title: Omalizumab in Japanese children with severe allergic asthma uncontrolled with standard therapy.
abstract: BACKGROUND
  Omalizumab has demonstrated clinical benefits in children with moderate to severe allergic asthma. However, no studies have been performed in Japanese asthmatic children. The aim of this study was to evaluate the efficacy including free IgE suppression and safety of omalizumab in Japanese children with severe allergic asthma. The primary objective was to examine whether omalizumab decreases serum free IgE levels to less than 25 ng/ml (target level of suppression).
  
  
  METHODS
  Thirty-eight Japanese children (6-15 years) with uncontrolled severe allergic asthma despite inhaled corticosteroids (>200 μg/day fluticasone propionate or equivalent) and two or more controller therapies received add-on treatment with omalizumab in a 24-week, multicenter, uncontrolled, open-label study.
  
  
  RESULTS
  The geometric mean serum free IgE level at 24 weeks was 15.6 ng/mL. Compared with baseline, total asthma symptom scores, daily activity scores and nocturnal sleep scores at 24 weeks were significantly improved. The rates of asthma exacerbation and hospitalization due to asthma were reduced by 69.2% and 78.2%, respectively (p < 0.001), versus baseline. Quality-of-life scores were also significantly improved (p < 0.001). In addition, 11 (28.9%) patients reduced the dose of any asthma controller medications. Thirty-six (94.7%) patients experienced at least one adverse event during the treatment period. All adverse events were mild or moderate in severity and no new safety concerns were detected. No patients discontinued the study.
  
  
  CONCLUSIONS
  In Japanese children with severe allergic asthma, omalizumab decreased free IgE levels to less than 25 ng/mL. Omalizumab improved asthma control and was well-tolerated, as well.
authors.affiliation: Department of Pediatrics, Fukuoka National Hospital, Fukuoka, Japan. Electronic address: odaji@mfukuoka2.hosp.go.jp.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Odajima
authors.affiliation: Department of Allergy, Clinical Research Center for Allergology and Rheumatology, Sagamihara National Hospital, Kanagawa, Japan.
authors.forename: Motohiro
authors.initials: M
authors.lastname: Ebisawa
authors.affiliation: Yoga Allergy Clinic, Tokyo, Japan.
authors.forename: Toshikazu
authors.initials: T
authors.lastname: Nagakura
authors.affiliation: Institute for Clinical Research, Mie National Hospital, Mie, Japan.
authors.forename: Takao
authors.initials: T
authors.lastname: Fujisawa
authors.affiliation: Division of Allergy, Tokyo Metropolitan Children's Medical Center, Tokyo, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Akasawa
authors.affiliation: Department of Allergy, Aichi Children's Health and Medical Center, Aichi, Japan.
authors.forename: Komei
authors.initials: K
authors.lastname: Ito
authors.affiliation: Department of Pediatrics, Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, Osaka, Japan.
authors.forename: Satoru
authors.initials: S
authors.lastname: Doi
authors.affiliation: Department of Pediatrics, The Fraternity Memorial Hospital, Tokyo, Japan.
authors.forename: Koichi
authors.initials: K
authors.lastname: Yamaguchi
authors.affiliation: Department of Pediatrics, Jikei Daisan Hospital, Tokyo, Japan.
authors.forename: Toshio
authors.initials: T
authors.lastname: Katsunuma
authors.affiliation: Department of Allergy, Kanagawa Children's Medical Center, Kanagawa, Japan.
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Kurihara
authors.affiliation: Department of Pediatrics, Graduate School of Medicine, Gifu University, Gifu, Japan.
authors.forename: Naomi
authors.initials: N
authors.lastname: Kondo
authors.affiliation: Department of Pediatrics, Fukuyama Medical Center, Hiroshima, Japan.
authors.forename: Kazuko
authors.initials: K
authors.lastname: Sugai
authors.affiliation: Department of Pediatrics, Tenri Hospital, Nara, Japan.
authors.forename: Mitsuhiko
authors.initials: M
authors.lastname: Nambu
authors.affiliation: Department of Allergy and Rheumatology, Chiba Children's Hospital, Chiba, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Hoshioka
authors.affiliation: Department of Pediatrics, Dokkyo Medical University, Tochigi, Japan.
authors.forename: Shigemi
authors.initials: S
authors.lastname: Yoshihara
authors.affiliation: Clinical Development, Novartis Pharma K.K., Tokyo, Japan.
authors.forename: Norio
authors.initials: N
authors.lastname: Sato
authors.affiliation: Clinical Development, Novartis Pharma K.K., Tokyo, Japan.
authors.forename: Noriko
authors.initials: N
authors.lastname: Seko
authors.affiliation: Department of Pediatrics, Fukuoka National Hospital, Fukuoka, Japan.
authors.forename: Sankei
authors.initials: S
authors.lastname: Nishima
mesh_terms: D000293:Adolescent; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000888:Antibodies, Anti-Idiotypic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D001249:Asthma / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D002648:Child; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood / Q000276:immunology; D007564:Japan; D008297:Male; D000069444:Omalizumab / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D012129:Respiratory Function Tests; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D018927:Anti-Asthmatic Agents; D000888:Antibodies, Anti-Idiotypic; D000069444:Omalizumab; D007073:Immunoglobulin E
keywords: Bronchial asthma; Children; Japanese; Omalizumab; Quality of life