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EFFICACY OF INFLIXIMAB THERAPY FOR SEVERE ULCERATIVE COLITIS
CH Seow, MS Silverberg, AH Steinhart, A Newman, GR Greenberg
Inflammatory Bowel Disease Center, Mount Sinai Hospital, Toronto
BACKGROUND: Infliximab has been shown to be effective therapy for inducing and maintaining remission in patients with moderate-severe active ulcerative colitis (UC) and may reduce the requirement for emergency colectomy.
OBJECTIVE: To assess short and long-term outcomes of infliximab therapy for acute UC patients who failed treatment with corticosteroids.
METHODS: Acute UC patients treated with 3-dose induction followed by scheduled maintenance infliximab (5mg/kg) at a single tertiary IBD referral centre between January 2000 and August 2007 were evaluated for rate of colectomy, clinical and endoscopic activity, steroid discontinuation, and safety. Clinical remission was defined as a modified Mayo Score of 0 (normal number of stools and no rectal bleeding). Endoscopic healing was defined as a Baron Score of 0 (normal mucosal pattern).
RESULTS: A cohort of 84 UC patients (43% female) with a median age of 34 yr (range: 18-79 yr) were treated. The indication for infliximab was acute, severe UC in 15 pts (18%) and chronic disease activity in 69 pts (82%).Two-thirds of the patients had pancolitis. At baseline, 64% of pts had received immunomodulators, (concurrent 35%; prior 30%). A short-term clinical response at 10 weeks occurred in 58 patients (69%) and 7 pts (8%) required colectomy. With a median follow-up of 12 mo (range: 3-95 mo), clinical remission was achieved in 34 pts (40%). The rate of remission was not different for pts with acute severe disease (20%) vs. chronic active disease (45%) (p= 0.13). Endoscopic follow-up evaluation in 67 pts showed mucosal healing in 12 pts (18%). Infliximab was discontinued in 26 pts (31%); 24 pts (29%) required colectomy, at a median time from first infliximab infusion of 3.8 mo (range 0.3-47.5 mo). The rate of colectomy tended to be higher for acute severe disease (43%) vs. chronic refractory disease (26%) (p = 0.28). Of 58 pts continuing on infliximab, 36 (62%) discontinued steroid use. Continuous oral steroid use for >1 yr prior to infliximab initiation predicted lack of clinical response (p=0.04). Age at diagnosis, gender, extent and duration of disease, CRP and the use of concurrent immunosuppression were not significant predictors of clinical remission or response. A single serious adverse event, tuberculosis, occurred in 1 pt, after discontinuation of infliximab.
CONCLUSIONS: Infliximab is a moderately beneficial and safe therapy for patients with steroid refractory UC. The efficacy appears to be similar for acute severe UC requiring hospitalization and chronic active disease. Continuous oral steroid use for >1 yr predicts a lack of clinical response to infliximab.