Sanofi, Regeneron: Dupilumab effective in patients with chronic sinusitis, nasal polyps

Sanofi and Regeneron Pharmaceuticals announced that a phase 2a study of dupilumab met all endpoints in patients with chronic sinusitis with nasal polyps who did not respond to intranasal corticosteroids, according to a press release.

“These data suggest the potential of dupilumab for use in the treatment of another allergic inflammatory condition,” Gianluca Pirozzi, MD, PhD, vice president, global project head at Sanofi, said in the release. “We plan to move forward with further clinical development of dupilumab in patients with chronic sinusitis with nasal polyps, in addition to the ongoing development in atopic dermatitis and in asthma.”

Sixty adults with moderate-to-severe chronic sinusitis with nasal polyps (CSwNP) were randomly assigned 300 mg dupilumab, an investigational fully human monoclonal antibody that blocks interleukin (IL)-4 and IL-13 signaling, or placebo subcutaneously, administered once weekly for 16 weeks, after an initial 600-mg dose. Standard corticosteroid nasal spray also was administered.

Patients with severe CSwNP despite standard therapy for at least 1 month were eligible for the study. Fifty percent of patients had prior surgery for their condition, according to the release, and 58% had asthma.

Corticosteroid measurements by endoscopic Nasal Polyp Score showed a statistically significant decrease in polyp size in patients treated with dupilumab. Secondary endpoints, including objective measures of sinusitis by CT scan, nasal air flow, and patient-reported symptoms of sense of smell, congestion, postnasal drip, runny nose and sleep disturbance, also showed significant improvement.

“In pre-specified exploratory analysis, dupilumab-treated patients who also had asthma demonstrated significant improvements in asthma control,” the release said.

Injection site reactions, nasopharyngitis, oropharyngeal pain, epistaxis, headache and dizziness were the most common adverse events reported.

“Many patients with chronic sinusitis with nasal polyps also have asthma or atopic dermatitis and vice versa,” Neil Graham, MD, vice president, program management at Regeneron, said in the release. “The new data … support the growing body of scientific evidence that these conditions may result from a core allergic inflammatory process driven by the IL-4/IL-13 pathway.”

Details of the study results will be presented at an upcoming meeting, the release said.