David M Lang1, Mark A Aronica2, Elizabeth S Maierson2, Xiao-Feng Wang3, Dorothy C Vasas2, Stanley L Hazen4. 1. Respiratory Institute, Department of Allergy and Clinical Immunology, Cleveland Clinic Foundation, Cleveland, Ohio. Electronic address: langd@ccf.org. 2. Respiratory Institute, Department of Allergy and Clinical Immunology, Cleveland Clinic Foundation, Cleveland, Ohio. 3. Lerner Research Institute, Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, Ohio. 4. Lerner Research Institute, Department of Cellular and Molecular Medicine, Cleveland Clinic Foundation, Cleveland, Ohio.
Abstract
BACKGROUND:Aspirin desensitization has been associated with benefit in management of aspirin-exacerbated respiratory disease (AERD). An intervention that would encourage aspirin desensitization to be performed more frequently has substantial potential for improving outcomes and quality of life in patients with AERD. OBJECTIVE: We investigated whether omalizumab administration would be associated with attenuation of aspirin-provoked bronchospasm in patients with AERD undergoing aspirin desensitization. METHODS: We carried out a randomized, double-blind, placebo-controlled study in which subjects with AERD who fulfilled label criteria for omalizumab receivedomalizumab or placebo for 16 weeks, and then underwent aspirin desensitization. RESULTS:Eleven subjects completed aspirin desensitization. Of the 7 who were randomized to omalizumab, 5 had no respiratory reaction during aspirin desensitization. Compared with placebo, omalizumab was associated with a significantly greater likelihood for subjects with AERD to have no respiratory reaction during desensitization (P = .04, Fisher exact test). There was an overall difference in urinary leukotriene E4 (LTE4) levels in subjects who received omalizumab and did not have a respiratory reaction during desensitization compared with subjects randomized to placebo (P = .035, mixed model with interaction). Urinary LTE4 levels were significantly higher with respiratory reaction in placebo subjects compared with levels obtained after the 100-mg dose in AERD subjects who had no respiratory reaction (P < .001, mixed model with interaction). CONCLUSION: In atopic AERD subjects, omalizumab administration for 16 weeks was associated with "clinically silent" desensitization. Further studies to investigate the therapeutic utility of omalizumab in patients with AERD who are candidates for aspirin desensitization are warranted based on these findings. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT00555971.
RCT Entities:
BACKGROUND:Aspirin desensitization has been associated with benefit in management of aspirin-exacerbated respiratory disease (AERD). An intervention that would encourage aspirin desensitization to be performed more frequently has substantial potential for improving outcomes and quality of life in patients with AERD. OBJECTIVE: We investigated whether omalizumab administration would be associated with attenuation of aspirin-provoked bronchospasm in patients with AERD undergoing aspirin desensitization. METHODS: We carried out a randomized, double-blind, placebo-controlled study in which subjects with AERD who fulfilled label criteria for omalizumab received omalizumab or placebo for 16 weeks, and then underwent aspirin desensitization. RESULTS: Eleven subjects completed aspirin desensitization. Of the 7 who were randomized to omalizumab, 5 had no respiratory reaction during aspirin desensitization. Compared with placebo, omalizumab was associated with a significantly greater likelihood for subjects with AERD to have no respiratory reaction during desensitization (P = .04, Fisher exact test). There was an overall difference in urinary leukotriene E4 (LTE4) levels in subjects who received omalizumab and did not have a respiratory reaction during desensitization compared with subjects randomized to placebo (P = .035, mixed model with interaction). Urinary LTE4 levels were significantly higher with respiratory reaction in placebo subjects compared with levels obtained after the 100-mg dose in AERD subjects who had no respiratory reaction (P < .001, mixed model with interaction). CONCLUSION: In atopic AERD subjects, omalizumab administration for 16 weeks was associated with "clinically silent" desensitization. Further studies to investigate the therapeutic utility of omalizumab in patients with AERD who are candidates for aspirin desensitization are warranted based on these findings. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT00555971.
Authors: Whitney W Stevens; Elina Jerschow; Alan P Baptist; Larry Borish; John V Bosso; Kathleen M Buchheit; Katherine N Cahill; Paloma Campo; Seong H Cho; Anjeni Keswani; Joshua M Levy; Anil Nanda; Tanya M Laidlaw; Andrew A White Journal: J Allergy Clin Immunol Date: 2020-12-09 Impact factor: 10.793
Authors: Hanneke N G Oude Elberink; Mathilde Jalving; Hilda Dijkstra; Annick A J M van de Ven Journal: Clin Transl Allergy Date: 2020-01-29 Impact factor: 5.871