DEFINING THE FREQUENT EXACERBATOR PHENOTYPE DURING A PANDEMIC IN COPD

Abstract

TOPIC: Obstructive Lung Diseases TYPE: Original Investigations PURPOSE: Prior-year exacerbation history is the best predictor of future exacerbations and forms part of the global clinical guidelines for management of COPD patients. Frequent exacerbators (FEs) are patients who have >=2 moderate-to-severe exacerbations in a year. They have a high risk of poor outcomes and may benefit from close monitoring and therapeutic interventions. Clinical trials of novel COPD treatments that reduce exacerbations also select for patients who meet the FE definition. During the COVID-19 pandemic, the COPD exacerbation rate has declined dramatically, complicating the use of prior-year exacerbation frequency for identifying FEs. An alternate approach is to extend the observation period from one to two previous years; however, the impact of this change on the prognostic value of exacerbation history is not well understood. The aim of this study was to compare the prevalence of FEs in subsequent years when a two-year vs. one-year exacerbation history is used to identify FEs. METHODS: We used US national claims data (IQVIA Pharmetrics Plus) from 2015-2019 to identify COPD patients aged >=40 years on standard-of-care combination therapy and with 1-3 years of follow-up. Two patient groups were created; those with ≥2 exacerbations over a continuous 12-month period within two years preceding follow-up [group A] and those with ≥2 exacerbations in the year preceding follow-up [group B, a subset of group A]. Exacerbations were defined as COPD-related ER visits or hospital admissions and prescription fills for an antibiotic or an oral corticosteroid burst. We compared baseline characteristics and proportions of FEs in each follow-up year between groups A and B. RESULTS: Of the 41,998 COPD patients who met the inclusion criteria, 14,972 (35.6%) were in group A and 9,781 (23.3%) were in group B. Patients in groups A and B had comparable age and gender distributions. In years 1, 2 and 3 of follow-up, 41.7%, 38.6% and 38.0% of group A patients and 48.9%, 44.8% and 43.5% of group B patients had >=2 exacerbations. Overall, group A patients had a lower rate of exacerbations during follow-up (0.87 per patient-year (PY), 95% CI: 0.86-0.88) compared to group B patients (1.00 per PY, 95% CI: 0.99-1.01). Among patients with 3 years of follow-up, the proportions of FEs in group A vs. B were: 38.2% vs. 45.6% in year 1, 22.4% (58.6% of year 1 FEs) vs. 28.5% (62.6% of year 1 FEs) in year 2 and 15.7% (70.1% of year 2 FEs) vs. 20.5% (71.9% of year 2 FEs) in year 3. CONCLUSIONS: 41.7% of group A patients and 48.9% of group B patients were FEs in year 1 of follow-up. In both groups, the overall prevalence of FEs was consistent in each year of follow-up and the FE phenotype remained stable over the three years of follow-up. CLINICAL IMPLICATIONS: A two-year exacerbation history may be an acceptable alternative to the prior-year history to guide patient management while pandemic measures continue to impact typical patient behaviors and exacerbation rates. DISCLOSURES: Employee relationship with Genentech Inc. Please note: Current Added 04/01/2021 by Parul Dayal, source=Web Response, value=Salary Employee relationship with Genentech, Inc. Please note: 03/2021 to current Added 04/29/2021 by Colin Dimond, source=Web Response, value=Salary No relevant relationships by Matthew Kent, source=Web Response Employee relationship with Genentech Please note: June 2020 - ongoing Added 04/29/2021 by Divya Mohan, source=Web Response, value=Salary Employee relationship with GSK Please note: Aug 2015 - May 2020 Added 04/29/2021 by Divya Mohan, source=Web Response, value=Salary Employee relationship with Genentech Please note: 2019-present Added 04/27/2021 by Shemra Rizzo, source=Web Response, value=Salary Stockholder relationship with Roche Please note: 2019-present Added 04/27/2021 by Shemra Rizzo, source=Web Response, value=stocks Employee relationship with Genentech Please note: 4 years Added 04/27/2021 by Xiaoying Yang, source=Web Response, value=Salary