Journal article
Tofacitinib Response in Ulcerative Colitis (TOUR): Early Response After Initiation of Tofacitinib Therapy in a Real-world Setting
Inflammatory bowel diseases, Vol.29(4), pp.570-578
04/2023
DOI: 10.1093/ibd/izac121
PMCID: PMC10069660
PMID: 35700276
Abstract
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 PROM IS 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.
Details
- Title: Subtitle
- Tofacitinib Response in Ulcerative Colitis (TOUR): Early Response After Initiation of Tofacitinib Therapy in a Real-world Setting
- Creators
- Millie D. Long - University of North Carolina at Chapel HillAnita Afzali - The Ohio State UniversityMonika Fischer - Indiana UniversityDavid Hudesman - NYU Langone HealthMaisa Abdalla - University of RochesterRobert McCabe - MNGI Digestive HealthBenjamin L. Cohen - Icahn School of Medicine at Mount SinaiRyan C. Ungaro - Icahn School of Medicine at Mount SinaiWill Harlan - HealthPartnersJohn HansonGauree Konijeti - Scripps ClinicSteven Polyak - University of IowaTimothy Ritter - GI Alliance, Southlake, TX, USA.Bruce Salzberg - Atlanta Gastroenterology AssociatesJennifer Seminerio - University of South FloridaEmily English - University of North Carolina at Chapel HillXian Zhang - University of North Carolina at Chapel HillPuza P. Sharma - Pfizer (United States)Hans H. Herfarth - MNGI Digestive Health
- Resource Type
- Journal article
- Publication Details
- Inflammatory bowel diseases, Vol.29(4), pp.570-578
- DOI
- 10.1093/ibd/izac121
- PMID
- 35700276
- PMCID
- PMC10069660
- NLM abbreviation
- Inflamm Bowel Dis
- ISSN
- 1078-0998
- eISSN
- 1536-4844
- Publisher
- Oxford Univ Press
- Number of pages
- 9
- Grant note
- Pfizer Inc.; Pfizer
- Language
- English
- Electronic publication date
- 06/14/2022
- Date published
- 04/2023
- Academic Unit
- Internal Medicine
- Record Identifier
- 9984363307902771
Metrics
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