A Clinical Severity Index for Eosinophilic Esophagitis: Development, Consensus, and Future Directions

Dellon, Evan S.; Khoury, Paneez; Muir, Amanda B.; Liacouras, Chris A.; Safroneeva, Ekaterina; Atkins, Dan; Collins, Margaret H.; Gonsalves, Nirmala; Falk, Gary W.; Spergel, Jonathan M.; Hirano, Ikuo; Chehade, Mirna; Schoepfer, Alain; Menard‐Katcher, Calies; Katzka, David A.; Bonis, Peter A; Bredenoord, Albert J.; Geng, Bob; Jensen, Elizabeth T.; Pesek, Robert D.; Feuerstadt, Paul; Gupta, Sandeep K.; Lucendo, Alfredo J.; Genta, Robert M.; Hiremath, Girish; McGowan, Emily C.; Moawad, Fouad J.; Peterson, Kathryn A.; Rothenberg, Marc E.; Straumann, Alex; Furuta, Glenn T.; Aceves, Seema S.

doi:10.1053/j.gastro.2022.03.025

Cited by 44 publications

(19 citation statements)

References 110 publications

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“…There was a modest but significant improvement in endoscopic severity with mepolizumab, particularly for inflammatory features, and the medication was generally well tolerated with no new safety signals detected. Notably, these results were observed in an EoE patient population that could be classified as severe 41. Patients had long-standing disease, were treatment experienced (all patients were PPI non-responders, half were steroid non-responders, about one in six had received a biologic in a prior clinical trial), and were largely fibrostenotic (three quarters had prior oesophageal dilations).…”

Section: Discussionmentioning

confidence: 71%

Mepolizumab for treatment of adolescents and adults with eosinophilic oesophagitis: a multicentre, randomised, double-blind, placebo-controlled clinical trial

Dellon

Peterson

Mitlyng

et al. 2023

Gut

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ObjectiveWe aimed to determine whether mepolizumab, an anti-IL-5 antibody, was more effective than placebo for improving dysphagia symptoms and decreasing oesophageal eosinophil counts in eosinophilic oesophagitis (EoE).MethodsWe conducted a multicentre, randomised, double-blind, placebo-controlled, trial. In the first part, patients aged 16–75 with EoE and dysphagia symptoms (per EoE Symptom Activity Index (EEsAI)) were randomised 1:1 to 3 months of mepolizumab 300 mg monthly or placebo. Primary outcome was change in EEsAI from baseline to month 3 (M3). Secondary outcomes included histological, endoscopic and safety metrics. In part 2, patients initially randomised to mepolizumab continued 300 mg monthly for 3 additional months (mepo/mepo), placebo patients started mepolizumab 100 mg monthly (pbo/mepo), and outcomes were reassessed at month 6 (M6).ResultsOf 66 patients randomised, 64 completed M3, and 56 completed M6. At M3, EEsAI decreased 15.4±18.1 with mepolizumab and 8.3±18.0 with placebo (p=0.14). Peak eosinophil counts decreased more with mepolizumab (113±77 to 36±43) than placebo (146±94 to 160±133) (p<0.001). With mepolizumab, 42% and 34% achieved histological responses of <15 and ≤6 eos/hpf compared with 3% and 3% with placebo (p<0.001 and 0.02). The change in EoE Endoscopic Reference Score at M3 was also larger with mepolizumab. At M6, EEsAI decreased 18.3±18.1 points for mepo/mepo and 18.6±19.2 for pbo/mepo (p=0.85). The most common adverse events were injection-site reactions.ConclusionsMepolizumab did not achieve the primary endpoint of improving dysphagia symptoms compared with placebo. While eosinophil counts and endoscopic severity improved with mepolizumab at 3 months, longer treatment did not yield additional improvement.Trial registration numberNCT03656380.

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Section: Discussionmentioning

confidence: 71%

Mepolizumab for treatment of adolescents and adults with eosinophilic oesophagitis: a multicentre, randomised, double-blind, placebo-controlled clinical trial

Dellon

Peterson

Mitlyng

et al. 2023

Gut

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“…Because the extent of the inflamed esophageal mucosa has been recognized to be important in assessing disease activity and treatment response in EoE [25,26], we conducted our analysis 11 separately according to two endoscopic phenotypes-namely, the diffuse type and localized type. In the diffuse type with no treatment, endoscopic abnormalities persisted but did not exacerbate in most patients without developing symptoms requiring active treatment.…”

Section: Discussionmentioning

confidence: 99%

Long-term course of untreated asymptomatic esophageal eosinophilia and minimally symptomatic eosinophilic esophagitis

Abe,

Kikuchi,

Sasaki

et al. 2024

Endosc Int Open

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Background/study aim: The long-term course of untreated asymptomatic esophageal eosinophilia (aEE) and minimally symptomatic eosinophilic esophagitis (mEoE) are not well understood. This study aimed to clarify this course. Patients and Methods: A total of 36 patients with EE who were endoscopically followed up for more than 5 years, and who underwent more than one endoscopy evaluation after the first diagnosis, were investigated. These patients were divided into two groups according to the presence or absence of the continuous treatment: no treatment group (NT group, n=22) and proton pump inhibitor/potassium competitive acid blocker group (Tx group, n=14). Symptoms and endoscopic and histological findings were retrospectively reviewed according to endoscopic phenotypes. Endoscopic assessment was performed using the EoE endoscopic reference score (EREFS). Results: The median follow-up period was 84.5 months in the Tx group and 92 months in the NT group. During the follow-up period, about half of the patients in the Tx-diffuse group persisted EREFS>3, while the remaining half had EREFS≤2. The total EREFS in the NT-diffuse group remained almost unchanged (median: 2–4) without apparent exacerbation. In contrast, EREFS in the NT-localized group exhibited an unchanged or gradually decreasing trend, with statistical significance from the first diagnosis to 72–83 months after. Conclusions: Untreated aEE and mEoE are not likely to worsen even without treatment at least for a median follow-up of 7 years. Instead, the localized type may spontaneously improve, implying a different pathogenesis in the presence of the diffuse type. Further studies should clarify the long-term prognosis.

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“…Recently, a multidisciplinary team of experts iteratively created a clinically usable EoE severity scoring system, denominated “I‐SEE,” to guide practitioners in EoE management by standardising disease components reflecting disease severity beyond eosinophil counts 96 . Initial data show that this provides an accurate severity characterisation that shows improvement in overall severity with successful treatment 97 …”

Section: Diagnosismentioning

confidence: 99%

“…to guide practitioners in EoE management by standardising disease components reflecting disease severity beyond eosinophil counts. 96 Initial data show that this provides an accurate severity characterisation that shows improvement in overall severity with successful treatment. 97 Although endoscopy with biopsy is currently required to complete the EoE diagnostic algorithm, there is a movement towards more non-invasive testing to decrease procedure burden to patients and healthcare costs.…”

Section: Eosinophilic Oesophagitismentioning

confidence: 99%

Review article: Emerging insights into the epidemiology, pathophysiology, diagnostic and therapeutic aspects of eosinophilic oesophagitis and other eosinophilic gastrointestinal diseases

Low,

Dellon

2023

Aliment Pharmacol Ther

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SummaryBackgroundEosinophilic gastrointestinal diseases (EGIDs) are chronic, immune‐mediated disorders characterised clinically by gastrointestinal symptoms and histologically by a pathologic increase in eosinophil‐predominant inflammation in the gastrointestinal tract, in the absence of secondary causes of eosinophilia.AimsTo highlight emerging insights and research efforts into the epidemiology, pathophysiology, diagnostic and therapeutic aspects of eosinophilic oesophagitis (EoE) and non‐EoE EGIDs, and discuss key remaining knowledge gaps.MethodsWe selected and reviewed original research, retrospective studies, case series, randomised controlled trials, and meta‐analyses.ResultsStandardised nomenclature classifies EGIDs as EoE, eosinophilic gastritis (EoG), eosinophilic enteritis (EoN), and eosinophilic colitis (EoC). Incidence and prevalence of EoE are rising, emphasising the need to better understand how environmental risk factors and genetic features interact. Advances in understanding EoE pathophysiology have led to clinical trials of targeted therapy and the approval (in the United States) of dupilumab for EoE. Several therapies that are under investigation hope to satisfy both histologic and clinical targets. For non‐EoE EGIDs, efforts are focused on better defining clinical and histopathologic disease determinants and natural history, as well as establishing new therapies.ConclusionsUnmet needs for research are dramatically different for EoE and non‐EoE EGIDs. In EoE, non‐invasive diagnostic tests, clinicopathologic models that determine the risk of disease progression and therapeutic failure, and novel biologic therapies are emerging. In contrast, in non‐EoE EGIDs, epidemiologic trends, diagnostic histopathologic thresholds, and natural history models are still developing for these more rare disorders.

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A Clinical Severity Index for Eosinophilic Esophagitis: Development, Consensus, and Future Directions

Cited by 44 publications

References 110 publications

Mepolizumab for treatment of adolescents and adults with eosinophilic oesophagitis: a multicentre, randomised, double-blind, placebo-controlled clinical trial

Mepolizumab for treatment of adolescents and adults with eosinophilic oesophagitis: a multicentre, randomised, double-blind, placebo-controlled clinical trial

Long-term course of untreated asymptomatic esophageal eosinophilia and minimally symptomatic eosinophilic esophagitis

Review article: Emerging insights into the epidemiology, pathophysiology, diagnostic and therapeutic aspects of eosinophilic oesophagitis and other eosinophilic gastrointestinal diseases

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