Disease Activity and Health-related Quality of Life Relationships with Work Productivity in Patients with Ulcerative Colitis in OCTAVE Induction 1 and 2 and OCTAVE Sustain

Laura Targownik; Marla C Dubinsky; Flavio Steinwurz; Andrew G Bushmakin; Joseph C Cappelleri; Elaine Tai; Sean Gardiner; Peter Hur; Julian Panés

doi:10.1093/ecco-jcc/jjac161

Disease Activity and Health-related Quality of Life Relationships with Work Productivity in Patients with Ulcerative Colitis in OCTAVE Induction 1 and 2 and OCTAVE Sustain

J Crohns Colitis. 2023 Apr 19;17(4):513-523. doi: 10.1093/ecco-jcc/jjac161.

Authors

Laura Targownik¹, Marla C Dubinsky², Flavio Steinwurz³, Andrew G Bushmakin⁴, Joseph C Cappelleri⁴, Elaine Tai⁵, Sean Gardiner⁶, Peter Hur⁶, Julian Panés⁷

Affiliations

¹ Division of Gastroenterology and Hepatology, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada.
² Susan and Leonard Feinstein IBD Center, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
³ Unit of Inflammatory Bowel Disease, Hospital Israelita Albert Einstein, São Paulo, Brazil.
⁴ Pfizer Inc, Groton, CT, USA.
⁵ Pfizer Canada Inc, Kirkland, QC, Canada.
⁶ Pfizer Inc, New York, NY, USA.
⁷ Formerly: Department of Gastroenterology, Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.

Abstract

Background: Tofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of ulcerative colitis [UC]. We evaluated the relationship between Mayo/Inflammatory Bowel Disease Questionnaire [IBDQ] scores and Work Productivity and Activity Impairment-UC [WPAI-UC] components in patients with UC.

Methods: All available pooled data from three Phase 3 tofacitinib studies [OCTAVE Induction 1 and 2 and OCTAVE Sustain] were included. Relationships were estimated using repeated measures regression models with Mayo score/subscores or IBDQ total/domain scores as a separate anchor predictor and WPAI-UC components as the outcome.

Results: Evidence for linear relationships was confirmed between Mayo/IBDQ scores and WPAI-UC components. Robust relationships between total Mayo score/IBDQ total score and WPAI-UC presenteeism, work productivity loss, and activity impairment were observed; relationships with absenteeism were weak. Total Mayo scores of 0 and 12 corresponded, on average, to WPAI-UC component scores of < 15% and ≥ 60%, respectively, and IBDQ total scores of 224 and 32 corresponded, on average, to WPAI-UC component scores of < 6% and ≥ 90%, respectively. Presenteeism, work productivity loss, and activity impairment [all 0-100%], respectively, improved on average by 14.7, 13.6, and 16.4 percentage points for every 3-point improvement in total Mayo score, and by 8.1, 7.9, and 8.8 percentage points for every 16-point improvement in IBDQ total score.

Conclusion: Robust relationships between Mayo/IBDQ scores with WPAI-UC presenteeism, work productivity loss, and activity impairment suggest that patient productivity and non-work activities are strongly associated with disease activity and HRQoL. The weak relationships with absenteeism suggest that patients attend work regardless of their disease activity/poor HRQoL. ClinicalTrials.gov: NCT01465763;NCT01458951;NCT01458574.

Keywords: Janus kinase inhibitors; patient-reported outcomes; quality of life; tofacitinib; ulcerative colitis; work productivity.

Publication types

Clinical Trial, Phase III

MeSH terms

Colitis, Ulcerative* / drug therapy
Humans
Janus Kinase Inhibitors*
Piperidines / therapeutic use
Quality of Life
Surveys and Questionnaires

Substances

Janus Kinase Inhibitors
Piperidines

Associated data

ClinicalTrials.gov/NCT01458574
ClinicalTrials.gov/NCT01465763
ClinicalTrials.gov/NCT01458951