The collaborative Phase IIa COURSE trial by AstraZeneca and Amgen was a proof-of-concept study in people with moderate to very severe chronic obstructive pulmonary disease (COPD) with a broad range of blood eosinophil counts (BEC) and irrespective of emphysema, chronic bronchitis or smoking status.1
The results
The primary results showed that treatment with Tezspire (tezepelumab) led to a 17% reduction in the annual rate of moderate or severe COPD exacerbations compared to placebo at week 52. The results of the study are being presented at the American Thoracic Society (ATS) International Conference.
Importantly, in patients with BEC ≥150 cells/µL, tezepelumab led to a nominally significant reduction of 37% in the rate of moderate or severe exacerbations compared to placebo.
Studies suggest that approximately 65% of bio-eligible patients with COPD have a BEC greater than or equal to 150 cells/μL.2
Treatment with tezepelumab resulted in numerical improvements in lung function as measured by forced expiratory volume (FEV1)
In patients with BEC ≥300 cells/µL tezepelumab led to a numerical reduction of 46% in the rate of moderate or severe exacerbations.
Dr Dave Singh, Professor of Respiratory Pharmacology at the University of Manchester and lead investigator on the trial, said: “I believe that biologics will play a critical role in the future care of COPD and trials such as the tezepelumab COURSE trial are central to understanding and shaping the treatment landscape. The tezepelumab COURSE results are particularly important as they show activity in COPD across a broad patient population including those with baseline blood eosinophil counts greater than 150 cells/μL.”
A subgroup analysis of the COURSE trial also showed treatment with tezepelumab resulted in numerical improvements in lung function as measured by forced expiratory volume (FEV1) (improvement of 63mL and 146mL in BEC ≥150 and ≥300 cells/μL respectively, compared to placebo) and in quality of life as measured by the St. George’s Respiratory Questionnaire (SGRQ) score (reduction of 4.2 points and 9.5 points in BEC ≥150 and ≥300 cells/μL respectively).
Safety, tolerability and adverse events
The safety and tolerability profile for tezepelumab was consistent with its approved severe asthma indication; the most frequently reported (>10%) adverse events for tezepelumab were worsening of COPD (12.1%) and incidents of COVID-19 infections (14.5%) (this trial commenced in July 2019).1 (Table 2.)
References
1 Singh D, et al. Tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (COPD): efficacy and safety from the phase 2a COURSE study. American Thoracic Society (ATS) 2024. May 2024.
2 Data on File REF-228444 – Blood Eosinophil Count in 65% COPD patients.