Dupilumab demonstrates long-term safety, efficacy among children with asthma
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NASHVILLE, Tenn. — Children aged 6 to 11 years with uncontrolled, moderate to severe type 2 asthma experienced clinical improvements with dupilumab through a 2-year study period, according to a presentation at the CHEST Annual Meeting.
Treatment had an acceptable long-term safety profile as well, Leonard B. Bacharier, MD, Janie Robinson and John Moore Lee Chair in Pediatrics at Vanderbilt University Medical Center, and colleagues wrote.
“This was a planned follow-up of the VOYAGE study to better learn the long-term safety and efficacy of dupilumab in children 6 to 11 years of age with moderate to severe asthma,” Bacharier told Healio.
The analysis involved 125 children who were on placebo during the 52-week VOYAGE study and then on dupilumab (Dupixent, Sanofi Genzyme/Regeneron) for the 52-week follow-up EXCURSION study (placebo/dupilumab group), as well as 240 children who were on dupilumab for both studies (dupilumab/dupilumab group).
Dosages during the EXCURSION study included 100 mg or 200 mg of subcutaneous dupilumab every 2 weeks, with a subgroup receiving 300 mg every 4 weeks.
During EXCURSION, 68% of the placebo/dupilumab group and 61.3% of the dupilumab/dupilumab group experienced treatment-emergent adverse events, which served as the study’s primary endpoint.
“We found no new safety signals, with a safety profile comparable to that seen in VOYAGE,” Bacharier said.
Also, the placebo/dupilumab group had a 0.124 annualized rate of severe exacerbations, and the dupilumab/dupilumab group had a 0.118 rate.
The mean baseline percentage predicted pre-bronchodilator FEV1 totals in the VOYAGE study were 78.7% for the placebo/dupilumab group and 76.9% for the dupilumab/dupilumab group.
Mean changes in predicted pre-bronchodilator FEV1 from the VOYAGE baseline included increase of 3.8 at week 0 of EXCURSION, 8.7 at week 2 and 9.4 at week 52 for the placebo/dupilumab group, with corresponding increases of 12.5, 11.3 and 12.6 for the dupilumab/dupilumab group.
The proportion of patients needing systemic corticosteroids (SCS) fell from VOYAGE to EXCURSION for both the placebo/dupilumab group (40.4% vs. 13.2%) and dupilumab/dupilumab group (24.2% vs. 10.5%).
Specifically, unadjusted annualized total SCS courses per patient fell by 78% for the placebo/dupilumab group, from 0.816 during VOYAGE to 0.181 during EXCURSION. For the dupilumab/dupilumab group, these totals fell by 63% from 0.414 to 0.152.
Overall, the researchers said that the patients who switched from placebo to dupilumab between VOYAGE and EXCURSION experienced rapid improvements in lung function.
The researchers also cited the sustained reductions in exacerbations, annualized courses of SCS, improvements in lung function and long-term safety profile over the 52 weeks of the EXCURSION study.
“There was sustained improvement in lung function in children who continued dupilumab for a second year, and in those children in the placebo arm of the VOYAGE trial, there was a rapid and sustained improvement in lung function after starting dupilumab,” Bacharier said.
Although the exacerbation rate also was low during the second year, Bacharier said that the researchers do not know with any certainty if these trends will continue into a third year.
“However, the findings were very similar to those seen during year 1,” he said.
Also, Bacharier said, providers can include these findings as they discuss treatment with families, as they provide reassurance about dupilumab’s longer-term safety profile.
Bacharier also said that the researchers will continue with additional analysis examining other parameters of lung function and type 2 biomarkers.