title: Efficacy of long-term omalizumab therapy in patients with severe asthma.
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.
authors.affiliation: 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.
authors.forename: Junko
authors.initials: J
authors.lastname: Saji
authors.affiliation: 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.
authors.forename: Takahito
authors.initials: T
authors.lastname: Yamamoto
authors.affiliation: Tsurukawa Rehabilitation Hospital, Tokyo, Japan. Electronic address: mara@marianna-u.ac.jp.
authors.forename: Motonaka
authors.initials: M
authors.lastname: Arai
authors.affiliation: Division of Respiratory Disease, Department of Internal Medicine, St. Marianna University School of Medicine, Kanagawa, Japan. Electronic address: m-mine@marianna-u.ac.jp.
authors.forename: Masamichi
authors.initials: M
authors.lastname: Mineshita
authors.affiliation: Division of Respiratory Disease, Department of Internal Medicine, St. Marianna University School of Medicine, Kanagawa, Japan. Electronic address: miyazawat@marianna-u.ac.jp.
authors.forename: Teruomi
authors.initials: T
authors.lastname: Miyazawa
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy*; D018450:Disease Progression; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007073:Immunoglobulin E / Q000276:immunology; D007279:Injections, Subcutaneous; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage; D008875:Middle Aged; D000069444:Omalizumab / Q000008:administration & dosage*; D011446:Prospective Studies; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018927:Anti-Asthmatic Agents; D000069444:Omalizumab; D007073:Immunoglobulin E; D008775:Methylprednisolone
keywords: ACT; AHQ; Anti-IgE antibody; Omalizumab; Severe asthma