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Allergic asthma is a chronic inflammatory disease caused by immunoglobulin E (IgE)-mediated allergy. Omalizumab is a monoclonal anti-IgE antibody for the treatment of severe allergic asthma (SAA). The primary objective of the study was to assess asthma-related control in patients with SAA receiving omalizumab therapy. Secondary objectives included quality of life, treatment effectiveness, rate of severe exacerbations, and safety. This was a prospective, multi-centre, non-interventional study to assess patient-related long-term outcomes of omalizumab treatment in Germany. This 3-year study enrolled patients aged ≥ 18 years with SAA. Asthma control was assessed using the asthma control questionnaire (ACQ-6) and physician-assessed global evaluation of treatment effectiveness (GETE). Exacerbations were recorded, and quality of life was assessed using the mini-asthma quality of life questionnaire (mini-AQLQ). Of 161 patients screened, 153 participated in this study. Most patients (92.2%) had been receiving prior omalizumab therapy for mean (SD) 2.9 (2.3) years. Omalizumab slightly decreased mean ACQ-6 score from 2.0 (1.22) at baseline to 1.7 (1.23) at the end of the 3-year treatment period [difference: –0.18 (1.07), P = 0.340]. Post-hoc analyses of ACQ-6 for the small number of treatment-naive patients showed a decrease in mean (SD) ACQ-6 from 2.7 (1.08) at baseline to 1.4 (1.40) after 3 years of omalizumab treatment. Mini-AQLQ increased from 4.5 (1.26) at baseline to 4.7 (1.48) after 3 years [difference: 0.26 (1.35), P = 0.186]. GETE was reported as excellent or good for most patients (67.46–84.69%) and more than two-thirds had no severe exacerbation. There were no unexpected safety signals during the study period and no tachyphylaxis was observed. In conclusion, despite most patients receiving prior omalizumab treatment for approximately 3 years, there was no decrease in effectiveness or safety over the subsequent 3 years during this study. This supports the long-term use of omalizumab in maintaining asthma control and quality of life. Novartis Pharma GmbH, Germany.

Background Regular treatment of patients with asthma with oral corticosteroids (OCS) remains common despite potential severe side effects and alternative treatment options. However, there is limited data on the prevalence of OCS prescriptions for patients with asthma in Germany. Methods Records from 1039 General practitioners for the years 2015–2017 in the German IMS® Disease Analyzer database were retrospectively analysed for patients with at least two confirmed asthma diagnoses (ICD-10) per observed year, representing approximately 30,000 patients per year. Asthma treatment steps (1–5) were assigned according to the German national guideline, based on prescribed therapies. Results In the years 2015–2017, 20.3–21.3% of patients were classified as being in treatment step 1, 4.7–5.2% in step 2, 38.8–40.1% in step 3, 31.7–32.1% in step 4 and 2.7–3.2% in step 5. Proportions of patients treated with OCS >30 days/year were 9.4% (2015), 9.6% (2016) and 8.9% (2017), reducing to 8.1%, 8.2% and 7.4%, respectively, when patients with other inflammatory diseases possibly requiring OCS treatment were excluded. Use of OCS >30 days/year was more prevalent in patients aged >65 years (14.1–15.0%) than those aged 18–65 years (6.8–7.8%). Median daily prednisolone dose was 10–15 mg/day. Approximately 30% of patients treated with OCS >30 days/year were not in step 5 (based on their prescribed inhaled therapies). Conclusion These data suggest that a substantial proportion of patients with asthma in non-specialised care in Germany receive OCS prescriptions regularly, despite the availability of less harmful alternative treatment options.