[Therapy with omalizumab in patients with severe persistent allergic asthma: a real life data in Turkey]. / Agir allerjik astimli hastalarda anti-IgE (omalizumab) tedavisi: Gerçek yasam verileri.

ABSTRACT

Omalizumab is a biologic agent, which has been shown to be effective in clinical trials in allergic, severe asthmatics. The aim of this study was to evaluate the clinical, functional effectiveness, and side effects of omalizumab in real-life conditions respectively. A total of 18 patients (female/male 11/7) were included to the study. The mean ± SD age, total IgE, disease duration were 41.8 ± 11.2 years, 255.1 ± 197.3 kU/L, 12.8 ± 9.4 years, respectively. Eight patients had isolated mite, seven patients had mite + other inhalant allergen, three patients had only other allergen sensitivity. Mean duration of omalizumab treatment (months ± SD) was 15.1 ± 8.6 (min-max 1-29) months. Omalizumab dose was 150 mg/month in five patients, 300 mg/month in five, 300 mg/15 days in three, 375 mg/15 days in four, 225 mg/15 days in one patient. Data at the date of last visit were compared with one year prior to omalizumab treatment. Mean systemic steroid dose reduced by 83% (14.7 ± 14.6 vs. 3.2 ± 8 mg), number of other asthma medications reduced by 28% (3.6 ± 1.3 vs. 2.5 ± 1.3) (p< 0.05). FEV1% values (53.5 ± 21.2 vs. 64.5 ± 23.5) did not significantly change. Mean numbers of exacerbations (20 ± 57.6 vs. 0.4 ± 0.7), emergency visits (16.5 ± 46.1 vs. 0.4 ± 1.2), hospitalizations (2.1 ± 2.6 vs. 0.1 ± 0.3) decreased by 93%, 95%, 86%, respectively (p< 0.05). ACT scores increased by 94% (10.4 ± 3.4 vs. 20.4 ± 5.7) (p< 0.05). Fifteen patients (88%) were stated as responsive to treatment with omalizumab. Eleven patients (64.8%) stated that their expectations are met, three patients (17.6%) stated that their expectations are close to being met, three patients (17.6%) stated that their expectations are not met. A local side effect was seen in one patient. In conclusion, our data has shown that omalizumab is effective, and safe in severe allergic asthmatics under real-life conditions.