A Retrospective Database Study to Evaluate Rates of Influenza and Related Diagnoses between Patients Treated with Tofacitinib and Other Systemic Therapies within Cohorts of RA, PsA, and UC Patients: A Post-Authorization Safety Study of Tofacitinib

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50329
• EU PAS number:
  EUPAS39242
• Study ID:
  50329
• Official title and acronym:
  A Retrospective Database Study to Evaluate Rates of Influenza and Related Diagnoses between Patients Treated with Tofacitinib and Other Systemic Therapies within Cohorts of RA, PsA, and UC Patients: A Post-Authorization Safety Study of Tofacitinib
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Patients with immune-mediated diseases such as rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ulcerative colitis (UC) are known to have an increased risk of infections compared to the general population. As such, it is important to assess the safety of tofacitinib and other treatments in this patient population. The research questions addressed by this study is: what are the rates of influenza and influenza like illness, including associated morbidity and death, among persons prescribed tofacitinib or other systemic treatments among groups of patients with RA, PsA and UC? The objectives for this study are: (1) to describe demographics and clinical characteristics of RA, PsA, and UC patient cohorts overall and within each treatment group and (2) to describe the frequency, incidence rates and clinical outcomes of influenza infections and influenza-like illness and their complications in patients receiving tofacitinib and other systemic therapies within RA, PsA and UC cohorts, stratified by age (<65 and 65 and older). This is a retrospective records-based cohort study involving secondary analysis of Optum Electronic Health Record databases in the United States consisting of longitudinal health information about patients derived from participating healthcare provider organizations.
• Study status:
  Finalised

Research institution and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Planned: 26/01/2021

Actual: 26/01/2021

Study start date

Planned: 15/02/2021

Actual: 15/02/2021

Data analysis start date

Planned: 15/02/2021

Actual: 15/02/2021

Date of final study report

Planned: 31/01/2023

Actual: 11/02/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

FINAL A3921383 Non-Interventional Protocol Study 01 December 2020

Updated protocol

A3921383 Non-Interventional Protocol Study Amendment 1 (CLEAN) 29 October 2021_Redacted

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable