News of Note

Dupilumab Improves Quality of Life for COPD Patients 

Boston, MA - Patients with chronic obstructive pulmonary disease (COPD) and type 2 inflammation had greater improvements in quality of life with dupilumab (Dupixent) versus placebo, according to a pooled analysis of data from the phase III BOREAS and NOTUS trials. At 52 weeks, the least-squares mean difference from baseline in the total St. George's Respiratory Questionnaire (SGRQ) score with dupilumab versus placebo was -3.4 points (95% CI -5.0 to -1.8, nominal P<0.0001), reported Surya Bhatt, MD, of the University of Alabama at Birmingham, during the CHEST annual meeting hosted by the American College of Chest Physicians. For individual SGRQ domain scores, the least-squares mean differences at 52 weeks with dupilumab versus placebo were:

Symptoms: -3.5 (95% CI -5.5 to -1.5, nominal P<0.0006)

Impacts: -2.9 (95% CI -4.6 to -1.1, nominal P=0.0012)

Activity: -4.0 (95% CI -5.9 to -2.1, nominal P<0.0001)

Impairments in quality of life "contribute significantly to morbidity in COPD," Bhatt told attendees. "The total SGRQ score changed quickly," he noted. "Within 4 weeks there was a big difference between the placebo arm and the [dupilumab] arm, and this difference persisted over the 52-week time period." "Even in the subdomains, this trend was very similar," he added. "Dupilumab has a significant impact on quality of life in addition to its primary impact on exacerbation reduction and secondary reduction improvements in lung function" in patients with COPD. The 36-item SGRQ measures patient-reported impacts of obstructive airway diseases on overall health, common daily activities, and perceived well-being. The total SGRQ score and those of three domains range from 0 to 100, with higher scores indicating poorer health-related quality of life. At baseline, the total SGRQ score "was quite high, to the tune of almost 50 on average in both groups," Bhatt pointed out. For the specific domains across both groups, the mean activity score was approximately 66, the symptoms domain score was roughly 59, and the impacts domain score was about 38. "Although dupilumab appears to be a promising biologic treatment for COPD, its use is currently limited to those with an eosinophilic phenotype, which represents a minority of patients with the disease," session moderator Subhakar Kandi, MBBS, MD, of Kamineni Hospitals in Hyderabad, India, told MedPage Today. More treatments are desperately needed for COPD because of its substantial burden on patients and caregivers, he emphasized. However, he noted that he would have liked to see data from the analysis broken down according to disease severity or exacerbation risk. Dupilumab, an injectable interleukin (IL)-4 and IL-13 pathway inhibitor, recently received FDA approval as the first-ever biologic for treatment of COPD. It is indicated as an add-on maintenance treatment for inadequately controlled COPD with an eosinophilic phenotype. Primary support for the approval came from the phase III BOREAS trial, showing that dupilumab led to a 30% reduction in annual exacerbations, and from the phase III NOTUS trial, which showed a 34% reduction. The BOREAS and NOTUS trials assessed the efficacy and safety of dupilumab as add-on therapy in patients with COPD and type 2 inflammation (blood eosinophil count ≥300 cells/µL) who had moderate-to-severe airflow limitation and were taking inhaled triple therapy. This prespecified pooled analysis assessed the change from baseline in the SGRQ total and domain scores at week 52 in patients enrolled in those trials. The final population in this analysis included 830 patients in the dupilumab group (mean age 65, 65.9% men) and 830 in the placebo group (mean age 65, 67.6% men). Most patients were former smokers (70-71%).

For more information: https://tinyurl.com/2vedt6v5

NOC's of Note

A Notice of Compliance (NOC) is a Health Canada term. It is issued to a drug manufacturer following the satisfactory review of a submission for a new drug. The issuance of an NOC signifies compliance with Canada's Food and Drug Regulations
 

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