257:
Tezepelumab demonstrates clinically meaningful improvements in asthma control (ACQ-6) in patients with uncontrolled asthma: results from a phase 2b clinical trial
Saturday, March 3, 2018: 2:00 PM
S330AB (Convention Center)
Jonathan Corren, , , , , , ,
RATIONALE: To evaluate the effect of tezepelumab, a human anti-thymic stromal lymphopoietin mAb, on asthma control in patients with severe, uncontrolled asthma.

METHODS: This 52-week, randomized, double-blind, placebo-controlled study (NCT02054130) included patients with severe, uncontrolled asthma (Asthma Control Questionnaire-6 [ACQ-6] ≥1.5). A total of 584 eligible adults were randomly assigned to subcutaneous tezepelumab 70mg Q4W (low), 210mg Q4W (medium), 280mg Q2W (high), or placebo Q2W. Mean change from baseline to Week 52 in ACQ-6; proportion of patients classified as responders (improvement ≥0.5); proportion of patients who were well-controlled (ACQ-6 ≤0.75), partially controlled (>0.75 ACQ-6 ≤1.5), and uncontrolled (ACQ-6 >1.5); and time-to-first asthma control (partial or well) were compared between treatment groups as secondary endpoints, without multiplicity adjustment.

RESULTS: At Week 52, mean improvements from baseline in ACQ-6 were: placebo (–0.89); tezepelumab low (–1.13), medium (–1.16), high (–1.22) (P <0.05 for medium and high doses). A greater proportion of patients in the tezepelumab groups (75.6% overall) achieved clinically meaningful improvements ≥0.5 from baseline compared with placebo (61.7%) at Week 52 (P <0.05, LOCF). A greater proportion of patients in the tezepelumab groups were either well-controlled (27.2% in tezepelumab overall; 14.9% in placebo) or partially-controlled (22.0% in tezepelumab overall; 19.1% in placebo) at Week 52 (P <0.05, LOCF). The median time-to-first partially‑ or well‑controlled asthma was reduced by half in the tezepelumab groups compared with placebo (70 days in tezepelumab overall; 140 days in placebo; P <0.05) through Week 52.

CONCLUSIONS: Tezepelumab improves asthma control in patients with severe, uncontrolled asthma.