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Development and validation of a multivariable risk prediction model for serious infection in patients with psoriasis receiving systemic therapy

Yiu, Z.Z.N.; Sorbe, C.; Lunt, M.; Rustenbach, S.J.; Kühl, L.; Augustin, M.; Mason, K.J.; Ashcroft, D.M.; Griffiths, C.E.M.; Warren, R.B.; BADBIR Study Group, the; Ormerod, Anthony D.; Barker, Jonathan N.W.N.; Evans, Ian; McElhone, Kathleen; Smith, Catherine H.; Reynolds, Nick J.; Murphy, Ruth; Benham, Marilyn; David Burden, A.; Hussain, Sagair; Kirby, Brian; Lawson, Linda; Owen, Caroline M.

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Authors

Z.Z.N. Yiu

C. Sorbe

M. Lunt

S.J. Rustenbach

L. Kühl

M. Augustin

D.M. Ashcroft

C.E.M. Griffiths

R.B. Warren

the BADBIR Study Group

Anthony D. Ormerod

Jonathan N.W.N. Barker

Ian Evans

Kathleen McElhone

Catherine H. Smith

Nick J. Reynolds

Ruth Murphy

Marilyn Benham

A. David Burden

Sagair Hussain

Brian Kirby

Linda Lawson

Caroline M. Owen



Abstract

BACKGROUND: Patients with psoriasis are often concerned about the risk of serious infection associated with systemic psoriasis treatments. OBJECTIVES: To develop and externally validate a prediction model for serious infection in patients with psoriasis within 1 year of starting systemic therapies. METHODS: The risk prediction model was developed using the British Association of Dermatologists Biologic Interventions Register (BADBIR), and the German Psoriasis Registry PsoBest was used as the validation dataset. Model discrimination and calibration were assessed internally and externally using the C-statistic, the calibration slope and the calibration in the large. RESULTS: Overall 175 (1·7%) out of 10 033 participants from BADBIR and 41 (1·7%) out of 2423 participants from PsoBest developed a serious infection within 1 year of therapy initiation. Selected predictors in a multiple logistic regression model included nine baseline covariates, and starting infliximab was the strongest predictor. Evaluation of model performance showed a bootstrap optimism-corrected C-statistic of 0·64 [95% confidence interval (CI) 0·60-0·69], calibration in the large of 0·02 (95% CI -0·14 to 0·17) and a calibration slope of 0·88 (95% CI 0·70-1·07), while external validation performance was poor, with C-statistic 0·52 (95% CI 0·42-0·62), calibration in the large 0·06 (95% CI -0·25 to 0·37) and calibration slope 0·36 (95% CI -0·24 to 0·97). CONCLUSIONS: We present the first results of the development of a multivariable prediction model. This model may help patients and dermatologists in the U.K. and the Republic of Ireland to identify modifiable risk factors and inform therapy choice in a shared decision-making process.

Journal Article Type Article
Acceptance Date Nov 5, 2018
Publication Date Apr 1, 2019
Publicly Available Date Mar 28, 2024
Journal British Journal of Dermatology
Print ISSN 0007-0963
Publisher Wiley
Peer Reviewed Peer Reviewed
Volume 180
Issue 4
Pages 894 -901
DOI https://doi.org/10.1111/bjd.17421
Keywords Adult,Biological Products, Drug Therapy, Combination, Female, Follow-Up Studies, Germany, Hospitalization, Humans, Immunosuppressive Agents, Infections, Ireland, Logistic Models, Male, Middle Aged, Models, Biological, Pharmacovigilance , Prospective Studi
Publisher URL https://doi.org/10.1111/bjd.17421

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