BODE index score does not change dupilumab efficacy in COPD with type 2 inflammation

Key takeaways:

• The adjusted annualized moderate/severe exacerbation rate went down with dupilumab vs. placebo in both BODE index score groups.
• Those receiving dupilumab in both groups had greater lung function improvement.

Dupilumab’s impact on exacerbation rate and lung function in adults with COPD and type 2 inflammation did not differ based on BODE index score, according to a poster presented at the European Respiratory Society International Congress.

The BODE index score is made up of BMI, airflow obstruction, dyspnea and exercise capacity and predicts 5-year mortality risk, according to researchers.

“These results demonstrate that dupilumab can improve signs and symptoms of disease even in patients with COPD who are at risk for poor outcomes at baseline, for those who are eligible for this treatment,” Claus F. Vogelmeier, MD, professor of medicine and head of the department of medicine, pulmonary and critical care medicine, at University Medical Center Giessen and Marburg, told Healio.

Using data from the multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 3 BOREAS study, Vogelmeier and colleagues assessed 939 adults with moderate to severe COPD and type 2 inflammation primarily on background triple therapy to see if dupilumab’s (Dupixent; Regeneron, Sanofi) impact on exacerbation rate and lung function differs based on baseline BODE index score.

As Healio previously reported, the BOREAS study found that current/former smokers with moderate to severe COPD and type 2 inflammation receiving dupilumab had a lower exacerbation rate and better lung function at 52 weeks vs. placebo.

Within the total cohort, 468 patients received 300 mg of dupilumab every 2 weeks, and 471 patients received placebo every 2 weeks. The dupilumab group included 278 patients with a lower BODE score (≤ 4) and 186 patients with a higher BODE score (> 4), which “predict worse outcomes in COPD,” according to researchers. The placebo group included 299 patients with a lower BODE score and 171 with a higher BODE score.

“Assessing dupilumab in people with a range of BODE scores demonstrates the potential of this treatment regardless of how sick patients are to begin with,” Vogelmeier told Healio.

In both the dupilumab group and the placebo group, researchers noted a similar proportion of patients with a BODE index score of 0 to two (18.5% vs. 20.2%), three to four (41.4% vs. 43.4%), five to six (31.7% vs. 29.6%) and seven to 10 (8.4% vs. 6.8%).

Among those with a lower BODE score (≤ 4), the adjusted annualized moderate/severe exacerbation rate went down by 28.2% with dupilumab vs. placebo. Similarly, patients with a higher BODE index score (> 4) receiving dupilumab had a 34.4% decrease in the adjusted annualized moderate/severe exacerbation rate compared with placebo.

Between baseline and week 12, patients in the lower BODE index score group receiving dupilumab showed 0.1 L greater improvement in pre-bronchodilator FEV₁ compared with placebo. Following the same pattern, patients with a higher BODE index score receiving dupilumab vs. placebo had 0.06 L greater improvement in pre-bronchodilator FEV₁ between baseline and week 12.

“These results are in line with what we would expect for dupilumab improving outcomes in COPD, but further validate the value of this treatment regardless of baseline characteristics,” Vogelmeier told Healio. “In this case, dupilumab reduced exacerbations and improved lung function compared to placebo irrespective of baseline 5-year mortality risk measured by the BODE index score.

“Future studies will assess how dupilumab works in real-world settings and in diverse populations as dupilumab is approved for the treatment of COPD in countries around the world,” Vogelmeier added.