B0412 - Relationship Between Health-Related Quality of Life and Work Productivity in Patients With Ulcerative Colitis in the Tofacitinib OCTAVE Phase 3 Induction and Maintenance Studies

Monday, October 24, 2022

10:00 AM – 12:00 PM ET

Location: Crown Ballroom

Has Audio

Presenting Author(s)

Laura E. Targownik, MD, MSHS

Mount Sinai Hospital, University of Toronto
Toronto, ON, Canada

Laura Targownik, MD, MSHS¹, Marla C. Dubinsky, MD², Flavio Steinwurz, MD, MSc, MACG³, Andrew G. Bushmakin, MS⁴, Joseph C. Cappelleri, PhD, MPH⁴, Elaine Tai, PharmD⁵, Sean Gardiner, MD⁶, Peter Hur, ⁶, Julian Panés, MD, PhD⁷
¹Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada; ²Susan and Leonard Feinstein IBD Center, Icahn School of Medicine, Mount Sinai, New York, NY; ³Unit of Inflammatory Bowel Disease, Hospital Israelita Albert Einstein, São Paulo, Sao Paulo, Brazil; ⁴Pfizer Inc, Groton, CT; ⁵Pfizer Canada, Kirkland, PQ, Canada; ⁶Pfizer Inc, New York, NY; ⁷Formerly, Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Catalonia, Spain

Introduction: Tofacitinib is an oral small molecule JAK inhibitor for the treatment of UC. Tofacitinib induction treatment has been shown to improve work productivity in patients (pts) with UC. However, the relationship between health-related quality of life (HRQoL) and work productivity in the tofacitinib OCTAVE clinical program has not been described.

Methods: We aimed to evaluate the relationship between Inflammatory Bowel Disease Questionnaire (IBDQ) domains and Work Productivity and Activity Impairment-Ulcerative Colitis (WPAI-UC) components among pts in Phase 3 studies evaluating tofacitinib as induction or maintenance therapy for UC (OCTAVE Induction 1&2 [NCT01465763; NCT01458951]; OCTAVE Sustain [NCT01458574]). Relationships between IBDQ (total and domain scores) and WPAI-UC components (absenteeism, presenteeism, productivity loss, and activity impairment) were estimated using a repeated measures longitudinal model in which IBDQ domain score was a continuous anchor and WPAI-UC component score was the outcome (i.e., a linear relationship was imposed between the outcome and anchor). In sensitivity analyses, IBDQ domain score was used as a categorical anchor to assess the linearity assumption (which did not impose any functional relationship between outcome and anchor). Productivity loss includes absenteeism and presenteeism and thus is the most comprehensive WPAI-UC component. Analyses used all available pooled data from pts receiving tofacitinib or placebo.

Results: Relationships between IBDQ total score and WPAI-UC components were very similar when using the IBDQ total score as a continuous anchor, compared with a categorical anchor, supporting the linearity assumption. The relationship between IBDQ total score and productivity loss was robust, with IBDQ total scores of 224 and 32 (higher score = better HRQoL) corresponding to a 5.6% (95% CI 3.4, 7.8) and 100.7% (97.3, 104.1) impact, respectively (Table). For every 16‑point increase in IBDQ total score, productivity loss (0–100%) improved by 7.9% (7.5, 8.4; Table). Similar trends were observed between IBDQ total score and activity impairment and presenteeism; the relationship with absenteeism was weak. Similar relationships were observed between IBDQ domains and WPAI-UC components.

Discussion: In induction and maintenance studies, robust relationships between IBDQ (total and domain scores) and productivity loss were observed. These post hoc clinical trial data may not be fully generalizable to clinical practice.

Table. Percentage of productivity loss at IBDQ total scores in patients with UC in OCTAVE Phase 3 induction and maintenance studies (main model with IBDQ total score as a continuous anchor)
	Productivity loss, least squares mean, % (95% CI)
IBDQ total score
32	100.7 (97.3, 104.1)
40	96.8 (93.6, 99.9)
60	86.9 (84.2, 89.5)
80	76.9 (74.7, 79.2)
100	67.0 (65.3, 68.8)
120	57.1 (55.7, 58.5)
140	47.2 (46.1, 48.4)
160	37.3 (36.2, 38.4)
180	27.4 (26.1, 28.8)
200	17.5 (15.8, 19.2)
220	7.6 (5.5, 9.7)
224	5.6 (3.4, 7.8)
Point decrease in IBDQ total score
1	0.5 (0.5, 05)
16	7.9 (7.5, 8.4)
The WPAI-UC is a self-administered six-item survey that generates four metrics: absenteeism (work time missed), presenteeism (impairment whilst working), productivity loss (overall work impairment from the combination of absenteeism and presenteeism), and activity impairment (non-work activity impairment). WPAI component scores are expressed as percentages, with a higher percentage indicating greater impairment and less productivity The IBDQ evaluates disease-related quality of life by 32 items over four domains: bowel (total domain score ranges from 10 to 70), emotional (total domain score ranges from 12 to 84), social (total domain score ranges from 5 to 35), and systemic (total domain score ranges from 5 to 35). For the total score (ranges from 32 to 224) and each domain, a higher score indicates a better quality of life CI, confidence interval; IBDQ, Inflammatory Bowel Disease Questionnaire; UC, ulcerative colitis; WPAI-UC, Work Productivity and Activity Impairment-Ulcerative Colitis

Disclosures:

Laura Targownik: AbbVie – Advisory Committee/Board Member, Grant/Research Support. Amgen – Advisory Committee/Board Member, Grant/Research Support. Celltrion – Advisory Committee/Board Member. Gilead Sciences – Grant/Research Support. JAMP – Advisory Committee/Board Member. Janssen Pharmaceuticals – Advisory Committee/Board Member. Merck – Advisory Committee/Board Member. Pfizer Inc – Advisory Committee/Board Member, Grant/Research Support. Roche – Advisory Committee/Board Member, Grant/Research Support. Sandoz – Advisory Committee/Board Member, Grant/Research Support. Takeda – Advisory Committee/Board Member, Grant/Research Support.

Marla Dubinsky: AbbVie – Consultant. Arena Pharmaceuticals – Consultant. Bristol Myers Squibb – Consultant. Celgene – Consultant. Eli Lilly – Consultant. Galapagos – Consultant. Genetech – Consultant. Gilead Sciences – Consultant. Janssen Pharmaceuticals – Consultant. Pfizer Inc – Consultant. Prometheus Laboratories – Consultant. Takeda – Consultant. Trellus Health – Shareholder. UCB – Consultant.

Flavio Steinwurz: AbbVie – Consultant, Speaker fees. Amgen – Consultant, Speaker fees. Celltrion – Advisory Committee/Board Member, Speaker fees. Eurofarma – Consultant, Speaker fees. Ferring Pharmaceuticals – Consultant, Speaker fees. Janssen Pharmaceuticals – Consultant, Speaker fees. Pfizer Inc – Advisory Committee/Board Member. Sandoz – Consultant, Speaker fees. Takeda – Consultant, Speaker fees. UCB – Consultant, Speaker fees.

Andrew Bushmakin: Pfizer Inc – Employee, Stock Options.

Joseph Cappelleri: Pfizer Inc – Employee, Stock Options.

Elaine Tai: Pfizer Canada – Employee, Stock Options.

Sean Gardiner: Pfizer Inc – Employee, Stock Options, Stock-publicly held company(excluding mutual/index funds).

Peter Hur: Pfizer Inc – Employee, Stock Options.

Julian Panés: AbbVie – Grant/Research Support, Personal fees. Arena – Personal fees. Athos – Personal fees. Boehringer Ingelheim – Personal fees. Celgene – Personal fees. Celltrion – Personal fees. Ferring Pharmaceuticals – Personal fees. Galapagos – Personal fees. Genentech/Roche – Personal fees. GSK – Personal fees. Immunic – Personal fees. Janssen Pharmaceuticals – Personal fees. Mirum – Personal fees. Morphic – Personal fees. Nestlé – Personal fees. Origo – Personal fees. Pandion – Personal fees. Pfizer Inc – Grant/Research Support, Personal fees. Progenity – Personal fees. Takeda – Personal fees. Theravance Biopharma – Personal fees. Wassermann – Personal fees.

Laura Targownik, MD, MSHS¹, Marla C. Dubinsky, MD², Flavio Steinwurz, MD, MSc, MACG³, Andrew G. Bushmakin, MS⁴, Joseph C. Cappelleri, PhD, MPH⁴, Elaine Tai, PharmD⁵, Sean Gardiner, MD⁶, Peter Hur, ⁶, Julian Panés, MD, PhD⁷. B0412 - Relationship Between Health-Related Quality of Life and Work Productivity in Patients With Ulcerative Colitis in the Tofacitinib OCTAVE Phase 3 Induction and Maintenance Studies, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.