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Comparative efficacy of biologics in resolving extraintestinal manifestations of inflammatory bowel disease (IBD): a systematic review and meta-analysis
Proposal
1813
Title of Proposed Research
Comparative efficacy of biologics in resolving extraintestinal manifestations of inflammatory bowel disease (IBD): a systematic review and meta-analysis
Lead Researcher
Purna C. Kashyap, MBBS
Affiliation
Mayo Clinic
Funding Source
None
Potential Conflicts of Interest
Data Sharing Agreement Date
4 Mar 2019
Lay Summary
The inflammatory bowel diseases (IBD) are a group of heterogeneous diseases of the digestive system. Over 1 million individuals are estimated to have IBD in the United States with direct medical costs calculated to exceed $6 billion. The most common forms of IBD are Crohn's disease (CD) and ulcerative colitis (UC). Although both forms of IBD are characterized by inflammation of the digestive tract, there are several features that distinguish one from the other. CD tends to commonly affect the terminal ileum, which is the final segment of the small intestine before it reaches the colon. In addition, CD can also affect any segment of the digestive tract from the mouth to the anus. On the other hand, UC is usually limited to the colon and rarely affects any other segment of the digestive tract. Unfortunately, IBD is not limited to the digestive system. Many patients with IBD also suffer from systemic complications or extraintestinal manifestations (EIMs). This includes inflammation of the joints, skin, and eyes. EIMs are relatively common, as they are present in approximately 38 - 41% of patients with IBD. In addition, EIMs have been shown to affect the quality of life. Understanding the best way to manage these complications is important because inefficient management of IBD can lead to increased costs and unwanted complications.Many clinical trials have demonstrated the efficacy of a group of drugs known as biologics in reducing intestinal inflammation and improving symptoms in patients with moderate-to-severe IBD. Biologic drugs are a group of medications that are obtained from living organisms, including humans, animals, and microorganisms. However, evidence on the efficacy of biologics in resolving EIMs collected in these trials is mostly unpublished or unreported. We propose a systematic review and meta-analysis of randomized controlled trials to compare the efficacy of biologic drugs in resolving EIMs of IBD. We decided to study biologics because patients with moderate-to-severe IBD are usually treated with this class of medications and EIMs are more common in patients with moderate-to-severe IBD. We chose to do a systematic review and meta-analysis because it involves a clear step-by-step process of exploring the scientific literature and collecting all the available evidence to answer our question. As part of this review, we plan to contact study authors and industry sponsors of randomized clinical trials that evaluated the efficacy of biologics in treating intestinal inflammation in IBD for this data. The results from this study will help determine which of the available biologics, if any, is more effective in resolving EIMs in adult patients with IBD that suffer from these complications.
Study Data Provided
[{ "PostingID": 2347, "Title": "TAKEDA-C13006", "Description": "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" },{ "PostingID": 2350, "Title": "TAKEDA-C13002", "Description": "Phase 2, Randomized, Placebo-Controlled, Double-Blind Label Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MLN0002 Following Multiple Intravenous Doses in Patients With Ulcerative Colitis" },{ "PostingID": 2352, "Title": "TAKEDA-L299-016", "Description": "Phase 2 Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study to Determine the Safety, Pharmacokinetics, and Effectiveness of LDP-02 in Patients With Mildly to Moderately Active Crohn's Disease" },{ "PostingID": 2360, "Title": "UCB-C87031", "Description": "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)" },{ "PostingID": 2361, "Title": "UCB-C87032", "Description": "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)." },{ "PostingID": 2365, "Title": "UCB-AKS001", "Description": "Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis" },{ "PostingID": 3918, "Title": "UCB-C87085", "Description": "Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease" },{ "PostingID": 3919, "Title": "UCB-CDP870037", "Description": "Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease" }]
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