TY - JOUR
T1 - Responsiveness of a Histologic Scoring System Compared with Peak Eosinophil Count in Eosinophilic Esophagitis
AU - Ma, Christopher
AU - Jairath, Vipul
AU - Feagan, Brian G.
AU - Guizzetti, Leonardo
AU - Zou, Guangyong
AU - McFarlane, Stefanie C.
AU - Shackelton, Lisa M.
AU - Collins, Margaret H.
AU - Hirano, Ikuo
AU - De Rooij, Willemijn E.
AU - Schaeffer, David F.
AU - Pai, Rish K.
AU - Bredenoord, Albert J.
AU - Dellon, Evan S.
N1 - Funding Information:
Potential competing interests: C.M. has received consulting fees from AVIR Pharma and Alimentiv (formerly Robarts Clinical Trials); speaker fees from AVIR Pharma. V.J. has received consulting fees from Alimentiv (formerly Robarts Clinical Trials). B.G.F. has received consulting fees from Allakos, Alimentiv (formerly Robarts Clinical Trials), Sanofi, Bristol Myers Squibb. L.G. is an employee of Alimentiv. G.Z. and his institution have received consulting fees from Alimentiv. S.C.M. is an employee of Alimentiv. L.M.S. is an employee of Alimentiv. M.H.C. is a consultant for Allakos, Astra Zeneca, BMS, Calypso, EsoCap, GlaxoSmithKline, Regeneron, and Takeda and has performed contract work for Receptos (Celgene, BMS), Regeneron, and Shire (a Takeda company). I.H. has received consulting fees from Receptos, Regeneron, Shire, and Roche. W.E.d.R. has no conflicts of interest to declare. D.F.S. has received consulting fees from Alimentiv, Pfizer, Amgen, Merck, and Diaceutics and stockownership in Satisfai Health. R.K.P. has received consulting fees from AbbVie, Eli Lilly, Allergan, Genentech, and Alimentiv. A.J.B. has received research support from Norgine, Nutricia, SST, and Bayer; speaker and consulting fees from AstraZeneca, Medtronic, Laborie, Alimentiv, Celgene, DrFalkPharma, Arena, EsoCap, and Calypsio. E.S.D. has received research support from Adare/Ellodi, Allakos, AstraZeneca, GSK, Meritage, Miraca, Nutricia, Celgene/Receptos/BMS, Regeneron, and Shire/Takeda; consulting fees from Abbott, Adare/Ellodi, Aimmune, Allakos, Amgen, Arena, AstraZeneca, Avir, Biorasi, Calypso, Celgene/Receptos/BMS, Celldex, Eli Lilly, EsoCap, GSK, Gossamer Bio, Parexel, Regeneron, Robarts/Alimentiv, Salix, Sanofi, and Shire/Takeda; and educational grants from Allakos, Banner, Holoclara. Alimentiv (formerly Robarts Clinical Trials) is an academic gastrointestinal contract research organization (CRO), operating under the Alimentiv Health Trust. Alimentiv provides centralized imaging management solutions in clinical trials, including endoscopy, histopathology, and magnetic resonance imaging. Alimentiv provides full service CRO capabilities and precision medicine services. L.G., S.C.M., and L.M.S, are employees of Alimentiv. C.M., V.J., B.G.F., D.F.S., R.K.P., A.J.B., and E.S.D. are consultants and have neither equity positions nor shares in the corporation.
Publisher Copyright:
Copyright © 2021 by The American College of Gastroenterology.
PY - 2022/2/1
Y1 - 2022/2/1
N2 - INTRODUCTION:The optimal instrument for assessing histologic disease activity in patients with eosinophilic esophagitis (EoE) is unclear. We assessed the responsiveness of the EoE Histologic Scoring System (EoE-HSS) when compared with that of the peak eosinophil count (PEC).METHODS:Histopathology slides were obtained from patients with EoE at baseline and after 8 weeks of treatment with swallowed topical budesonide or elimination diet. Two blinded gastrointestinal pathologists scored biopsies on the EoE-HSS, PEC, and 100-mm visual analog scale (VAS) of overall histologic severity. Change was defined as an improvement by ≥0.5 SD in baseline VAS. Responsiveness was quantified using the standardized effect size (SES) and the probability that the index distinguishes a patient with improvement from a patient without improvement, which is the area under the receiver operating characteristic curve (AUC). Longitudinal validity was assessed using Pearson correlations between changes in EoE-HSS and both PEC and VAS.RESULTS:The EoE-HSS grade (SES 2.18 [95% confidence interval, CI: 1.46-2.88]; AUC 0.73 [95% CI: 0.57-0.84]) and stage (SES 2.07 [95% CI: 1.37-2.77]; AUC 0.73 [95% CI: 0.58-0.84]) were highly responsive, similar to PEC (SES 1.44 [95% CI: 0.80-2.07]; AUC 0.73 [95% CI: 0.58-0.84]). The EoE-HSS grade and stage were more highly correlated with changes in VAS (grade 0.92 [95% CI: 0.86-0.95]; stage 0.89 [95% CI: 0.81-0.94]) than with changes in PEC (grade 0.74 [95% CI: 0.58-0.85]; stage 0.66 [95% CI: 0.47-0.80]).DISCUSSION:The EoE-HSS is highly responsive, performs similarly to PEC, and is better correlated with changes in overall histologic activity in patients with EoE.
AB - INTRODUCTION:The optimal instrument for assessing histologic disease activity in patients with eosinophilic esophagitis (EoE) is unclear. We assessed the responsiveness of the EoE Histologic Scoring System (EoE-HSS) when compared with that of the peak eosinophil count (PEC).METHODS:Histopathology slides were obtained from patients with EoE at baseline and after 8 weeks of treatment with swallowed topical budesonide or elimination diet. Two blinded gastrointestinal pathologists scored biopsies on the EoE-HSS, PEC, and 100-mm visual analog scale (VAS) of overall histologic severity. Change was defined as an improvement by ≥0.5 SD in baseline VAS. Responsiveness was quantified using the standardized effect size (SES) and the probability that the index distinguishes a patient with improvement from a patient without improvement, which is the area under the receiver operating characteristic curve (AUC). Longitudinal validity was assessed using Pearson correlations between changes in EoE-HSS and both PEC and VAS.RESULTS:The EoE-HSS grade (SES 2.18 [95% confidence interval, CI: 1.46-2.88]; AUC 0.73 [95% CI: 0.57-0.84]) and stage (SES 2.07 [95% CI: 1.37-2.77]; AUC 0.73 [95% CI: 0.58-0.84]) were highly responsive, similar to PEC (SES 1.44 [95% CI: 0.80-2.07]; AUC 0.73 [95% CI: 0.58-0.84]). The EoE-HSS grade and stage were more highly correlated with changes in VAS (grade 0.92 [95% CI: 0.86-0.95]; stage 0.89 [95% CI: 0.81-0.94]) than with changes in PEC (grade 0.74 [95% CI: 0.58-0.85]; stage 0.66 [95% CI: 0.47-0.80]).DISCUSSION:The EoE-HSS is highly responsive, performs similarly to PEC, and is better correlated with changes in overall histologic activity in patients with EoE.
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U2 - 10.14309/ajg.0000000000001571
DO - 10.14309/ajg.0000000000001571
M3 - Article
C2 - 34797816
AN - SCOPUS:85124056401
SN - 0002-9270
VL - 117
SP - 264
EP - 271
JO - American Journal of Gastroenterology
JF - American Journal of Gastroenterology
IS - 2
ER -