P596 Analysis on adverse drug reactions of 103 inflammatory bowel disease patients using thalidomide
P. Xiang*1, S. Ming-li2, G. xiang2, Z. Ming2
1The Sixth Affiliated Hospital, Sun Yan-sen University, Department of Gastroenterology, Guangzhou, China, 2The Sixth Affiliated Hospital, Sun Yan-sen University, Guangzhou, China
To examine the safety of thalidomide, for providing clinical reference, in the treatment of inflammatory bowel disease
In total, 103 patients with inflammatory bowel diseases (92 Crohn’s disease; 11 ulcerative colitis) treated with thalidomide were enrolled in this study, in which the incidence, type, severity, duration of thalidomide-related adverse drug reaction (ADR) and the dose-effect relationship of neurotoxicity were analysed.
All the patients were treated with a mean dose of thalidomide (79.12 ± 28.23) mg/d for (21.3 ± 11.9) months, and 79 occurred ADR. The 3 most frequent ADR were somnolence [52.4% (37/103)], numbness [35.9% (37/103)], constipation [30.0% (31/103)]. The median time to development of 3 ADR were 0.26, 2.30, and 1.20 months, respectively. Severe ADR leading to withdrawal accounted for 12.6% (13/103), including reasons of numbness (5/103), constipation (4/103), dermatitis (1/103), ALT/AST abnormal (1/103), thrombosis (1/103), memory decline (1/103). The incidence of peripheral neuritis was not significantly related to maximal and initial dose of thalidomide (p > 0.05).
Thalidomide can be safely used in patients with inflammatory bowel disease under close monitoring even though accompanying with relatively high incidence of ADR, most of which were mild and well tolerated, during the treatment of thalidomide.