2020-10-26 07:25:59 ALLK Allakos
10/26/20 10/2607:25 10/26/2007:25 | Allakos reports results from prospective prevalence studyAllakos reported results from a prospective study examining the rates of elevated eosinophil and mast cell levels in patients with chronic unexplained gastrointestinal symptoms or functional gastrointestinal disorders such as irritable bowel syndrome and functional dyspepsia. The results suggest that eosinophilic gastritis and/or eosinophilic duodenitis are significantly underdiagnosed. This prospective, multi-center study assessed eosinophil and mast cell levels in biopsies obtained from patients with active, chronic unexplained gastrointestinal symptoms or FGIDs. Inclusion in the study required patients to have greater than or equal to6-month history of abdominal pain, abdominal cramping, nausea, vomiting, diarrhea, bloating and/or early satiety without identifiable cause and unresponsive to pharmacologic or dietary intervention, or a diagnosis of IBS or FD. Gastric and duodenal biopsies were performed in patients who had an average weekly single symptom severity score greater than or equal to3 for abdominal pain, abdominal cramping, nausea, vomiting, diarrhea, bloating or early satiety and a total symptom severity score greater than or equal to10 as assessed by the patient reported outcome questionnaire used in the Company's Phase 2 and Phase 3 EG and/or EoD studies. The primary endpoints were: The proportion of symptomatic patients that underwent biopsy and met the histologic criteria for EG and/or EoD. The proportion of symptomatic patients that underwent biopsy with greater than or equal to30 mast cells/HPF in five gastric HPFs and/or greater than or equal to30 mast cells/HPF in three duodenal HPFs and less than30 eosinophils/HPF, referred to as MGID. 73% of patients screened met the symptom severity criteria and underwent endoscopy with biopsy. Of the patients biopsied, 45% met the histologic criteria for EG and/or EoD, representing 33%. In addition, 50% of patients biopsied had greater than or equal to30 mast cells/HPF and less than30 eosinophils/HPF. |
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