Journal Article10.1111/APT.14559
Reliability of histologic assessment in patients with eosinophilic oesophagitis.
Marijn J. Warners,C. A. Ambarus,Arjan Bredenoord,Joanne Verheij,Gregory Y. Lauwers,J. C. Walsh,David A. Katzka,Sigrid Nelson,T. van Viegen,Glenn T. Furuta,Sandeep Gupta,Larry Stitt,Guangyong Zou,Claire E Parker,Lisa M. Shackelton,G. R. D`Haens,W J Sandborn,Evan S. Dellon,Brian G. Feagan,Margaret H. Collins,Vipul Jairath,Rish K. Pai +21 more
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TL;DR: The validity of the eosinophilic oesophagitis histologic scoring system (EoEHSS) has been demonstrated, but only preliminary reliability data exist.
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Abstract: Background The validity of the eosinophilic oesophagitis (EoE) histologic scoring system (EoEHSS) has been demonstrated, but only preliminary reliability data exist. Aim Formally assess the reliability of the EoEHSS and additional histologic features. Methods Four expert gastrointestinal pathologists independently reviewed slides from adult patients with EoE (N = 45) twice, in random order, using standardised training materials and scoring conventions for the EoEHSS and additional histologic features agreed upon during a modified Delphi process. Intra- and inter-rater reliability for scoring the EoEHSS, a visual analogue scale (VAS) of overall histopathologic disease severity, and additional histologic features were assessed using intra-class correlation coefficients (ICCs). Results Almost perfect intra-rater reliability was observed for the composite EoEHSS scores and the VAS. Inter-rater reliability was also almost perfect for the composite EoEHSS scores and substantial for the VAS. Of the EoEHSS items, eosinophilic inflammation was associated with the highest ICC estimates and consistent with almost perfect intra- and inter-rater reliability. With the exception of dyskeratotic epithelial cells and surface epithelial alteration, ICC estimates for the remaining EoEHSS items were above the benchmarks for substantial intra-rater, and moderate inter-rater reliability. Estimation of peak eosinophil count and number of lamina propria eosinophils were associated with the highest ICC estimates among the exploratory items. Conclusion The composite EoEHSS and most component items are associated with substantial reliability when assessed by central pathologists. Future studies should assess responsiveness of the score to change after a therapeutic intervention to facilitate its use in clinical trials.
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Citations
Efficacy of Dupilumab in a Phase 2 Randomized Trial of Adults With Active Eosinophilic Esophagitis
Ikuo Hirano,Evan S. Dellon,Jennifer D. Hamilton,Margaret H. Collins,Kathryn A. Peterson,Mirna Chehade,Alain M. Schoepfer,Ekaterina Safroneeva,Marc E. Rothenberg,Gary W. Falk,Yehudith Assouline-Dayan,Qiong Zhao,Zhen Chen,Brian N. Swanson,Gianluca Pirozzi,Leda Mannent,Neil M.H. Graham,Bolanle Akinlade,Neil Stahl,George D. Yancopoulos,Allen Radin +20 more
TL;DR: In a phase 2 trial of patients with active EoE, dupilumab reduced dysphagia, histologic features of disease (including eosinophilic infiltration and a marker of type 2 inflammation), and abnormal endoscopic features, compared with placebo, and was generally well tolerated.
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RPC4046, a Monoclonal Antibody Against IL13, Reduces Histologic and Endoscopic Activity in Patients With Eosinophilic Esophagitis.
Ikuo Hirano,Margaret H. Collins,Yehudith Assouline-Dayan,Larry Evans,Sandeep K. Gupta,Alain M. Schoepfer,Alex Straumann,Ekaterina Safroneeva,Michael Grimm,Heather Smith,Cindy-ann Tompkins,Amy Woo,Robert Peach,Paul A. Frohna,Sheila Gujrathi,Darryl Penenberg,Caiyan Li,Gregory J. Opiteck,Allan Olson,Richard Aranda,Marc E. Rothenberg,Evan S. Dellon +21 more
TL;DR: In a phase 2 trial of patients with EoE, RPC4046 (a monoclonal antibody against IL13) was found to reduce histologic and endoscopic features compared with placebo and was well tolerated.
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A Conceptual Approach to Understanding Treatment Response in Eosinophilic Esophagitis.
Evan S. Dellon,Sandeep K. Gupta +1 more
TL;DR: This review will discuss the various stakeholders involved in assessment of treatment endpoints of a complex condition, including patients, practitioners and regulatory agencies, and the myriad care settings in which treatment response is assessed, including routine clinical care, clinical trials, and observational studies.
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Long-term Efficacy and Tolerability of RPC4046 in an Open-Label Extension Trial of Patients With Eosinophilic Esophagitis
Evan S. Dellon,Margaret H. Collins,Marc E. Rothenberg,Yehudith Assouline-Dayan,Larry Evans,Sandeep K. Gupta,Alain M. Schoepfer,Alex Straumann,Ekaterina Safroneeva,Cristian Rodriguez,Neil Minton,Steven Y. Hua,Ikuo Hirano +12 more
TL;DR: One year treatment with RPC4046 is generally well tolerated and results in continued improvement and/or maintenance of endoscopic, histologic, and clinical measures of EoE disease activity relative to baseline.
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Persistent Basal Cell Hyperplasia Is Associated With Clinical and Endoscopic Findings in Patients With Histologically Inactive Eosinophilic Esophagitis.
Kelly A. Whelan,Bridget Godwin,Benjamin J. Wilkins,Okan U. Elci,Alain Benitez,Maureen DeMarshall,Medha Sharma,Jonathan Gross,Andres J. Klein-Szanto,Chris A. Liacouras,Evan S. Dellon,Jonathan M. Spergel,Gary W. Falk,Amanda B. Muir,Hiroshi Nakagawa +14 more
TL;DR: In patients with EoE, the presence of BCH might indicate ongoing disease activity, independent of eosinophil count, which might account for the persistent symptoms in patients who are considered to be in remission based on histologic factors.
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