Dupilumab Improves Pre-, Postbronchodilator Lung Function Measures in Patients With COPD, Type 2 Inflammation

Dupilumab improved both pre- and post-bronchodilator (BD) lung function measures in patients with chronic obstructive pulmonary disease (COPD) and type 2 (T2) inflammation, according to 2 abstracts presented at the American Thoracic Society (ATS) 2024 International Conference.^1,2

Both abstracts analyzed the phase 3 LIBERTY COPD BOREAS study (NCT03930732), a 52-week, randomized, double-blind, placebo-controlled trial that evaluated the safety and efficacy of subcutaneous dupilumab at a dosage of 300 mg every 2 weeks vs placebo on lung function parameters in patients with moderate to severe COPD and T2 inflammation.³ Dupilumab is a monoclonal antibody that works by blocking the shared receptor component for interleukin (IL)-4 and IL-13.¹ The study population consisted of 939 patients, with 468 randomized to dupilumab and 471 to placebo.

Woman holding pair of paper lungs | Image Credit: LIGHTFIELD STUDIOS - stock.adobe.com

The first abstract analyzed both the pre-bronchodilator forced expiratory volume in 1 second (pre-BD FEV₁) and forced vital capacity (FVC) of patients with COPD and T2 inflammation through mixed-effects models for repeated measures. Among the study population, the mean (SD) baseline pre-BD FEV₁ was 1.28 (0.45) L for the dupilumab group and 1.32 (0.46) L for the placebo group. At week 12, the least squares (LS) mean change from the baseline pre-BD FEV₁ was 0.16 L (95% CI, 0.126-0.195) for dupilumab and 0.077 L (95% CI, 0.042-0.112) for placebo (mean difference, 0.083 L; 95% CI, 0.116-0.189; P < .001).

At week 52, the researchers found the LS mean change from the baseline pre-BD FEV₁ to be 0.153 L (95% CI, 0.116-0.189) for the dupilumab group and 0.07 L (95% CI, 0.033-0.107) for the placebo group (mean difference, 0.083 L; 95% CI, 0.038-0.128; P < .001). Of the study population, 41.1% of patients in the dupilumab group had improved pre-BD FEV₁ by 100 mL or more at week 52 compared with 34.3% of the placebo group.

Mean (SD) baseline pre-BD FVC was 2.71 (0.74) L for patients in the dupilumab group and 2.83 (0.90) L for the placebo group. At week 12, the researchers found the LS mean change from baseline pre-BD FVC to be 0.098 L (95% CI, 0.054-0.141) for the dupilumab group and 0.029 L (95% CI, –0.015 to 0.072) for the placebo group (mean difference, 0.069; 95% CI, 0.016-0.121; P = .01).

At week 52, the LS mean change from baseline pre-BD FVC was 0.079 (95% CI, 0.032-0.127) in the dupilumab group and –0.009 L (95% CI, –0.057 to 0.039) in the placebo group (mean difference, 0.088; 95% CI, 0.029-0.148; P = .004). Overall, the researchers determined that dupilumab improved pre-BD lung function measures in patients with COPD and T2 inflammation.

Although the second abstract also analyzed the BOREAS trial, it investigated the post-BD FEV₁ and FEV₁/FVC ratio among patients with COPD and T2 inflammation.² First, the researchers determined the mean baseline post-BD FEV₁ to be 1.39 (0.47) L in the dupilumab group and 1.41 (0.47) L in the placebo group. At week 12, the LS mean change from the baseline post-BD FEV₁ was 0.156 L (95% CI, 0.121-0.192) among the dupilumab group and 0.084 L (95% CI, 0.048-0.120) among the placebo group (mean difference, 0.072; 95% CI, 0.030-0.115; P = .001).

At week 52, the LS mean change from baseline post-BD FEV₁ was 0.138 L (95% CI, 0.101-0.174) for those in the dupilumab group vs 0.058 L (95% CI, 0.021-0.096) for those in the placebo group (mean difference, 0.079; 95% CI, 0.034-0.124; P < .001). Additionally, 38.3% of patients in the dupilumab group had their post-BD FEV₁ increase by 100 mL or more at week 52 vs 29.5% in the placebo group.

As for the mean baseline post-BD FEV₁/FVC ratio, it was 0.49 (0.12) for the dupilumab group and 0.49 (0.11) for the placebo group. The week 12 LS mean change from baseline post-BD FEV₁/FVC was 0.037 (95% CI, 0.030-0.044) for those in the dupilumab group and 0.023 (95% CI, 0.015-0.030) for those in the placebo group (mean difference, 0.014; 95% CI, 0.005-0.023; P = .002).

Lastly, at week 52, the dupilumab group’s LS mean change from baseline post-BD FEV₁/FVC was 0.333 (95% CI, 0.025-0.041), and the placebo group's LS mean change was 0.023 (95% CI, 0.016-0.031); the mean difference was 0.010 (95% CI, –0.000 to 0.019; P = .055). Overall, the researchers found that dupilumab improved post-BD FEV₁ and FEV₁/FVC ratio in those with COPD and T2 inflammation.

Based on the findings presented in both abstracts, dupilumab improved both pre- and post-BP lung function measures in patients with COPD and T2 inflammation, namely FEV₁, FVC, and FEV₁/FVC ratio. Therefore, these abstracts show that dupilumab effectively improves lung function in this patient population.

References

1. Papi A, Hanania NA, Bhatt SP, et al. Dupilumab improves pre-bronchodilator lung function measures in patients with chronic obstructive pulmonary disease (COPD) with type 2 inflammation: data from the phase 3 Boreas trial. Abstract presented at: ATS 2024. May 17-22, 2024; San Diego, CA.
2. Hanania NA, Bhatt SP, Rabe KF, et al. Dupilumab improves post-bronchodilator lung function in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) with type 2 inflammation: data from the phase 3 Boreas trial. Abstract presented at: ATS 2024. May 17-22, 2024; San Diego, CA.
3. Bhatt SP, Rabe KF, Hanania NA, et al. Dupilumab for COPD with type 2 Inflammation indicated by eosinophil counts. New England Journal of Medicine. 2023;389(3). doi:10.1056/nejmoa2303951