Hiroshi Odajima1, Motohiro Ebisawa2, Toshikazu Nagakura3, Takao Fujisawa4, Akira Akasawa5, Komei Ito6, Satoru Doi7, Koichi Yamaguchi8, Toshio Katsunuma9, Kazuyuki Kurihara10, Takahide Teramoto11, Kazuko Sugai12, Mitsuhiko Nambu13, Akira Hoshioka14, Shigemi Yoshihara15, Norio Sato16, Noriko Seko16, Sankei Nishima17. 1. Department of Pediatrics, Fukuoka National Hospital, Fukuoka, Japan. Electronic address: odaji@mfukuoka2.hosp.go.jp. 2. Department of Allergy, Clinical Research Center for Allergology and Rheumatology, Sagamihara National Hospital, Sagamihara, Japan. 3. Yoga Allergy Clinic, Tokyo, Japan. 4. Institute for Clinical Research, Mie National Hospital, Tsu, Japan. 5. Division of Allergy, Tokyo Metropolitan Children's Medical Center, Tokyo, Japan. 6. Department of Allergy, Aichi Children's Health and Medical Center, Obu, Japan. 7. Department of Pediatrics, Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, Habikino, Japan. 8. Department of Pediatrics, The Fraternity Memorial Hospital, Tokyo, Japan. 9. Department of Pediatrics, Jikei Daisan Hospital, Tokyo, Japan. 10. Department of Allergy, Kanagawa Children's Medical Center, Yokohama, Japan. 11. Department of Pediatrics, Graduate School of Medicine, Gifu University, Gifu, Japan. 12. Department of Pediatrics, Fukuyama Medical Center, Fukuyama, Japan. 13. Department of Pediatrics, Tenri Hospital, Tenri, Japan. 14. Department of Allergy and Rheumatology, Chiba Children's Hospital, Chiba, Japan. 15. Department of Pediatrics, Dokkyo Medical University, Tochigi, Japan. 16. Clinical Development, Novartis Pharma K.K., Tokyo, Japan. 17. Department of Pediatrics, Fukuoka National Hospital, Fukuoka, Japan.
Abstract
BACKGROUND: Omalizumab is effective and well-tolerated in children with moderate to severe allergic asthma. However, the effects of long-term treatment with omalizumab in this population haven't been well investigated. The objective of this study is to evaluate the long-term safety, efficacy, pharmacokinetics and pharmacodynamics of omalizumab in children with uncontrolled severe asthma. METHODS: Thirty-eight Japanese children (aged 7-16 years) who completed the 24-week treatment core study were included in an uncontrolled extension study, in which treatment with omalizumab continued until the pediatric indication was approved in Japan (ClinicalTrials.gov number: NCT01328886). RESULTS: Thirty-five patients (92.1%) completed the extension study. The median exposure throughout the core and extension studies was 116.6 weeks (range, 46.9-151.1 weeks). The most common adverse events were nasopharyngitis, influenza, upper respiratory tract infection, and asthma. Serious adverse events developed in 10 patients (26.3%), but resolved completely with additional treatments. Incidence of adverse events didn't increase with extended exposure with omalizumab. Twenty-nine patients (76.3%) achieved completely- or well-controlled asthma compared with 9 patients (23.7%) at the start of the extension study. QOL scores, the rates (per year) of hospitalizations and ER visits were significantly improved compared with the baseline of the core study [39.0 vs 48.0 (median), p < 0.001 for QOL, 1.33 vs 0.16, p < 0.001 for hospitalization, 0.68 vs 0.15, p = 0.002 for ER visits]. Remarkably, the mean total IgE level showed a decreasing trend while exposure to omalizumab remained at steady-state. CONCLUSIONS: Long-term treatment with omalizumab is well-tolerated and effective in children with uncontrolled severe allergic asthma. No new safety findings were identified.
BACKGROUND:Omalizumab is effective and well-tolerated in children with moderate to severe allergic asthma. However, the effects of long-term treatment with omalizumab in this population haven't been well investigated. The objective of this study is to evaluate the long-term safety, efficacy, pharmacokinetics and pharmacodynamics of omalizumab in children with uncontrolled severe asthma. METHODS: Thirty-eight Japanese children (aged 7-16 years) who completed the 24-week treatment core study were included in an uncontrolled extension study, in which treatment with omalizumab continued until the pediatric indication was approved in Japan (ClinicalTrials.gov number: NCT01328886). RESULTS: Thirty-five patients (92.1%) completed the extension study. The median exposure throughout the core and extension studies was 116.6 weeks (range, 46.9-151.1 weeks). The most common adverse events were nasopharyngitis, influenza, upper respiratory tract infection, and asthma. Serious adverse events developed in 10 patients (26.3%), but resolved completely with additional treatments. Incidence of adverse events didn't increase with extended exposure with omalizumab. Twenty-nine patients (76.3%) achieved completely- or well-controlled asthma compared with 9 patients (23.7%) at the start of the extension study. QOL scores, the rates (per year) of hospitalizations and ER visits were significantly improved compared with the baseline of the core study [39.0 vs 48.0 (median), p < 0.001 for QOL, 1.33 vs 0.16, p < 0.001 for hospitalization, 0.68 vs 0.15, p = 0.002 for ER visits]. Remarkably, the mean total IgE level showed a decreasing trend while exposure to omalizumab remained at steady-state. CONCLUSIONS: Long-term treatment with omalizumab is well-tolerated and effective in children with uncontrolled severe allergic asthma. No new safety findings were identified.
Authors: Madhur D Shastri; Wai Chin Chong; Kamal Dua; Gregory M Peterson; Rahul P Patel; Malik Q Mahmood; Murtaza Tambuwala; Dinesh K Chellappan; Nicole G Hansbro; Shakti D Shukla; Philip M Hansbro Journal: Inflammopharmacology Date: 2020-11-05 Impact factor: 4.473
Authors: Celeste Porsbjerg; Charlotte Ulrik; Tina Skjold; Vibeke Backer; Birger Laerum; Sverre Lehman; Crister Janson; Thomas Sandstrøm; Leif Bjermer; Barbro Dahlen; Bo Lundbäck; Dora Ludviksdottir; Unnur Björnsdóttir; Alan Altraja; Lauri Lehtimäki; Paula Kauppi; Jussi Karjalainen; Hannu Kankaanranta Journal: Eur Clin Respir J Date: 2018-03-06
Authors: Laura Vollono; Arianna Piccolo; Caterina Lanna; Maria Esposito; Mauro Bavetta; Elena Campione; Luca Bianchi; Laura Diluvio Journal: Drug Des Devel Ther Date: 2019-09-06 Impact factor: 4.162