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TYPE I INTERFERONS FOR THE INDUCTION OF REMISSION IN ULCERATIVE COLITIS – A SYSTEMATIC REVIEW & METANALYSIS
CH Seow1,2, EI Benchimol3, AM Griffiths3, AH Steinhart1
1IBD Center, Mount Sinai Hospital, Toronto, Ontario; 2University of Western Australia, Perth, Australia; 3Hospital for Sick Children, Toronto, Ontario
BACKGROUND: Interferons (IFNs) possess immunoregulatory properties and have been used to treat a number of chronic inflammatory disorders. It is postulated that Type I IFNs may re-establish the Th1/Th2 balance in Th2 predominant diseases like ulcerative colitis (UC).
AIM: To systematically evaluate the efficacy and safety of Type I IFN therapy for inducing remission in UC.
METHODS: Randomized controlled trials of Type I IFNs for the induction of remission in UC were reviewed. Electronic databases (MEDLINE, EMBASE, the Cochrane Central Register and ClinicalTrials.gov), review articles, their bibliographies and recent proceedings from major gastroenterology meetings were searched. The study population included patients of any age with active UC as defined by a published disease activity index. There were no exclusions based on the type, dose or duration of IFN treatment. Two independent investigators reviewed studies for eligibility, extracted data and assessed study quality using Jadad’s criteria. A random or fixed effects model was chosen based on an assessment of heterogeneity, and studies were weighted using the DerSimonian & Laird or the Mantel-Haenszel method accordingly.
RESULTS: Four studies were eligible for inclusion. Three studies compared Type I IFNs to placebo and a single study of patients with left-sided colitis compared IFNs with prednisolone enemas. There was no significant benefit of Type I IFNs for inducing remission in ulcerative colitis. (RR 1.24; 95% CI 0.81 to 1.90; p=0.33). There was no difference in the time to remission, nor an improvement in clinical, histological or endoscopic endpoints when the IFN group was compared to the control group. Patients who were treated with IFN were three times more likely to withdraw from a trial due to adverse events (RR = 3.14; 95% CI 0.57 to 17.39; p=0.19), however there was no difference in ‘serious’ adverse events (RR 1.02, 95% CI 0.08 – 13.88).
CONCLUSIONS: The existing literature does not support the efficacy of Type I IFNs for inducing remission in patients with UC. Given IFN’s adverse effect profile and limited tolerability, we suggest that results of two identified ongoing trials be evaluated for efficacy and safety prior to commencement of further randomized controlled trials of Type I IFNs in UC.