Proof-of Concept External Control Arm Study Evaluating Annualized Exacerbation Rates with Depemokimab Versus Short-Acting Biologics

Asthma diagnosis, defined as greater than or equal to (>=) 2 diagnosis codes for asthma or eosinophilic asthma on distinct dates >=30 days apart

• At least one record of Short-acting biologic (SAB) (omalizumab, mepolizumab, benralizumab, dupilumab, or tezepelumab) after the asthma diagnosis, on or after 01 January 2020. The first SAB record on or after the date of the second asthma diagnosis code defines the index date
• Continuous observability (defined as clinical activity or continuous medical and pharmacy insurance enrollment) for >=12 months prior to index date. Records are required to be either overlapping or adjacent to be considered a continuous period of clinical activity or insurance enrollment, with no gaps between them
• Blood eosinophil count of >=300 cells per microliters (cells/mcL) in the past 12 months, or >=150 cells/mcL in the past 42 days, prior to index date
• >=2 asthma exacerbations in the 12 months prior to index date, including In-patient (IP)/emergency department (ED)-defined and systemic corticosteroids (SCS)-defined exacerbations
• Treatment for asthma meeting the following criteria: o Treatment with medium- to high-dose Inhaled corticosteroids (ICS) during the 12 months preceding the index date for ICS dose classification methodology), AND o Treatment with an additional controller therapy (e.g., Long-acting beta agonist [LABA], Long-acting muscarinic antagonist [LAMA], Leukotriene receptor antagonist [LTRA], or theophylline) during the 3 months preceding the index date o Age >=18 years at index date.
• Eligible participants who initiated depemokimab in SWIFT and went on to participate in AGILE. The eligible cohort for the present analysis will be limited to patients in the AGILE Safety Analysis Set who consented to data re-use.
• Given the small number of participants aged 12-17 years in the integrated SWIFT + AGILE data who consented to data re-use, the treated cohort will be limited to participants aged >=18 years to avoid unreliable comparisons

Initiation of reslizumab as the index SAB. Due to the small number of patients initiating reslizumab these participants will be excluded from the external comparator cohort to avoid unstable comparisons

• Record of SABs or depemokimab in the 12 months prior to (not including) index
• Current cigarette smoking, as defined using electronic health record (EHR) and claims data. Participants were classified as current smokers if the most recent smoking-related observation in the EHR during the 12 months prior to the index date indicated “current smoker”. If smoking status was missing in the EHR data, smoking-related International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM), Healthcare Common Procedure Coding System (HCPCS), and Current Procedural Terminology (CPT) codes during the 12 months prior to index were used to identify current smokers
• Any diagnosis of bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, Chronic obstructive pulmonary disease (COPD), Eosinophilic granulomatosis with polyangiitis (EGPA), eosinophilic esophagitis, or Hypereosinophilic syndrome (HES) in the 12 months prior to index, or any diagnosis of lung cancer at any time prior to index
• Any cancer diagnosis (except localized carcinoma of skin) in the past 12 months prior to index