STAR-RA-Cancer: Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)-Cancer Endpoints

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04798287

Collaborator

(none)

105,711

Enrollment

Location

14.2

Actual Duration (Months)

7448.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: Tofacitinib Drug: TNF Inhibitor

Study Design

Study Type:

Observational

Actual Enrollment :

105711 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)-Cancer Endpoints

Actual Study Start Date :

Mar 10, 2021

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

May 16, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients treated with Tofacitinib Real-World Evidence (RWE) and RCT-Duplicate	Drug: Tofacitinib First eligible prescription for treating rheumatoid arthritis (RA)
Patients treated with TNF inhibitors Real-World Evidence (RWE) and RCT-Duplicate	Drug: TNF Inhibitor First eligible prescription for treating rheumatoid arthritis (RA) Other Names: infliximab adalimumab certolizumab pegol etanercept golimumab

Arm

Intervention/Treatment

Patients treated with Tofacitinib

Real-World Evidence (RWE) and RCT-Duplicate

Drug: Tofacitinib

First eligible prescription for treating rheumatoid arthritis (RA)

Patients treated with TNF inhibitors

Real-World Evidence (RWE) and RCT-Duplicate

Drug: TNF Inhibitor

First eligible prescription for treating rheumatoid arthritis (RA)

Other Names:

infliximab

adalimumab

certolizumab pegol

etanercept

golimumab

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 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 lymphatic/hematopoietic tissue cancers [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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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)

Exclusion Criteria

Index drug in 365 days prior to cohort entry date (prevalent users)
Missing data on age or gender
Admission to nursing facility or hospice on or prior to cohort entry date (ever look-back)
Diagnosis of malignant cancer prior to cohort entry date (ever look-back period)
TNFi users with history of any Janus kinase (JAK) inhibitors (tofacitinib, upadacitinib, or baricitinib) (ever look-back period)
TNFi users initiating with more than one TNFi on same date
Tofacitinib users with a prescription of baricitinib, upadacitinib (ever look-back period)
Tofacitinib users initiating treatment on multiple JAK inhibitors on same day (tofacitinib and baricitinib, tofacitinib and upadacitinib)

Exclusion criteria specific to RWE cohorts:

Patients less than 18 years of age (MarketScan and Optum) and 65 years of age (Medicare) at cohort entry

Inclusion criteria specific to RCT-duplicate cohorts:

Patients with at least one methotrexate dispensation (six months look-back period)
Patients with at least one cardiovascular risk factor (including smoking, hypertension, dyslipidemia, diabetes mellitus, ischemic heart disease, family history of ischemic heart disease) (one-year look-back period)