PHOENIX – Patients who have nasal polyps appeared to get symptom relief when treated with omalizumab (Xolair) regardless of comorbid asthma, according to a post-hoc trial analysis.
All patients taking omalizumab achieved deep drops in symptoms on various tests and improvements remained even after the study drug was discontinued during a follow-up period compared with baseline scores, said Philippe Gevaert, MD, PhD, of the University of Ghent, Belgium.
“Our post-hoc analyses of the POLYP I and POLYP II open-label extension study found that omalizumab improves outcomes for patients with nasal polyps, regardless of whether they have comorbid asthma,” said Gevaert in his oral presentation at the annual meeting of the American Academy of Allergy, Asthma & Immunology here.
The nasal polyp score dipped nonsignificantly among the placebo patients but by a significant 1 to 1.5 points in the treated group both with asthma and without it during the 24-week randomized phase of the trial.
When all patients shifted to 28-week open-label omalizumab in the trial, there were similar dips in the nasal polyp score for all participants — although those originally on omalizumab maintained a deeper decrease. While some rebound occurred in the follow-up period afterward, all the patients maintained about a 0.5-point drop in their nasal polyp score from baseline at 24 weeks after discontinuation.
That same pattern was repeated for the nasal congestion score as well as the Sino-Nasal Outcome Test.
“About 20% to 30% of people diagnosed with nasal polyps also have asthma,” Gevaert noted. “These people often have severe asthma that is characterized by increased polyp frequency and recurrence; greater rhinosinusitis severity; poorly-controlled asthma; higher rates of corticosteroid dependence; increased airway obstruction, including nasal obstruction; marked inflammation of the lower airways; [and] lower quality of life, which also includes the loss of smell.”
Surgery to remove polyps is often unsatisfactory because there is a tendency for the polyps to recur, he added. In the open-label extension trial, polyp recurrence occurred in 5.2% (13 of 249).
“We are very happy as ear, nose, and throat surgeons that after 20 years of endeavor and after several trials, we now can treat these patients without surgery,” Gevaert said.
In commenting on the study, Roxana Siles, MD, co-director of the Asthma Center at the Cleveland Clinic, agreed.
Nasal polyps are really pockets of inflammation, she told MedPage Today. “Asthma is an inflammatory condition so these polyps can become an asthmatic problem too. We do see that type of patient who has polyps and who has asthma, and they tend to be a bit more challenging to control.”
Siles noted that many of these patients often had surgery to remove the polyps, but surgery didn’t prevent the return of these lesions, so patients had to undergo multiple surgical treatments that have their own risks.
“Now it seems we have something to prevent that re-growth and to target that inflammation,” she said. “When allergists work with ear, nose, and throat specialists, it is not uncommon that we have to recommend surgery. With these treatments, we may be able to prevent that.”
While omalizumab, an anti-IgE monoclonal antibody is efficacious in patients with nasal polyps, its use in patients with both nasal polyps and comorbid asthma had not been scrutinized.
Gevaert and colleagues examined the POLYP I and POLYP II trials, as well as the open-label extension trial that followed the randomized period. They scrutinized outcomes in the 69 asthma patients originally treated with placebo and then switched to omalizumab; the 73 asthma patients who were on omalizumab for the entire trial; the 57 non-asthmatic patients who were first assigned to placebo and then switched to omalizumab; and the 50 non-asthmatic patients who took omalizumab for the entire trial.
Gevaert disclosed relationships with Novartis, Roche/Genentech, ALK, Argenx, AstraZeneca, Hal Allergy, Regeneron, Sanofi, and Stallergenes.
Siles disclosed relationships with DynaMed.