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Tumor necrosis factor inhibitor (TNFi) persistence and reasons for discontinuation in a predominantly male cohort with axial spondyloarthritis

  • Observational Research
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Abstract

Although tumor necrosis factor inhibitors (TNFi) have favorably altered the treatment landscape for patients with axial spondyloarthritis (axSpA), there is limited data regarding TNFi persistence and reasons for discontinuation. This is an observational time-to-event study utilizing data collected for a prospective multiple-disease registry of US Veterans with axSpA treated with TNFi therapies and recruited over a 10 year period. Clinical, serological, and comorbid parameters were collected. Corporate Data Warehouse Pharmacy files provided courses of the 5 TNFi agents, and response to treatment was documented. Individual TNFi persistence was established utilizing univariate and multivariate Cox proportional models, and reasons for discontinuation were obtained by physician chart review. Two-hundred and fifty-five axSpA patients received 731 TNFi courses. A majority of patients (84.3%) had TNFi persistence at 12 months; 63.5% and 47.1% at 24 and 36 months, respectively. Compared to adalimumab, infliximab demonstrated greater persistence, certolizumab the least. Age, smoking status, BMI, comorbidity burden, inflammatory markers and HLA-B27 did not predict TNFi persistence or discontinuation. Stroke and peripheral arterial disease increased the probability of TNFi discontinuation. Secondary non-response (SNR) was the most common reason for discontinuation (46% of all courses); non-adherence (6%) and clinical remission (2%) were uncommon. Pain score at enrollment, myocardial infarction, African American race and inflammatory bowel disease (IBD) predicted TNFi response. While initial persistence of TNFi treatment was high, a large proportion of the patients discontinued initial TNFi therapy by 3 years, primarily due to loss of efficacy. While further research identifying potential predictors of TNFi discontinuation in axSpA is warranted, access to alternate disease-modifying therapies is needed.

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Data availability

The Veterans Health Administration has sole ownership of the data gathered for this study and data are not available for sharing or public viewing.

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Funding

Our study was designed by the Investigators and the sponsor (Novartis) provided input in project planning, but was not involved in the collection of data, analyses or reporting. Financial support for the study was provided by Novartis.

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Authors and Affiliations

  1. Mayo Clinic, 200 First St. SW, Rochester, MN, 55905, USA

    Delamo I. Bekele

  2. Rocky Mountain Regional Veterans Affairs Medical Center and UC Denver SOM, Aurora, CO, USA

    Elizabeth Cheng, Kavya Ganuthula & Ryan Duong

  3. Dallas VA Medical Center and University of Texas-Southwestern, Dallas, TX, USA

    Andreas Reimold

  4. SUNY Upstate Medical University, Syracuse, NY, USA

    Christian Geier

  5. Salt Lake City Veterans Affairs and University of Utah Medical Center, Salt Lake City, UT, USA

    Jessica A. Walsh & Daniel O. Clegg

  6. VA Boston Healthcare System and Boston University School of Medicine, Boston, MA, USA

    Maureen Dubreuil

  7. Stratton VAMC, Albany, NY, USA

    Prashant Kaushik

  8. VA Puget Sound Healthcare System and of Washington, Seattle, WA, USA

    Bernard Ng

  9. Phoenix VAHCS, Phoenix, AZ, USA

    Elizabeth Chang

  10. Health Economics and Outcomes Research, Novartis, East Hanover, NJ, USA

    Jina Park

  11. DC VAMC, Georgetown and Howard University, 50 Irving ST, NW, Washington, DC, 20422, USA

    Gail S. Kerr

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  1. Delamo I. Bekele
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Correspondence to Delamo I. Bekele or Gail S. Kerr.

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Conflict of interest

The other authors have disclosed no conflicts of interest. Dr. Kerr has received current and prior grant funding from Novartis, BMS and Pfizer. She currently serves on the advisory board for Janssen. Dr. Walsh has received consulting fees from AbbVie, Lilly, Novartis and UCB (all less than $10,000). She has also received research funding from AbbVie and Pfizer. Dr. Clegg has received VA Merit Review funding. Dr. Reimold has served as a consultant for Lilly (less than $10,000).

Ethical approval

Approval obtained by the local Institutional Review Board at each participating site, and by the independent Scientific Ethics and Advisory Committee for the Department of Veterans Affairs (VA) Program to Understand the Longterm Outcomes in SpondyloARthritis registry (PULSAR). Ethics Approval MIRB number: 01138. Initial approval: 08/28/2008.

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Bekele, D.I., Cheng, E., Reimold, A. et al. Tumor necrosis factor inhibitor (TNFi) persistence and reasons for discontinuation in a predominantly male cohort with axial spondyloarthritis. Rheumatol Int 42, 1925–1937 (2022). https://doi.org/10.1007/s00296-021-05024-w

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