period and 10 in clinical remission period. Among patients with baseline in clinical active period, three patients did not reach the target dose because of ADR, the left 16 patients were treated with thalidomide for one year and 14 patients achieved clinical remission.The median time of inducing clinical remission was one month. A totle of 24 patients with clinical remission induced by thalidomide and with baseline in clinical remission period were assessed in efficacy evaluation of mucosal healing. Thalidomide was withdrawn in three patients in six months because of ADR and colonoscopy evaluation did not complete, while the other 21 patients received colonoscopy evaluation among whom 33.3%(7/21) achieved mucosal healing after two years of thalidomide treatment. Numbness of the hands, feet or mouth, somnolence and dermatitis were the top three ADR of thalidomide treatment. A total of nine patients withdrew the medication because of ADR (four (13.8%) with numbness of the hands, feet or mouth, four (13.8%) with dermatitis and one (3.4%) with leukopenia). Conclusions Thalidomide 100 to 200 mg per day can induce clinical remission and mucosal healing in refractory CD. However, it has some adverse reactions and close monitoring and follow up are required during treatment. Key words: Thalidomide; Crohn disease; Remission induction; Mucosal healing; Adverse reactions