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Q&A Defecatory disorders and FI / Simple solution to vexing problems

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Q&A Defecatory disorders and FI / Simple solution to vexing problems

Adil Bharucha 1, Emma V. Carrington 2

1 Mayo Clinic, Rochester, United States

2 University of North Carolina / NCRBSI, London, United Kingdom

Event

UEG Postgraduate Teaching Programme 2023

Topics

Small Intestine & Nutrition Surgery

Session

Getting to the bottom of benign anorectal symptoms

Published

2023

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NICE diet

Sanna Nybacka 1

1 University of Gothenburg, Gothenburg, Sweden

Event

UEG Week Copenhagen 2023

Topics

Small Intestine & Nutrition Education & Training Neurogastroenterology & Motility

Session

Dietary advice for functional gastrointestinal disorders

Published

2023

UEG Presentation

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Q&A Dysphagia: A bitter pill that’s hard to swallow - Neurogenic dysphagia

Shaheen Hamdy 1, Ayodele Sasegbon 2

1 Department of GI Science, Salford, United Kingdom

2 University of Manchester, Manchester, United Kingdom

Event

UEG Postgraduate Teaching Programme 2023

Topics

Neurogastroenterology & Motility Oesophagus

Session

Dysphagia: A bitter pill that’s hard to swallow

Published

2023

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DUPILUMAB EFFICACY AND SAFETY UP TO 52 WEEKS IN ADULT AND ADOLESCENT PATIENTS WITH EOSINOPHILIC ESOPHAGITIS: RESULTS FROM PARTS B AND C OF THE RANDOMIZED, PLACEBO-CONTROLLED, THREE-PART, PHASE 3 LIBERTY EOE TREET STUDY

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Introduction

In Parts A and B of the 3-part phase 3 LIBERTY EoE TREET study (NCT03633617), dupilumab 300 mg weekly (DPL qw) vs placebo (PBO) demonstrated significant efficacy and acceptable safety up to 24 weeks in adults and adolescents with eosinophilic esophagitis (EoE). For patients who completed Parts A and B, Part C was an extended active treatment period for 28 weeks with patients receiving treatment up to 52 weeks. We previously reported continued improvements in all aspects of disease up to 52 weeks in DPL patients who completed Part A/C, and that PBO patients from Part A who received DPL in Part C showed similar efficacy. Here we present results from patients who completed Part B and continued to Part C, which assessed efficacy and safety of DPL up to 52 weeks in a larger number of patients.

Aims & Methods

Of 80 DPL qw patients in Part B, 74 continued DPL qw in Part C (DPL/DPL). Of 79 PBO patients in Part B, 37 received DPL qw in Part C (PBO/DPL). Part B co-primary endpoints were proportion of patients achieving peak esophageal intraepithelial eosinophil (eos) count ≤6 eos/high power field (hpf) and absolute change from Part B baseline (BL) in Dysphagia Symptom Score (DSQ) score at Week 24. Secondary endpoints are listed in the Table. In Part C, all endpoints were assessed at Week 52 as secondary endpoints. Safety was also assessed.

Table. Summary of co-primary and secondary endpoints at Weeks 24 (Part B) and 52 (Part C) of the 3-part phase 3 LIBERTY EoE TREET study.

	Wk 24 (Part B) DPL 300mg qw (n=80)	Wk 24 (Part B) PBO (n=79)	Wk 52 (Part C [patients from Part B]) DPL 300 mg qw /DPL 300 mg qw (n=74)	Wk 52 (Part C [patients from Part B]) PBO /DPL 300 mg qw (n=37)
Proportion of patients achieving peak eosinophil count of ≤6 eos/hpf Part B baseline, mean, eos/hpf (SD) n Proportion of patients achieving peak eosinophil count of ≤6 eos/hpf, n (%) Difference dupilumab vs placebo (95% CI) P value	89.2 (46.67) 80 47 (58.8) 53.5 (41.20–65.79) <0.0001	84.3 (41.20) 79 5 (6.3)	65^a 55 (84.6)	37^a 25 (67.6)
Absolute change from Part B baseline in DSQ score Part B baseline, mean (SD) n/imputed pts^b LS mean (SE)/mean (SD)^c Difference dupilumab vs placebo (95% CI) P value	38.4 (10.71) 63/17 −23.78 (1.86) −9.92 (−14.81 to −5.02) <0.0001	36.1 (10.55) 59/19 −13.86 (1.91)	54^a −30.26 (15.39)	24^a −27.25 (11.46)
Absolute change from Part B baseline in total EoE-EREFS Part B baseline, mean (SD) n/imputed pts^b LS mean (SE)/mean (SD)^c Difference dupilumab vs placebo (95% CI) P value	6.8 (2.96) 69/9 –4.5 (0.36) –3.8 (–4.77 to –2.93) <0.0001^d	7.2 (3.34) 68/11 –0.6 (0.38)	63^a –5.3 (2.85)	37^a –6.1 (3.60)
Percent change from Part B baseline in peak eos count (eos/hpf) n/imputed pts^b LS mean (SE)/mean (SD)^c Difference dupilumab vs placebo (95% CI) P value	71/9 −80.24 (8.34) −88.62 (−112.19 to −65.05) <0.0001^d	69/10 8.38 (10.09)	65^a −95.85 (4.04)	37^a −84.21 (42.17)
Absolute change from Part B baseline in EoE-HSS grade score Part B baseline, mean (SD) n/imputed pts^b LS mean (SE)/mean (SD)^c Difference dupilumab vs placebo (95% CI) P value Absolute change from Part B baseline in EoE-HSS stage score Part B baseline, mean (SD) n/imputed pts^b LS mean (SE)/mean (SD)^c Difference dupilumab vs placebo (95% CI) P value	1.31 (0.39) 71/9 –0.83 (0.04) –0.68 (−0.79 to −0.57) <0.0001^d 1.29 (0.33) 71/9 –0.80 (0.04) –0.67 (–0.78, –0.57) <0.0001^d	1.23 (0.40) 69/10 –0.15 (0.05) 1.22 (0.36) 69/10 –0.13 (0.04)	65^a –0.97 (0.43) 65^a –0.93 (0.37)	37^a –0.91 (0.39) 37^a –0.87 (0.35)
Percent change from Part B baseline in DSQ score n/imputed pts^b LS mean (SE)/mean (SD)^c Difference dupilumab vs placebo (95% CI) P value	63/17 –64.32 (5.07) –22.89 (–36.27 to –9.51) 0.0008	59/19 –41.43 (5.26)	54^a –80.74 (32.87)	24^a –78.13 (31.00)
Proportion of patients achieving peak eosinophil count of <15 eos/hpf n Proportion of patients achieving peak eosinophil count of <15 eos/hpf, n (%) Difference dupilumab vs placebo (95% CI) P value	80 66 (82.5) 74.9 (64.25–85.50) <0.0001^d	79 6 (7.6)	65^a 65 (100)	37^a 29 (78.4)
Relative change from Part B baseline in EDP gene signature n/imputed pts^b NES, median Difference dupilumab vs placebo (95% CI) P value	40/0 –2.67 –1.85 (–2.44, –1.15) <0.0001^d	41/0 –0.73	49^a –2.69	24^a –2.62
Relative change from Part B baseline in type 2 inflammation gene signature n/imputed pts^b NES, median Difference dupilumab vs placebo (95% CI) P value Part C analyses were purely descriptive. ^aNumber of patients with non-missing values at the visit. ^bIn Part B, values after first rescue treatment used were set to missing (censoring) and their Week 24 data were imputed; Part C summary is based on all observed values regardless of rescue treatment. ^cLS mean (SE) calculated for Part B; mean (SD) calculated for Part C. ^dNominal P value. CI, confidence interval; DSQ, Dysphagia Symptom Questionnaire; EDP, EoE Diagnostic Panel; EoE, eosinophilic esophagitis; EREFS, Endoscopic Reference Score; HSS, Histologic Scoring System; LS, least squares; NES, normalized enrichment score; pts, patients; SD, standard deviation; SE, standard error.	40/0 –1.93 –1.28 (–1.82, –1.07) <0.0001^d	41/0 –0.64	49^a –1.97	24^a –1.96

Results

Part B BL characteristics were similar across groups. At Week 52 of Part C, 84.6% of patients in the DPL/DPL and 67.6% of patients in the PBO/DPL groups achieved peak eos count of ≤6 eos/hpf and mean (SD) absolute change from Part B BL in DSQ score was −30.26 (15.39) for DPL/DPL and −27.25 (11.46) for PBO/DPL patients. At Week 52, 100% of patients in the DPL/DPL and 78.4% PBO/DPL groups achieved peak eos count of <15 eos/hpf. Compared to Part B BL, peak eos count, EREFS, HSS grade and stage scores were reduced, and EDP and T2 normalized enrichment scores were suppressed in the DPL/DPL and PBO/DPL groups at Week 52 (Table). Dupilumab demonstrated an acceptable safety profile in Part C; the most common (occurring ≥10%) treatment-emergent adverse events in the DPL/DPL and PBO/DPL groups were injection-site reactions (13.5% and 10.8%), COVID-19 (9.5% and 10.8%), and nasopharyngitis (4.1% and 10.8%).

Conclusion

As observed in Part A/C, dupilumab qw demonstrated persistent improvements in clinical, symptomatic, histologic, endoscopic, and molecular features of EoE up to 52 weeks and Overall safety was consistent with the known dupilumab safety profile. PBO patients from Part B who received dupilumab in Part C showed similar efficacy to dupilumab qw patients of Part B.

Disclosure

Dellon ES: Abbott, Abbvie, Adare/Ellodi, Aimmune, Akesobio, Alfasigma, ALK, Allakos, Amgen, Aqilion, Arena/Pfizer, Aslan, AstraZeneca, Avir, Biorasi, Calypso, Celgene/Receptos/BMS, Celldex, Eli Lilly, EsoCap, Eupraxia, Ferring, GSK, Gossamer Bio, Holoclara, Invea, Landos, LucidDx, Morphic, Nextstone Immunology, Nutricia, Parexel/Calyx, Phathom, Regeneron, Revolo, Robarts/Alimentiv, Salix, Sanofi, Shire/Takeda, Target RWE, Upstream Bio – consultant; Adare/Ellodi, Allakos, Arena, AstraZeneca, GSK, Meritage, Miraca, Nutricia, Celgene/Receptos/BMS, Regeneron, Revolo, and Shire/Takeda – research funding; Allakos, Holoclara, Invea – educational grant.
Rothenberg ME: Allakos, AstraZeneca, BMS, Celldex, ClostraBio, Ellodi Pharmaceuticals, GSK, Nextstone One, PulmOne, Regeneron Pharmaceuticals Inc., Revolo, Sanofi, Santa Ana Bio, Serpin Pharma, Spoon Guru ‒ consultant; Celldex, ClostraBio, Nextstone One, PulmOne, Santa Ana Bio, Serpin Pharma, Spoon Guru ‒ equity interest; Mapi Research Trust ‒ royalties from PEESSv2; Teva Pharmaceuticals ‒ royalties from reslizumab; UpToDate ‒ royalties; inventor of patents owned by Cincinnati Children’s Hospital.
Collins MH: Alimentiv, Allakos, Arena, AstraZeneca, BMS, Calypso, EsoCap, GSK, Regeneron Pharmaceuticals, Inc., Shire – consultant.
Hirano I: Adare/Ellodi, Allakos, Arena/Pfizer, AstraZeneca, Eli Lilly, EsoCap, Gossamer Bio, GSK, Nexstone Immunology, Parexel/Calyx, Phathom, Receptos/BMS, Regeneron Pharmaceuticals Inc., Sanofi, Shire/Takeda – consultant; Adare/Ellodi, Allakos, Receptos/BMS, Regeneron Pharmaceuticals Inc., Shire/Takeda – research funding.
Chehade M: Adare/Ellodi, Allakos, AstraZeneca, BMS, Phathom; Recludix, Regeneron Pharmaceuticals Inc., Sanofi, Shire/Takeda – consultant; Adare/Ellodi, Allakos, AstraZeneca, Danone, Regeneron Pharmaceuticals Inc., Shire/Takeda – research funding.