Health-Related Quality of Life Outcomes With Tofacitinib Treatment in Patients With Ulcerative Colitis in the Open-Label Extension Study, OCTAVE Open

Luc Biedermann; Marla C Dubinsky; Séverine Vermeire; Marc Fellmann; Sean Gardiner; Peter Hur; Rajiv Mundayat; Julian Panés; David T Rubin

doi:10.1093/ibd/izac222

Health-Related Quality of Life Outcomes With Tofacitinib Treatment in Patients With Ulcerative Colitis in the Open-Label Extension Study, OCTAVE Open

Inflamm Bowel Dis. 2023 Sep 1;29(9):1370-1379. doi: 10.1093/ibd/izac222.

Authors

Luc Biedermann¹, Marla C Dubinsky², Séverine Vermeire³, Marc Fellmann⁴, Sean Gardiner⁵, Peter Hur⁵, Rajiv Mundayat⁵, Julian Panés⁶, David T Rubin⁷

Affiliations

¹ Department of Gastroenterology and Hepatology, University Hospital Zürich, Zürich, Switzerland.
² Susan and Leonard Feinstein IBD Center, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
³ Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.
⁴ Pfizer Switzerland AG, Zürich, Switzerland.
⁵ Pfizer Inc, New York, NY, USA.
⁶ Department of Gastroenterology, Hospital Clínic de Barcelona, August Pi i Sunyer Biomedical Research Institute, Centro de Investigación Biomédica en Red Enfermedades Hepáticas y Digestivas, Barcelona, Spain.
⁷ University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, IL, USA.

Abstract

Background: Tofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of ulcerative colitis. We report health-related quality of life (HRQoL) outcomes in patients with ulcerative colitis in the phase 3 open-label, long-term extension study, OCTAVE Open.

Methods: The Inflammatory Bowel Disease Questionnaire (IBDQ), EuroQoL-5 Dimensions Health Questionnaire, and 36-Item Short Form Survey scores were analyzed up to month (M) 72 in 4 subpopulations: patients in remission at baseline (maintenance remitters) assigned tofacitinib 5 mg twice daily and patients not in remission at baseline (maintenance nonremitters, maintenance treatment failures, and induction nonresponders [IndNRs]) assigned tofacitinib 10 mg twice daily in OCTAVE Open. Data were analyzed overall and stratified by corticosteroid use at baseline, prior tumor necrosis factor inhibitor failure, and prior immunosuppressant failure.

Results: Among maintenance remitters and nonremitters, HRQoL outcomes were maintained up to M72: 80.0% and 100.0% of patients had an IBDQ total score ≥170, respectively. At baseline, 7.4% of maintenance treatment failures had an IBDQ total score ≥170, and this increased to 54.3% and 75.0% at M2 and M72, respectively. Corresponding values for IndNRs were 22.6%, 51.0%, and 86.0%. HRQoL outcomes were independent of treatment history. Among patients not in remission at baseline, improvement in EuroQoL-5 Dimensions Health Questionnaire and 36-Item Short Form Survey scores was maintained or achieved by M2, and steady to M72 or M33, with maintenance treatment failures and IndNR subpopulations undergoing the biggest improvements from baseline.

Conclusions: A continued favorable impact on HRQoL was revealed with long-term tofacitinib treatment in OCTAVE Open, regardless of baseline remission status or treatment history. (ClinicalTrials.gov; number: NCT01470612).

Keywords: quality of life; tofacitinib; ulcerative colitis.

Plain language summary

Health-related quality of life was assessed in patients with ulcerative colitis in an open-label, long-term extension study, OCTAVE Open. Patients had sustained beneficial effects on health-related quality of life with long-term tofacitinib treatment, regardless of treatment history/remission status at OCTAVE Open baseline.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Colitis, Ulcerative* / chemically induced
Colitis, Ulcerative* / drug therapy
Humans
Janus Kinase Inhibitors*
Pyrroles / adverse effects
Quality of Life
Treatment Outcome

Substances

tofacitinib
Pyrroles
Janus Kinase Inhibitors

Associated data

ClinicalTrials.gov/NCT01470612