TEZSPIRE Shows Promise for Future COPD Treatment: ATS 2024 Data

Late-breaking findings from the Phase IIa COURSE trial have provided new insights regarding the effects of TEZSPIRE® (tezepelumab) on chronic obstructive pulmonary disease (COPD) exacerbations in patients with varying levels of blood eosinophil counts (BEC).

The Phase IIa COURSE trial was designed as a proof-of-concept study targeting patients with moderate to very severe COPD, regardless of their history of emphysema, chronic bronchitis, or smoking status. The trial's primary results indicated a 17% numerical reduction in the annual rate of moderate or severe COPD exacerbations when treated with TEZSPIRE, compared to a placebo at the 52-week mark. However, this reduction was not statistically significant.

Notably, in individuals with BEC levels equal to or exceeding 150 cells/µL, TEZSPIRE showed a nominally significant 37% reduction in exacerbation rates compared to placebo. Approximately 65% of COPD patients are estimated to have BEC levels at or above this threshold. For those with BEC levels of 300 cells/µL or higher, TEZSPIRE achieved a 46% numerical reduction in exacerbation rates.

Dr. Dave Singh, a professor at the University of Manchester and the lead investigator of the trial, emphasized the importance of biologics in future COPD treatment, stating that trials like the tezepelumab study are crucial in understanding and shaping the treatment landscape. Sharon Barr, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, highlighted the encouraging nature of these results and revealed that planning for Phase III trials is underway, given the promising data.

Further analysis from the COURSE trial also showed that treatment with TEZSPIRE led to improvements in lung function, as measured by forced expiratory volume (FEV1), and in the quality of life, as assessed by the St. George’s Respiratory Questionnaire (SGRQ). Specifically, for patients with BEC levels of 150 cells/µL or higher, there were improvements of 63mL in FEV1 and a 4.2-point reduction in SGRQ scores. For those with BEC levels of 300 cells/µL or higher, the improvements were 146mL in FEV1 and a 9.5-point reduction in SGRQ scores.

TEZSPIRE's safety and tolerability profile in the trial was consistent with its approved use for severe asthma. The most frequently reported adverse events were COPD exacerbation (12.1%) and COVID-19 infections (14.5%).

The COURSE trial was a multicentre, randomized, double-blind, placebo-controlled study. It involved 337 COPD patients who were receiving triple inhaled maintenance therapy and had experienced two or more COPD exacerbations in the year preceding the trial. Participants received either 420 mg of TEZSPIRE or a placebo via subcutaneous injection every four weeks over a 52-week period, with an additional 12-week post-treatment follow-up.

COPD encompasses a range of lung diseases, such as chronic bronchitis and emphysema, characterized by airflow obstruction and breathing difficulties. It is a significant health concern, being the third leading cause of death from chronic disease in the U.S. and resulting in approximately 150,000 deaths annually. COPD mechanisms also increase the risk of heart and lung events, underscoring the importance of effective management strategies.

TEZSPIRE is a human monoclonal antibody developed by AstraZeneca in collaboration with Amgen. It inhibits TSLP, a cytokine involved in multiple inflammatory pathways linked to severe asthma and other airway inflammations. The drug has received approval for severe asthma treatment in several regions, including the US, EU, and Japan.

Overall, these findings suggest that TEZSPIRE may significantly impact COPD management, particularly for patients with elevated eosinophil levels. Further studies, particularly the upcoming Phase III trials, will be essential to confirm these initial findings and potentially expand the therapeutic options for COPD patients.