Long-term safety study of Rinvoq in RA patients enrolled in the Corrona RA Registry in the United States

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:
  7500

Study design details

• Main study objective:
  The main objective is to compare the incidence of malignancy (excluding non-melanoma skin cancer, NMSC), NMSC, MACE, VTE, SIE, and mortality in adults with RA who receive Rinvoq relative to those who are treated with biologic medications approved for the treatment of RA, in the course of routine clinical care.
• Outcomes:
  To compare the incidence of malignancy (excluding non-melanoma skin cancer, NMSC), NMSC, MACE, VTE, SIE, and mortality in adults with RA who receive Rinvoq relative to those who are treated with biologic medications approved for the treatment of RA, in the course of routine clinical care. To describe the incidence rates of the following adverse events: herpes zoster (HZ), opportunistic infections (OI), active tuberculosis (TB), gastrointestinal (GI) perforations, and evidence of drug-induced liver injury (DILI) in adults with RA who receive Rinvoq relative to those who are treated with biologic medications approved for the treatment of RA, in the course of routine clinical care.
• Data analysis plan:
  The population of patients in the study will be characterized with respect to demographic, clinical, disease and patient-reported outcomes using descriptive statistics. The main analyses will employ propensity score methods to address confounding by indication (channeling bias) followed by estimation of incident rates as well as multivariable Cox proportional hazards modeling to estimate HRs and associated 95% CIs.