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Discontinuation of anti-TNF-alpha treatment due to blood test abnormalities and cost-effectiveness of alternate blood monitoring strategies

Abhishek, Abhishek; Stevenson, Matthew D; Nakafero, Georgina; Grainge, Matthew J; Evans, Ian; Alabas, Oras; Card, Tim; Taal, Maarten W; Aithal, Guruprasad P; Fox, Christopher P; Mallen, Christian D; van der Windt, Danielle A; Riley, Richard D; Warren, Richard B; Williams, Hywel C

Authors

Abhishek Abhishek

Matthew D Stevenson

Georgina Nakafero

Matthew J Grainge

Ian Evans

Oras Alabas

Tim Card

Maarten W Taal

Guruprasad P Aithal

Christopher P Fox

Richard D Riley

Richard B Warren

Hywel C Williams



Abstract

Background There is no evidence base supporting the use of six-monthly monitoring blood tests for the early detection of liver, blood, and renal toxicity during established anti-TNF-alpha treatment. Objectives To evaluate the incidence and risk factors of anti-TNF-alpha treatment cessation due to liver, blood, and renal side-effects and, to estimate the cost-effectiveness of alternate intervals between monitoring blood tests. Methods A secondary-care based retrospective cohort study was performed. Data from the British Association of Dermatologists Biologic and Immunomodulators Register were used. Patients with at-least moderate psoriasis prescribed their first anti-TNF-alpha treatment were included. Treatment discontinuation due to monitoring blood test abnormality was the primary-outcome. Patients were followed-up from treatment start to the earliest of outcome, drug-discontinuation, death, five years, or 31/07/2021. The incidence rate and 95% confidence intervals (CIs) of anti-TNF-alpha discontinuation with monitoring blood test abnormality was calculated. Multivariate Cox regression was used to examine the association between risk-factors and outcome. A mathematical model evaluated costs and quality-adjusted life years (QALYs) associated with lengthening the time between monitoring blood tests during anti-TNF-alpha treatment. Results The cohort included 8,819 participants (3,710 (42.1%) female, mean age (standard deviation) 44.76 (13.20) years) that contributed 25,058 person-years of follow-up and experienced 125 treatment discontinuations due to monitoring blood test abnormality at an incidence rate (95%CI) of 5.85 (4.91-6.97)/1,000 person-years. Of these, 64, and 61 discontinuations occurred within the first year, and after the first-year of treatment start at an incidence rate (95% CI) of 8.62 (6.74-11.01) and 3.44 (2.67-4.42)/1000 person-years respectively. Increasing age in years, diabetes, and liver disease associated with anti-TNF-alpha discontinuation with monitoring blood test abnormality with adjusted Hazard Ratio (95%CI) of 1.02 (1.01-1.04), 1.68 (1.00-2.81), and 2.27 (1.26-4.07) respectively. Assuming a threshold of £20,000 per QALY gained, no monitoring was most cost-effective but all extended periods were cost-effective compared to three monthly or six-monthly monitoring. Conclusion Anti-TNF-alpha drugs were uncommonly discontinued due to abnormal monitoring blood tests after the first year of treatment. Extending the duration between monitoring blood-tests was cost-effective. Our results produce evidence for specialist society guidance to reduce patient monitoring burden and healthcare costs.

Journal Article Type Article
Acceptance Date Oct 31, 2023
Online Publication Date Nov 1, 2023
Deposit Date Nov 20, 2023
Journal British Journal of Dermatology
Print ISSN 0007-0963
Publisher Wiley
Peer Reviewed Peer Reviewed
DOI https://doi.org/10.1093/bjd/ljad430
Keywords Dermatology