Clinical Long-Term Outcomes of Patient-Reported Outcomes in the Prospective Real-World Tofacitinib Response in Ulcerative Colitis Registry.

Autor:	Herfarth HH; University of North Carolina at Chapel Hill, Division of Gastroenterology and Hepatology, Chapel Hill, North Carolina, USA., Afzali A; University of Cincinnati, Cincinnati, Ohio, USA., Fischer M; Indiana University, Division of Gastroenterology and Hepatology, Indianapolis, Indiana, USA., Hudesman D; NYU Langone Medical Center, New York, New York, USA., Abdalla M; University of Rochester, Division of Gastroenterology and Hepatology, Rochester, New York, USA., McCabe R; MNGI Digestive Health, Minneapolis, Minnesota, USA., Cohen BL; Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA., Ungaro RC; Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA., Harlan W; Digestive Health Partners, Ashville, North Carolina, USA., Hanson J; Atrium Health Gastroenterology and Hepatology, Charlotte, North Carolina, USA., Konijeti GG; Scripps Clinic, Division of Gastroenterology & Hepatology, La Jolla, California, USA., Polyak S; University of Iowa, Division of Gastroenterology and Hepatology, Iowa City, Iowa, USA., Ritter T; GI Alliance Research, Southlake, Texas, USA., Salzberg B; Atlanta Gastroenterology Specialists, Atlanta, Georgia, USA., Seminerio J; Division of Digestive Diseases and Nutrition, University of South Florida Morsani College of Medicine, Tampa, Florida, USA., English E; University of North Carolina at Chapel Hill, Division of Gastroenterology and Hepatology, Chapel Hill, North Carolina, USA., Zhang X; University of North Carolina at Chapel Hill, Division of Gastroenterology and Hepatology, Chapel Hill, North Carolina, USA., Long MD; University of North Carolina at Chapel Hill, Division of Gastroenterology and Hepatology, Chapel Hill, North Carolina, USA.
Jazyk:	angličtina
Zdroj:	Clinical and translational gastroenterology [Clin Transl Gastroenterol] 2024 Mar 01; Vol. 15 (3), pp. e00669. Date of Electronic Publication: 2024 Mar 01.
DOI:	10.14309/ctg.0000000000000669
Abstrakt:	Introduction: We previously reported the results of tofacitinib induction therapy in the prospective multisite US real-world Tofacitinib Response in Ulcerative Colitis registry. We now assessed patient-reported outcomes (PROs) and predictors of success during tofacitinib maintenance therapy. Methods: Tofacitinib Response in Ulcerative Colitis included 103 patients with refractory ulcerative colitis (UC); 67% had failed ≥ 2 biologics. Patients reported the Simple Clinical Colitis Activity Index (SCCAI), Patient-Reported Outcome Measurement Information System measures for anxiety, depression, social satisfaction, and adverse events between weeks 8 and 52 using a web-based system. Paired t test and P for trend were used 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 patients with refractory UC. Dose reductions infrequently occurred during maintenance. Unmet needs in UC maintenance include improvement of urgency and psychosocial factors (NCT03772145). (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The American College of Gastroenterology.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu