First Biologic for COPD Crosses Another Hurdle
According to Sanofi, the biologic drug Dupixent® reduced COPD exacerbations by 34% when compared to placebo in the second of two Phase 3 trials. The NOTUS trial also confirmed that treatment with Dupixent led to rapid and significant improvements in lung function by 12 weeks and that those improvements were sustained at 52 weeks.
Safety results were in keeping with the known safety profile of the drug in its approved indications.
The study was conducted among 1,874 adults with uncontrolled COPD who showed evidence of type 2 inflammation, defined as blood eosinophils ≥300 cells per μL, and were on maximal standard-of-care inhaled therapy (triple therapy).
While these results came from an interim analysis, given the overwhelming positive efficacy of the primary endpoint, they will be considered the primary analysis of the trial.
The findings hold out hope that the first biologic for COPD may be on its way to FDA approval. Sanofi and its partner Regeneron plan to submit the data from this replicate trial, along with positive results from the Phase 3 BOREAS trial, to the FDA by the end of the year.
“This is the first and only time an investigational biologic in COPD has shown a significant and clinically meaningful reduction in exacerbations in two Phase 3 trials and we are pleased that we can potentially deliver Dupixent faster to patients in need where no new advancements have been identified in over a decade,” said Naimish Patel, MD, head of global development, immunology and inflammation at Sanofi.
Based on the positive results from the BOREAS trial, the FDA granted Breakthrough Therapy designation for Dupixent earlier this year as an add-on maintenance treatment in adult patients with uncontrolled COPD associated with a history of exacerbations and an eosinophilic phenotype.
The researchers plan to present their findings from the NOTUS trial at an upcoming scientific conference. Results of the BOREAS trial were published in The New England Journal of Medicine. Read More
Prone Position Falls Short in ECMO Study
Prone positioning has received a lot of attention since the COVID-19 pandemic, with some studies showing it improves outcomes for patients with severe acute respiratory distress syndrome (ARDS). Does it work for severe ARDS patients placed on extracorporeal membrane oxygenation (ECMO) as well?
A new study from French investigators suggests the answer is no. They randomized 170 patients who were mainly suffering from severe ARDS due to COVID-19 to either a prone or supine position during venovenous ECMO. About 44% of the patients in both groups were successfully weaned from ECMO at sixty days.
No significant differences were seen in days on ECMO or ICU length of stay, and 90-day mortality rates were also similar between the groups.
Since 94% of the patients in this study had COVID-19, the authors speculate these findings may have been influenced by the probability that COVID-19 produced more lung damage than is typically seen with ARDS. “It remains uncertain whether the current trial findings are generalizable to patients with severe non-COVID-19-related ARDS,” write the authors.
The study was conducted in 14 ICUs in France and published by JAMA. Read More
Better BVM Could Significantly Improve Outcomes in CPR
A landmark study published in Circulation suggests more consistent use of bag-valve-mask (BVM) ventilation during chest compressions in out-of-hospital CPR could translate to huge benefits for people who experience these events.
Investigators from UT Southwestern, who also presented their findings at the American Heart Association’s annual Scientific Conference in Philadelphia in November, based that conclusion on data from a study conducted at six sites in the U.S. and Canada participating in the Resuscitation Outcomes Consortium’s clinical trial on the effectiveness of continuous compressions vs. standard CRP.
Overall, the study included 1,976 records from patients who underwent 30:2 CPR and had usable recordings. Results showed detectable ventilation occurred in only 40% of compression pauses. However, in patients who had measurable ventilation in at least half of the pauses, return of spontaneous circulation, survival to hospital discharge, and survival with favorable neurological outcome all improved.
Most significantly, cardiac arrest patients receiving measurable ventilation in at least half of the pauses had a four times greater survival rate than those who received ventilation in less than half of the pauses.
The authors note little research has been conducted on BVM during CPR and believe their study sheds groundbreaking light on the important role it plays in the procedure.
“The assumption was that ventilation with the bag and mask took place whenever the ventilation bag was squeezed. But our study found that in actual out-of-hospital conditions, BVM has significant shortcomings — primarily because it is difficult for emergency personnel to know whether proper lung inflation is occurring during early CPR,” said study author Ahamed Idris, MD.
Dr. Ahamed goes on to say that BVM is a skill that requires regular practice to maintain proficiency and he encourages health care providers to do what it takes to ensure proficiency is maintained. “Our hope is that this study spurs EMS medical directors to find solutions that work best for their agencies, ensuring that staff in the field is aware of the limitations of BVM and have been trained in how to overcome them,” he said. Read More
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Debbie Bunch is an AARC contributor who writes feature articles, news stories, and other content for Newsroom, the AARC website, and associated emailed newsletters. In her spare time, she enjoys reading, traveling, photography, and spending time with her children and grandchildren. Connect with Debbie by email or on AARConnect or LinkedIn.
