The new drug is a “game changer,” for these patients, Dr. Han said in a video interview.
In some patients, treatment produced complete polyp resolution. He and his colleagues in the otolaryngology field are now trying to decide exactly which patients with polyps secondary to sinusitis will be good candidates for dupilumab after it receives an expected indication for shrinking nasal polyps.
Roughly 4% of the adult population has chronic rhinosinusitis that generates polyps. How many of these patients are affected severely enough to warrant dupilumab treatment is not clear, but will likely include several hundreds of thousands of U.S. adults, said Dr. Han, professor of otolaryngology and chief of the division of allergy at Eastern Virginia Medical School in Norfolk.
The SINUS-24 (A Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps) trial enrolled patients at 76 sites in the United States and in several European countries. The study randomized 143 patients who received standard treatment plus a 300-mg dupilumab subcutaneous injection every 2 weeks, and 133 patients who received standard treatment plus placebo injections. Standard treatment included a nasal corticosteroid spray.
After 24 weeks of treatment, the endoscopically-measured nasal polyp score, which averaged about 6 at baseline on a scale of 0-8, fell by an average of 2.06 points, compared with controls, which was a statistically significant and clinically meaningful change, said Dr. Han.
The second primary endpoint, patient self-assessment of nasal congestion on a scale of 0-3, showed an average 0.89 improvement, compared with controls, which was also a statistically significant and meaningful change from the average baseline score of about 2.4.
Other efficacy measures also showed benefits from treatment, including a substantial improvement compared with controls in a quality-of-life measure. The safety profile was benign compared with placebo, and consistent with existing safety data for the drug.SINUS-24 was funded by Regeneron and Sanofi, the companies that market dupilumab. Dr. Han has been an adviser to Regeneron and Sanofi.
SOURCE: Han JK et al. AAAAI 2019, Abstract L4.