Lead Investigator: Andrea E. van der Meulen – de Jong, Leiden University Medical Center
Title of Proposal Research: Anemia and therapy with Janus Kinase Inhibitors in patients with ulcerative colitis
Vivli Data Request: 8686
Funding Source: None
Potential Conflicts of Interest: A.E. van der Meulen – de Jong received unrestricted research grants from Vedanta, Nestle, Norgine, Galapagos, and received speaker’s fees from Tramedico, Takeda, Galapagos, and Janssen Pharmaceuticals. None of these companies have an impact on the interpretation of the results.
R. Loveikyte has received speaker’s fees and served on the advisory board of Cablon Medical, and received travel expenses from Galapagos and Cablon Medical. None of these companies have an impact on the interpretation of the results.
Summary of the Proposed Research:
Ulcerative colitis (UC) is one of the two entities of inflammatory bowel disease (IBD). In the Netherlands, about 90,000 patients suffer from IBD. UC is characterized by inflammation of the large intestine. The inflammation causes sores, rectal bleeding, abdominal pain, reduced quality of life, and it is linked to a higher risk of colorectal cancer. There is no cure for UC; however, therapy with medications such as Janus Kinase Inhibitors (e.g., tofacitinib, filgotinib, upadacitinib) can treat the inflammation and reduce the risk of colorectal cancer. In recent years, many different medications have been shown effective in treating UC. Most of these medications are almost equally effective, but patients can experience primary and secondary loss of response and due to various mechanisms of action the medications are linked to different types of side effects.
Janus Kinase Inhibitors (JAKi) are one of the newest medications for UC. Due to the mechanism of action, JAKi might cause the following abnormalities in the blood: a reduction in the number of red blood cells that transport oxygen, cells that help blood clot, and cells that help fight infections. Previous studies have shown patients with UC suffering from a reduced number of red blood cells need to use healthcare services more frequently, have a lower quality of life, and have an increased risk of being admitted to a hospital. For this reason, international guidelines advise physicians to regularly screen and treat patients for these abnormalities.
We aim to evaluate how many patients are affected by these abnormalities during treatment with JAKi and whether different types of JAKi are more or less likely to cause these abnormalities in the blood. Due to the lack of literature, we will analyze existing data from clinical trials during therapy with a placebo, filgotinib, or tofacitinib. The results of this study will inform the need for future studies to investigate these abnormalities in greater detail and will eventually aid in formulating clinical guidelines for physicians regarding the appropriate management of patients who are about to start or are already undergoing treatment with JAKi.
Requested Studies:
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 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: NCT01458951
Sponsor ID: A3921095
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis
Data Contributor: Pfizer Inc.
Study ID: NCT01458574
Sponsor ID: A3921096