TY - JOUR
T1 - Effectiveness and Safety of High- vs Low-Dose Swallowed Topical Steroids for Maintenance Treatment of Eosinophilic Esophagitis
T2 - A Multicenter Observational Study
AU - Greuter, Thomas
AU - Godat, Anne
AU - Ringel, Amit
AU - Almonte, Hector Samuel
AU - Schupack, Daniel
AU - Mendoza, Gabriela
AU - McCright-Gill, Talaya
AU - Dellon, Evan S.
AU - Hirano, Ikuo
AU - Alexander, Jeffrey
AU - Chehade, Mirna
AU - Safroneeva, Ekaterina
AU - Bussmann, Christian
AU - Biedermann, Luc
AU - Schreiner, Philipp
AU - Schoepfer, Alain M.
AU - Straumann, Alex
AU - Katzka, David A.
N1 - Funding Information:
Funding This work was supported by grants from the Swiss National Science Foundation to Alain M. Schoepfer (grant no. 32003B_135665/1 ), Alex Straumann (grant no. 32003B_160115) and Thomas Greuter (grant no. P2ZHP3_168561), a young investigator award from the Swiss Society of Gastroenterology to Thomas Greuter, a research grant from the Novartis Foundation for Medical-Biological Research to Thomas Greuter, a research award from the Swiss IBDnet to Thomas Greuter, and a training grant from the Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR) to Thomas Greuter. CEGIR (U54 AI117804) is part of the Rare Disease Clinical Research Network, an initiative of the Office of Rare Diseases Research, National Center for Advancing Translational Sciences , and is funded through collaboration between the National Institute of Allergy and Infectious Diseases , National Institute of Diabetes and Digestive and Kidney Diseases , and National Center for Advancing Translational Sciences . CEGIR is also supported by patient advocacy groups including the American Partnership for Eosinophilic Disorders , Campaign Urging Research for Eosinophilic Disease , and Eosinophilic Family Coalition. As a member of the Rare Disease Clinical Research Network, CEGIR is also supported by its Data Management and Coordinating Center (U2CTR002818).
Funding Information:
Funding This work was supported by grants from the Swiss National Science Foundation to Alain M. Schoepfer (grant no. 32003B_135665/1), Alex Straumann (grant no. 32003B_160115) and Thomas Greuter (grant no. P2ZHP3_168561), a young investigator award from the Swiss Society of Gastroenterology to Thomas Greuter, a research grant from the Novartis Foundation for Medical-Biological Research to Thomas Greuter, a research award from the Swiss IBDnet to Thomas Greuter, and a training grant from the Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR) to Thomas Greuter. CEGIR (U54 AI117804) is part of the Rare Disease Clinical Research Network, an initiative of the Office of Rare Diseases Research, National Center for Advancing Translational Sciences, and is funded through collaboration between the National Institute of Allergy and Infectious Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, and National Center for Advancing Translational Sciences. CEGIR is also supported by patient advocacy groups including the American Partnership for Eosinophilic Disorders, Campaign Urging Research for Eosinophilic Disease, and Eosinophilic Family Coalition. As a member of the Rare Disease Clinical Research Network, CEGIR is also supported by its Data Management and Coordinating Center (U2CTR002818).
Funding Information:
Conflicts of interest These authors disclose the following: Thomas Greuter received a travel grant from Falk Pharma GmbH and Vifor, and an unrestricted research grant from Novartis. Evan S. Dellon received research funding from Adare, Allakos, GSK, Meritage, Miraca, Nutricia, Celgene/Receptos, Regeneron, and Shire/Takeda; reports consulting fees for Abbott, Adare, Aimmune, Allakos, Arena, AstraZeneca, Biorasi, Calypso, Celgene/Receptos, Eli Lilly, EsoCap, GSK, Gossamer Bio, Parexel, Regeneron, Robarts, Salix, Shire/Takeda; and reports educational grants from Allakos, Banner, Holoclara. Ikuo Hirano has received consulting fees from Receptos, Regeneron, Shire, and Roche. Jeffrey Alexander has a financial interest in Meritage Pharmacia and receives research funding from Shire. Mirna Chehade received research support from Shire, Regeneron, and Allakos; consulting fees from Shire, Regeneron, Allakos, Adare, and Nutricia; and lecture honoraria from Nutricia, Medscape, and the Annenberg Center for Health Sciences at Eisenhower. Ekaterina Safroneeva is a consultant for Celgene, Regeneron Pharmaceuticals, and Novartis. Luc Biedermann received travel grants from Vifor and Falk Pharma GmbH and fees for consulting from Shire. Philipp Schreiner received fees for consulting from Pfizer, Janssen and Takeda. Alain M. Schoepfer is a consultant for Falk Pharma GmbH, Adare Pharmaceuticals, Celgene-Receptos, and Sanofi-Regeneron. Alex Straumann has consulting contracts with Actelion, Celgene-Receptos, Falk Pharma GmbH, Roche-Genentech, GSK, Novartis, Nutricia and Sanofi-Regeneron. The remaining authors disclose no conflicts.
Publisher Copyright:
© 2021 AGA Institute
PY - 2021/12
Y1 - 2021/12
N2 - Background & Aims: Data evaluating efficacy of different doses of swallowed topical corticosteroids (STC) in the long-term management of eosinophilic esophagitis (EoE) are lacking. We assessed long-term effectiveness and safety of different STC doses for adults with EoE after achievement of histological remission. Methods: We performed a retrospective multicenter study at five EoE referral centers (US and Switzerland). We analyzed data on 82 patients with EoE in histological remission and ongoing STC treatment with therapeutic adherence of ≥75% (58 males; mean age at diagnosis, 37.2±14.4 years). Patients were followed for a median of 2.2 years (interquartile range [IQR], 1.0-3.8 years). We collected data from 217 follow-up endoscopy visits. The primary endpoint was time to histological relapse. Results: Histological relapse occurred in 67% of patients. Relapse rates were comparable in patients taking low dose (≤0.5 mg per day, n = 58) and high dose STC (>0.5 mg per day, n = 24) with 72 vs 54% (ns). However, histological relapse occurred significantly earlier with low dose STC (1.0 vs 1.8 years, P =.030). There was no difference regarding rates of and time to stricture formation for low vs high dose STC. Esophageal candidiasis was observed in 6% of patients (5% for low dose, 8% for high dose, ns). No dysplasia or mucosal atrophy was detected. Conclusion: Histological relapse frequently occurs in EoE despite ongoing STC treatment regardless of STC doses. However, relapse develops later in patients on high dose STC without an increase in side-effects. Doses higher than 0.5 mg/day may be considered for EoE maintenance treatment, but advantage over lower doses appears to be small.
AB - Background & Aims: Data evaluating efficacy of different doses of swallowed topical corticosteroids (STC) in the long-term management of eosinophilic esophagitis (EoE) are lacking. We assessed long-term effectiveness and safety of different STC doses for adults with EoE after achievement of histological remission. Methods: We performed a retrospective multicenter study at five EoE referral centers (US and Switzerland). We analyzed data on 82 patients with EoE in histological remission and ongoing STC treatment with therapeutic adherence of ≥75% (58 males; mean age at diagnosis, 37.2±14.4 years). Patients were followed for a median of 2.2 years (interquartile range [IQR], 1.0-3.8 years). We collected data from 217 follow-up endoscopy visits. The primary endpoint was time to histological relapse. Results: Histological relapse occurred in 67% of patients. Relapse rates were comparable in patients taking low dose (≤0.5 mg per day, n = 58) and high dose STC (>0.5 mg per day, n = 24) with 72 vs 54% (ns). However, histological relapse occurred significantly earlier with low dose STC (1.0 vs 1.8 years, P =.030). There was no difference regarding rates of and time to stricture formation for low vs high dose STC. Esophageal candidiasis was observed in 6% of patients (5% for low dose, 8% for high dose, ns). No dysplasia or mucosal atrophy was detected. Conclusion: Histological relapse frequently occurs in EoE despite ongoing STC treatment regardless of STC doses. However, relapse develops later in patients on high dose STC without an increase in side-effects. Doses higher than 0.5 mg/day may be considered for EoE maintenance treatment, but advantage over lower doses appears to be small.
KW - Esophagus
KW - Long-Term Outcome
KW - Relapse
KW - Response to Therapy
KW - Swallowed Topical Corticosteroids
UR - http://www.scopus.com/inward/record.url?scp=85100473995&partnerID=8YFLogxK
U2 - 10.1016/j.cgh.2020.08.027
DO - 10.1016/j.cgh.2020.08.027
M3 - Article
C2 - 32798703
AN - SCOPUS:85100473995
SN - 1542-3565
VL - 19
SP - 2514-2523.e2
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
IS - 12
ER -