TY - JOUR
T1 - Dupilumab demonstrated efficacy and was well tolerated regardless of prior use of swallowed topical corticosteroids in adolescent and adult patients with eosinophilic oesophagitis
T2 - A subgroup analysis of the phase 3 LIBERTY EoE TREET study
AU - Bredenoord, Albert J.
AU - Dellon, Evan
AU - Hirano, Ikuo
AU - Lucendo, Alfredo J.
AU - Schlag, Christoph
AU - Sun, Xian
AU - Glotfelty, Lila
AU - Mannent, Leda
AU - Maloney, Jennifer
AU - Laws, Elizabeth
AU - Mortensen, Eric
AU - Shabbir, Arsalan
N1 - Funding Information:
The authors wish to thank Arpita Nag of Sanofi and Changming Xia from Regeneron Pharmaceuticals for their contributions, and Eilish McCann from Regeneron Pharmaceuticals for her insight on the Dysphagia Symptom Questionnaire. Medical writing support provided by Sibyl Bertrand, PhD, of Adelphi Group, Macclesfield, UK, funded by Sanofi and Regeneron Pharmaceuticals in accordance with Good Publication Practice.
Funding Information:
Research sponsored by Sanofi and Regeneron Pharmaceuticals Inc. ClinicalTrials.gov identifiers: NCT03633617 .
Publisher Copyright:
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2023
Y1 - 2023
N2 - Objective: To assess the effect of long-Term dupilumab on histological, symptomatic and endoscopic aspects of eosinophilic oesophagitis (EoE) in adolescent and adult patients with and without prior use of swallowed topical corticosteroids (STC) or prior inadequate response, intolerance or contraindication to STC. Design: Pre-specified analysis of data from the phase 3 LIBERTY EoE TREET study on patients who received dupilumab 300 mg once a week or placebo for 24 weeks (W24) in parts A and B, and an additional 28 weeks (W52) in part C. Patients were categorised as with/without prior STC use and with/without inadequate/intolerance/contraindication to STC. The proportion of patients achieving ≤6 eosinophils per high-power field (eos/hpf), absolute change in Dysphagia Symptom Questionnaire (DSQ) score, mean change in Endoscopic Reference Score and Histologic Scoring System grade/stage scores were assessed for each subgroup. Results: Regardless of prior STC use, dupilumab increased the proportion of patients achieving ≤6 eos/hpf and improved DSQ score versus placebo at W24, with improvements maintained or improved at W52. The DSQ score and the proportion of patients achieving ≤6 eos/hpf after switching from placebo to dupilumab at W24 were similar to those observed in the dupilumab group at W24, regardless of prior STC use or inadequate/intolerance/contraindication to STC. Improvements in other outcomes with dupilumab were similar in patients with/without prior STC use or inadequate/intolerance/contraindication to STC. Conclusion: Dupilumab 300 mg once a week demonstrated efficacy and was well tolerated in patients with EoE regardless of prior STC use or inadequate response, intolerance and/or contraindication to STC. Trial registration number: NCT03633617.
AB - Objective: To assess the effect of long-Term dupilumab on histological, symptomatic and endoscopic aspects of eosinophilic oesophagitis (EoE) in adolescent and adult patients with and without prior use of swallowed topical corticosteroids (STC) or prior inadequate response, intolerance or contraindication to STC. Design: Pre-specified analysis of data from the phase 3 LIBERTY EoE TREET study on patients who received dupilumab 300 mg once a week or placebo for 24 weeks (W24) in parts A and B, and an additional 28 weeks (W52) in part C. Patients were categorised as with/without prior STC use and with/without inadequate/intolerance/contraindication to STC. The proportion of patients achieving ≤6 eosinophils per high-power field (eos/hpf), absolute change in Dysphagia Symptom Questionnaire (DSQ) score, mean change in Endoscopic Reference Score and Histologic Scoring System grade/stage scores were assessed for each subgroup. Results: Regardless of prior STC use, dupilumab increased the proportion of patients achieving ≤6 eos/hpf and improved DSQ score versus placebo at W24, with improvements maintained or improved at W52. The DSQ score and the proportion of patients achieving ≤6 eos/hpf after switching from placebo to dupilumab at W24 were similar to those observed in the dupilumab group at W24, regardless of prior STC use or inadequate/intolerance/contraindication to STC. Improvements in other outcomes with dupilumab were similar in patients with/without prior STC use or inadequate/intolerance/contraindication to STC. Conclusion: Dupilumab 300 mg once a week demonstrated efficacy and was well tolerated in patients with EoE regardless of prior STC use or inadequate response, intolerance and/or contraindication to STC. Trial registration number: NCT03633617.
KW - clinical trials
KW - gastrointestinal pathology
KW - health economics
KW - inflammatory diseases
KW - quality of life
UR - https://www.scopus.com/pages/publications/85179070025
U2 - 10.1136/gutjnl-2023-330220
DO - 10.1136/gutjnl-2023-330220
M3 - Article
C2 - 38050037
SN - 0017-5749
JO - Gut
JF - Gut
M1 - 330220
ER -