Tezspire Trial Shows Higher EoE Remission Through 52 Weeks

Tezspire met both primary goals in a phase 3 trial for eosinophilic esophagitis, with two doses producing higher histologic remission rates and greater reductions in swallowing symptom scores than placebo at week 24.

Eosinophilic esophagitis (EoE) is a chronic inflammatory condition that can make swallowing difficult. The CROSSING trial tested 210-milligram and 420-milligram doses of Tezspire, given by injection every four weeks, against placebo.

The trial randomized 368 patients ages 12 to 80. Participants could continue stable EoE treatments, including proton pump inhibitors and swallowed topical corticosteroids.

At week 24, histologic remission was reported in 64.8% of patients receiving 210 milligrams and 68.9% receiving 420 milligrams, compared with 3.5% on placebo. The trial defined remission as a peak count of six or fewer eosinophils per high-power field in esophageal tissue. Both dose comparisons had p-values below 0.001.

Adjusted mean scores on the patient-reported Dysphagia Symptom Questionnaire fell 18.8 points with the 210-milligram dose and 22.0 points with the 420-milligram dose, versus 14.7 points with placebo. The reported p-value was 0.049 for the lower dose and below 0.001 for the higher dose.

After 52 weeks, histologic remission was recorded in 67.8% of the lower-dose group and 63.3% of the higher-dose group, versus 5.4% of placebo recipients. Adjusted mean swallowing symptom scores fell 22.1 and 24.0 points, respectively, versus 13.2 points on placebo.

Endoscopic remission, defined as no visible EoE features on endoscopy, was reported in 34.4% of the 210-milligram group and 29.5% of the 420-milligram group at week 52, compared with 4.1% on placebo.

“Importantly, these meaningful results were seen even in patients who were allowed to remain on their stable background therapy,” said Arjan Bredenoord, a CROSSING investigator and professor at Amsterdam University Medical Center. The most frequently reported adverse events among Tezspire recipients were upper respiratory infection (nasopharyngitis), headache and diarrhea.

Tezspire is approved in the U.S. for severe asthma and chronic rhinosinusitis with nasal polyps, but not EoE. AstraZeneca plans to share the trial results with regulators.