Impact of Methotrexate Discontinuation, Interruption, or Persistence in US Patients with Rheumatoid Arthritis Initiating Tofacitinib + Oral Methotrexate Combination

Stanley B Cohen; Boulos Haraoui; Jeffrey R Curtis; Timothy W Smith; John Woolcott; David Gruben; Christopher W Murray

doi:10.1016/j.clinthera.2022.05.002

Impact of Methotrexate Discontinuation, Interruption, or Persistence in US Patients with Rheumatoid Arthritis Initiating Tofacitinib + Oral Methotrexate Combination

Clin Ther. 2022 Jul;44(7):982-997.e2. doi: 10.1016/j.clinthera.2022.05.002. Epub 2022 Jun 4.

Authors

Stanley B Cohen¹, Boulos Haraoui², Jeffrey R Curtis³, Timothy W Smith⁴, John Woolcott⁵, David Gruben⁶, Christopher W Murray⁷

Affiliations

¹ Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, Texas, USA.
² Institut de Rhumatologie de Montréal, Montreal, Quebec, Canada.
³ University of Alabama, Birmingham, Alabama, USA.
⁴ Pfizer Inc, New York, New York, USA.
⁵ Pfizer Inc, Collegeville, Pennsylvania, USA. Electronic address: john.woolcott@pfizer.com.
⁶ Pfizer Inc, Groton, Connecticut, USA.
⁷ Pfizer Inc, Collegeville, Pennsylvania, USA.

PMID: 35667900
DOI: 10.1016/j.clinthera.2022.05.002

Abstract

Purpose: Using data from real-world practice, this analysis compared outcomes in patients with rheumatoid arthritis (RA) initiating treatment with an oral Janus kinase inhibitor, tofacitinib, in combination with persistent, discontinued, or interrupted treatment with oral methotrexate (MTX).

Methods: This retrospective claims analysis (MarketScan® databases) included data from US patients with RA and at least one prescription claim for tofacitinib, dated between January 1, 2013, and April 30, 2017. Eligible patients were continuously enrolled for ≥12 months before and after treatment initiation, and initiated tofacitinib in combination with oral MTX, with at least two prescription claims for each. Patients were grouped according to treatment pattern (MTX-Persistent, MTX-Discontinued, or MTX-Interrupted). Tofacitinib treatment persistence, adherence, and effectiveness, as well as all-cause and RA-related health care costs, were assessed.

Findings: A total of 671 patients were eligible for inclusion; 504 (75.1%) were MTX-Persistent; 131 (19.5%), MTX-Discontinued; and 36 (5.4%), MTX-Interrupted. Rates of tofacitinib treatment persistence, adherence, and effectiveness at 12 months were similar between the MTX-Persistent and MTX-Discontinued cohorts. The percentage of patients switched from tofacitinib to another advanced disease-modifying antirheumatic drug within 12 months of tofacitinib initiation was greater in the MTX-Persistent cohort compared with that in the MTX-Discontinued cohort. RA-related health care costs at 12 months post-initiation were significantly greater in the MTX-Persistent cohort compared with those in the MTX-Discontinued cohort.

Implications: The findings from this analysis of real-world data indicate that patients who initiate tofacitinib in combination with oral MTX may discontinue MTX and still experience outcomes similar to those in patients who persist with MTX, with lesser RA-related health care costs. These results support those from a previous clinical study on methotrexate withdrawal in patients with RA (NCT02831855).

Keywords: Conventional synthetic disease-modifying antirheumatic drugs; Registry; Rheumatoid arthritis; tofacitinib.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Antirheumatic Agents* / administration & dosage
Arthritis, Rheumatoid* / drug therapy
Clinical Studies as Topic
Drug Therapy, Combination
Humans
Methotrexate* / administration & dosage
Piperidines
Pyrimidines
Retrospective Studies
Treatment Outcome

Substances

Antirheumatic Agents
Piperidines
Pyrimidines
tofacitinib
Methotrexate

Associated data

ClinicalTrials.gov/NCT02831855