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We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio Key takeaways: Improvements with tezepelumab vs. placebo in EoE at week 24 were also found at week 52. AstraZeneca and Amgen said they will share trial data with regulatory authorities. Adolescents and adults with eosinophilic esophagitis receiving tezepelumab vs. placebo had improved frequency and severity of dysphagia and more achievement of histologic remission at week 24, according to phase 3 trial topline results. \u201cThe positive phase 3 CROSSING trial demonstrates that Tezspire could provide a new approach to treating EoE, helping more patients achieve histologic remission and meaningful symptom relief on an every-4-week dosing schedule,\u201d Evan S. Dellon, MD, MPH, professor of medicine and director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina at Chapel Hill, told Healio.
Tezepelumab (Tezspire; AstraZeneca, Amgen) is already FDA-approved for severe asthma and chronic rhinosinusitis with nasal polyps and is being studied in COPD, according to press releases from AstraZeneca and Amgen. In the multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 CROSSING trial, researchers assessed 368 patients aged 12 to 80 years with symptomatic and histologically active EoE on maintenance therapy to determine how receipt of subcutaneous tezepelumab (given as a low or high dose) every 4 weeks impacts histologic remission and dysphagia vs. placebo at week 24. \u201cThere remains a significant unmet need in EoE,\u201d Dellon said. \u201cBecause nearly half of patients do not achieve adequate disease control with current first-line therapies or dietary restrictions, a second biologic with a first-in-class mechanism of action and every-4-weeks dosing schedule would be a welcome addition to the treatment options for EoE.\u201d The releases highlighted that patients achieved histologic remission if they had a peak esophageal eosinophil count no greater than six eosinophils per high-power field. For dysphagia, researchers compared baseline Dysphagia Symptom Questionnaire (DSQ) scores with week 24 scores. For both outcomes, patients receiving tezepelumab had \u201cstatistically significant and clinically meaningful improvements\u201d vs. those receiving placebo, according to the releases. This result was also found when analyzing endoscopic disease features and histologic severity and extent at week 24. At week 52, researchers continued to find significant and clinically meaningful improvements in these outcomes with tezepelumab vs. placebo. In terms of safety, the releases noted a safety profile \u201cgenerally consistent with its approved indications.\u201d \u201cTezspire has the potential to help patients achieve histologic remission and meaningful symptom improvement, bringing a new treatment option to patients whose lives have been significantly altered by EoE,\u201d Dellon told Healio. Clinicians can expect to see full data from the CROSSING trial at an upcoming medical meeting, according to the releases. AstraZeneca and Amgen also said they will share these data with regulatory authorities. For more information: Evan S. Dellon, MD, MPH, can be reached at allergy@healio.com. Sources\/Disclosures Source: Press Release Reference:
Disclosures:
Dellon reports having financial relationships with AbbVie, Adare\/Ellodi, Alfasignma, ALK, Allakos, Amgen, Anaptysbio\/First Tracks Bio, Apogee, Apollo, Aqilion, Arena\/Pfizer, AstraZeneca, Bethanamist, BioCryst, Bryn, Calypso, Celgene\/Receptos\/BMS, Celldex, Cyted, Domain, Dr. Falk Pharma, Eli Lilly, EsoCap, Eupraxia, Ferring, First Tracks Bio, GI Reviewers, GSK, Holoclara, Invea, Johnson & Johnson, Knightpoint, Kymera, LucidDx, Meritage, Miraca, Noa, Nexstone Immunology\/Uniquity, Nutricia, Parexel\/Calyx, Phathom, Regeneron, Revolo, Robarts\/Alimentiv, Roivant, Sanofi, Shire\/Takeda, Target RWE, Third Harmonic Bio and Uniquity..
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