The purpose of this study is to estimate the incidence rates of malignancy, excluding non-melanoma skin cancer (NMSC), venous thromboembolic events VTE (deep venous thrombosis \[DVT\] and pulmonary embolism \[PE\]), NMSC, major adverse cardiac events (MACE), progressive multifocal leukoencephalopathy (PML), infections, hospitalization and specific antibiotic or antiviral treatment, lung cancer, lymphoma, herpes zoster, myocardial infarction (MI), gastrointestinal (GI) perforations, fractures, surgery for UC and death; through 4 sub-groups: adult patients with UC who initiate tofacitinib in the course of routine clinical care compared to other medications approved to treat UC.
Adult patients aged ≥18 years,
With Ulcerative colitis diagnosis per ECCO guidelines,
Enrolled in UR-CARE registry with 12 months of medical history available in UR-CARE prior to the index date,
With an informed consent signed. A minimum follow-up duration of 12 months will allow evaluation of safety events of interest.
Patients not meeting the inclusion criteria
Patients who have any records of Crohn's Diseases (CD) or IBD unspecified in UR-CARE between the last UC diagnosis and index date [i.e. date of first prescription for tofacitinib].
Adult patients with UC aged ≥18 years treated with tofacitinib compared to patient receiving alternative treatment or not treatment. The study will use secondary data collected in the UR-CARE platform, which is an ongoing, prospective, observational, cohort of European Union (EU) patients with inflammatory bowel disease (IBD) with the primary aim of facilitating daily patient care and research studies in IBD. This study will focus only on patients with UC enrolled in the UR-CARE platform.
Cohort
Prospective
Not listed
Malignancy excluding non-melanoma skin cancer (NMSC)
Malignancy excluding non-melanoma skin cancer (NMSC). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.
venous thromboembolic events (VTE),(deep venous thrombosis [DVT] and pulmonary embolism [PE])
deep venous thrombosis \[DVT\] and pulmonary embolism \[PE\]. As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.
Non melanoma skin cancer (NMSC)
Non melanoma skin cancer (NMSC). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.
Lung cancer
Lung cancer. As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.
Lymphoma
Lymphoma (including 3 main subtypes Hodgkin's lymphoma, non-Hodgkin's lymphoma, and chronic lymphocytic lymphoma). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.
Serious infections
Serious infections. As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.
Click on the lead sponsor to view all of their trials.
