Changes in Characteristics of Patients Initiating and Discontinuing Advanced Therapies for Rheumatoid Arthritis Following the Release of Safety Data

Author:

Song Stephanie1ORCID,England Bryant R.2ORCID,Sauer Brian3ORCID,George Michael D.4ORCID,Riley Thomas R.4ORCID,Wallace Beth5,Cannon Grant W.3ORCID,Mikuls Ted R.2ORCID,Baker Joshua F.1ORCID

Affiliation:

1. Corporal Michael J. Crescenz VA Medical Center and University of Pennsylvania, Perelman School of Medicine Philadelphia

2. University of Nebraska Medical Center Omaha

3. Salt Lake City VA Medical Center and University of Utah Salt Lake City

4. University of Pennsylvania Perelman School of Medicine Philadelphia

5. Center for Clinical Management Research, VA Ann Arbor Healthcare System and University of Michigan Ann Arbor

Abstract

ObjectiveThe objective of this study was to determine the impact of emerging safety data on practice patterns by describing the characteristics of patients initiating and discontinuing advanced therapies for rheumatoid arthritis (RA) before and after January 2021.MethodsThis cohort study evaluated US veterans with RA between April 2019 and September 2022. This period was divided into two 664‐day periods before and after January 2021. Eligible patients had ≥1 diagnosis code for RA and initiated a tumor necrosis factor inhibitor (TNFi), non‐TNFi biologic, or JAK inhibitor (JAKi). We tested for interaction within regression models to determine whether changes in patient characteristics for tofacitinib recipients were different from changes observed for other therapies. We also evaluated factors associated with therapy discontinuation in Cox models adjusted for age, sex, and duration on therapy, including assessment for effect modification.ResultsWhen comparing patients with RA initiating tofacitinib before (n = 2,111) with those initiating tofacitinib after (n = 1,664) January 2021, there was a decrease in mean age (64.1 vs 63.0 years) and in the proportion with cardiovascular comorbidities (all P < 0.01). These changes were significantly different from those observed for patients initiating TNFi or non‐TNFi biologics. Among active advanced therapy recipients, the likelihood of discontinuation was higher for tofacitinib than TNFi (hazard ratio 1.18, 95% confidence interval 1.10–1.26, P < 0.001). The higher rate of tofacitinib discontinuation was more pronounced in the presence of cardiovascular comorbidities (P < 0.05).ConclusionRecent safety data significantly affected prescribing practices for advanced therapies, with a reduction in JAKi initiation and an increase in JAKi discontinuation among older patients and those at high cardiovascular risk.image

Publisher

Wiley

Subject

Rheumatology

Reference12 articles.

1. Cardiovascular and Cancer Risk with Tofacitinib in Rheumatoid Arthritis

2. US Food and Drug Administration.FDA requires warnings about increased risk of serious heart‐related events cancer blood clots and death for JAK inhibitors that treat certain chronic inflammatory conditions. September 1 2021.https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-warnings-about-increased-risk-serious-heart-related-events-cancer-blood-clots-and-death

3. Tofacitinib and risk of cardiovascular outcomes: results from the Safety of TofAcitinib in Routine care patients with Rheumatoid Arthritis (STAR-RA) study

4. Waiting for JAK inhibitor safety data

5. Cardiovascular risks associated with Janus kinase inhibitors: peering outside the black box

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