Reslizumab in children and adolescents with eosinophilic esophagitis: Results of a double-blind, randomized, placebo-controlled trial

Spergel, Jonathan M.; Rothenberg, Marc E.; Collins, Margaret H.; Furuta, Glenn T.; Markowitz, Jonathan E.; Fuchs, George J.; O’Gorman, Molly; Abonia, J. Pablo; Young, James B.; Henkel, Tim; Wilkins, Hannah; Liacouras, Chris A.

doi:10.1016/j.jaci.2011.11.044

Cited by 482 publications

(372 citation statements)

References 20 publications

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“…Among the interventional trials (randomized controlled trial studies [RCTs] or trials with historical controls), 80 (80%) compared treatment effect using histological remission as values within the range of 0 to ≤5 eosinophils/hpf. Among studies that examined the effectiveness of monoclonal antibody treatment in EoE subjects, 80% defined histological remission as peak esophageal eosinophil counts within the range of 0 to ≤5 24, 25, 26, 27, 28. Approximately 26% (N = 15) of the eligible studies examined remission among EoE patients who received only the diet elimination treatment formula (SFED, FFGED, ELED) compared to other forms of treatment, with the most common definitions falling within 0 to ≤5 eosinophils/hpf 29, 30, 31, 32, 33, 34 or 11 to ≤15 eosinophils/hpf 35, 36, 37, 38, 39, 40.…”

Section: Resultsmentioning

confidence: 99%

“…Notably, practically similar treatment options were used in the management of EoE subjects at the center 31, 34, 40, 41, 51. Two studies published from another US center, although with different treatment options and study design, used two different criteria to define histological remission 26, 52…”

Section: Resultsmentioning

confidence: 99%

“…Although there were no common criteria to define histological remission in the studies reviewed, a majority of the randomized controlled trial studies used more stringent values ranging from 0 to ≤5 eosinophils/hpf to define histological remission or resolution 22, 26, 66, 67, 68. Compared to dietary treatment studies (e.g.…”

Section: Discussionmentioning

confidence: 99%

“…diet elimination or restriction), we observed that medication trial studies (e.g. steroids, monoclonal antibody) used more rigorous criteria in their definition of histological remission in study subjects with EoE 21, 26, 27, 35, 53, 60. It is possible that different cut‐off values of peak eosinophil counts per hpf are appropriate for the definition of histological improvement because of the variations in the trial methodology (treatment, subjects’ characteristics).…”

Section: Discussionmentioning

confidence: 99%

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Systematic review of histological remission criteria in eosinophilic esophagitis

Eke

White

et al. 2018

JGH Open

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Elemental diets, dietary elimination, and steroid therapies are the most common therapies in the clinical trials for eosinophilic esophagitis (EoE). Histological findings (usually reported as eosinophils per microscopic high‐powered field [hpf]) remain the most common end‐point used to define response. Yet, the threshold for defining “response” and “remission” are ill‐defined among consensus guidelines and may vary from study to study. We conducted a systematic literature review of articles on eosinophilic esophagitis, published between January 2007 and November 2017, considering histological remission as the primary outcome. We abstracted treatment information and definitions of histological remission or response. A comparison of definitions of histological remission across and within institutions was performed. A total of 61 articles were included in this review, with approximately 60% of the studies published from centers in the United States. Histological definitions of remission of EoE ranged from 0 to ≤20 eosinophils/hpf. The most stringent criteria, ranging from 0 to ≤5 eosinophils/hpf, were commonly used in interventional trial studies that examined the effects of new treatments. We found remarkable variability in definitions between studies, treatment types, and regions. Age or epidemiological distribution of study subjects did not influence the criteria for histological remission. Clinical and histological improvements are important measures of the effects of treatment. Histological findings, the most objective measure of treatment, should provide an optimal method for comparing the effectiveness of various treatments. Yet, our findings suggest a lack of consistent remission criteria in published studies. Considering these inconsistencies, it is difficult to compare the effectiveness of various treatments.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 2 more Smart Citations

Systematic review of histological remission criteria in eosinophilic esophagitis

Eke

White

et al. 2018

JGH Open

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“…Thus, while the anti-TNF-α infliximab was found to have no beneficial effects in adult EoE patient [90], the anti-IL-5 monoclonal antibody mepolizumab, which was analyzed in randomized controlled trials in both adult [91] and pediatric [92] patients, was shown to significantly reduce tissue eosinophils; nevertheless, clinical improvement was minimal. Recently, reslizumab produced similar findings in assays in pediatric EoE patients [93], in which demonstrated a significant histologic response but no significant clinical response when compared with placebo.…”

Section: Other Drugsmentioning

confidence: 86%

Adult versus pediatric eosinophilic esophagitis: important differences and similarities for the clinician to understand

Lucendo

Sánchez-Cazalilla

2012

Expert Review of Clinical Immunology

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Medical treatment of eosinophilic esophagitis

Franciosi

Gordon

Sinopoulou

et al. 2023

Cochrane Database of Systematic Reviews

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Background Eosinophilic esophagitis (EoE) is a chronic antigen‐mediated eosinophilic inflammatory disease isolated to the esophagus. As a clinicopathologic disorder, a diagnosis of EoE requires a constellation of clinical symptoms of esophageal dysfunction and histologic findings (at least 15 eosinophils/high‐powered microscope field (eos/hpf)). Current guidelines no longer require the failure of response to proton pump inhibitor medications to establish a diagnosis of EoE, but continue to suggest the exclusion of other etiologies of esophageal eosinophilia. The treatment goals for EoE are improvement in clinical symptoms, resolution of esophageal eosinophilia and other histologic abnormalities, endoscopic improvement, improved quality of life, improved esophageal function, minimized adverse effects of treatment, and prevention of disease progression and subsequent complications. Currently, there is no cure for EoE, making long‐term treatment necessary. Standard treatment modalities include dietary modifications, esophageal dilation, and pharmacologic therapy. Effective pharmacologic therapies include corticosteroids, rapidly emerging biological therapies, and proton pump inhibitor medications. Objectives To evaluate the efficacy and safety of medical interventions for people with eosinophilic esophagitis. Search methods We searched CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, and WHO ICTRP to 3 March 2023. Selection criteria Randomized controlled trials (RCTs) comparing any medical intervention or food elimination diet for the treatment of eosinophilic esophagitis, either alone or in combination, to any other intervention (including placebo). Data collection and analysis Pairs of review authors independently selected studies and conducted data extraction and risk of bias assessment. We expressed outcomes as a risk ratio (RR) and as the mean or standardized mean difference (MD/SMD) with 95% confidence interval (CI). We assessed the certainty of the evidence using GRADE. Our primary outcomes were: clinical, histological, and endoscopic improvement, and withdrawals due to adverse events. Secondary outcomes were: serious and total adverse events, and quality of life. Main results We included 41 RCTs with 3253 participants. Eleven studies included pediatric patients while the rest recruited both children and adults. Four studies were in patients with inactive disease while the rest were in patients with active disease. We identified 19 intervention comparisons. In this abstract we present the results of the primary outcomes for the two main comparisons: corticosteroids versus placebo and biologics versus placebo, based on the prespecified outcomes defined of the primary studies. Fourteen studies compared corticosteroids to placebo for induction of remission and the risk of bias for these...

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Reslizumab in children and adolescents with eosinophilic esophagitis: Results of a double-blind, randomized, placebo-controlled trial

Cited by 482 publications

References 20 publications

Systematic review of histological remission criteria in eosinophilic esophagitis

Systematic review of histological remission criteria in eosinophilic esophagitis

Adult versus pediatric eosinophilic esophagitis: important differences and similarities for the clinician to understand

Medical treatment of eosinophilic esophagitis

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