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P272. Infliximab for moderate to severe ulcerative colitis: Short‑ and long-term therapy and predictors of response

Y. Ron1, H. Yanai1, M. Ben Yehoyada1, E. Meirovithz1, L. Yahav1, D. Yeshurun2, E. Santo1, I. Dotan1

1Tel Aviv Sourasky Medical Center, Department of Gastroenterology & Hepatology, Tel Aviv, Israel; 2Tel Aviv Sourasky Medical Center, Internal Medicine Consultations, Tel Aviv, Israel

Background: Infliximab was reported as an effective therapy for moderate to severe ulcerative colitis (UC). Yet, its post-marketing short and long term effects are still vague and prediction of response is obscure.

Methods: A prospective study was conducted at the Tel Aviv Sourasky Medical Center, a tertiary referral center for inflammatory bowel disease patients. Steroid dependent or refractory UC patients who received at least one infliximab infusion (5 mg/kg) were included.

Demographic, clinical, endoscopic and laboratory parameters, including infliximab trough levels, were detected in at least 2 time points.

Clinical response was defined as partial: decrease in 1 point of the Mayo score, or complete: decrease of at least 3 points or 30% decrease in the Mayo score. Response was assessed for the short (=12 weeks) and long (=52 weeks) term. Adverse events were registered as well.

Results: Thirty patients were recruited (age 34.5±15 yrs) 17 females, 43.3% smokers & ex-smokers. Median follow-up was 36 months (range 3–84 weeks). Mayo scores at the beginning of infliximab was 8±2 and after induction therapy, within a period of 12 weeks the score decreased to 3±2. Twenty one patients (70%) had short term complete response. Sixteen of the initial responders (55.7%) maintained long term complete clinical remission without steroids, while 4 of them (13.8%) had partial response. Dose intensification was required in 8 patients (26.7%), 5 patients (17.3%) did not respond and therapy was changed.

Five adverse events were detected in 4 patients: serum sickness (1), and infectious complications (4). Only one event was serious. No infusion reactions were experienced in this group.

Short and long term response in active smokers and ex-smokers was 83.3% (10 patients) and 58.3% (7 patients), respectively.

Endoscopic evaluation performed at two time points demonstrated mucosal healing in five patients (16.7%), and partial endoscopic improvement in 10 patients (33.3%) Mucosal healing correlated with clinical response.

Infliximab average trough levels detected during maintenance were 2.41 µg/ml. Correlation between trough levels and clinical response existed in 16 patients (53.3%).

Conclusions: Infliximab is an effective and safe treatment for moderate to severe, steroid refractory/dependent UC.

Smoking is a positive predictive factor for initial response to infliximab in UC patients.

Significant correlation was found between clinical response, endoscopic parameters and serum infliximab levels.