Statistically significant and clinically meaningful disease and symptom improvements compared to placebo maintained through week 52

Efficacy in a third epithelial-driven inflammatory disease supports broad potential of TEZSPIRE

Positive high-level results from the Phase III CROSSING trial in patients with eosinophilic esophagitis (EoE) showed that AstraZeneca and Amgen’s TEZSPIRE® (tezepelumab-ekko) demonstrated statistically significant and clinically meaningful improvements across both co-primary and all key secondary endpoints at week 24, which were sustained through week 52 in both doses tested. The co-primary endpoints were histologic remission and the frequency and severity of dysphagia (difficulty swallowing) compared to placebo. The safety profile of TEZSPIRE in the trial was generally consistent with its approved indications.

CROSSING is a randomized, double-blind trial that evaluated the efficacy and safety of TEZSPIRE administered subcutaneously every four weeks compared to placebo in adults and adolescents with symptomatic and uncontrolled EoE while on maintenance therapy.1 In the trial, the first co-primary endpoint, histologic remission, was defined as having a low count of peak eosinophils in the esophageal tissue. The second co-primary endpoint, the frequency and severity of dysphagia, was assessed using the patient-reported Dysphagia Symptom Questionnaire (DSQ) and measured as a mean change from baseline in DSQ score.

EoE is a chronic and progressive epithelial-driven inflammatory disorder of the esophagus affecting more than 470,000 people in the US, with the prevalence increasing five-fold since 2009. The inflammation of the esophagus can lead to dysphagia, food impaction and esophageal narrowing. Nearly half of patients, including adolescents, do not achieve adequate disease control with current first-line treatments, which include dietary restriction, swallowed topical corticosteroids and proton pump inhibitors. For patients, the risk of food moving slowly or becoming stuck can make daily meals difficult and stressful.