Persistently normal blood tests in patients taking methotrexate for RA or azathioprine for IBD: a retrospective cohort study

Abstract

Background: Disease-modifying anti-rheumatic drugs (DMARDs), including methotrexate and azathioprine, are commonly used to treat rheumatoid arthritis (RA) and inflammatory bowel disease (IBD). Blood-test safety monitoring is mainly undertaken in primary care. Normal blood results are common. Aim To determine the frequency and associations of persistently normal blood tests in patients with RA prescribed methotrexate, and patients with IBD prescribed azathioprine.
Design and setting: Two-year retrospective study of a cohort taken from an electronic pseudonymised primary care/ laboratory database covering >1.4 million patients across Hampshire, UK. Method Patients with RA and IBD, and associated methotrexate and azathioprine prescriptions, respectively, were identified. Tests and test thresholds recommended by the National Institute for Health and Care Excellence were applied. Persistent normality was defined as no abnormalities of any tests nor alanine aminotransferase (ALT), white blood count (WBC), neutrophils, and estimated glomerular filtration rate (eGFR) individually. Logistic regression was used to identify associations with test normality.
Results Of 702 265 adults, 7102 had RA and 8597 had IBD. In total, 3001 (42.3%) patients with RA were prescribed methotrexate and 1162 (13.5%) patients with IBD were prescribed azathioprine; persistently normal tests occurred in 1585 (52.8%) and 657 (56.5%) of the populations, respectively. In patients with RA on methotrexate, 585 (19.5%) had eGFR, 219 (7.3%) ALT, 217 (7.2%) WBC, and 202 (6.7%) neutrophil abnormalities. In patients with IBD on azathioprine, 138 (11.9%) had WBC, 88 (7.6%) eGFR, 72 (6.2%) ALT, and 65 (5.6%) neutrophil abnormalities. Those least likely to have persistent test normality were older and/or had comorbidities.
Conclusion: Persistent test normality is common when monitoring these DMARDs, with few hepatic or haematological abnormalities. More stratified monitoring approaches should be explored.

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Identifiers

ORCID for Simon Fraser: orcid.org/0000-0002-4172-4406

ORCID for David Culliford: orcid.org/0000-0003-1663-0253

ORCID for Kinda Ibrahim: orcid.org/0000-0001-5709-3867

ORCID for James Batchelor: orcid.org/0000-0002-5307-552X

ORCID for Joanna Adams: orcid.org/0000-0003-1765-7060

ORCID for Paul Roderick: orcid.org/0000-0001-9475-6850

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