Clinical long-term outcomes of patient-reported outcomes in the prospective real-world Tofacitinib Response in Ulcerative Colitis (TOUR) registry

Hans H. Herfarth, Anita Afzali, Monika Fischer, David Hudesman, Maisa Abdalla, Robert McCabe, Benjamin L. Cohen, Ryan C. Ungaro, Will Harlan, John Hanson, Gauree G. Konijeti, Steven Polyak, Timothy Ritter, Bruce Salzberg, Jennifer Seminerio, Emily English, Xian Zhang, Millie D. Long

Research output: Contribution to journalArticlepeer-review

Abstract

Introduction: 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. Methods: 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. Results: 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. Discussion: 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.

Original languageEnglish
JournalClinical and Translational Gastroenterology
DOIs
StateAccepted/In press - 2023

Keywords

  • inflammatory bowel diseases
  • patient-reported outcomes
  • safety
  • tofacitinib
  • ulcerative colitis

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