A Descriptive Retrospective Database Study to Evaluate Serious Clinical Manifestations and Outcomes among SARS-CoV-2 Diagnosed Patients with RA, PsA or UC treated with systemic therapies: A Post Approval Safety Study of Tofacitinib in the Context of the COVID-19 Pandemic

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA29) tofacitinib

  tofacitinib
• Medical condition to be studied:
  Rheumatoid arthritis

  Colitis ulcerative

  Psoriatic arthropathy

Population studied

• Short description of the study population:
  The study population involved patients aged 18 years or older diagnosed with SARS-CoV2 identified from the Optum covid testing database.; Inclusion criteria:; 1. SARS-CoV2 diagnosis; 2. At least 6 months of continuous enrollment prior to index date; 3. Age 18 or older at index date; ; For indicated subcohort: Evidence of RA, PsA, UC diagnosis withing baseline period prior to index date.; For non-indicated subcohort: No evidence of RA, PsA, UC diagnosis withing baseline period prior to index date.; ; Exclusion criteria:; 1. There are no exclusion criteria for this study.
• 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)
• Special population of interest:
  Immunocompromised

  Other
• Special population of interest, other:
  Patients with SARS-CoV2 infection
• Estimated number of subjects:
  1385530

Study design details

• Main study objective:
  What proportions of SARS-CoV-2 diagnosed patients have RA, PsA, or UC or not and what is risk of serious clinical manifestations & outcomes of interest in these subcohorts? What is the proportion treated at baseline with the following systemic therapies: tofacitinib, JAK inhibitors, TNFi, non TNFi, and csDMARD & what is risk of serious clinical manifestations and outcomes by treatment strata?
• Outcomes:
  Determine the proportions of patients with a diagnosis of RA, PsA, & UC, describe baseline demographic characteristics, treatment history and comorbidities, estimate proportion experiencing serious clinical manifestations and outcomes of interest, determine the proportions of patients treated with the following systemic therapies at baseline: tofacitinib, JAK inhibitors, TNFi, non-TNFi & csDMARD.
• Data analysis plan:
  After selection of the study population, summary statistics of baseline variables will be determined for the baseline period. The index date for each patient is defined as the first date that the study inclusion criteria are satisfied. Baseline variables will be summarized as appropriate for categorical and continuous variables with 95% CI provided to show precision of the estimate. Among patients who are included in the study, outcomes will be included that occur during the risk window from index date until the first of death (based on discharge status), 3 months post SARS CoV 2 diagnosis, or end of study period/datacut. The endpoints of interest within each indication, non indicated subcohort and indication/treatment combination will be summarized as appropriate for categorical and continuous variables with 95% CI provided to show precision of the estimate.