Clinical Study Data Request Registered Users, Please Login


Proposal 1470

Title of the Proposed Research

The efficacy of biologic drugs in short-duration versus long-duration inflammatory bowel disease

Lead Researcher

Shomron Ben-Horin M.D.

Affiliation

Gastroenterology Department, First Affiliated Hospital of Sun-YatSen University, Guangzhou, China

Funding Source

None

Potential Conflicts of Interest

Consultancy and/or Advisory board fees: Janssen, Takeda, Celltrion, AbbVie, Schering Plough, Falk GmbH, Ferring.

Research support: Celltrion, AbbVie

Consultancy and/or Advisory board fees: Mitsubishi Tanabe Pharma,AbbVie, Eisai

Research support: Eisai

Consultancy and/or Advisory board fees: MSD, Janssen, Sandoz, Biogaran, Hospira, Pfizer, Takeda, Genetech, Celltrion, AbbVie, Mitsubishi, Lily, Celegene, Amgen, Boerhinger, Forward Pharma GmbH, Index Pharmac. Research support: Shire, GSK, AbbVie

Data Sharing Agreement Date

6 June 2016

Lay Summary

Crohn's disease and ulcerative colitis are chronic inflammatory diseases of the gut, affecting roughly 0.1 to 0.5% of the population in westernized countries. The chronic nature of these diseases with accompanying symptoms of diarrhea, rectal bleeding abdominal pain, all take a significant toll on patients quality of life. Moreover, these diseases, collectively known as inflammatory bowel disease (IBD) can culminate in the need for intestinal or colon resection with ensuing surgical morbidity and mortality. Novel biologic therapies have emerged in recent years that are very effective and may change the natural history of IBD. Specifically, some evidence suggest that the use of such agents early after disease onset may be more effective and can prevent future complications before damage to the bowel wall becomes irreversible. However, the data on the benefit of such early use of biologic agents shortly after disease onset is still scant. Coupled with their high cost and possible although rare adverse events, this knowledge gap has lead to unsettled debate on whether therapy with biologics should be initiated at an early phase after disease onset, or whether it should be reserved to later stages in disease course and instituted only in patients who did not respond to prior attempts of treatment with more conventional medicines.

Therefore, the present study aims to systematically analyze all data from clinical trials of FDA-approved biologic agents in IBD, in order to compare their efficacy in patients with short-term early IBD versus their efficacy in patients with a longer duration of disease. For this purpose, we will conduct a meta-analysis of all published randomized controlled trials using approved biologic agents in IBD, and will assess the efficacy of these biologic drugs for IBD in patients with short-term disease of less than 18 months duration, compared to their efficacy in patients with longer disease duration. If this systematic analysis indeed shows there is a tangible benefit for use of biologics early after disease onset rather than at later disease stages, this may comprise an important step forward in our therapeutic strategies aiming to optimize the therapy of IBD and to improve the care of patients with these chronic inflammatory conditions. The results of this study will be disseminated to patients and care-givers by variety of routes including disease-specific educational websites, publication in medical journals as well as in general press, and distribution to patients' societies

Study Data Provided

Study TAKEDA-C13006: A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients With Moderate to Severe Ulcerative Colitis
Study TAKEDA-C13007: A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease
Study TAKEDA-C13011: A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease
Study UCB-C87031: A Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo)
Study UCB-C87032: Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo), Following 3 Doses of Active Drug (CDP870).
Study UCB-C87085: Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease
Study UCB-CDP870037: Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease

Statistical Analysis Plan

The statistical analysis plan will be added after the research is published.

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.