T Tajiri1, H Matsumoto2, Y Gon3, R Ito3, S Hashimoto3, K Izuhara4, M Suzukawa5, K Ohta5, J Ono6, S Ohta7, I Ito1, T Oguma1, H Inoue1, T Iwata1, Y Kanemitsu1, T Nagasaki1, A Niimi1,8, M Mishima1. 1. Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan. 2. Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan. hmatsumo@kuhp.kyoto-u.ac.jp. 3. Division of Respiratory Medicine, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan. 4. Division of Medical Biochemistry, Department of Biomolecular Sciences, Saga Medical School, Saga, Japan. 5. Respiratory Center, National Hospital Organization Tokyo National Hospital, Tokyo, Japan. 6. Shino-Test Corporation, Kanagawa, Japan. 7. Department of Laboratory Medicine, Saga Medical School, Saga, Japan. 8. Division of Respiratory Medicine, Department of Medical Oncology and Immunology, Nagoya City University School of Medical Sciences, Aichi, Japan.
Abstract
BACKGROUND: Omalizumab, a humanized anti-IgE monoclonal antibody, has demonstrated efficacy in patients with severe allergic asthma. However, treatment responses vary widely among individuals. Despite a lack of data, free serum IgE levels following omalizumab treatment have been proposed as a marker of treatment responsiveness. METHODS: In this prospective, observational study, we assessed the utility of biomarkers of type 2 inflammation in predicting omalizumab treatment responses, as determined by the absence of asthma exacerbation during the first year of treatment. Free serum IgE levels were monitored for 2 years to examine their association with baseline biomarker levels and the number of exacerbations. RESULTS: We enrolled thirty patients who had been treated with omalizumab for at least 1 year, of whom 27 were treated for 2 years. Baseline serum periostin levels and blood eosinophil counts were significantly higher in patients without exacerbations during the first year of treatment than in patients with exacerbations. Baseline serum periostin levels, but not eosinophil counts, were negatively associated with free serum IgE levels after 16 or 32 weeks of treatment. Reduced free serum IgE levels during treatment from those at baseline were associated with reduced exacerbation numbers at 2 years. In 14 patients who continued to have exacerbations during the first year of treatment, exacerbation numbers gradually and significantly decreased over the 2-year study period, with concurrent significant reductions in free serum IgE levels. CONCLUSION: Baseline serum periostin levels and serum free IgE levels during treatment follow-up may be useful in evaluating responses to omalizumab treatment.
BACKGROUND:Omalizumab, a humanized anti-IgE monoclonal antibody, has demonstrated efficacy in patients with severe allergic asthma. However, treatment responses vary widely among individuals. Despite a lack of data, free serum IgE levels following omalizumab treatment have been proposed as a marker of treatment responsiveness. METHODS: In this prospective, observational study, we assessed the utility of biomarkers of type 2 inflammation in predicting omalizumab treatment responses, as determined by the absence of asthma exacerbation during the first year of treatment. Free serum IgE levels were monitored for 2 years to examine their association with baseline biomarker levels and the number of exacerbations. RESULTS: We enrolled thirty patients who had been treated with omalizumab for at least 1 year, of whom 27 were treated for 2 years. Baseline serum periostin levels and blood eosinophil counts were significantly higher in patients without exacerbations during the first year of treatment than in patients with exacerbations. Baseline serum periostin levels, but not eosinophil counts, were negatively associated with free serum IgE levels after 16 or 32 weeks of treatment. Reduced free serum IgE levels during treatment from those at baseline were associated with reduced exacerbation numbers at 2 years. In 14 patients who continued to have exacerbations during the first year of treatment, exacerbation numbers gradually and significantly decreased over the 2-year study period, with concurrent significant reductions in free serum IgE levels. CONCLUSION: Baseline serum periostin levels and serum free IgE levels during treatment follow-up may be useful in evaluating responses to omalizumab treatment.
Authors: Harold Kim; Anne K Ellis; David Fischer; Mary Noseworthy; Ron Olivenstein; Kenneth R Chapman; Jason Lee Journal: Allergy Asthma Clin Immunol Date: 2017-11-17 Impact factor: 3.406