The initial results from the Phase IIa COURSE trial indicated that AstraZeneca and Amgen's Tezspire (tezepelumab) achieved a 17% reduction in the annual rate of moderate or severe COPD exacerbations compared to a placebo at week 52. However, this reduction was not statistically significant, according to the companies.
The Phase IIa COURSE trial served as a proof-of-concept study targeting individuals with moderate to very severe chronic obstructive pulmonary disease (COPD). Participants included a broad range of blood eosinophil counts (BEC) and were not restricted by emphysema, chronic bronchitis, or smoking status.
The companies highlighted that Tezspire achieved a nominally significant 37% reduction in the rate of moderate or severe exacerbations compared to placebo. Studies suggest that about 65% of bio-eligible COPD patients have blood eosinophil counts of at least 150 cells per microliter. Notably, in patients with blood eosinophil counts of 300 cells per microliter or higher, Tezspire resulted in a 46% numerical reduction in the rate of moderate or severe exacerbations.
Subgroup analysis from the COURSE trial also demonstrated that treatment with Tezspire led to numerical improvements in lung function, measured by forced expiratory volume (FEV1), and in quality of life, measured by the St. George's Respiratory Questionnaire (SGRQ) score. The safety and tolerability profile of Tezspire was consistent with its approved indication for severe asthma. The most frequently reported adverse events were worsening of COPD (12.1%) and incidents of COVID-19 infections (14.5%).
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