A0182 - Dupilumab Reduces the Emotional and Dysphagia-Related Impacts of Eosinophilic Esophagitis to Improve Health-Related Quality of Life

Jonathan Spergel, MD, PhD¹, Juby Jacob-Nara, MD², Evan Dellon, MD, MPH³, Zhen Chen, MPH, PhD⁴, Tiffany Pela, MPH, PharmD², Angela Khodzhayev, PharmD⁴, Arpita Nag, MBA, MS, PhD², Danen Cunoosamy, PhD⁵, Amr Radwan, MA, MBBChir⁴, Siddhesh Kamat, MS, MBA⁴, Eilish McCann, PhD^4
1Children’s Hospital of Pennsylvania, Perelman School of Medicine at University of Pennsylvania, Philadelphia, PA; ²Sanofi, Bridgewater, NJ; ³University of North Carolina School of Medicine, Chapel Hill, NC; ⁴Regeneron Pharmaceuticals, Tarrytown, NY; ⁵Sanofi, Cambridge, MA

Introduction: Eosinophilic esophagitis (EoE) is a chronic, type 2 inflammatory disease of the esophagus which substantially impairs quality of life (QoL). Dupilumab, a fully human mAb, blocks the shared receptor component for IL-4/IL-13, key drivers of type 2 inflammation in EoE. In the 3-part LIBERTY-EoE-TREET phase 3 trial (NCT03633617), Parts A and B demonstrated that weekly (qw) dupilumab 300mg improved clinical, symptomatic, histologic, and endoscopic aspects of EoE and was generally well tolerated in patients (pts) ≥12 years at Wk 24. The objective of this post-hoc analysis was to assess the effect of dupilumab vs placebo on improving aspects of QoL using the EoE Impact Questionnaire (EoE-IQ), a novel disease-specific measure of health-related QoL in EoE patients, during the 24-wk double-blind treatment period in Parts A and B.

Methods: In Part A, 42 pts received dupilumab 300mg qw, and 39 received placebo. In Part B, 80 pts received dupilumab 300mg qw, and 79 received placebo for 24 wks. The EoE-IQ is a patient-reported 11-item questionnaire that measures the impact of EoE on emotional, social, work and school, and sleep aspects of a patient (over a 7-day recall period). It was developed in line with best practices in the field of clinical outcomes assessment and includes the most relevant QoL impacts of EoE as identified through literature review and discussion with therapeutic area experts and confirmed via patient interviews. Response to each item is on a 5-point scale ranging from 1-5 with a higher score indicating a more negative impact on QoL.

Results: The most burdensome impacts of EoE at baseline were related to overall emotional impact and anxiety around dysphagia (Table). Dupilumab showed a nominally significant reduction vs placebo in 6 items in Parts A and B: ‘bothered’, ‘worried about swallowing’, ‘worried about choking’, ‘worried about swallowing in public’, ‘social activities’, ‘sleep disruption’ (all nominal p< 0.05), and in 1 additional item in Part B (‘embarrassed’, nominal p< 0.05). The largest placebo adjusted change from baseline to Wk 24 was observed in items relating to overall emotional impact and anxiety, including ‘worried about swallowing in public’ (Part A: –0.90; Part B: –0.45), ‘bothered’ (–0.64; –0.53), ‘worried about swallowing’ (–0.73; –0.65), and ‘worried about choking’ (–0.61; –0.57).

Discussion: EoE QoL was improved among pts on dupilumab 300mg qw, with improvement driven by emotional and social impacts, and sleep.



Disclosures:


Jonathan Spergel, MD, PhD¹, Juby Jacob-Nara, MD², Evan Dellon, MD, MPH³, Zhen Chen, MPH, PhD⁴, Tiffany Pela, MPH, PharmD², Angela Khodzhayev, PharmD⁴, Arpita Nag, MBA, MS, PhD², Danen Cunoosamy, PhD⁵, Amr Radwan, MA, MBBChir⁴, Siddhesh Kamat, MS, MBA⁴, Eilish McCann, PhD⁴. A0182 - Dupilumab Reduces the Emotional and Dysphagia-Related Impacts of Eosinophilic Esophagitis to Improve Health-Related Quality of Life, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.