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5. Patient and health professional views on risk-stratified monitoring of immune-suppressing treatment in adults with inflammatory diseases

Author

Fuller, Amy, primary, Hancox, Jennie, additional, Williams, Hywel C, additional, Card, Tim, additional, Taal, Maarten W, additional, Aithal, Guruprasad P, additional, Fox, Christopher P, additional, Mallen, Christian D, additional, Maxwell, James R, additional, Bingham, Sarah, additional, Vedhara, Kavita, additional, and Abhishek, Abhishek, additional

Published
2024
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8. The impact of reader fatigue on the accuracy of capsule endoscopy interpretation

Author

Ching, Hey-Long, Koulaouzidis, Anastasios, Yung, Diana, Panter, Simon, Mcalindon, Mark, Johnson, Matthew, Kurup, Arun, Shonde, Anthony, San-Juan Acosta, Miliedis, Sansone, Stefano, Simmon, Ebby, Thurston, Victoria, Healy, Ailish, Chetcuti Zammit, Stefania, Schembri, John, Lau, Michelle S, Lam, Ching, Nizamuddin, Mohammed, Baxter, Andrew, Patel, Jay, Archer, Tom, Oppong, Phillip, Phillips, Frank, Dorn, Tara, Fateen, Waleed, White, Jonathan, Budihal, Shivkumar, Tan, Huey, Tiwari, Rajini, Beg, Sabina, Card, Tim, Sidhu, Reena, Wronska, Ewa, and Ragunath, Krish

Published
2021
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18. Discontinuation of anti-tumour necrosis factor alpha treatment owing to blood test abnormalities, and cost-effectiveness of alternate blood monitoring strategies.

Author

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

Subjects
BLOOD testing, TERMINATION of treatment, QUALITY-adjusted life years, HUMAN abnormalities, COST effectiveness
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. [ABSTRACT FROM AUTHOR]

Published
2024
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19. Discontinuation of anti-tumour necrosis factor alpha treatment owing to blood test abnormalities, and cost-effectiveness of alternate blood monitoring strategies

Author

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

Published
2023
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24. Inverse association between blood pressure and pulse oximetry accuracy: an observational study in patients with suspected or confirmed COVID-19 infection

Author

Crooks, Colin J, primary, West, Joe, additional, Morling, Jo, additional, Simmonds, Mark, additional, Juurlink, Irene, additional, Briggs, Steve, additional, Cruickshank, Simon, additional, Hammond-Pears, Susan, additional, Shaw, Dominick, additional, Card, Tim, additional, and Fogarty, Andrew W, additional

Published
2022
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31. Incidence, prevalence and survival in patients with Langerhans cell histiocytosis: A national registry study from England, 2013–2019

Author

Liu, Hanhua, primary, Stiller, Charles A., additional, Crooks, Colin J., additional, Rous, Brian, additional, Bythell, Mary, additional, Broggio, John, additional, Rankin, Judith, additional, Nanduri, Vasanta, additional, Lanyon, Peter, additional, Card, Tim R., additional, Ban, Lu, additional, Elliss‐Brookes, Lucy, additional, Broughan, Jennifer M., additional, Paley, Lizz, additional, Wong, Kwok, additional, Bacon, Andrew, additional, Bishton, Mark, additional, and West, Joe, additional

Published
2022
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36. Risk stratified monitoring for methotrexate toxicity in immune mediated inflammatory diseases: prognostic model development and validation using primary care data from the UK.

Author

Nakafero, Georgina, Grainge, Matthew J., Williams, Hywel C., Card, Tim, Taal, Maarten W., Aithal, Guruprasad P., Fox, Christopher P., Mallen, Christian D., van der Windt, Danielle A., Stevenson, Matthew D., Riley, Richard D., and Abhishek, Abhishek

Subjects
INFLAMMATORY bowel diseases, CONFIDENCE intervals, RESEARCH methodology, CALIBRATION, DISCRIMINATION (Sociology), RETROSPECTIVE studies, ACQUISITION of data, METHOTREXATE, PRIMARY health care, DRUG monitoring, MEDICAL records, DRUGS, DESCRIPTIVE statistics, RESEARCH funding, PREDICTION models, BLOOD testing, DEATH, DRUG toxicity, LONGITUDINAL method, PROPORTIONAL hazards models
Published
2023
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37. Development and validation of a prognostic model for leflunomide discontinuation with abnormal blood tests during long-term treatment: cohort study using data from the Clinical Practice Research Datalink Gold and Aurum

Author

Nakafero, Georgina, Grainge, Matthew J., Card, Tim, Taal, Maarten W., Aithal, Guruprasad P., Zhang, Weiya, Doherty, Michael, Fox, Christopher P., Mallen, Christian D., and Abhishek, Abhishek

Subjects
Rheumatology, Pharmacology (medical)
Abstract

OBJECTIVE: To develop and validate a prognostic model for LEF discontinuation with abnormal blood test results. METHODS: Data from the Clinical Practice Research Datalink Gold and Aurum were used for model development and external validation, respectively. Participants prescribed LEF between 1 January 2007 and 31 December 2019 were followed up from 6?months after the first general practitioner prescription to the earliest of date of outcome, death, 5?year follow-up or 31 December 2019. Candidate prognostic factors were ascertained using theory and data-driven approaches. Penalized Cox regression was performed to develop the risk equation, followed by internal validation using 500 bootstraps to correct for optimism. Multiple imputation was applied to handle missing data. Model performance was assessed in terms of calibration and discrimination. RESULTS: Data for 1487 and 2329 participants contributing 3140 and 5246 person-years follow-up were included in the development and validation cohorts, respectively. Thirteen candidate predictors were included in the model. Epilepsy and either cytopenia or elevated liver enzymes during the first 6?months of shared-care LEF prescription were strong predictors of drug discontinuation with a hazard ratio of 4.39 (95% CI 1.74, 11.06) and 3.06 (2.15, 4.35), respectively. The unadjusted and optimism-adjusted calibration slope in development data was 1.00 (95% CI 0.75, 1.25) and 0.72 (95% CI 0.47, 0.97), respectively. The calibration slope in validation data was 0.91 (95% CI 0.74, 1.07). The model showed prognostic separation with an optimism-adjusted Royston D statistic of 0.73 (95% CI 0.44, 1.02). CONCLUSION: We have developed and externally validated an easy-to-use prognostic model that may be used to risk stratify monitoring for LEF toxicity and to make informed choices about risks when choosing treatments.

Published
2022

38. Incidence and pattern of mycophenolate discontinuation associated with abnormal monitoring blood-test results: cohort study using data from the Clinical Practice Research Datalink Aurum

Author

Nakafero, Georgina, primary, Grainge, Matthew J, additional, Card, Tim, additional, Mallen, Christian D, additional, Riley, Richard, additional, van der Windt, Danielle, additional, Fox, Christopher P, additional, Taal, Maarten W, additional, Aithal, Guruprasad P, additional, Williams, Hywel C, additional, and Abhishek, Abhishek, additional

Published
2022
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42. Is vaccination against COVID-19 associated with autoimmune rheumatic disease flare? A self-controlled case series analysis.

Author

Nakafero, Georgina, Grainge, Matthew J, Card, Tim, Mallen, Christian D, Van-Tam, Jonathan S Nguyen, Williams, Hywel C, and Abhishek, Abhishek

Subjects
EVALUATION of medical care, COVID-19, CONFIDENCE intervals, COVID-19 vaccines, AUTOIMMUNE diseases, CASE-control method, RESEARCH funding, RHEUMATISM, DRUG side effects
Abstract

Objectives To investigate the association between vaccination against coronavirus disease 2019 (COVID-19) and autoimmune rheumatic disease (AIRD) flare. Material and methods Patients with AIRDs vaccinated against COVID-19 who consulted for disease flare between 1 December 2020 and 31 December 2021 were ascertained in Clinical Practice Research Datalink (Aurum). AIRD flare was defined as consultation for AIRD with CS prescription on the same day or the next day. Vaccination was defined using date of vaccination and product code. The observation period was partitioned into vaccine-exposed (21 days after vaccination), pre-vaccination (7 days before vaccination) and remaining vaccine-unexposed periods. Participants contributed data with multiple vaccinations and outcomes. Season adjusted incidence rate ratios (aIRR) and 95% CI were calculated using self-controlled case series analysis. Results Data for 3554 AIRD cases, 72% female, mean age 65 years and 68.3% with RA, were included. COVID-19 vaccination was associated with significantly fewer AIRD flares in the 21-day vaccine-exposed period when all vaccinations were considered [aIRR (95% CI) 0.89 (0.80, 0.98)]. Using dose-stratified analyses there was a statistically significant negative association in the 21 days after first COVID-19 vaccination but no association after the second or third COVID-19 vaccinations [aIRR (95% CI) 0.76 (0.66, 0.89), 0.94 (0.79, 1.11) and 1.01 (0.85, 1.20), respectively]. On AIRD-type stratified analyses, vaccination was not associated with disease flares. Vaccination without or after severe acute respiratory syndrome coronavirus 2 infection, and with vectored DNA or mRNA vaccines, associated with comparable reduced risk of AIRD flares in the vaccine-exposed period after first COVID-19 vaccination. Conclusions Vaccination against COVID-19 was not associated with increased AIRD flares regardless of prior COVID-19, AIRD type, and whether mRNA or DNA vaccination technology were used. [ABSTRACT FROM AUTHOR]

Published
2023
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45. Response to letter

Author

Fogarty, Andrew, primary, Card, Tim, additional, Shaw, Dominick Edward, additional, Simmonds, Mark, additional, West, Joe, additional, and Crooks, Colin, additional

Published
2022
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47. Characterizing the risk interplay between alcohol intake and body mass index on cirrhosis morbidity

Author

Morling, Joanne R., Innes, Hamish, Crooks, Colin J., West, Joe, Aspinall, Esther, Hamill, Victoria, Dillon, John, Hayes, Peter C., Hutchinson, Sharon, Card, Tim R., and Guha, Neil I.

Abstract

Background and Aims: It is thought that alcohol intake and body mass index (BMI) interact supra-additively to modulate the risk of cirrhosis, but evidence for this phenomenon is limited. We investigated the interrelationship between alcohol and BMI on the incidence of cirrhosis morbidity for participants of the United Kingdom Biobank (UKB) study. Approach and Results: The primary outcome was the cumulative incidence of cirrhosis morbidity, defined as a first-time hospital admission for cirrhosis (with noncirrhosis mortality incorporated as a competing risk). All UKB participants without a previous hospital admission for cirrhosis were included in the analysis. We determined the ratio of the 10-year cumulative incidence in harmful drinkers versus safe drinkers according to BMI. We also calculated the excess cumulative incidence at 10 years for individuals with obesity and/or harmful alcohol compared to safe drinkers with a healthy BMI of 20–25.0 kg/m2. A total of 489,285 UK Biobank participants were included, with mean of 10.7 person-years’ follow-up. A total of 2070 participants developed the primary outcome, equating to a crude cumulative incidence of 0.36% at 10 years (95% CI:0.34–0.38). The 10-year cumulative incidence was 8.6 times higher for harmful (1.38%) versus safe drinkers (0.16%) if BMI was healthy. Conversely, it was only 3.6 times higher for obese participants (1.99% vs. 0.56%). Excess cumulative incidence was 1.22% (95% CI:0.89–1.55) for harmful drinkers with a healthy BMI, 0.40% (95% CI:0.34–0.46) for obese individuals drinking at safe levels, and 1.83% (95% CI:1.46–2.20) for obese harmful drinkers (all compared to safe drinkers with a healthy BMI). Conclusions: Alcohol intake and obesity are independent risk factors for cirrhosis morbidity, but they do not interact supra-additively to modulate the cumulative incidence of this outcome.

Published
2022

48. Incidence and survival of haemophagocytic lymphohistiocytosis: A population‐based cohort study from England

Author

West, Joe, primary, Card, Tim R., additional, Bishton, Mark J., additional, Lanyon, Peter, additional, Ban, Lu, additional, Bythell, Mary, additional, Elliss‐Brookes, Lucy, additional, Manson, Jessica J., additional, Nanduri, Vasanta, additional, Rankin, Judith, additional, Tattersall, Rachel S., additional, and Crooks, Colin J., additional

Published
2021
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50. Development and validation of a prognostic model for leflunomide discontinuation with abnormal blood tests during long-term treatment: cohort study using data from the Clinical Practice Research Datalink Gold and Aurum

Author

Nakafero, Georgina, primary, Grainge, Matthew J, additional, Card, Tim, additional, Taal, Maarten W, additional, Aithal, Guruprasad P, additional, Zhang, Weiya, additional, Doherty, Michael, additional, Fox, Christopher P, additional, Mallen, Christian D, additional, and Abhishek, Abhishek, additional

Published
2021
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