Prediction of early clinical response in patients receiving tofacitinib in the OCTAVE Induction 1 and 2 studies

Introduction: Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). Outcome prediction based on early treatment response, along with clinical and laboratory variables, would be very useful for clinical practice. The aim of this study was to deter...

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Autores principales:	Charlie W. Lees, J. Jasper Deuring, Michael Chiorean, Marco Daperno, Gianluca Bonfanti, Rebecca Germino, Pritha Bhadra Brown, Irene Modesto, Roger A. Edwards
Formato:	article
Lenguaje:	EN
Publicado:	SAGE Publishing 2021
Materias:	Diseases of the digestive system. Gastroenterology RC799-869
Acceso en línea:	https://doaj.org/article/b976d18342f54008bf2cc85a781bf595
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spelling	oai:doaj.org-article:b976d18342f54008bf2cc85a781bf5952021-12-01T23:33:46ZPrediction of early clinical response in patients receiving tofacitinib in the OCTAVE Induction 1 and 2 studies1756-284810.1177/17562848211054710https://doaj.org/article/b976d18342f54008bf2cc85a781bf5952021-11-01T00:00:00Zhttps://doi.org/10.1177/17562848211054710https://doaj.org/toc/1756-2848Introduction: Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). Outcome prediction based on early treatment response, along with clinical and laboratory variables, would be very useful for clinical practice. The aim of this study was to determine early variables predictive of responder status in patients with UC treated with tofacitinib. Methods: Data were collected from patients treated with tofacitinib 10 mg twice daily in the OCTAVE Induction 1 and 2 studies (NCT01465763 and NCT01458951). Logistic regression and random forest analyses were performed to determine the power of clinical and/or laboratory variables to predict 2- and 3-point partial Mayo score responder status of patients at Weeks 4 or 8 after baseline. Results: From a complete list of variables measured in OCTAVE Induction 1 and 2, analyses identified partial Mayo score, partial Mayo subscore (stool frequency, rectal bleeding, and Physician Global Assessment), cholesterol level, and C-reactive protein level as sufficient variables to predict responder status. Using these variables at baseline and Week 2 predicted responder status at Week 4 with 84–87% accuracy and Week 8 with 74–79% accuracy. Variables at baseline, Weeks 2 and 4 could predict responder status at Week 8 with 85–87% accuracy. Conclusion: Using a limited set of time-dependent variables, statistical and machine learning models enabled early and clinically meaningful predictions of tofacitinib treatment outcomes in patients with moderately to severely active UC.Charlie W. LeesJ. Jasper DeuringMichael ChioreanMarco DapernoGianluca BonfantiRebecca GerminoPritha Bhadra BrownIrene ModestoRoger A. EdwardsSAGE PublishingarticleDiseases of the digestive system. GastroenterologyRC799-869ENTherapeutic Advances in Gastroenterology, Vol 14 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Diseases of the digestive system. Gastroenterology RC799-869
spellingShingle	Diseases of the digestive system. Gastroenterology RC799-869 Charlie W. Lees J. Jasper Deuring Michael Chiorean Marco Daperno Gianluca Bonfanti Rebecca Germino Pritha Bhadra Brown Irene Modesto Roger A. Edwards Prediction of early clinical response in patients receiving tofacitinib in the OCTAVE Induction 1 and 2 studies
description	Introduction: Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). Outcome prediction based on early treatment response, along with clinical and laboratory variables, would be very useful for clinical practice. The aim of this study was to determine early variables predictive of responder status in patients with UC treated with tofacitinib. Methods: Data were collected from patients treated with tofacitinib 10 mg twice daily in the OCTAVE Induction 1 and 2 studies (NCT01465763 and NCT01458951). Logistic regression and random forest analyses were performed to determine the power of clinical and/or laboratory variables to predict 2- and 3-point partial Mayo score responder status of patients at Weeks 4 or 8 after baseline. Results: From a complete list of variables measured in OCTAVE Induction 1 and 2, analyses identified partial Mayo score, partial Mayo subscore (stool frequency, rectal bleeding, and Physician Global Assessment), cholesterol level, and C-reactive protein level as sufficient variables to predict responder status. Using these variables at baseline and Week 2 predicted responder status at Week 4 with 84–87% accuracy and Week 8 with 74–79% accuracy. Variables at baseline, Weeks 2 and 4 could predict responder status at Week 8 with 85–87% accuracy. Conclusion: Using a limited set of time-dependent variables, statistical and machine learning models enabled early and clinically meaningful predictions of tofacitinib treatment outcomes in patients with moderately to severely active UC.
format	article
author	Charlie W. Lees J. Jasper Deuring Michael Chiorean Marco Daperno Gianluca Bonfanti Rebecca Germino Pritha Bhadra Brown Irene Modesto Roger A. Edwards
author_facet	Charlie W. Lees J. Jasper Deuring Michael Chiorean Marco Daperno Gianluca Bonfanti Rebecca Germino Pritha Bhadra Brown Irene Modesto Roger A. Edwards
author_sort	Charlie W. Lees
title	Prediction of early clinical response in patients receiving tofacitinib in the OCTAVE Induction 1 and 2 studies
title_short	Prediction of early clinical response in patients receiving tofacitinib in the OCTAVE Induction 1 and 2 studies
title_full	Prediction of early clinical response in patients receiving tofacitinib in the OCTAVE Induction 1 and 2 studies
title_fullStr	Prediction of early clinical response in patients receiving tofacitinib in the OCTAVE Induction 1 and 2 studies
title_full_unstemmed	Prediction of early clinical response in patients receiving tofacitinib in the OCTAVE Induction 1 and 2 studies
title_sort	prediction of early clinical response in patients receiving tofacitinib in the octave induction 1 and 2 studies
publisher	SAGE Publishing
publishDate	2021
url	https://doaj.org/article/b976d18342f54008bf2cc85a781bf595
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Prediction of early clinical response in patients receiving tofacitinib in the OCTAVE Induction 1 and 2 studies

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