Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

RINVOQ

Medical condition to be studied

Rheumatoid arthritis
Population studied

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

12000
Study design details

Main study objective

The purpose of this study is to evaluate and characterise the important identified and potential risks of upadacitinib (Rinvoq™) and missing information on the safety of upadacitinib, as described in the European Union (EU) Risk Management Plan (RMP) for Rinvoq™ (upadacitinib). This study aims to evaluate the long-term safety of upadacitinib among patients with RA receiving routine clinical care.

Outcomes

To describe and compare (when possible) the incidence rates of the following important risks: serious and opportunistic infections (including herpes zoster and tuberculosis TB), malignancies, major adverse cardiovascular events (MACE), venous thromboembolism (VTE), mortality, gastrointestinal (GI) perforations, and liver injury (including drug-induced liver injury DILI. To describe the incidence rates among patients with missing information on the safety of upadacitinib, including the very elderly (≥ 75 years of age), and when data are available, in patients with moderate hepatic impairment, patients with severe renal impairment, and patients with evidence of chronic infection with hepatitis B or hepatitis C.

Data analysis plan

Analyses will be conducted separately for each outcome in each registry and will include descriptive analyses of baseline characteristics and cumulative rates of study endpoints (i.e. events of special interest or serious adverse events SAEs, depending on registry) for each exposure cohort. Comparative analyses will be performed to evaluate whether upadacitinib treatment is associated with an increased risk of outcomes of interest relative to control cohorts.