Asthma · Biologics for severe asthma
Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma
| Design | Phase 3, multicentre, double-blind, placebo-controlled RCT |
|---|---|
| Treatment | Tezepelumab 210 mg subcutaneously every 4 weeks |
| Control | Placebo |
| Population | 1061 patients aged 12 to 80 with severe, uncontrolled asthma |
| Follow-up | 52 weeks |
| Primary endpoint | Annualised rate of asthma exacerbations over 52 weeks |
| Result | 0.93 per year (95% CI 0.80 to 1.07) with tezepelumab versus 2.10 (1.84 to 2.39) with placebo — rate ratio 0.44 (0.37 to 0.53), p<0.001. In patients with blood eosinophils below 300 cells/microlitre the rates were 1.02 versus 1.73 (rate ratio 0.59, 0.46 to 0.75, p<0.001). Prebronchodilator FEV1 improved by 0.23 versus 0.09 litres (difference 0.13 L, p<0.001). |
| Secondary endpoints | FEV1, ACQ-6, Asthma Quality of Life Questionnaire, Asthma Symptom Diary |
Patients with severe, uncontrolled asthma who received tezepelumab had fewer exacerbations and better lung function, asthma control, and health-related quality of life than those who received placebo.
The trial authors, in the published abstract
The first biologic to work irrespective of phenotype. Because it acts upstream at TSLP rather than on a single type-2 cytokine, it reaches the low-eosinophil patients excluded from benefit by the anti-IL-5 agents such as SWIFT — which is why the prespecified low-eosinophil subgroup result is the important number here, not the headline.
Menzies-Gow A, Corren J, Bourdin A, et al. Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma. N Engl J Med 2021 May 13;384(19):1800-1809.