Optimal Histologic Cutpoints for Treatment Response in Patients With Eosinophilic Esophagitis: Analysis of Data From a Prospective Cohort Study

Reed, Craig C.; Wolf, W. Asher; Cotton, Cary C.; Rusin, Spencer; Perjar, Irina; Hollyfield, Johnathan; Woosley, John T.; Shaheen, Nicholas J.; Dellon, Evan S.

doi:10.1016/j.cgh.2017.09.046

Cited by 98 publications

(63 citation statements)

References 37 publications

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“…25 The EREFS score ranges from 0 to 9, with higher scores indicating more severe endoscopic findings. We also analyzed levels of histologic response, including peak counts of <15 eos/hpf, <5 eos/hpf, and <1 eos/hpf, 26,27 and measured dysphagia severity with the EoE Symptom Activity Index (EEsAI), a validated patient-reported outcome with a 7day recall that also incorporates dietary avoidance and modification (scores range from 0 to 100, with higher scores indicated more severe symptoms; a score <20 indicates symptom remission). 28 Medication compliance and adverse events were also assessed.…”

Section: Impactmentioning

confidence: 99%

Efficacy of Budesonide vs Fluticasone for Initial Treatment of Eosinophilic Esophagitis in a Randomized Controlled Trial

et al. 2019

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See editorial on page 14. See Covering the Cover synopsis on 1.BACKGROUND AND AIMS: Topical steroid treatments for eosinophilic esophagitis (EoE) include swallowed fluticasone from a multi-dose inhaler (MDI) or oral viscous budesonide (OVB) slurry, but the 2 have never been compared. We assessed whether OVB was more effective than MDI for initial treatment of patients with EoE. METHODS: In a double-blind, doubledummy trial, patients with a new diagnosis of EoE were randomly assigned to groups given 8 weeks of either OVB (1 mg/4 mL) twice daily plus a placebo inhaler (n ¼ 56) or fluticasone MDI (880 mg) twice daily plus a placebo slurry (n ¼ 55). Primary outcomes were post-treatment maximum eosinophil counts per high-power field (eos/hpf) and a validated dysphagia score (dysphagia symptom questionnaire [DSQ]) at week 8. Secondary outcomes included endoscopic severity (validated EoE endoscopic reference score), histologic response (<15 eos/ hpf), and safety. RESULTS: In a modified intention-to-treat analysis, the subjects had baseline peak eosinophil counts of 73 and 77 eos/hpf in the OVB and MDI groups, respectively, and DSQ scores of 11 and 8. Post-treatment eosinophil counts were 15 and 21 in the OVB and MDI groups, respectively (P ¼ .31), with 71% and 64% achieving histologic response (P ¼ .38). DSQ scores were 5 and 4 in the OVB and MDI groups (P ¼ .70). Similar trends were noted for post-treatment total EoE endoscopic reference scores (2 vs 3; P ¼ .06). Esophageal candidiasis developed in 12% of patients receiving OVB and 16% receiving MDI; oral thrush was observed in 3% and 2%, respectively. CONCLUSIONS: In a randomized clinical trial, initial treatment of EoE with either OVB or fluticasone MDI produced a significant decrease in esophageal eosinophil counts and improved dysphagia and endoscopic features. However, OVB was not superior to MDI, so either is an acceptable treatment for EoE. ClinicalTrials.gov ID NCT02019758.Abbreviations used in this paper: DSQ, dysphagia symptom questionnaire; EoE, eosinophilic esophagitis; eos/hpf, eosinophil counts per high-power field; EREFS, EoE Endoscopic Reference Score; MDI, multi-dose inhaler; OVB, oral viscous budesonide; PPI, proton pump inhibitor. Most current article

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Section: Impactmentioning

confidence: 99%

Efficacy of Budesonide vs Fluticasone for Initial Treatment of Eosinophilic Esophagitis in a Randomized Controlled Trial

et al. 2019

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“…However, there are important limitations to relying solely on eosinophil count for measurement of disease activity in clinical trials. First, there is no standardised definition of histologic remission based on eosinophil count; definitions range from <1 eosinophil/HPF to <15 eosinophils/HPF in the literature . Second, EoE is a patchy disease and eosinophils are unequally distributed in the oesophageal mucosa .…”

Section: Introductionmentioning

confidence: 99%

Reliability of histologic assessment in patients with eosinophilic oesophagitis

Warners¹,

Ambarus²,

Bredenoord³

et al. 2018

Aliment Pharmacol Ther

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“…For patients with a histologic response to compounded budesonide, defined as esophageal biopsies with < 15 eosinophils/high-powered field (eos/hpf), [22,23] compounded budesonide dosing was subsequently modified at the discretion of the provider. In some cases of complete response, the approach was to decrease the dose and to subsequently assess if response was maintained on the lower dose.…”

Section: Methodsmentioning

confidence: 99%

Compounded Oral Viscous Budesonide is Effective and Provides a Durable Response in Eosinophilic Esophagitis

Reed

Fan

Koutlas

et al. 2018

Journal of Gastroenterology and Hepatology Research

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Aim Because no approved medications exist for eosinophilic esophagitis (EoE), patients must use off-label drugs or create their own formulations. We assessed the efficacy of a standardized compounded budesonide suspension for treatment of EoE. Materials and methods We conducted a retrospective cohort study of EoE patients at the University of North Carolina treated with compounded budesonide dispensed by a specialty compounding pharmacy. Outcomes (symptomatic global response [yes/no], endoscopic response [% with individual findings], and histologic response [absolute eosinophil count; % with <15 eos/hpf])were assessed after the initial and last treatment in our system. Results We identified 48 patients treated with compounded budesonide (mean age 33.6; 69% male; 96% white; 2.4 mg mean initial dose). After a mean length of follow-up of 17.0 months (range: 4.2 - 56.3), there was a significant decrease in symptoms of dysphagia (95% vs. 32%, p < 0.001), improvements in heartburn (37% vs. 11%, p=0.06) and global symptom response (81%). The median of the peak eosinophil counts decreased from 55 to 20 eos/hpf (p<0.001) with 42% achieving a response of <15 eos/hpf. Esophageal candidiasis was rare (6%). In the 18 patients with prior non-response to corticosteroids or dietary elimination, 83% had symptomatic and 38% had histologic response. Conclusion Compounded budesonide suspension produced a durable symptomatic, endoscopic, and histologic response in a cohort followed for more than a year. Many patients previously refractory to prior therapy responded to compounded budesonide. This formulation can be used clinically until there are approved drugs with esophageal formulations for EoE.

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Optimal Histologic Cutpoints for Treatment Response in Patients With Eosinophilic Esophagitis: Analysis of Data From a Prospective Cohort Study

Cited by 98 publications

References 37 publications

Efficacy of Budesonide vs Fluticasone for Initial Treatment of Eosinophilic Esophagitis in a Randomized Controlled Trial

Efficacy of Budesonide vs Fluticasone for Initial Treatment of Eosinophilic Esophagitis in a Randomized Controlled Trial

Reliability of histologic assessment in patients with eosinophilic oesophagitis

Compounded Oral Viscous Budesonide is Effective and Provides a Durable Response in Eosinophilic Esophagitis

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