Study: Tezepelumab Reduces Annual Rates of Exacerbations Related to COPD

Tezepelumab (Tezspire; AstraZeneca, Amgen) reduced the annual rate of moderate or severe chronic obstructive pulmonary disease (COPD) exacerbations compared with the placebo at 52 weeks by 17%, but was not statistically significant, according to a news release. The results were presented at the American Thoracic Society International Conference.¹

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“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,” Dave Singh, MD, professor of Respiratory Pharmacology at the University of Manchester, said in the news release.¹

The COURSE (NCT04039113) trial is a phase 2a, multicenter, randomized, double-blind study evaluating the safety and efficacy of tezepelumab in adults with moderate to severe COPD. Individuals included in the trial received triple inhaled maintenance therapy and had 2 or more documented COPD exacerbations 12 months prior to the first visit in the study. There were approximately 338 participants who received either tezepelumab or the placebo, which was administered as a subcutaneous injection over the 52-week period. Furthermore, there was a follow-up period of 12 weeks, according to the clinical trial information.²

Individuals were excluded if they had another clinically important pulmonary disease, including current and previous asthma diagnoses, major surgery within 8 weeks before enrollment, history of clinically significant infections requiring antibiotics or antiviral medication 14 days before enrollment, or if they were pregnant.²

The primary end point was exacerbation rate based on exacerbations reported by investigators over the 52-week period. Secondary end points included time to first moderate or severe COPD exacerbation, proportion of at least 1 moderate or severe COPD exacerbation, severe COPD exacerbation rate ratio (determined by the study drug and the placebo), change from baseline in pre-bronchodilator forced expiratory volume in 1 second, and change in respiratory health status and health-related quality of life. Furthermore, other secondary end points included change from baseline in St. George’s Respiratory Questionnaire Total Score, change from baseline in COPD Assessment Test Total Score, and the pharmacokinetics and immunogenicity of tezepelumab.²

Investigators found that, for patients with a blood eosinophil count (BEC) of 150 cells/µL or more, tezepelumab had a significant reduction of approximately 37% in the rate of moderate or severe exacerbations when compared with the placebo, suggesting that about 65% of bio-eligible patients with COPD have a BEC greater than or equal to 150 cells/µL. For patients with BEC of 300 cells/µL or more, tezepelumab showed a reduction of 46% for moderate to severe exacerbations.¹

In February 2023, the FDA approved pre-filled single-use pens for patients 12 years and older with severe asthma. With this, tezepelumab could be self-administered by patients, showing a 71%, and 48% reduction in annual asthma exacerbation rate over 52 weeks for those with 300 or greater cells/µL 150 greater than or equal cells/µL . The reduction was 48% for those with less than 150 cells/µL.³

References

1. New data presented at ATS 2024 show the potential of TEZSPIRE to play a role in the future treatment of chronic obstructive pulmonary disease. News release. AstraZeneca. May 19, 2024. Accessed May 23, 2024. https://www.astrazeneca-us.com/media/press-releases/2024/new-data-presented-at-ats-2024-show-the-potential-of-tezspire-to-play-a-role-in-the-future-treatment-of-chronic-obstructive-pulmonary-disease.html

2. Tezepelumab COPD Exacerbation Study (COURSE). ClinicalTrials.gov Identification: NCT04039113. February 22, 2024. Accessed May 23, 2024. https://clinicaltrials.gov/study/NCT04039113#publications

3. Antrim A. FDA Approves Pre-Filled Pen for Self-Administration of Tezepelumab-ekko to Treat Asthma. Pharmacy Times. February 6, 2023. Accessed May 23, 2024. https://www.pharmacytimes.com/view/fda-approves-pre-filled-pen-for-self-administration-of-tezepelumab-ekko-to-treat-asthma