CONFERENCE UPDATE: ERS 2023

Dupilumab demonstrates significant efficacy and safety outcomes for patients with COPD and type 2 inflammation: The phase 3 BOREAS trial

RESPIROLOGY
17 Nov 2023

STUDY DESIGN

Patients with chronic obstructive pulmonary disease (COPD) and type 2 (T2) inflammation are often burdened with an elevated risk of exacerbation and decline in lung function, resulting in subsequent morbidity and death.1 Novel biologics like dupilumab, a human monoclonal antibody that blocks interleukin (IL)-4 and IL-13 receptors, display a promising potential in alleviating T2 inflammation.1 As such, the BOREAS study was conducted to investigate the efficacy and safety of dupilumab in patients with moderate or severe COPD with T2 inflammation.1

The BOREAS study was a randomized, double-blinded, placebo-controlled, phase 3 study that enrolled a total of 939 patients with moderate-to-severe COPD and a blood eosinophil count of ≥300cells/µL.1 The study population was randomized to receive either dupilumab 300mg (n=468) or placebo (n=471) subcutaneously (SC) once every 2 weeks (Q2W) for 52 weeks.1 The primary endpoint of this study was the annualized rate of moderate-to-severe exacerbations from baseline to week 52.1 Secondary endpoints included treatment outcomes in terms of patients’ lung functionality, quality of life, and safety, which included the change from baseline to weeks 12 and 52 in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) and scores of patient-reported questionnaires such as St. George’s Respiratory Questionnaire (SGRQ) as well as the Evaluating Respiratory Symptoms in COPD (E-RS: COPD) questionnaire.1

 

Primary endpoint:
  • The primary endpoint of this study was the annualized rate of moderate-to-severe exacerbations from baseline to week 521
  • The dupilumab arm exhibited a 30% lower annualized incidence of moderate-to-severe exacerbations compared to the placebo arm (1.10 vs. 0.78; p<0.001)1
  • In addition, the dupilumab arm possessed a relatively lower exacerbation-associated annualized total systemic corticosteroid treatment duration when compared with the placebo arm (13.57 days vs. 19.09 days)1

Secondary endpoints:
  • The secondary endpoints of this study included the change from baseline to weeks 12 and 52 in pre-BD FEV1, SGRQ scores and E-RS: COPD scores1
  • A significant improvement in FEV1 was observed in the dupilumab arm [Least squares mean (LSM) difference=83mL; 95% CI: 42-125; p<0.001] at week 12. The improvement was maintained at week 52 (LSM difference=83mL; 95% CI: 38-128; p<0.001)1
  • At Week 52, the dupilumab arm also had a significantly lower SGRQ score (LSM difference=-3.4; 95% CI: -5.5 to -1.3; p=0.002) and E-RS: COPD score (LSM difference=-1.1; 95% CI: -1.8 to -0.4; p=0.002) when compared with its placebo counterpart1

Safety:
  • Overall, the safety outcomes of the two arms were comparable, with both arms possessing similar incidences of treatment-emergent adverse events (TEAEs) (dupilumab=76.0% vs. placebo=77.4%) and treatment-emergent serious adverse events (TESAEs) (dupilumab=15.5% vs. placebo=13.6%)1
  • The prevalent TEAEs of the dupilumab and placebo arms were similar, consisting of nasopharyngitis (9.6% vs. 9.4%), headache (6.8% vs. 8.1%) and upper respiratory tract infection (9.8% vs. 7.9%) respectively1
  • Treatment discontinuation rate of the dupilumab arm was akin to that of the placebo arm at 3.4% vs. 3.0% respectively1
  • Similar incidences of TEAEs leading to death were reported in both arms at 1.7% and 1.5% for the dupilumab and placebo arms respectively1

 

"Dupilumab exhibited sustained and significant improvements in reducing exacerbations, maintaining lung function and quality of life in COPD patients with type 2 inflammation."

Professor Surya P. Bhatt
University of Alabama at Birmingham, Birmingham,
Alabama, United States

 

Get access to our exclusive articles.