Abstract
Background: In July 2005, omalizumab was approved as add-on therapy in Germany to improve asthma control in patients with severe allergic asthma (SAA). X-Tab, a German non-interventional study was designed to address real-life outcomes, including measures of asthma control and health-related quality of life (QoL), in patients treated with omalizumab.
Methods: 161 patients at 35 centers were included into the ongoing study with a follow-up of 3 years. At baseline, allergic history, lung function and Asthma control questionnaire (ACQ) and Mini-Asthma Quality of Life Questionnaire (MiniAQLQ) were documented.
Results: At baseline, mean age was 48.8±12.2 years (60.9% female). The mean duration of SAA was 16.2±12.6 years. The mean level of IgE prior to therapy with omalizumab was 437 IU/mL (median 260.5). Frequencies of specific IgE were as follows: 60.9% (mites), 46.6% (animal epithel) and 51.6% (molds) of patients. Additionally, 51.6% of patients had allergic rhinitis and 20.5% had food allergy. 74.5% had a lung function of FEV1 <80 % predicted and 28.6% suffered at least one exacerbation in the previous year. Mean (SD) MiniAQLQ was 4.42 (1.27) and mean (SD) ACQ score 1.95 (1.17)(scores ≥1.5 indicated uncontrolled asthma).
Conclusion: The baseline characteristics of this SAA cohort indicate that most patients that initiate treatment with omalizumab in Germany have evidence of atopy and relatively high levels of serum IgE, compromised lung function and a lack of asthma control. Clinical data that will emerge from this cohort will provide information that is important for patients, providers and payers, including asthma control and health-related QoL.
- Copyright ©the authors 2016
