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- W2894901168 abstract "Reply: We appreciate the comments from Dr Fuchs regarding our previous submission and the opportunity to address his concerns. Dr Fuchs has correctly pointed out that the original study from which our cohort emanated showed a significant decrease in esophageal eosinophil burden but did not demonstrate a statistically significant reduction in symptoms versus the placebo group (1). It was failure to meet this clinical endpoint that ultimately prevented the drug from receiving an indication for eosinophilic esophagitis (although it has received an FDA indication for eosinophilic asthma). Although the space allotment for this letter precludes an in-depth explanation for this finding, suffice it to say that the design of the original study had limitations that likely led to the lack of a statistically significant clinical response. In contrast to the short duration of the randomized trial, the longitudinal nature of our report provides evidence for efficacy of the drug. The fact that patients remain symptom-free over many years, in association with a durable histologic remission is an important finding. The lack of any detectable fibrosis in these patients after approximately a decade of treatment further supports the conclusion that the disease is truly in remission in our patients. Finally, while Dr Fuchs considered the slightly different diets in our patients a confounding factor, diet management in patients with EoE must be tailored to their specific allergies. In that respect, each of these patients has received the same dietary approach, which is to limit foods that cause obvious symptoms. We accept that case reports that involve a small number of subjects must be looked upon critically. In pediatrics, this situation is, however, not uncommon, particularly with novel therapies such as biologic agents. In short, we believe our limited data is informative despite the limitations. Perhaps our data will serve as an impetus to design a follow-up study that will give the definitive answer on the drug's safety and efficacy. Until then, we hope that our report provides some insight into those questions." @default.
- W2894901168 created "2018-10-12" @default.
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- W2894901168 date "2018-10-01" @default.
- W2894901168 modified "2023-10-18" @default.
- W2894901168 title "Response to the Letter on “Efficacy of Reslizumab for EoE” by Dr Fuchs" @default.
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- W2894901168 doi "https://doi.org/10.1097/mpg.0000000000002088" @default.
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