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Tofacitinib Response in Ulcerative Colitis (TOUR): Early Response After Initiation of Tofacitinib Therapy in a Real-world Setting

BACKGROUND: Tofacitinib is an oral, small-molecule JAK inhibitor for the treatment of ulcerative colitis (UC). Using a novel electronic reporting tool, we aimed to prospectively describe the onset of tofacitinib efficacy during induction therapy in a real-world study. METHODS: Patient-reported outco...

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Autores principales: Long, Millie D, Afzali, Anita, Fischer, Monika, Hudesman, David, Abdalla, Maisa, McCabe, Robert, Cohen, Benjamin L, Ungaro, Ryan C, Harlan, Will, Hanson, John, Konijeti, Gauree, Polyak, Steven, Ritter, Timothy, Salzberg, Bruce, Seminerio, Jennifer, English, Emily, Zhang, Xian, Sharma, Puza P, Herfarth, Hans H
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10069660/
https://www.ncbi.nlm.nih.gov/pubmed/35700276
http://dx.doi.org/10.1093/ibd/izac121
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author Long, Millie D
Afzali, Anita
Fischer, Monika
Hudesman, David
Abdalla, Maisa
McCabe, Robert
Cohen, Benjamin L
Ungaro, Ryan C
Harlan, Will
Hanson, John
Konijeti, Gauree
Polyak, Steven
Ritter, Timothy
Salzberg, Bruce
Seminerio, Jennifer
English, Emily
Zhang, Xian
Sharma, Puza P
Herfarth, Hans H
author_facet Long, Millie D
Afzali, Anita
Fischer, Monika
Hudesman, David
Abdalla, Maisa
McCabe, Robert
Cohen, Benjamin L
Ungaro, Ryan C
Harlan, Will
Hanson, John
Konijeti, Gauree
Polyak, Steven
Ritter, Timothy
Salzberg, Bruce
Seminerio, Jennifer
English, Emily
Zhang, Xian
Sharma, Puza P
Herfarth, Hans H
author_sort Long, Millie D
collection PubMed
description BACKGROUND: Tofacitinib is an oral, small-molecule JAK inhibitor for the treatment of ulcerative colitis (UC). Using a novel electronic reporting tool, we aimed to prospectively describe the onset of tofacitinib efficacy during induction therapy in a real-world study. METHODS: Patient-reported outcome data (PROs) including the simple clinical colitis activity index (SCCAI), PRO Measurement Identification Systems (PROMIS) measures, and adverse events were collected daily for the first 14 days and at day 28 and 56. Paired t tests and P for trend were utilized to compare changes in SCCAI over time. Bivariate analyses and logistic regression models were performed to describe response (SCCAI <5) and remission (SCCAI ≤2) by clinical factors. RESULTS: Of all included patients (n = 96), 67% had failed ≥2 biologics, and 61.5% were on concomitant steroids. Starting at day 3, PROs showed significant and persistent decline of the mean SCCAI (−1.1, P < 000.1) including significantly lower SCCAI subscores for stool frequency (−0.3; P < .003), bleeding (−0.3; P < .0002) and urgency (−0.2; P < .001). Steroid-free remission at day 14, 28, and 56 was achieved in 25%, 30.2%, and 29.2% of patients, respectively. Neither prior biologics nor endoscopic severity were independently predictive of response or remission in multivariate models. Numeric improvements in all PROMIS measures (anxiety, depression, social satisfaction) were seen through day 56. Rates of discontinuation due to adverse events were low. CONCLUSIONS: In this prospective real-world study, tofacitinib resulted in a rapid and persistent improvement in UC disease activity PROs. The safety findings were consistent with the established safety profile of tofacitinib.
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spelling pubmed-100696602023-04-04 Tofacitinib Response in Ulcerative Colitis (TOUR): Early Response After Initiation of Tofacitinib Therapy in a Real-world Setting Long, Millie D Afzali, Anita Fischer, Monika Hudesman, David Abdalla, Maisa McCabe, Robert Cohen, Benjamin L Ungaro, Ryan C Harlan, Will Hanson, John Konijeti, Gauree Polyak, Steven Ritter, Timothy Salzberg, Bruce Seminerio, Jennifer English, Emily Zhang, Xian Sharma, Puza P Herfarth, Hans H Inflamm Bowel Dis Clinical Research BACKGROUND: Tofacitinib is an oral, small-molecule JAK inhibitor for the treatment of ulcerative colitis (UC). Using a novel electronic reporting tool, we aimed to prospectively describe the onset of tofacitinib efficacy during induction therapy in a real-world study. METHODS: Patient-reported outcome data (PROs) including the simple clinical colitis activity index (SCCAI), PRO Measurement Identification Systems (PROMIS) measures, and adverse events were collected daily for the first 14 days and at day 28 and 56. Paired t tests and P for trend were utilized to compare changes in SCCAI over time. Bivariate analyses and logistic regression models were performed to describe response (SCCAI <5) and remission (SCCAI ≤2) by clinical factors. RESULTS: Of all included patients (n = 96), 67% had failed ≥2 biologics, and 61.5% were on concomitant steroids. Starting at day 3, PROs showed significant and persistent decline of the mean SCCAI (−1.1, P < 000.1) including significantly lower SCCAI subscores for stool frequency (−0.3; P < .003), bleeding (−0.3; P < .0002) and urgency (−0.2; P < .001). Steroid-free remission at day 14, 28, and 56 was achieved in 25%, 30.2%, and 29.2% of patients, respectively. Neither prior biologics nor endoscopic severity were independently predictive of response or remission in multivariate models. Numeric improvements in all PROMIS measures (anxiety, depression, social satisfaction) were seen through day 56. Rates of discontinuation due to adverse events were low. CONCLUSIONS: In this prospective real-world study, tofacitinib resulted in a rapid and persistent improvement in UC disease activity PROs. The safety findings were consistent with the established safety profile of tofacitinib. Oxford University Press 2022-06-14 /pmc/articles/PMC10069660/ /pubmed/35700276 http://dx.doi.org/10.1093/ibd/izac121 Text en © 2022 Crohn’s & Colitis Foundation. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Clinical Research
Long, Millie D
Afzali, Anita
Fischer, Monika
Hudesman, David
Abdalla, Maisa
McCabe, Robert
Cohen, Benjamin L
Ungaro, Ryan C
Harlan, Will
Hanson, John
Konijeti, Gauree
Polyak, Steven
Ritter, Timothy
Salzberg, Bruce
Seminerio, Jennifer
English, Emily
Zhang, Xian
Sharma, Puza P
Herfarth, Hans H
Tofacitinib Response in Ulcerative Colitis (TOUR): Early Response After Initiation of Tofacitinib Therapy in a Real-world Setting
title Tofacitinib Response in Ulcerative Colitis (TOUR): Early Response After Initiation of Tofacitinib Therapy in a Real-world Setting
title_full Tofacitinib Response in Ulcerative Colitis (TOUR): Early Response After Initiation of Tofacitinib Therapy in a Real-world Setting
title_fullStr Tofacitinib Response in Ulcerative Colitis (TOUR): Early Response After Initiation of Tofacitinib Therapy in a Real-world Setting
title_full_unstemmed Tofacitinib Response in Ulcerative Colitis (TOUR): Early Response After Initiation of Tofacitinib Therapy in a Real-world Setting
title_short Tofacitinib Response in Ulcerative Colitis (TOUR): Early Response After Initiation of Tofacitinib Therapy in a Real-world Setting
title_sort tofacitinib response in ulcerative colitis (tour): early response after initiation of tofacitinib therapy in a real-world setting
topic Clinical Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10069660/
https://www.ncbi.nlm.nih.gov/pubmed/35700276
http://dx.doi.org/10.1093/ibd/izac121
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