Xolair effective for nasal congestion, polyps
HOUSTON — Xolair signicantly improved nasal congestion and nasal polyp scores in patients with corticosteroid-refractory nasal polyps, according to data from two phase 3 trials presented at the American College of Allergy, Asthma and Immunology Annual Scientific Meeting.
“We don’t have a lot of treatment options for these patients,” Philippe Gevaert, of the upper airway research laboratory at Ghent University Hospital in Belgium, told attendees.
Researchers randomly assigned 265 patients (age range, 35 to 64 years; majority of them, men) in a 1:1 ratio to receive subcutaneous Xolair (omalizumab, Genentech and Novartis) or placebo every 2 to 4 weeks for 24 weeks. The patients continued to receive background mometasone.
“Our study participants had to have IgE levels between 30 IU/mL and 1,500 IU/mL and body weight of between 30 and 150 kilograms at screening,” Gevaert said.
Researchers found that after 24 weeks, nasal congestion scores improved among omalizumab recipients vs. placebo recipients in the first trial (–0.89 vs. –0.35; P = .0004) and in the second trial (–0.7 vs. –0.2; P = .0017). Nasal polyps score also improved among omalizumab recipients vs. placebo recipients in the first trial (–1.08 vs. +0.06; P < .0001) and in the second trial (–0.9 vs. –0.31; P = .014).
In addition, and also in both trials, those receiving omalizumab had significantly improved anterior rhinorrhea, loss of smell and postnasal drip symptoms compared with those who received placebo. Adverse events — mostly headaches and nasopharyngitis — were generally similar between study cohorts and no unexpected safety signals were identied.
“Taken together, these trial results are very exciting,” Gevaert said, adding that a previous trial involving omalizumab showed that the drug was also effective in nasal polyposis.
Genentech indicated in a recent press release that the company intends to discuss the new results with the FDA to seek authorized expansion of omalizumab’s indications as soon as possible. – by Janel Miller
Reference: Gevaert, P. Omalizumab efficacy and safety in nasal polyposis: results from two parallel, double-blind, placebo-controlled trials. Presented at: American College of Allergy, Asthma and Immunology Annual Scientific Meeting; Nov. 7-11, 2019; Houston.
Disclosures : Gevaert reports disclosures related to Argenx, Ablynx, ALK, Genentech, Hal Energy, Novartis, Regeneron, Roche, Sanofi and Stallergenes. Please see the poster for other authors’ relevant financial disclosures.