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

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, Christian D Mallen, Danielle A van der Windt, Richard D Riley, Richard B Warren, Hywel C Williams

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish
Article numberljad430
JournalThe British journal of dermatology
Early online date1 Nov 2023
Publication statusE-pub ahead of print - 1 Nov 2023


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