NOTUS: Dupilumab safe and efficacious in COPD with type 2 inflammation

Dupilumab reduced exacerbations, improved lung function, and ameliorated quality-of-life in patients with chronic obstructive pulmonary disease (COPD) and type 2 inflammation, results of the phase 3 NOTUS trial revealed.

“A subset of patients with COPD still experiences exacerbations while receiving the maximum standard-of-care inhaled triple therapy,” expressed Dr Surya Bhatt (University of Alabama at Birmingham, AL, USA). In the phase 3 BOREAS trial, dupilumab displayed efficacy in patients with COPD and type 2 inflammation, reducing the number of moderate and severe exacerbations and improving participants’ quality- of-life [1]. The current phase 3 NOTUS (NCT04456673) trial aimed to confirm these findings [2]. In total, 935 patients with moderate or severe COPD and type 2 inflammation between 40–85 years of age were randomised 1:1 to dupilumab, 300 mg every 2 weeks, or a placebo. The primary outcome measure was the annualised rate of moderate or severe exacerbations. Dr Bhatt presented the findings after 52 weeks. The annualised rate of moderate or severe exacerbations was significantly lower in the active arm than in the placebo arm (0.86 vs
1.30; P<0.001). Also, the change from baseline in pre-bronchodilator FEV1 favoured the dupilumab arm over the control arm, with LS mean differences between the study arms of 82 mL at week 12 and 62 mL at week 52. Furthermore, Dr Bhatt reported quality-of-life improvements in the dupilumab group compared with the placebo group: the St. George’s Respiratory Questionnaire (SGRQ) LS mean difference at week 52 was -3.4.

Finally, the safety profile of dupilumab in this study was consistent with the known safety profile of the agent. “Dupilumab reduced the annualised rate of moderate-to-severe exacerbations by 34% compared with placebo, confirming the findings of the BOREAS trial,” concluded Dr Bhatt.

1. Bhatt SP, et al. N Engl J Med 2023;389:205-214.
2. Bhatt SP, et al. Efficacy and safety of dupilumab in patients with moderate-to-severe COPD and type 2 inflammation: phase 3 NOTUS trial. Late-breaking abstracts: science that will impact clinical care. ATS 2024, 17–22 May, San Diego, USA.

Medical writing support was provided by Robert van den Heuvel.

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Posted on 10 June 202412 June 2024