Type I interferons for treatment of active ulcerative colitis

Seow CH, Benchimol EI, Griffiths AM, Steinhart AH

Published Online:

October 7, 2009

Interferons (IFNs) are mediators of the immune system and have been used to successfully treat a number of chronic inflammatory disorders. The purpose of this systematic review was to examine the effectiveness of type I IFNs for the treatment of active ulcerative colitis (UC). Four studies were eligible for inclusion; three studies compared Type I IFNs to placebo. One study compared type I IFNs to prednisolone enemas. There was no significant benefit of Type I IFNs for the treatment of active UC (including induction of remission). There was no difference in the proportion of patients experiencing 'serious' side effects as a result of therapy, or in the number of patients who withdrew from the trials due to disease progression or side effects. Based on current evidence, the use of type I IFNs for the treatment of active UC cannot be recommended. There are two ongoing trials in this area. We suggest that the results of these trials are evaluated prior to the development of further randomised controlled trials of type I IFNs in UC.

Abstract (click to read)

Background:

Interferons (IFNs) are cytokines which possess immunoregulatory properties and have been used to successfully treat a number of chronic inflammatory disorders. It has been postulated that Type I IFNs may be able to re-establish the Th1/Th2 balance in Th2 predominant diseases like ulcerative colitis.

Objectives:

To systematically evaluate the efficacy and safety of type I IFN therapy for induction of remission in ulcerative colitis.

Search strategy:

The following electronic databases were searched: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, the Cochrane Inflammatory Bowel Disease and Functional Bowel Disorders (IBD/FBD) Group Specialised Trial Register, and http://ClinicalTrials.gov. Reference lists of trials and review articles, as well as recent proceedings from major gastroenterology meetings were manually searched. Contact was made with pharmaceutical companies manufacturing type I IFNs.

Selection criteria:

Randomised controlled trials of type I IFNs for induction of remission in UC were included. The study population included patients of any age with active ulcerative colitis. There were no exclusions based on type, dose or duration of IFN treatment. The primary outcome was induction of remission of ulcerative colitis. Secondary outcomes included: time to remission, mean change in disease activity index score, clinical, histological or endoscopic improvement, improvement in quality of life, and adverse events.

Data collection and analysis:

Two independent investigators reviewed studies for eligibility, extracted the 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. Meta-analysis was performed using RevMan 4.2.10 software.

Main results:

Four studies were eligible for inclusion. Three studies compared type I IFNs to placebo and a single study compared IFNs to prednisolone enemas in patients with left-sided colitis. Meta-analysis was based on the three IFN-placebo studies. There was no significant benefit of type I IFNs over placebo for inducing remission in ulcerative colitis (RR 1.24; 95% CI 0.81 to 1.90). There were no statistically significant differences in any of the secondary outcome variables.

Authors' conclusions:

The existing literature does not support the efficacy of type I IFNs for induction of remission in patients with UC. Given concerns regarding the tolerability of IFN therapy, we suggest that the results of two ongoing trials are evaluated for efficacy and safety prior to development or commencement of further randomised controlled trials of type I IFNs in UC.

This record should be cited as:

Seow CH, Benchimol EI, Griffiths AM, Steinhart AH. Type I interferons for induction of remission in ulcerative colitis. Cochrane Database of Systematic Reviews 2008, Issue 3. Art. No.: CD006790. DOI: 10.1002/14651858.CD006790.pub2

Assessed as up to date:

March 25, 2008

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Primary Review Group:

Inflammatory Bowel Disease and Functional Bowel Disorders Group

Health topics:

Gastroenterology > Inflammatory bowel disease > Ulcerative colitis: induction of remission

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Type I interferons for treatment of active ulcerative colitis

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