Discontinuation of anti-tumour necrosis factor alpha treatment owing to blood test abnormalities, and cost-effectiveness of alternate blood monitoring strategies

Author:

Abhishek Abhishek1ORCID,Stevenson Matthew D2,Nakafero Georgina1ORCID,Grainge Matthew J3,Evans Ian4,Alabas Oras4,Card Tim3,Taal Maarten W5,Aithal Guruprasad P6,Fox Christopher P7,Mallen Christian D8ORCID,van der Windt Danielle A8,Riley Richard D9,Warren Richard B1011ORCID,Williams Hywel C3

Affiliation:

1. Academic Rheumatology, University of Sheffield , Sheffield , UK

2. School of Health and Related Research, University of Sheffield , Sheffield , UK

3. Lifespan and Population Health, University of Sheffield , Sheffield , UK

4. BADBIR, University of Manchester , Manchester , UK

5. Centre for Kidney Research and Innovation, Translational Medical Sciences, University of Nottingham , Derby , UK

6. Nottingham Digestive Diseases Centre, Translational Medical Sciences, University of Nottingham , Nottingham , UK

7. Centre for Cancer Studies, Translational Medical Sciences, School of Medicine, University of Nottingham , Derby , UK

8. Primary Care Centre Versus Arthritis, Keele University , Keele , UK

9. Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham , Birmingham , UK

10. Dermatology Centre, Northern Care Alliance NHS Foundation Trust , Manchester , UK

11. NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre , Manchester , UK

Abstract

Abstract Background There is no evidence base to support the use of 6-monthly monitoring blood tests for the early detection of liver, blood and renal toxicity during established anti-tumour necrosis factor alpha (TNFα) treatment. Objectives To evaluate the incidence and risk factors of anti-TNFα treatment cessation owing 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 (BADBIR) were used. Patients with at least moderate psoriasis prescribed their first anti-TNFα treatment were included. Treatment discontinuation due to a monitoring blood test abnormality was the primary outcome. Patients were followed-up from start of treatment to the outcome of interest, drug discontinuation, death, 31 July 2021 or up to 5 years, whichever came first. The incidence rate (IR) and 95% confidence intervals (CIs) of anti-TNFα 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 increasing the length of time between monitoring blood tests during anti-TNFα treatment. Results The cohort included 8819 participants [3710 (42.1%) female, mean (SD) age 44.76 (13.20) years] that contributed 25 058 person-years (PY) of follow-up and experienced 125 treatment discontinuations owing to a monitoring blood test abnormality at an IR of 5.85 (95% CI 4.91–6.97)/1000 PY. Of these, 64 and 61 discontinuations occurred within the first year and after the first year of treatment start, at IRs of 8.62 (95% CI 6.74–11.01) and 3.44 (95% CI 2.67–4.42)/1000 PY, respectively. Increasing age (in years), diabetes and liver disease were associated with anti-TNFα discontinuation after a monitoring blood test abnormality [adjusted hazard ratios of 1.02 (95% CI 1.01–1.04), 1.68 (95% CI 1.00–2.81) and 2.27 (95% CI 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 vs. 3- or 6-monthly monitoring. Conclusions Anti-TNFα drugs were uncommonly discontinued owing 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.

Funder

National Institute for Health and Care Research

NIHR Manchester Biomedical Research Centre

Publisher

Oxford University Press (OUP)

Subject

Dermatology

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