ATLANTA – Patients with severe and recalcitrant chronic rhinosinusitis who were treated with omalizumab reported improvement in symptoms, compared with controls, results from a small single-center study suggested.
A recombinant DNA-derived humanized monoclonal antibody that binds to human IgE, omalizumab is approved for use in patients 12 years or older with moderate to severe persistent asthma and inadequately controlled symptoms with inhaled corticosteroids. Two small randomized controlled trials (J Allergy Clin Immunol. 2013;131[1]:110-6 and Rhinology 2010;48[3]:318-24) have shown that omalizumab reduces polyp size and improves sinus inflammation, Shaun J. Kilty, MD, said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
Dr. Shaun J. Kilty
For the current study, Dr. Kilty and his associates evaluated the clinical effect of omalizumab on sinus symptom and disease control in 25 patients with recalcitrant chronic rhinosinusitis (CRS) who were receiving anti-IgE therapy as part of their asthma treatment. Five control patients were included. The researchers used a visual analog scale to measure changes over time among study participants in overall CRS symptoms and major CRS symptoms, including facial pain, nasal obstruction, rhinorrhea, and olfaction. The mean age of the patients was 50 years and 49 years in the omalizumab and control groups, respectively. The mean duration of treatment was 19 months, and most had nasal polyps (76% in the omalizumab group and 80% in the control group).
Dr. Kilty reported that among patients in the omalizumab treatment group, overall symptoms improved by 70%. The individual symptom that improved the most was facial pain (79%), followed by nasal obstruction (70%), rhinorrhea (56%), and olfaction (56%). Among the control group, overall symptoms improved by 17%. Rhinorrhea improved by 16% and nasal obstruction by 15%, but no improvements in facial pain or in olfaction were observed. Symptom improvement was significantly higher for omalizumab-treated patients in every category (P less than .05).
A subset analysis of eight patients in the treatment group and three in the control group who had aspirin-exacerbated respiratory disease (AERD) revealed significant differences between groups for nasal obstruction (P = .05) and olfaction (P = .03), but not for rhinorrhea and overall symptom improvement (P = .5 and P = .1, respectively). “Within the group treated with omalizumab, there were no significant differences in any of the categories when comparing patients with CRS with nasal polyps to those with AERD,” the researchers wrote in their abstract.
“I think there’s a strong enough signal to indicate that this biologic therapy does work in patients with chronic sinusitis with polyps,” Dr. Kilty said. “I think it needs to be better determined exactly what patient cohort is best to use it, and similarly better-structured randomized trials are needed to evaluate the effect of this biologic.”
He reported having no relevant financial disclosures.