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Meta-Analysis
. 2015 Sep 14;2015(9):CD006790.
doi: 10.1002/14651858.CD006790.pub3.

Type I interferons for induction of remission in ulcerative colitis

Yongjun Wang  1 , John K MacDonald, Eric I Benchimol, Anne Marie Griffiths, A Hillary Steinhart, Remo Panaccione, Cynthia H Seow
Affiliations
Meta-Analysis

Type I interferons for induction of remission in ulcerative colitis

Yongjun Wang et al. Cochrane Database Syst Rev. .

Abstract

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: We searched MEDLINE, EMBASE, CENTRAL, the Cochrane IBD/FBD group specialised register, and ClinicalTrials.gov from inception to August 8, 2014. Reference lists of trials and review articles, as well as recent proceedings from major gastroenterology meetings were manually searched.

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.

Data collection and analysis: Two independent authors reviewed studies for eligibility, extracted the data and assessed study quality using the Cochrane risk of bias tool. The overall quality of the evidence supporting the outcomes was evaluated using the GRADE criteria. 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. We calculated the risk ratio (RR) and corresponding 95% confidence interval (CI) for dichotomous outcomes. We calculated the mean difference and corresponding 95% confidence interval for continuous outcomes. Meta-analysis was performed using RevMan 5.3.5 software.

Main results: Six studies were eligible for inclusion (517 patients). Five studies compared type I IFNs to placebo injections (485 patients) and a single study compared IFNs to prednisolone enemas in patients with left-sided colitis (32 patients). The active comparator study was rated as high risk of bias due to an open-label design. Three studies were rated as unclear risk of bias for random sequence generation and allocation concealment. Two studies described as double blind were rated as unclear risk of bias for blinding. There was no significant benefit of type I IFNs over placebo for inducing clinical remission or improvement in patients with active ulcerative colitis. Thirty-six per cent (87/242) of patients in the type I IFNs group achieved clinical remission by 8 to 12 weeks compared to 30% (36/120) of placebo patients (RR 1.16, 95% CI 0.84 to 1.58; 4 studies, 362 patients). A GRADE analysis indicated that the overall quality of the evidence supporting the outcome clinical remission was moderate due to sparse data (123 events). Fifty-six per cent (149/264) of patients in the type I IFNs group improved clinically by 8 to 12 weeks compared to 48% (77/161) of placebo patients (RR 1.16, 95% CI 0.96 to 1.40; 4 studies, 425 patients). A GRADE analysis indicated that the overall quality of the evidence supporting the outcome clinical improvement was moderate due to sparse data (226 events). Patients who received type I IFNs were significantly more likely to withdraw from the studies due to adverse events than those who received placebo. Seven per cent (18/42) of type I IFNs patients withdrew due to adverse events compared to 2% (3/152) of placebo patients (RR 3.16, 95% CI 1.06 to 9.40). A GRADE analysis indicated that the overall quality of the evidence supporting the outcome withdrawal due to adverse events was low due to very sparse data (21 events). The study comparing type I IFNs to prednisolone enemas found no difference between the treatment groups in quality of life or disease activity scores. Common adverse events included headaches, arthralgias, myalgias, fatigue, back pain, nausea, application site reactions, rigors, and fevers. There were no statistically significant differences in the other secondary outcomes.

Authors' conclusions: Moderate quality evidence suggests that type I IFNs are not effective for the induction of remission in UC. In addition, there are concerns regarding the tolerability of this class of treatment.

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Conflict of interest statement

YW: None known.

JKM: None known.

EIB: None known.

AMG: Anne Marie Griffiths has received fee(s) from Johnson and Johnson for Board membership; fee(s) from Janssen, Abbvie and Ferring for consultancy; grants or grants pending from Johnson and Johnson and Abbive; lecture fee(s) from: Abbvie and Merck and payment for development of educational presentations from Ferring. All of these activities are outside the submitted work.

AHS: Hillary Steinhart has received fee(s) from Janssen, Abbvie, Shire, Pendopharm, Pfizer, and Takeda for consultancy; and lecture fee(s) from: Janssen, Abbvie, Shire, Warner Chilcott, Aptalis, and Takeda. His institution has received grants or grants pending from Janssen, Abbvie, Pfizer, Amgen, Takeda and Actavis. All of these activities are outside the submitted work. AHS was a collaborator on the paper "Interferon β‐1a in ulcerative colitis: a placebo controlled, randomised, dose escalating study." (Gut 2003;52:1286‐1290) and Mount Sinai Hospital, Toronto, Ontario, CANADA was one of the participating study centres in the clinical trial.

RP: Remo Panaccione has received fee(s) from Abbott, Abbvie, Allergan, Actavis, Biogen Idec, Celgene, Eisai, Elan, Ferring, Genentech, Janssen, Merck, Nestle, Osiris, Prometheus, Qu Biologics, Roche, Salix, Takeda, Teva, Vertex, Warner Chilcott for consultancy; grants or grants pending from Abbvie, Janssen; lecture fee(s) from: Abbott, Abbvie, Ferring, Janssen, Shire, Takeda; and payment for development of educational presentations from Abbvie, Janssen, Takeda, Shire. All of these activities are outside the submitted work. RP was a collaborator on the paper "Interferon‐ß‐1a in active moderate to severe ulcerative colitis: Efficacy and safety from a phase IIa multicenter study." (American Journal of Gastroenterology 2010;105:S446).

CHS: Cynthia Seow has served as a consultant and on advisory boards for Janssen Pharmaceuticals, Abbvie, Takeda, Shire and Actavis. She previously held a grant through Janssen Pharmaceuticals. Dr. Seow has also provided lectures for Janssen Pharmaceuticals and Warner Chilcott. All of these activities are outside the submitted work.

Figures

1
1
Study flow diagram.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
3
3
Forest plot of comparison: 1 Type I Interferons versus placebo, outcome: 1.1 Remission (non pooled data).
1.1
1.1. Analysis
Comparison 1 Type I Interferons versus placebo, Outcome 1 Remission (non pooled data).
1.2
1.2. Analysis
Comparison 1 Type I Interferons versus placebo, Outcome 2 Remission (pooled data).
1.3
1.3. Analysis
Comparison 1 Type I Interferons versus placebo, Outcome 3 Remission ‐ sensitivity analysis (IFN beta‐isoform).
1.4
1.4. Analysis
Comparison 1 Type I Interferons versus placebo, Outcome 4 Remission ‐ sensitivity analysis (IFN alpha‐isoform).
1.5
1.5. Analysis
Comparison 1 Type I Interferons versus placebo, Outcome 5 Time to remission.
1.6
1.6. Analysis
Comparison 1 Type I Interferons versus placebo, Outcome 6 Clinical improvement.
1.7
1.7. Analysis
Comparison 1 Type I Interferons versus placebo, Outcome 7 Clinical improvement ‐ sensitivity analysis published manuscripts only (fixed‐effect model).
1.8
1.8. Analysis
Comparison 1 Type I Interferons versus placebo, Outcome 8 Endoscopic activity index score.
1.9
1.9. Analysis
Comparison 1 Type I Interferons versus placebo, Outcome 9 Serious adverse events.
1.10
1.10. Analysis
Comparison 1 Type I Interferons versus placebo, Outcome 10 Serious adverse events ‐ sensitivity analysis published manuscripts only (random‐effects model).
1.11
1.11. Analysis
Comparison 1 Type I Interferons versus placebo, Outcome 11 Overall withdrawals.
1.12
1.12. Analysis
Comparison 1 Type I Interferons versus placebo, Outcome 12 Overall withdrawals ‐ sensitivity analysis published manuscripts only (fixed‐effect model).
1.13
1.13. Analysis
Comparison 1 Type I Interferons versus placebo, Outcome 13 Withdrawals due to adverse events.
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