Journal article
Clinical long-term outcomes of patient-reported outcomes in the prospective real-world Tofacitinib Response in Ulcerative Colitis (TOUR) registry: Tofacitinib Response in Ulcerative Colitis (TOUR)
Clinical and translational gastroenterology, Vol.15(3), e00669
03/2024
DOI: 10.14309/ctg.0000000000000669
PMCID: PMC10962890
PMID: 38131617
Abstract
We previously reported the results of tofacitinib induction therapy in the prospective multi-site US real-world TOUR registry. We now assessed patient-reported outcomes (PRO's) and predictors of success during tofacitinib maintenance therapy.
TOUR included 103 patients with refractory ulcerative colitis (UC); 67% had failed ≥ 2 biologics. Patients reported the simple clinical colitis activity index (SCCAI), PRO Measurement Information Systems measures (PROMIS) for anxiety, depression, social satisfaction, and adverse events between weeks 8 and 52 using a web-based system. Paired t-tests and p for trend were utilized to compare changes in PRO measures over time. Bivariate analyses and logistic regression models were used to determine factors associated with response (SCCAI<5) or remission (SCCAI<2) at week 52.
Of 103 patients, 82.5% entered the maintenance phase and 43.7% remained on tofacitinib at week 52. Tofacitinib de-escalation to 5 mg BID occurred in 15% of patients. At week 52, 42.7% and 31.1% of all patients reported an SCCAI<5 and SCCAI≤2, respectively. Normalization of bowel frequency, rectal bleeding, and urgency occurred in 79%, 61%, and 48% of patients remaining on maintenance therapy. Social satisfaction improved significantly (p<0.001), while anxiety and depression scores only numerically improved. No consistent predictors for tofacitinib long-term treatment efficacy were identified, and safety findings were consistent with the known safety profile of tofacitinib.
Tofacitinib is an effective maintenance therapy in refractory UC patients. Dose reductions infrequently occurred during maintenance. Unmet needs in UC maintenance include improvement of urgency and psychosocial factors. (NCT03772145).
Details
- Title: Subtitle
- Clinical long-term outcomes of patient-reported outcomes in the prospective real-world Tofacitinib Response in Ulcerative Colitis (TOUR) registry: Tofacitinib Response in Ulcerative Colitis (TOUR)
- Creators
- Hans H Herfarth - University of North Carolina at Chapel HillAnita Afzali - University of CincinnatiMonika Fischer - Indiana UniversityDavid Hudesman - NYU Langone HealthMaisa Abdalla - University of RochesterRobert McCabe - MNGI Digestive Health, Minneapolis, MNBenjamin L Cohen - Icahn School of Medicine at Mount SinaiRyan C Ungaro - Icahn School of Medicine at Mount SinaiWill Harlan - Digestive Health Partners, Ashville, NCJohn Hanson - Atrium Health Gastroenterology and Hepatology, Charlotte, NCGauree G Konijeti - Scripps ClinicSteven Polyak - University of IowaTimothy Ritter - GI Alliance Research, Southlake, TxBruce Salzberg - Atlanta Gastroenterology Specialists, Atlanta, GAJennifer Seminerio - Division of Digestive Diseases and Nutrition, University of South Florida Morsani College of Medicine, Tampa, FLEmily English - University of North Carolina at Chapel HillXian Zhang - University of North Carolina at Chapel HillMillie D Long - University of North Carolina at Chapel Hill
- Resource Type
- Journal article
- Publication Details
- Clinical and translational gastroenterology, Vol.15(3), e00669
- DOI
- 10.14309/ctg.0000000000000669
- PMID
- 38131617
- PMCID
- PMC10962890
- NLM abbreviation
- Clin Transl Gastroenterol
- eISSN
- 2155-384X
- Language
- English
- Electronic publication date
- 12/22/2023
- Date published
- 03/2024
- Academic Unit
- Internal Medicine
- Record Identifier
- 9984533286102771
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