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Chronic obstructive pulmonary disease (COPD) is a common lower respiratory disease characterized by cough, difficulty breathing, and progressive and irreversible airflow limitation. As of 2020, 6.0% of Americans aged 45-64 years report COPD, increasing to 10.8% of those aged 65 years and older 1 . Since treatment is not curative, maintenance therapy is aimed at improving symptoms, decreasing exacerbations, and improving quality of life 2 . Maintenance pharmacotherapy recommendations are based on a patient’s symptoms and history of exacerbations, comprising primarily inhaled therapies, but also include oral therapies in certain populations (e.g., azithromycin (off-label) and roflumilast (labeled)). Inhaled therapies include long-acting beta-agonists (LABAs), long-acting muscarinic antagonists (LAMAs), and inhaled corticosteroids (ICS). Patients may begin needing only one agent but – with increased severity and symptoms – may progress to inhaled triple therapy with a LABA, LAMA, and ICS.
While multiple inhaler triple therapy (MITT) has been available in different forms since the approval of the first LAMA in 2004, single inhaler triple therapy (SITT) is a comparatively new addition with two fixed dose combination (FDC) LABA+LAMA+ICS inhalers approved since 2017. On September 18, 2017, the U.S. Food and Drug Administration (FDA) approved a once-daily, triple therapy LABA+LAMA+ICS inhaler, under the brand name Trelegy Ellipta, for the maintenance treatment of patients with COPD. Trelegy Ellipta is a combination of fluticasone furoate, umeclidinium, and vilanterol, (ICS+LAMA+LABA, respectively) delivered as a dry powder inhaler. On July 24, 2020, the FDA approved an additional once-daily triple therapy inhaler for the maintenance treatment of patients with COPD, under the brand name Breztri Aerosphere. Breztri Aerosphere combines formoterol fumarate, glycopyrrolate, and budesonide 3 , (LABA+LAMA+ICS, respectively) delivered as a metered dose inhaler. In contrast, MITT use is more heterogeneous and may consist of three separate single therapy inhalers for LABA, LAMA, and ICS products, or two separate inhalers containing a permutation of these products (e.g., a dual therapy FDC inhaler containing ICS+LABA products in addition to a single therapy inhaler containing a LAMA product).
The objective of this study is to describe the utilization patterns of single and multiple inhaler triple therapy among a population of triple therapy-naïve patients with COPD who had evidence of exacerbations despite dual inhaler therapy maintenance treatment in the Sentinel Distributed Database.
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Contributors
Ashley I. Martinez, PharmD, PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Robert Busch, MD, MMSc; Division of Pulmonology, Allergy and Critical Care, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD
Iara Costa, MPH; James Marshall, MPH; Judith C. Maro, PhD, MS; Morgaine Payson; Ryan Schoeplein, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Marie Bradley, PhD, MScPH, MPharm; Office of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD
Andrew Clerman, MD; Division of Therapeutic Performance, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD
Stacy Chin, MD; Division of Pulmonology, Allergy, and Critical Care, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD
Yan Li, PhD; Division of Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD
Yunzhao Ren, MD; Division of Inflammation and Immune Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD
Rongmei Zhang, PhD, MS; Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD