Astrid L Voskamp1, Andrew Gillman2, Karen Symons2, Alessandra Sandrini2, Jennifer M Rolland3, Robyn E O'Hehir3, Jo A Douglass2. 1. Department of Allergy, Immunology and Respiratory Medicine, Alfred Hospital and Monash University, Melbourne, Australia; Department of Immunology, Monash University, Melbourne, Australia. Electronic address: A.L.Voskamp@lumc.nl. 2. Department of Allergy, Immunology and Respiratory Medicine, Alfred Hospital and Monash University, Melbourne, Australia. 3. Department of Allergy, Immunology and Respiratory Medicine, Alfred Hospital and Monash University, Melbourne, Australia; Department of Immunology, Monash University, Melbourne, Australia.
Abstract
BACKGROUND:Allergic bronchopulmonary aspergillosis (ABPA) often presents with persistently uncontrolled asthma despite the use of corticosteroids and antifungal therapy. Omalizumab is a humanized anti-IgE monoclonal antibody currently used to treat severe asthma. OBJECTIVE: The aim was to assess the clinical and immunologic effects of omalizumab in ABPA in a randomized, placebo-controlled trial. METHODS:Patients with chronic ABPA were randomized to 4-month treatment with omalizumab (750 mg monthly) or placebo followed by a 3-month washout period in a cross-over design. The main endpoint was number of exacerbations. Other clinical endpoints included lung function, exhaled nitric oxide (FeNO), quality of life and symptoms. In vitro basophil activation to Aspergillus fumigatus extract and basophil FcεR1 and surface-bound IgE levels were assessed by flow cytometry. RESULTS:Thirteen patients were recruited with mean total IgE 2314 ±2125 IU/mL. Exacerbations occurred less frequently during the active treatment phase compared with the placebo period (2 vs 12 events, P = .048). Mean FeNO decreased from 30.5 to 17.1 ppb during omalizumab treatment (P = .03). Basophil sensitivity to A. fumigatus and surface-bound IgE and FcεR1 levels decreased significantly after omalizumab but not after placebo. CONCLUSION:Omalizumab can be used safely to treat ABPA, despite high serum IgE levels. Clinical improvement was accompanied by decreased basophil reactivity to A. fumigatus and FcεR1 and surface-bound IgE levels.
RCT Entities:
BACKGROUND:Allergic bronchopulmonary aspergillosis (ABPA) often presents with persistently uncontrolled asthma despite the use of corticosteroids and antifungal therapy. Omalizumab is a humanized anti-IgE monoclonal antibody currently used to treat severe asthma. OBJECTIVE: The aim was to assess the clinical and immunologic effects of omalizumab in ABPA in a randomized, placebo-controlled trial. METHODS:Patients with chronic ABPA were randomized to 4-month treatment with omalizumab (750 mg monthly) or placebo followed by a 3-month washout period in a cross-over design. The main endpoint was number of exacerbations. Other clinical endpoints included lung function, exhaled nitric oxide (FeNO), quality of life and symptoms. In vitro basophil activation to Aspergillus fumigatus extract and basophil FcεR1 and surface-bound IgE levels were assessed by flow cytometry. RESULTS: Thirteen patients were recruited with mean total IgE 2314 ± 2125 IU/mL. Exacerbations occurred less frequently during the active treatment phase compared with the placebo period (2 vs 12 events, P = .048). Mean FeNO decreased from 30.5 to 17.1 ppb during omalizumab treatment (P = .03). Basophil sensitivity to A. fumigatus and surface-bound IgE and FcεR1 levels decreased significantly after omalizumab but not after placebo. CONCLUSION:Omalizumab can be used safely to treat ABPA, despite high serum IgE levels. Clinical improvement was accompanied by decreased basophil reactivity to A. fumigatus and FcεR1 and surface-bound IgE levels.
Authors: Mark A Wurth; Azadeh Hadadianpour; Dennis J Horvath; Jacob Daniel; Olivia Bogdan; Kasia Goleniewska; Anna Pomés; Robert G Hamilton; R Stokes Peebles; Scott A Smith Journal: JCI Insight Date: 2018-10-18
Authors: John Blakey; Li Ping Chung; Vanessa M McDonald; Laurence Ruane; John Gornall; Chris Barton; Sinthia Bosnic-Anticevich; John Harrington; Mark Hew; Anne E Holland; Trudy Hopkins; Lata Jayaram; Helen Reddel; John W Upham; Peter G Gibson; Philip Bardin Journal: Respirology Date: 2021-09-29 Impact factor: 6.175
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