Breakthroughs in the treatment of chronic obstructive pulmonary disease (COPD) appear to be on the horizon in thoracic medicine. Encouraging results from multiple clinical trials at the ATS 2024 International Conference signify a significant reduction in exacerbations with improved markers of lung function and quality of life.

NOTUS, a randomized, double-blind phase 3 trial studying dupilumab compared with placebo in adult patients with moderate or severe COPD and type 2 inflammation, was discussed during the session, “Breaking News: Clinical Trial Results in Pulmonary Medicine.” The study showed promising improvements for patients struggling with COPD and inflammation.

“NOTUS confirmed the results of the BOREAS trial that Dupilumab is effective in lowering exacerbation frequency in the specific endophenotype of high exacerbation risk in the setting of predominant type 2 inflammation,” explained Surya P. Bhatt, MD, MSPH, professor of pulmonary, allergy & critical care medicine and director of the Center for Lung Analytics and Imaging Research at the University of Alabama at Birmingham. “Dupilumab also improved lung function and quality of life. This is the first biologic to show benefits in a COPD endotype.”

Dupilumab is a monoclonal antibody that blocks the receptor for interleukin-4 and interleukin-13, key drivers of type 2 inflammation.

After 52 weeks of treatment, the annualized rate of moderate or severe COPD exacerbations was 34 percent lower among participants in the dupilumab group than those in the placebo group. This benefit was consistently shown across subgroups, including gender, age, and smoking status.

Findings from the Phase 2a COURSE study were also discussed during the clinical trials symposium at ATS 2024. The COURSE trial examined the effects of tezepelumab in adults with moderate to very severe COPD who had two or more exacerbations within the last year despite being administered stable triple inhaled therapy. Participants were placed in randomized groups to receive tezepelumab with triple therapy or triple therapy alone for 52 weeks.

Participants in the tezepelumab and triple therapy group showed a nonsignificant 17 percent reduction in the annualized rate of moderate or severe COPD exacerbations.

“Subgroup analyses suggested that tezepelumab may be effective as an add-on therapy in those with indicators of type 2 inflammation, such as high blood eosinophil count (BEC) and high fractional exhaled nitric oxide (FeNO),” said Dr. Bhatt. “Although the exacerbation reduction effect was notable at a blood eosinophil threshold of 150 or greater, the study was enriched for patients with three or more exacerbations per year. These results should be confirmed in an adequately powered phase 3 trial.”

Results from The Undiagnosed COPD and Asthma Population (UCAP) trial were discussed during the session, “AJRCCM, JAMA, NEJM Discussions on the Edge: Reports of Recently Published Pulmonary Research.” Researchers utilized a questionnaire-based method to identify undiagnosed asthma and COPD. The findings could lead to a shift in care strategies for some patients.

“Compared to usual care, pulmonologist-directed guideline-concordant treatment was associated with lower frequency of exacerbation and better lung function and quality of life,” Dr. Bhatt explained.

Throughout multiple sessions at ATS 2024 San Diego, including the Clinical Year in Review series, primary and secondary analyses of numerous clinical trials were shared and reflected the high number of drugs in development to treat patients with COPD.

“This is unprecedented in COPD and the therapeutic landscape is rapidly changing,” Dr. Bhatt said.