Intervention Review

Type I interferons for induction of remission in ulcerative colitis

  1. Cynthia H Seow1,*,
  2. Eric I Benchimol2,
  3. Anne Marie Griffiths2,
  4. A Hillary Steinhart3

Editorial Group: Cochrane Inflammatory Bowel Disease and Functional Bowel Disorders Group

Published Online: 16 JUL 2008

Assessed as up-to-date: 24 MAR 2008

DOI: 10.1002/14651858.CD006790.pub2


How to Cite

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.

Author Information

  1. 1

    University of Calgary, Departments of Medicine & Community Health Sciences, Calgary, Alberta, Canada

  2. 2

    The Hospital for Sick Children, Division of Gastroenterology, Hepatology & Nutrition, Toronto, Ontario, Canada

  3. 3

    University of Toronto, Department of Medicine, Toronto, Ontario, Canada

*Cynthia H Seow, Departments of Medicine & Community Health Sciences, University of Calgary, TRW Building Rm 6D18, 3280 Hospital Drive NW, Calgary, Alberta, T2N 4Z6, Canada. cynthia.seow@albertahealthservices.ca.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 16 JUL 2008

SEARCH

 

Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. アブストラクト

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 methods

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.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. アブストラクト

Type I interferons for treatment of active ulcerative colitis

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.

 

アブストラクト

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. アブストラクト

潰瘍性大腸炎の寛解導入のためのI型インターフェロン

背景

インターフェロン(IFN)は免疫調節特性を有するサイトカインであり、多数の慢性炎症性疾患を成功裏に治療するために使用されている。I型IFNは潰瘍性大腸炎のようなTh2優勢疾患においてTh1/Th2バランスを再確立できると仮定されている。

目的

潰瘍性大腸炎の寛解導入のためのI型IFN療法の有効性と安全性をシステマティックに評価する。

検索戦略

以下の電子データベースを検索した:MEDLINE、EMBASE、Cochrane Central Register of Controlled Trials、Cochrane Inflammatory Bowel Disease and Functional Bowel Disorders (IBD/FBD) Group Specialised Trial Register、http://ClinicalTrials.gov。試験とレビュー論文の参考文献リストおよび主要な消化器病学会の最近の大会予稿集をマニュアルで検索した。I型IFNを製造している製薬企業に問い合わせた。

選択基準

潰瘍性大腸炎の寛解導入のためのI型IFNに関するランダム化比較試験を含めた。研究対象集団にはあらゆる年齢の活動性潰瘍性大腸炎患者が含まれた。IFN治療の種類、投与量、投与期間に基づく除外は行わなかった。主要アウトカムは潰瘍性大腸炎の寛解導入とした。副次アウトカムには、寛解までの時間、クローン病活性指数の平均スコア変化、臨床的、組織的または内視鏡的改善、生活の質の改善、有害事象が含まれた。

データ収集と分析

2名のレビューアが研究の適格性を独自にレビューし、データを抽出し、Jadadの基準を用いて研究の質を評価した。異質性の評価に基づいてランダム効果モデルまたは固定効果モデルを選択し、適宜DerSimonian & Laird法またはMantel-Haenszel法を用いて重み付けを行った。RevMan 4.2.10ソフトウェアを用いてメタアナリシスを行った。

主な結果

4件の研究が適格と判断され選択された。3件の研究はI型IFNをプラセボと比較しており、1件の研究は左側大腸炎患者においてIFNをプレドニゾロン注腸と比較していた。3件のIFN-プラセボ研究に基づいてメタアナリシスが行なわれた。潰瘍性大腸炎の寛解導入について、I型IFNにはプラセボを上回る有意な利益はなかった(RR1.24、95% CI 0.81~1.90)。副次アウトカム変数のいずれについても統計学的に有意な差はなかった。

著者の結論

現時点の文献から、潰瘍性大腸炎患者の寛解導入のためのI型IFNの有効性を裏付けるデータはない。IFN療法の忍容性の問題を考慮し、潰瘍性大腸炎においてI型IFNに関するさらなるランダム化比較試験を展開または実施する前に、実施中の試験2件の結果からの有効性と安全性の評価を提案する。

訳注

監  訳: 吉田 雅博,2008.11.18

実施組織: 厚生労働省委託事業によりMindsが実施した。

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