Patients with asthma mediated by the allergen-IgE pathway may show a clinical benefit from treatment with hybridized antibody to IgE (omalizumab). Some patients with severe obstructive disease may also have a comorbid asthmatic component mediated by IgE antibody; we asked whether this patient group might also benefit from omalizumab.
We screened 250 patients in a pulmonary practice who carried a diagnosis of either asthma or chronic bronchitis. Twelve patients were identified who had clinically severe obstructive disease, primary or heavy secondary cigarette exposure, positive skin tests to one or more relevant allergens and an IgE of >30IU/ml. The endpoints of the study were reduction in the number of acute exacerbations resulting in hospitalizations or in outpatient visits, reduction in inhaler usage, and improvements in dyspnea and in cough severity. Each patient served as his own control. The baseline period was the 12 month period prior to the first omalizumab injection. The treatment period began 1 month after the initial injection.
The optimal FEV1 at baseline was < 60% predicted in 9 of the 12 patients (range 30% to 60%). Reversibility with bronchodilators (improvement > 20%) was present in just 2 of the 12. Eight patients have received omalizumab for 3 to 8 months (median 7.0 months), and their results are reported. (Four patients have received < 2 months of treatment). The total number of hospitalizations in the 8 patients decreased from 7 pretreatment to zero with treatment. Outpatient exacerbations decreased from 14 pretreatment to 1 with treatment. Inhalant usage decreased from 6.8 to 5.2/day/patient. Dyspnea improved in 6 patients. Of 4 patients with difficulty expectorating thick mucous, 3 improved.
Preliminary observations suggest that omalizumab might be effective in treating patients with severe obstructive disease with evidence of IgE directed against relevant allergens.
Patients with severe obstructive disease should be screened for an IgE-mediated allergic component and may benefit from treatment with omalizumab.
C.G. Risk, None.