Objective: This study aimed to evaluate the efficacy including the patients' response rates to infliximab (IFX) therapy, relapse rates after IFX-induced clinical remission, and the safety of IFX in Chinese patients with ulcerative colitis (UC) from a single center in southern China and to identify the risk factors associated with disease relapse.
Methods: Medical records of Chinese UC patients who were diagnosed and received at least two infusions of IFX at Nanfang Hospital, Southern Medical University from July 2010 to February 2013 were retrospectively reviewed. Primary outcomes were regarded as the clinical response and relapse rates during 30 weeks after the initiation of the therapy. Overall adverse events and relapse-related risk factors were also evaluated.
Results: A total of 24 UC patients was finally included. The clinical response and remission rates were 83.3% and 50.0% at week 2, 91.3% and 73.9% at week 6 and 84.6% and 61.5% by week 30. Relapse after IFX-induced clinical remission was initiated at the fourth infusion. The relapse rate was 29.4% at week 14, 25.0% at week 22 and 20.0% at week 30, respectively. After 30 weeks only 33.3% remained on maintenance therapy. IFX-associated adverse events occurred in 29.2% of patients, with most being mild and transient. Patients with distal or extensive colitis were at a higher risk of relapse than those with ulcerative proctitis.
Conclusions: IFX is effective and safe in treating Chinese UC patients, although long-term remission is hard to achieve. Distal or extensive colitis may be an independent predictor of disease relapse.
Keywords: China; drug-related side effects and adverse reactions; inflammatory bowel disease; infliximab; recurrence; ulcerative colitis.
© 2014 The Authors. Journal of Digestive Diseases published by Chinese Medical Association Shanghai Branch, Chinese Society of Gastroenterology, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine and Wiley Publishing Asia Pty Ltd.