Real-World Effectiveness of Tezepelumab in Allergic Bronchopulmonary Aspergillosis

An open-label study will evaluate effects of Tezepelumab in the treatment of severe asthma in patients with allergic bronchopulmonary aspergillosis

Inclusion Criteria: Female and Male patients aged 18-75 years inclusively at the time of Visit 1 with a physician diagnosis of Allergic Bronchopulmonary Aspergillosis has met the ISHAM Working Group Diagnostic Criteria for ABPA: Predisposing condition: Bronchial asthma Obligatory criteria (both should be present) Type I aspergillus skin test positive (immediate cutaneous hypersensitivity Aspergillus antigen) or elevated IgE level against Aspergillus fumigatus (Af) Aspergillus niger or Aspergillus flavus may be eligible provided antigen-specific IgE and IgG measurements are available for use. Elevated total IgE levels (\>1,000IU/mL)\* Other criteria (at least two of three) Presence of precipitating or IgG antibodies against Af in serum Radiographic pulmonary opacities consistent with ABPA Total eosinophil count \>500 cells/uL in steroid naïve patients (may be historical) (if the patient meets all other criteria, an IgE value \500ug of FP equivalent) plus at least one other asthma controller for at least 3 months prior to Visit 1 For ICS/LABA combination preparation, highest-strength maintenance doses approved in the U.S. will meet this criterion If the ICS and the other asthma controller therapies are given by separate inhalers, then the patient must be on a high daily ICS dose for 3 months prior to entering the study. History of at least 2 asthma exacerbations while on ICS plus another asthma controller (see inclusion criterion 2 for examples) that required treatment with systemic corticosteroids (IM, IV, or oral) in the 12 months prior to Visit 1. For patients receiving oral corticosteroids as a maintenance therapy, an exacerbation is defined as a temporary increase of their maintenance dose for a minimum of 3 days. Weight \> 40kg Exclusion Criteria: Clinically important pulmonary disease other than asthma with allergic bronchopulmonary aspergillosis (i.e., chronic obstructive pulmonary disease (COPD), cystic fibrosis, sarcoidosis, and pulmonary fibrosis). History of anaphylaxis to any biologic therapy. Known history of allergy or hypersensitivity reaction to tezepelumab or any of its components. Currently pregnant, breastfeeding, or lactating women. Concurrent enrollment in another interventional or post-authorization safety study, unless it is observational.