Junko Saji1, Takahito Yamamoto2, Motonaka Arai3, Masamichi Mineshita4, Teruomi Miyazawa5. 1. Division of Respiratory Diseases, Department of Internal Medicine, Kawasaki Municipal Tama Hospital, 1-30-37 Syukugawara, Tama-ku, Kawasaki, Kanagawa 214-8525, Japan; Division of Respiratory Disease, Department of Internal Medicine, St. Marianna University School of Medicine, Kanagawa, Japan. Electronic address: j2saji@marianna-u.ac.jp. 2. Division of Respiratory Diseases, Department of Internal Medicine, Kawasaki Municipal Tama Hospital, 1-30-37 Syukugawara, Tama-ku, Kawasaki, Kanagawa 214-8525, Japan; Division of Respiratory Disease, Department of Internal Medicine, St. Marianna University School of Medicine, Kanagawa, Japan. Electronic address: yam@marianna-u.ac.jp. 3. Tsurukawa Rehabilitation Hospital, Tokyo, Japan. Electronic address: mara@marianna-u.ac.jp. 4. Division of Respiratory Disease, Department of Internal Medicine, St. Marianna University School of Medicine, Kanagawa, Japan. Electronic address: m-mine@marianna-u.ac.jp. 5. Division of Respiratory Disease, Department of Internal Medicine, St. Marianna University School of Medicine, Kanagawa, Japan. Electronic address: miyazawat@marianna-u.ac.jp.
Abstract
BACKGROUND: The efficacy of omalizumab, an anti-immunoglobulin E (IgE) antibody, has been studied in patients with severe bronchial asthma. We conducted a study to evaluate, on the basis of both objective and subjective measures, the efficacy of omalizumab as a long-term therapy in patients with severe and persistent asthma. METHODS: Omalizumab was administered subcutaneously every two or four weeks. The results of pulmonary function tests, Asthma Control Test (ACT) and Asthma Health Questionnaire (AHQ)-33 scores, the dosage of methylprednisolone during the 12-month treatment period, and the number of emergency visits prior to the start of treatment with omalizumab were compared in patients pre- and post-treatment with omalizumab. RESULTS: Fourteen patients were enrolled in the study between June 2010 and February 2012. Ten patients completed the study. With omalizumab treatment, there was no improvement in lung function; however, the number of emergency visits (19.3 before treatment vs. 1.2 after treatment, p=0.020) and the dosage of methylprednisolone (871.5mg before treatment vs. 119.0mg after treatment, p=0.046) decreased significantly. ACT and AHQ-33 scores at 16 weeks after treatment were significantly better than baseline scores. Four patients continued treatment with omalizumab for four years, and a reduction in their corticosteroid usage was noted. CONCLUSIONS: Long-term omalizumab therapy in our patients was found to significantly reduce corticosteroid usage and the number of emergency visits. Long-term omalizumab therapy was effective and might have potential to reduce the frequency of asthma exacerbations. The trial has not been registered because it is not an intervention study.
BACKGROUND: The efficacy of omalizumab, an anti-immunoglobulin E (IgE) antibody, has been studied in patients with severe bronchial asthma. We conducted a study to evaluate, on the basis of both objective and subjective measures, the efficacy of omalizumab as a long-term therapy in patients with severe and persistent asthma. METHODS:Omalizumab was administered subcutaneously every two or four weeks. The results of pulmonary function tests, Asthma Control Test (ACT) and Asthma Health Questionnaire (AHQ)-33 scores, the dosage of methylprednisolone during the 12-month treatment period, and the number of emergency visits prior to the start of treatment with omalizumab were compared in patients pre- and post-treatment with omalizumab. RESULTS: Fourteen patients were enrolled in the study between June 2010 and February 2012. Ten patients completed the study. With omalizumab treatment, there was no improvement in lung function; however, the number of emergency visits (19.3 before treatment vs. 1.2 after treatment, p=0.020) and the dosage of methylprednisolone (871.5mg before treatment vs. 119.0mg after treatment, p=0.046) decreased significantly. ACT and AHQ-33 scores at 16 weeks after treatment were significantly better than baseline scores. Four patients continued treatment with omalizumab for four years, and a reduction in their corticosteroid usage was noted. CONCLUSIONS: Long-term omalizumab therapy in our patients was found to significantly reduce corticosteroid usage and the number of emergency visits. Long-term omalizumab therapy was effective and might have potential to reduce the frequency of asthma exacerbations. The trial has not been registered because it is not an intervention study.