6533b831fe1ef96bd12997da

RESEARCH PRODUCT

Long-term efficacy of omalizumab (OMA) for patients with severe allergic asthma (SAA). Clinical assessment and relationship to serum IgE concentrations

subject

description

Background: OMA is an effective treatment option in SAA. However, little data are available on the long-term-efficacy oft the drug. Objective: To determine the long-term efficacy of OMA in respect to clinical parameters and IgE serum levels. Methods: This was a retrospective, open-label, uncontrolled, multi-center observational study according to the definition of non-interventional studies. 22 non-smoking patients (10 m, 12 f; mean age 47,9 yrs) with SAA were enrolled. Pat were treated with OMA up to for 4 years and total serum IgE levels were assessed at initiation of therapy, after 2-6 ms and 3-5 yrs. Data were recorded on standardized CRFs by the treating physician. Results: The average duration of therapy was 3.5 +/-1.2 (3–7) years. The total serum IgE levels accounted for 307.0 IU/ml (median) at baseline, increased to 816.5 IU/ml after 1 year and decreased to 435.0 IU/ml after 4 yr therapy. Asthma symptoms declined from 95.5% at baseline to 9.1% at the the third yr. Lung function (FEV1; median 70.5% predicted at baseline) did not deteriorate over the treatment period. Physicians9 global evaluation of treatment effectiveness (GETE) was denoted 9excellent9 or ´good´ in 87, 92, 86, and 77% of the cases after 1 to 4 yrs treatment. The number of Pat with concomitant allergic diseases decreased (atopic dermatitis from 27 to 9%; food allergy from 36 to 27%) after 4-year therapy. No drug-related SADRs were observed. Conclusion: OMA induces and maintains long-term remission in SAA over a period of at least 4 yrs. After the initial increase, serum IgE levels tend to decrease over time.