NEW YORK (Reuters Health) – Omalizumab helps treat nasal polyps in patients with asthma, whether or not they suffer from allergies.
Dr. Philippe Gevaert from Ghent University Hospital, Belgium and colleagues investigated the clinical efficacy and safety of this anti-IgE treatment in 24 adults with chronic rhinosinusitis with nasal polyposis (CRSwNP) and comorbid asthma for more than two years.
These patients generally have a poor therapeutic response and a high nasal polyp recurrence rate after treatment with corticosteroids or sinus surgery. Omalizumab has been effective in at least one other study of CRSwNP.
In the four-month study, patients received subcutaneous omalizumab every two weeks or once a month, or placebo injections.
After 16 weeks, total nasal endoscopic polyp scores (the primary endpoint) were significantly lower in patients treated with omalizumab than in patients treated with placebo (p=0.02). Scores were significantly better with omalizumab from week eight of the study onward.
The Lund-Mackay scores for CT images improved significantly in the omalizumab group but worsened in the placebo group, resulting in a significant improvement in favor of omalizumab (p=0.04).
Compared with placebo, omalizumab produced significant improvements in nasal congestion, anterior rhinorrhea, loss of sense of smell, and dyspnea. Cough and spirometric results did not change significantly with treatment.
Physical health (but not mental health) improved significantly with omalizumab treatment, and asthma quality of life improved significantly in the omalizumab group.
Results were generally similar for allergic and nonallergic patients and for patients with and without aspirin hypersensitivity.
Most patients reported at least one adverse event, but only the common cold appeared significantly more often in the omalizumab group than in the placebo group. One patient in the omalizumab group developed a fatal lymphoblastic lymphoma one year after finishing the study; this was felt to be unrelated to omalizumab.
Dr. Maria Del Carmen Vennera from Hospital Clinico de Barcelona, Spain, who was not involved in the current research, reported results of a similar study in 2011. She told Reuters Health, “My patients had uncontrolled severe asthma with concomitant CRSwNP, who were treated with omalizumab mainly because of their asthma. When we realized that they improved their CRS as well as their asthma, we decided to analyze them, with the good results that were published.”
“These patients mostly improve with omalizumab,” Dr. Vennera said, “and I agree that it is independent of the atopic state. But, because of the costs, it is necessary to limit the indication to patients uncontrolled with the conventional treatment.”
“Omalizumab is a new drug that has surprised us because its excellent efficacy is much better than we expected,” Dr. Vennera concluded. “CRSwNP and the role of local IgE may open our mind to understand its probable efficacy in ‘intrinsic’ asthma, for example.”
Dr. Gevaert was unable to comment by press time.
J Allergy Clin Immunol 2012.