16 Questions
What percentage of patients in the dupilumab group reported adverse events during the 52-week study period?
66%
What was the least squares mean change in prebronchodilator forced expiratory volume in 1 second from baseline to 12 weeks in the dupilumab group?
139 mL
What was the percentage reduction in moderate or severe exacerbations in the dupilumab group compared to the placebo group at 52 weeks?
34%
What was the least squares mean change in total score on the St. George's Respiratory Questionnaire in the dupilumab group?
9.8
What was the percentage of patients in the placebo group who experienced serious adverse events?
15.9%
What was the most common adverse event reported in both the dupilumab and placebo groups?
COVID-19
How many patients in the dupilumab group experienced major adverse cardiovascular events?
3
What percentage of patients in the dupilumab group experienced adverse events resulting in death?
2.6%
What was the primary endpoint of the NOTUS study?
To reduce the annualized rate of moderate or severe COPD exacerbations at 52 weeks
What is the mechanism of action of dupilumab?
Inhibiting the signaling of the IL-4 and IL-13 pathways
How many patients were enrolled in the NOTUS study?
470 patients received dupilumab and 465 received placebo
What is the definition of type 2 inflammation in the NOTUS study?
A blood eosinophil count of ≥ 300 cells/µL
What is the duration of COPD for patients enrolled in the study?
At least 12 months
What is the minimum smoking history required for patients enrolled in the study?
At least 10 pack-years
What was the dosage of dupilumab administered in the NOTUS study?
300-mg subcutaneous dupilumab every 2 weeks
What conference was the NOTUS study presented at?
The American Thoracic Society (ATS) 2024 International Conference
Study Notes
Dupilumab Study on COPD
- Dupilumab significantly reduces exacerbations and improves lung function in adults with uncontrolled chronic obstructive pulmonary disease (COPD) and type 2 inflammation.
Study Details
- The NOTUS study randomized 470 adults with uncontrolled COPD and type 2 inflammation to 300-mg subcutaneous dupilumab or placebo every 2 weeks.
- Study population included adults aged 40-85 years with physician-diagnosed COPD for at least 12 months who had received background triple inhaler therapy.
Results
- Annualized rate of moderate or severe COPD exacerbations was significantly lower (34%) in the dupilumab group than in the placebo group (0.86 vs 1.30, P <.001) at 52 weeks.
- Dupilumab group saw a significantly greater improvement in lung function than the placebo group based on prebronchodilator forced expiratory volume in 1 second from baseline to 12 weeks (least squares mean change of 139 mL vs 57 mL).
- Improvement in lung function was sustained at 52 weeks (least squares mean change of 115 mL vs 54 mL).
- Changes in total score based on the St.George's Respiratory Questionnaire were greater in the dupilumab group than in the placebo group (least squares mean change of 9.8 vs 6.4).
Safety Outcomes
- Safety outcomes were similar between the dupilumab and placebo groups, with approximately 66% of patients in each group reporting adverse events during the 52-week study period.
- Serious adverse events occurred in 13% and 15.9% of dupilumab and placebo patients, respectively.
- Adverse events resulting in death occurred in 2.6% and 1.5%, respectively.
- Most common adverse events were COVID-19, headache, COPD, and nasopharyngitis.
A phase 3 trial, NOTUS, shows dupilumab's effectiveness in reducing exacerbations and improving lung function in adults with uncontrolled chronic obstructive pulmonary disease (COPD) and type 2 inflammation. The data was presented at the ATS 2024 International Conference and published in The New England Journal of Medicine.
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