Rheumatoid Arthritis
Conditions
Brief summary
There are two main aims of this study. First aim is to compare the risk of composite cancer outcomes, between patients treated with tofacitinib and patients treated with TNF inhibitors (TNFi) for rheumatoid arthritis (RA) among, 1) real world evidence (RWE) cohorts including routine care patient population from the US and, 2) Randomized controlled trial (RCT) DUPLICATE cohorts including routine care patient population who meet inclusion and exclusion criteria of the Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis (ORAL Surveillance, NCT02092467) clinical trial. Second aim is to examine the risk of common solid cancers (lung, colorectal, breast, prostate), hematological cancers, and non-melanoma skin cancer as separated endpoints when comparing tofacitinib with TNFi in patients with RA among, 1) real world evidence (RWE) cohort including routine care patient population from the US and, 2) Randomized controlled trial (RCT) DUPLICATE cohort including routine care patient population who meet inclusion and exclusion criteria of the Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis (ORAL Surveillance, NCT02092467) clinical trial.
Interventions
DRUGTofacitinib
First eligible prescription for treating rheumatoid arthritis (RA)
DRUGTNF Inhibitor
First eligible prescription for treating rheumatoid arthritis (RA)
Sponsors
Brigham and Women's Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Criteria: Please see https://www.bwhprime.org/resources.html for full code and algorithm definitions. Eligible cohort entry dates: * For US MarketScan, 2012-2018 * For Optum, 2012-2020 * For Medicare Claims Database (Parts A, B and D), 2012-2017 Cohort entry date: * First TNFi or tofacitinib dispensation/administration date Inclusion and
Exclusion criteria
Common to RWE and RCT-duplicate Cohorts: 1. Inclusion Criteria * Patients treated with tofacitinib or TNF inhibitors in IBM MarketScan, Optum, and Medicare fee-for-service * A minimum of 365 days of continuous enrollment in health plan prior to (and including) the cohort entry date * Two diagnosis codes for RA in any setting in 365 days baseline period (diagnosis codes between 7 and 365 days apart) 2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to second outpatient or inpatient diagnosis of any cancer (excluding NMSC and any carcinoma in situ diagnosis) | Through study time period (2012-2020) |
Secondary
| Measure | Time frame |
|---|---|
| Time to second outpatient or inpatient diagnosis of colorectal cancer (excluding any carcinoma in situ diagnosis) | Through study time period (2012-2020) |
| Time to second outpatient or inpatient diagnosis of breast cancer (excluding any carcinoma in situ diagnosis) | Through study time period (2012-2020) |
| Time to second outpatient or inpatient diagnosis of prostate cancer (excluding any carcinoma in situ diagnosis) | Through study time period (2012-2020) |
| Time to second outpatient or inpatient diagnosis of lung cancer (excluding any carcinoma in situ diagnosis) | Through study time period (2012-2020) |
| Time to second outpatient or inpatient diagnosis of lymphoma | Through study time period (2012-2020) |
| Time to second outpatient or inpatient diagnosis of leukemia | Through study time period (2012-2020) |
| Time to first procedure code occurring within 60 days of an outpatient or inpatient diagnosis of NMSC | Through study time period (2012-2020) |
| Time to second outpatient or inpatient diagnosis of lymphatic/hematopoietic tissue cancers | Through study time period (2012-2020) |
Countries
United States
Outcome results
None listed