Lead Investigator: Jaeyoun Choi, UC San Diego
Title of Proposal Research: The effect of frailty and old age on the efficacy and safety of biologics and small molecules in inflammatory bowel disease : A pooled analysis of individual patient data
Vivli Data Request: 10491
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Inflammatory bowel disease (IBD) is a lifelong, progressively debilitating disease affecting the small and large intestines. The two distinct types of IBD are Crohn’s disease (CD) and Ulcerative colitis (UC). This autoimmune disease (where the body’s immune system mistakenly attacks its own healthy tissues) often results in complications like narrowing of the intestinal lumen (the hollow space through the intestine) requiring surgeries to remove some part of the diseased intestine, hospitalizations and diminished quality of life. In the past decade, several highly effective advanced therapies including biologics (a treatment that uses substances derived from living organisms to treat disease) and small molecules (a drug that can enter cells easily because it is small) have been developed to manage this disease reducing the overall disease burden, improving the quality of life and reducing complications. However, these drugs are also associated with several potentially life-threatening adverse events. This is of particular concern in the old frail individuals with reduced ability to withstand additional health issues and increased vulnerability to a broad range of adverse health outcomes such as serious infection. Additionally, many of the elderly population have higher burden of the disease owing to longer disease duration and progressive nature of the disease. This may affect how this population responds to the medications. With advancements in the medical care and developments, the aged and frail population are increasing in number. This warrants an understanding of the effect of frailty on efficacy and safety of these advanced therapies which would be both effective in managing the disease and reducing risk of adverse events. The insights from this study will help select treatment options which are more suitable for this vulnerable group.
Requested Studies:
A Multi-Center Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn’s Disease
Data Contributor: AbbVie
Study ID: NCT00077779
Sponsor ID: M02-404
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
Data Contributor: Johnson & Johnson
Study ID: NCT02407236
Sponsor ID: CR106920
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn’s Disease (UNITI-2)
Data Contributor: Johnson & Johnson
Study ID: NCT01369342
Sponsor ID: CR018418
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy (UNITI-1)
Data Contributor: Johnson & Johnson
Study ID: NCT01369329
Sponsor ID: CR018415
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease
Data Contributor: Johnson & Johnson
Study ID: NCT01369355
Sponsor ID: CR018421
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)
Data Contributor: Lilly
Study ID: NCT03524092
Sponsor ID: 16823
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
Data Contributor: Lilly
Study ID: NCT03518086
Sponsor ID: 16591
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis
Data Contributor: Pfizer Inc.
Study ID: NCT01465763
Sponsor ID: A3921094
A Randomized, Placebo Controlled, Double Blind, Parallel Group Multi-Center Study In Order To Investigate Safety And Efficacy Of CP- 690 550 In Subjects With Moderate To Severe Ulcerative Colitis.
Data Contributor: Pfizer Inc.
Study ID: NCT00787202
Sponsor ID: A3921063
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
Data Contributor: Takeda
Study ID: NCT00783692
Sponsor ID: C13007
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
Data Contributor: Takeda
Study ID: NCT00783718
Sponsor ID: C13006