{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,6]],"date-time":"2026-04-06T00:06:10Z","timestamp":1775433970948,"version":"3.50.1"},"reference-count":37,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2025,11,21]],"date-time":"2025-11-21T00:00:00Z","timestamp":1763683200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2025,11,21]],"date-time":"2025-11-21T00:00:00Z","timestamp":1763683200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Br J Clin Pharmacol"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>The purpose of this study is to identify risk factors associated with pharmacokinetic failure, defined as immunogenicity or subtherapeutic drug concentrations, in patients treated with infliximab (IFX) or adalimumab (ADA), and to develop a predictive model (STRATIfy\u2010PK SCORE) to support proactive therapeutic drug monitoring (TDM).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A retrospective cohort study was conducted in adult patients with immune\u2010mediated inflammatory diseases receiving IFX or ADA. Pharmacokinetic failure was defined by anti\u2010drug antibodies or subtherapeutic serum concentrations, based on indication\u2010specific therapeutic thresholds. Multivariate logistic regression models were developed separately for each drug and outcome. Model performance was assessed using area under the receiver operating characteristic curve (AUC) and calibration plots.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of 457 patients (298 ADA, 159 IFX), 1035 TDM samples were analysed. Subtherapeutic drug concentrations occurred in 59.7% of patients, and immunogenicity was observed in 18.8%. In IFX\u2010treated patients, predictors of immunogenicity included prior low induction or maintenance levels, ankylosing spondylitis and rheumatoid arthritis. For ADA, predictors were non\u2010adherence, prior low maintenance levels, early TDM, monotherapy and rheumatic diagnoses. Predictors of subtherapeutic concentrations included prior low maintenance levels, early TDM, high inflammatory burden, and rheumatoid arthritis for IFX, and prior low maintenance levels, ankylosing spondylitis and early TDM for ADA. Predictive models demonstrated good discriminative performance (AUC 0.795\u20130.800 for immunogenicity; 0.686\u20130.700 for subtherapeutic levels) and satisfactory calibration.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>STRATIfy\u2010PK SCORE allows early identification of patients at high risk of pharmacokinetic failure and may support proactive, personalized TDM strategies to improve clinical outcomes.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/bcp.70346","type":"journal-article","created":{"date-parts":[[2025,11,21]],"date-time":"2025-11-21T12:37:46Z","timestamp":1763728666000},"page":"1098-1108","source":"Crossref","is-referenced-by-count":0,"title":["STRATIfy\u2010PK SCORE: A predictive tool for identifying pharmacokinetic failure risk in anti\u2010TNF\u2013treated patient"],"prefix":"10.1002","volume":"92","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3950-7250","authenticated-orcid":false,"given":"Carles","family":"Iniesta\u2010Naval\u00f3n","sequence":"first","affiliation":[{"name":"Department of Hospital Pharmacy Reina Sofia Hospital of Murcia  Murcia Spain"},{"name":"Pharmacokinetics and Applied Pharmacotherapy Group Biomedical Research Institute of Murcia (IMIB\u2010Pascual Parrilla)  Murcia Spain"},{"name":"Department of Pharmacology School of Medicine University of Murcia  Murcia 30120 Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Manuel","family":"R\u00edos\u2010Saor\u00edn","sequence":"additional","affiliation":[{"name":"Department of Hospital Pharmacy Reina Sofia Hospital of Murcia  Murcia Spain"},{"name":"Pharmacokinetics and Applied Pharmacotherapy Group Biomedical Research Institute of Murcia (IMIB\u2010Pascual Parrilla)  Murcia Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lorena","family":"Rentero\u2010Redondo","sequence":"additional","affiliation":[{"name":"Department of Hospital Pharmacy Reina Sofia Hospital of Murcia  Murcia Spain"},{"name":"Pharmacokinetics and Applied Pharmacotherapy Group Biomedical Research Institute of Murcia (IMIB\u2010Pascual Parrilla)  Murcia Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Juan Jos\u00e9","family":"Gasc\u00f3n\u2010C\u00e1novas","sequence":"additional","affiliation":[{"name":"Department of Public Health University of Murcia  Murcia Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria Rocio","family":"Gonz\u00e1lez\u2010Molina","sequence":"additional","affiliation":[{"name":"Department of Rheumatology Reina Sofia Hospital of Murcia  Murcia Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Isabel Nicol\u00e1s\u2010De","family":"Prado","sequence":"additional","affiliation":[{"name":"Pharmacokinetics and Applied Pharmacotherapy Group Biomedical Research Institute of Murcia (IMIB\u2010Pascual Parrilla)  Murcia Spain"},{"name":"Department of Gastroenterology Reina Sofia Hospital of Murcia  Murcia Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rosa","family":"G\u00f3mez\u2010Esp\u00edn","sequence":"additional","affiliation":[{"name":"Pharmacokinetics and Applied Pharmacotherapy Group Biomedical Research Institute of Murcia (IMIB\u2010Pascual Parrilla)  Murcia Spain"},{"name":"Department of Gastroenterology Reina Sofia Hospital of Murcia  Murcia Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elena","family":"Urbieta\u2010Sanz","sequence":"additional","affiliation":[{"name":"Department of Hospital Pharmacy Reina Sofia Hospital of Murcia  Murcia Spain"},{"name":"Pharmacokinetics and Applied Pharmacotherapy Group Biomedical Research 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