B0378 - Fatigue Improvement Correlates With Reductions in Work Productivity Impairment and Related Indirect Cost in Patients With Crohn’s Disease: Post Hoc Analysis of Phase 3 Rizankizumab Induction Trials

Monday, October 24, 2022

10:00 AM – 12:00 PM ET

Location: Crown Ballroom

Has Audio

Presenting Author(s)

EL

Edward V. Loftus, Jr., MD, FACG

Mayo Clinic College of Medicine and Science
Rochester, Minnesota

Edouard Louis, MD¹, Julian Panés, MD, PhD², Subrata Ghosh, MD³, Britta Siegmund, MD⁴, Wan-Ju Lee, PhD⁵, Huiwen Deng, PharmD⁶, Kristina Kligys, PhD⁵, Jasmina Kalabic, MD⁷, Edward V. Loftus, MD, FACG⁸
¹University Hospital CHU of Liège, Liège, Liege, Belgium; ²Formerly, Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Catalonia, Spain; ³College of Medicine and Health, University College, Cork, Cork, Ireland; ⁴Medizinische Klinik für Gastroenterologie, Infektiologie und Rheumatologie, Charité - Universitätsmedizin Berlin, Berlin, Berlin, Germany; ⁵AbbVie, Inc., North Chicago, IL; ⁶AbbVie, Inc. and University of Illinois at Chicago, Chicago, IL; ⁷AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Hessen, Germany; ⁸Mayo Clinic College of Medicine and Science, Rochester, MN

Introduction: Patients with Crohn’s disease (CD) frequently experience fatigue,¹ which may reduce quality of life and work productivity, contributing to patient and societal costs. This analysis used Phase 3 clinical trial data in CD patients to assess this relationship.

Methods: Pooled 12-week (wk) data was used from patients with moderate to severe CD who received risankizumab (600 or 1200mg IV) or placebo in ADVANCE and MOTIVATE. Patients completed Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and Work Productivity and Activity Index (WPAI) questionnaires at Baseline (BL) and Wk 12. Risankizumab or placebo IV patients with no missing values were analyzed. Correlation between FACIT-F and WPAI was assessed by Pearson correlation. Mean change from BL to Wk 12 in WPAI assessed and stratified by quartiles of mean change from BL FACIT-F scores. Linear relationship between improvements from BL in FACIT-F and WPAI Overall Work Impairment (OWI) was assessed; results from the regression analyses were used to calculate cost savings based on corresponding WPAI scores and average hourly wages in the US and Europe. Annualized cost savings were defined in patients with clinically meaningful improvement (≥9unit increase) in FACIT-F and compared between patients who achieved or did not achieve a FACIT-F score > normative value ( >40) at Wk 12.

Results: Mean age (std dev) of patients was 38.4 (13.3) years and 53.1%were male. Moderate correlation was observed between FACIT-F and all four domains of WPAI (Pearson coefficient range -0.55 to -0.30, P< 0.0001) at Wk 12. Greater improvements in WPAI scores from BL were observed in patients with greater mean change from BL scores in FACIT-F at Wk 12. A ≥9unit change from BL in FACIT-F at Wk 12 corresponded to a 12% reduction in OWI, resulting in 4.8 hours of improved work productivity per wk and an annualized cost savings per person of $7,749 in US and €7,117 in Europe. Patients with normative FACIT-F score of >40 at Wk 12 had a corresponding reduction in OWI of 29%, resulting in 12 hours less work impairment per wk and an annualized cost savings per person of $18,726 in US and €17,199 in Europe.

Discussion: A significant correlation was observed between fatigue and work productivity in the induction trials of risankizumab. Early clinically meaningful improvements, and achieving fatigue normality, were associated with improvements in work productivity leading to substantial indirect cost savings.

Mean change in WPAI Stratified by Mean Change in FACIT-F Scores from Baseline to Week 12
	FACIT-F < 2		2≤ FACIT-F < 9		9≤ FACIT-F < 17		FACIT-F ≥17		P-value
Work time missed	146	7.5 ± 32.5	133	-0.7 ± 25.6	162	-3.2 ± 30.1	185	-18.4 ± 36.7	< 0.0001
Overall work impairment	146	2.5 ± 27.3	133	-11.0 ± 26.3	162	-20.8 ± 29.2	185	-37.5 ± 31.3	< 0.0001
Impairment while working	130	-1.4 ± 21.9	121	-14.1 ± 22.6	147	-23.3 ± 23.5	160	-35.7 ± 26.1	< 0.0001
Activity impairment	303	-3.0 ± 23.0	310	-13.3 ± 22.5	300	-23.7 ± 23.7	341	-41.9 ± 26.7	< 0.0001
Data are n and mean change ± standard deviation. P-value derived from analysis of covariance (ANOVA).

Disclosures:

Edouard Louis: AbbVie – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Arena Pharmaceuticals – Advisory Committee/Board Member. Celgene – Advisory Committee/Board Member. Falk – Speakers Bureau. Ferring – Advisory Committee/Board Member, Speakers Bureau. Galapagos – Advisory Committee/Board Member. Gilead – Advisory Committee/Board Member. Hospira – Advisory Committee/Board Member, Speakers Bureau. Janssen – Advisory Committee/Board Member, Grant/Research Support, Speakers Bureau. MSD – Advisory Committee/Board Member, Grant/Research Support, Speakers Bureau. Pfizer – Advisory Committee/Board Member, Grant/Research Support, Speakers Bureau. Takeda – Advisory Committee/Board Member, Grant/Research Support, Speakers Bureau.

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.

Subrata Ghosh: AbbVie – Advisory Committee/Board Member, steering committee, Speakers Bureau. Boehringer Ingelheim – steering committee. Bristol Myers Squibb – steering committee. Celgene – steering committee. Celltrion – Speakers Bureau. Eli Lilly – Advisory Committee/Board Member. Ferring – Speakers Bureau. Gilead – Advisory Committee/Board Member, steering committee. Janssen – Advisory Committee/Board Member, steering committee, Speakers Bureau. Pfizer – Advisory Committee/Board Member, Speakers Bureau. Roche – Advisory Committee/Board Member. Takeda – Advisory Committee/Board Member, Speakers Bureau.

Britta Siegmund: AbbVie – Received payments to her institution. Arena Pharmaceuticals – Received payments to her institution. BMS – Received payments to her institution. Boehringer-Ingelheim – Received payments to her institution. CED Service GmbH – Speakers Bureau. Celgene – Consultant. Falk – Received payments to her institution. Ferring – Speakers Bureau. Galapagos – Received payments to her institution. Gilead – Received payments to her institution. Janssen – Received payments to her institution. Lilly – Received payments to her institution. Materia Prima – Received payments to her institution. Novartis – Speakers Bureau. Pfizer – Received payments to her institution. Predict Immune – Received payments to her institution. Prometheus – Consultant. Takeda – Consultant, Speakers Bureau.

Wan-Ju Lee: AbbVie – Employee, Stock Options.

Huiwen Deng: AbbVie – Employee. University of Illinois at Chicago – Employee, Research fellow and student.

Kristina Kligys: AbbVie – Employee, Stock Options.

Jasmina Kalabic: AbbVie – Employee, Stock Options.

Edward Loftus: AbbVie – Consultant, Grant/Research Support. Amgen – Consultant, Grant/Research Support. Arena Pharmaceuticals – Consultant. Boehringer Ingelheim – Consultant. Bristol-Myers Squibb – Consultant, Grant/Research Support. Calibr – Consultant. Celgene – Consultant, Grant/Research Support. Eli Lilly – Consultant. Genentech – Consultant, Grant/Research Support. Gilead – Consultant, Grant/Research Support. Iterative Scopes – Consultant. Janssen – Consultant, Grant/Research Support. Morphic – Consultant. Ono Pharma – Consultant. Pfizer – Consultant, Grant/Research Support. Protagonist – Consultant. Receptos – Grant/Research Support. Robarts Clinical Trials – Grant/Research Support. Scipher Medicine – Consultant. Sun Pharma – Consultant. Surrozen – Consultant. Takeda – Consultant, Grant/Research Support. Theravance – Grant/Research Support. UCB – Consultant, Grant/Research Support.

Edouard Louis, MD¹, Julian Panés, MD, PhD², Subrata Ghosh, MD³, Britta Siegmund, MD⁴, Wan-Ju Lee, PhD⁵, Huiwen Deng, PharmD⁶, Kristina Kligys, PhD⁵, Jasmina Kalabic, MD⁷, Edward V. Loftus, MD, FACG⁸. B0378 - Fatigue Improvement Correlates With Reductions in Work Productivity Impairment and Related Indirect Cost in Patients With Crohn’s Disease: Post Hoc Analysis of Phase 3 Rizankizumab Induction Trials, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.