Severe copd exacerbations in the united states: evaluation of risk among medicare patients with moderate or no baseline exacerbations

SESSION TITLE: COPD Assessment Tools and ComorbiditiesSESSION TYPE: Rapid Fire Original InvPRESENTED ON: 10/17/2022 12:15 pm - 1:15 pmPURPOSE: Chronic obstructive pulmonary disease (COPD) exacerbations, particularly severe exacerbations, cause significant morbidity and mortality. This study sought to describe the burden of severe exacerbations in the Medicare Fee-for-Service (MFFS) COPD population and assess risks of experiencing severe events among patients with a history of experiencing no or only moderate events.METHODS: This study used claims data from MFFS patients from the Inovalon MORE2 Registry®. Patients were aged ≥40 years, continuously enrolled and had a COPD diagnosis. Year 1 (Y1, baseline) exacerbation rates were used to classify patients into mutually exclusive categories (0 exacerbations, 1 moderate event, >1 moderate event); patients with severe events in Y1 were excluded. Moderate exacerbations are defined as COPD-related outpatient/ED visits with a corticosteroid/antibiotic claim within ±7 days of the visit. Severe exacerbations are hospitalizations with a primary COPD diagnosis. Exacerbations occurring ≤14 days apart were considered one episode, with highest severity assigned. Rate ratios (RR) for Year 2 (Y2) and Year 3 (Y3) were compared to patients having 0 baseline events using generalized linear model (GLM) unadjusted and adjusted for relevant covariates (p<0.05).RESULTS: A total of 1,392,002 patients met selection criteria; 66.2% of patients had 0 exacerbations during baseline year, 22.9% had 1 moderate, 10.9% had >1 moderate exacerbation. Across Y2 and Y3, 1.3M events were observed, 13% (168,289) events were identified as being severe; severe events per 100 person-years (PYs) was 5.29 and 6.79, respectively. Among those with 0 baseline events, 3.2% of patients (29,784) had a severe event in Y2 and 4.1% (37,899) in Y3, and 14.4% (77,776) of all events were severe. Patients with 1 moderate-only baseline event: 5.4% (17,346) and 6.6% (21,109) experienced severe events in Y2 and Y3 with 12.5% (45,988) of all events being severe. Among those with >1 moderate-only events during baseline, 10.6% (16,043) and 12.2% (18,577) had a severe event in Y2 and Y3, respectively; 11.0% (44,525) of all events were severe. 46% of all severe events occurred among those with 0 baseline events. After adjustment, compared to patients with no baseline events, patients with 1 moderate event and >1 moderate were 1.32 and 1.96 times more likely to have a severe event in Y2; adjusted RRs were 1.29 and 1.92 for Y3.CONCLUSIONS: Among COPD patients with no history of a severe event in the past year, a striking proportion of patients experienced ≥1 severe event over the next 2 years (4.5% Y2, 5.6% Y3); rates and risks were fairly consistent over the 2 year period with 13% of all events being severe.CLINICAL IMPLICATIONS: Providers should consider future risk of severe exacerbations even in patients without a recent history of a severe event; risks should be assessed particularly when treatment decisions are being made.DISCLOSURES: no disclosure on file for Jill Dreyfus;Employee relationship with AstraZeneca Pharmaceuticals LP Please note: >$100000 by Norbert Feigler, value=SalaryConsultantGrant relationship with NHLBI Please note: 2022 Added 04/14/2022 by Barry Make, value=Grant/Research SupportRemoved 04/14/2022 by Barry MakeGrant relationship with American Lung Association Please note: current Added 04/14/2022 by Barry Make, value=Grant/Research SupportRemoved 04/14/2022 by Barry MakeGrant relationship with Department of Defense Please note: 2021 Added 04/14/2022 by Barry Make, value=Grant/Research SupportRemoved 04/14/2022 by Barry MakeScientific Medical Advisor relationship with NHLBI Please note: Current Added 04/14/2022 by Barry Make, value=Grant/Research SupportRemoved 04/14/2022 by Barry MakeScientific Medical Advisor relationship with American Lung Association Please note: Current Added 04/14/2022 by Barry Make, value=Grant/Research SupportRemoved 04/14/2022 by Barry Makeunknown relationship with Department of Defense Please note: 2021 Added 04/14/2022 by Barry Make, value=Grant/Research SupportRemoved 04/14/2022 by Barry MakeScientific Medical Advisor relationship with NHLBI Please note: current Added 04/14/2022 by Barry Make, value=Grant/Research SupportRemoved 04/14/2022 by Barry MakeScientific Medical Advisor relationship with American Lung Association Please note: current Added 04/14/2022 by Barry Make, value=Grant/Research SupportRemoved 04/14/2022 by Barry MakeScientific Medical Advisor relationship with Department of Defense Please note: 2021 Added 04/14/2022 by Barry Make, value=Grant/Research SupportRemoved 04/14/2022 by Barry MakeAdvisory Committee Member relationship with Astra Zeneca Please note: current Added 04/14/2022 by Barry Make, value=Grant, Personal, Consulting, HRemoved 04/14/2022 by Barry MakeAdvisory Committee Member relationship with Glaxo Smith Kline Please note: April 2020 Added 04/14/2022 by Barry Make, value=Personal, Data Safety MonitorRemoved 04/14/2022 by Barry MakeScientific Medical Advisor relationship with NHLBI Please note: current Added 04/14/2022 by Barry Make, value=Grant/Research SupportScientific Medical Advisor relationship with American Lung Association Please note: current Added 04/14/2022 by Barry Make, value=Grant/Research SupportScientific Medical Advisor relationship with Department of Defense Please note: 2021 Added 04/14/2022 by Barry Make, value=Grant/Research SupportAdvisory Committee Member relationship with Astra Zeneca Please note: current Added 04/14/2022 by Barry Make, value=Grant, Personal, Consulting, HAdvisory Committee Member relationship with Glaxo Smith Kline Please note: April 2020 Added 04/14/2022 by Barry Make, value=Personal, Data Safety MonitorCME activity relationship with Novartis Please note: March 2020 Added 04/14/2022 by Barry Make, value=Personal, HonorariaAdvisory Committee Member relationship with Boehringer Ingelheim Please note: Oct 2021 Added 04/14/2022 by Barry Make, value=Personal, Data Safety MonitorAdvisory Committee Member relationship with Mylan Please note: Nov 2019 Added 04/14/2022 by Barry Make, value=Personal, Data Safety MonitorConsultant relationship with Third Pole Please note: 2019 Added 04/14/2022 by Barry Make, value=Consulting feeConsultant relationship with Wolters Kluwer Health (Up-To-Date) Please note: current Added 04/14/2022 by Barry Make, value=RoyaltyScientific Medical Advisor relationship with Pearl Please note: 2019 Added 04/14/2022 by Barry Make, value=Grant/Research SupportNo relevant relationships by Chad MoretzEmployee relationship with AstraZeneca Please note: >$100000 by Michael Pollack, value=SalaryNo relevant relationships by Dakota Powellno disclosure on file for Scott Robinson;Research funds to institution relationship with Regeneron Please note: 2021 Added 04/06/2022 by Sanjay Sethi, value=Grant/Research SupportSpeaker/Speaker's Bureau relationship with Boerhinger Ingelheim Please note: ongoing by Sanjay Sethi, value=HonorariaAdvisory Committee Member relationship with Glaxo Smith Kline Please note: ongoing by Sanjay Sethi, value=Consulting feeClinical Event adjudication committee relationship with Pulmonx Please note: ongoing Added 04/06/2022 by Sanjay Sethi, value=Consulting feeSpeaker/Speaker's Bureau relationship with Circassia Please note: 2019 by Sanjay Sethi, value=HonorariaRemoved 04/06/2022 by Sanjay SethiAdvisory Committee Member relationship with Pulmotect Please note: ongoing by Sanjay Sethi, value=Consulting feeScientific Medical Advisor relationship with Astra Zeneca Please note: ongoing by Sanjay Sethi, value=Consulting feeSpeaker/Speaker's Bureau relationship with Astra Zeneca Please note: 2019 by Sanjay Sethi, value=HonorariaScientific Medical Advisor relationship with Nuvaira Please note: ongoing by Sanjay Sethi, value=ConsultingSpeaker/Speaker's Bureau relationship with Glaxo Smith Kline Please note: ongoing by Sanjay Sethi, value=HonorariaAdvisory Committee Member relationship with Boehringer Ingelheim Please note: ongoing Added 04/06/2022 by Sanjay Sethi, value=Consulting feeAdvisory Committee Member relationship with Theravance Please note: 2019 by Sanjay Sethi, value=Consulting feeRemoved 04/06/2022 by Sanjay SethiConsultant relationship with apellis Please note: 2021 Added 04/06/2022 by Sanjay Sethi, value=Consulting feeConsultant relationship with aerogen Please note: 2021 Added 04/06/2022 by Sanjay Sethi, value=Consulting feeNo relevant relationships by Ann Xi SESSION TITLE: COPD Assessment Tools and Comorbidities SESSION TYPE: Rapid Fire Original Inv PRESENTED ON: 10/17/2022 12:15 pm - 1:15 pm PURPOSE: Chronic obstructive pulmonary disease (COPD) exacerbations, particularly severe exacerbations, cause significant morbidity and mortality. This study sought to describe the burden of severe exacerbations in the Medicare Fee-for-Service (MFFS) COPD population and assess risks of experiencing severe events among patients with a history of experiencing no or only moderate events. METHODS: This study used claims data from MFFS patients from the Inovalon MORE2 Registry®. Patients were aged ≥40 years, continuously enrolled and had a COPD diagnosis. Year 1 (Y1, baseline) exacerbation rates were used to classify patients into mutually exclusive categories (0 exacerbations, 1 moderate event, >1 moderate event); patients with severe events in Y1 were excluded. Moderate exacerbations are defined as COPD-related outpatient/ED visits with a corticosteroid/antibiotic claim within ±7 days of the visit. Severe exacerbations are hospitalizations with a primary COPD diagnosis. Exacerbations occurring ≤14 days apart were considered one episode, with highest severity assigned. Rate ratios (RR) for Year 2 (Y2) and Year 3 (Y3) were compared to patients having 0 baseline events using generalized linear model (GLM) unadjusted and adjusted for relevant covariates (p<0.05). RESULTS: A total of 1,392,002 patients met selection criteria; 66.2% of patients had 0 exacerbations during baseline year, 22.9% had 1 moderate, 10.9% had >1 moderate exacerbation. Across Y2 and Y3, 1.3M events were observed, 13% (168,289) events were identified as being severe; severe events per 100 person-years (PYs) was 5.29 and 6.79, respectively. Among those with 0 baseline events, 3.2% of patients (29,784) had a severe event in Y2 and 4.1% (37,899) in Y3, and 14.4% (77,776) of all events were severe. Patients with 1 moderate-only baseline event: 5.4% (17,346) and 6.6% (21,109) experienced severe events in Y2 and Y3 with 12.5% (45,988) of all events being severe. Among those with >1 moderate-only events during baseline, 10.6% (16,043) and 12.2% (18,577) had a severe event in Y2 and Y3, respectively; 11.0% (44,525) of all events were severe. 46% of all severe events occurred among those with 0 baseline events. After adjustment, compared to patients with no baseline events, patients with 1 moderate event and >1 moderate were 1.32 and 1.96 times more likely to have a severe event in Y2; adjusted RRs were 1.29 and 1.92 for Y3. CONCLUSIONS: Among COPD patients with no history of a severe event in the past year, a striking proportion of patients experienced ≥1 severe event over the next 2 years (4.5% Y2, 5.6% Y3); rates and risks were fairly consistent over the 2 year period with 13% of all events being severe. CLINICAL IMPLICATIONS: Providers should consider future risk of severe exacerbations even in patients without a recent history of a severe event; risks should be assessed particularly when treatment decisions are being made. DISCLOSURES: no disclosure on file for Jill Dreyfus; Employee relationship with AstraZeneca Pharmaceuticals LP Please note: >$100000 by Norbert Feigler, value=Salary Consultant Grant relationship with NHLBI Please note: 2022 Added 04/14/2022 by Barry Make, value=Grant/Research Support Removed 04/14/2022 by Barry Make Grant relationship with American Lung Association Please note: current Added 04/14/2022 by Barry Make, value=Grant/Research Support Removed 04/14/2022 by Barry Make Grant relationship with Department of Defense Please note: 2021 Added 04/14/2022 by Barry Make, value=Grant/Research Support Removed 04/14/2022 by Barry Make Scientific Medical Advisor relationship with NHLBI Please note: Current Added 04/14/2022 by Barry Make, value=Grant/Research Support Removed 04/14/2022 by Barry Make Scientific Medical Advisor relationship with American Lung Association Please note: Current Added 04/14/2022 by Barry Make, value=Grant/Research Support Removed 04/14/2022 by Barry Make unknown relationship with Department of Defense Please note: 2021 Added 04/14/2022 by Barry Make, value=Grant/Research Support Removed 04/14/2022 by Barry Make Scientific Medical Advisor relationship with NHLBI Please note: current Added 04/14/2022 by Barry Make, value=Grant/Research Support Removed 04/14/2022 by Barry Make Scientific Medical Advisor relationship with American Lung Association Please note: current Added 04/14/2022 by Barry Make, value=Grant/Research Support Removed 04/14/2022 by Barry Make Scientific Medical Advisor relationship with Department of Defense Please note: 2021 Added 04/14/2022 by Barry Make, value=Grant/Research Support Removed 04/14/2022 by Barry Make Advisory Committee Member relationship with Astra Zeneca Please note: current Added 04/14/2022 by Barry Make, value=Grant, Personal, Consulting, H Removed 04/14/2022 by Barry Make Advisory Committee Member relationship with Glaxo Smith Kline Please note: April 2020 Added 04/14/2022 by Barry Make, value=Personal, Data Safety Monitor Removed 04/14/2022 by Barry Make Scientific Medical Advisor relationship with NHLBI Please note: current Added 04/14/2022 by Barry Make, value=Grant/Research Support Scientific Medical Advisor relationship with American Lung Association Please note: current Added 04/14/2022 by Barry Make, value=Grant/Research Support Scientific Medical Advisor relationship with Department of Defense Please note: 2021 Added 04/14/2022 by Barry Make, value=Grant/Research Support Advisory Committee Member relationship with Astra Zeneca Please note: current Added 04/14/2022 by Barry Make, value=Grant, Personal, Consulting, H Advisory Committee Member relationship with Glaxo Smith Kline Please note: April 2020 Added 04/14/2022 by Barry Make, value=Personal, Data Safety Monitor CME activity relationship with Novartis Please note: March 2020 Added 04/14/2022 by Barry Make, value=Personal, Honoraria Advisory Committee Member relationship with Boehringer Ingelheim Please note: Oct 2021 Added 04/14/2022 by Barry Make, value=Personal, Data Safety Monitor Advisory Committee Member relationship with Mylan Please note: Nov 2019 Added 04/14/2022 by Barry Make, value=Personal, Data Safety Monitor Consultant relationship with Third Pole Please note: 2019 Added 04/14/2022 by Barry Make, value=Consulting fee Consultant relationship with Wolters Kluwer Health (Up-To-Date) Please note: current Added 04/14/2022 by Barry Make, value=Royalty Scientific Medical Advisor relationship with Pearl Please note: 2019 Added 04/14/2022 by Barry Make, value=Grant/Research Support No relevant relationships by Chad Moretz Employee relationship with AstraZeneca Please note: >$100000 by Michael Pollack, value=Salary No relevant relationships by Dakota Powell no disclosure on file for Scott Robinson; Research funds to institution relationship with Regeneron Please note: 2021 Added 04/06/2022 by Sanjay Sethi, value=Grant/Research Support Speaker/Speaker's Bureau relationship with Boerhinger Ingelheim Please note: ongoing by Sanjay Sethi, value=Honoraria Advisory Committee Member relationship with Glaxo Smith Kline Please note: ongoing by Sanjay Sethi, value=Consulting fee Clinical Event adjudication committee relationship with Pulmonx Please note: ongoing Added 04/06/2022 by Sanjay Sethi, value=Consulting fee Speaker/Speaker's Bureau relationship with Circassia Please note: 2019 by Sanjay Sethi, value=Honoraria Removed 04/06/2022 by Sanjay Sethi Advisory Committee Member relationship with Pulmotect Please note: ongoing by Sanjay Sethi, value=Consulting fee Scientific Medical Advisor relationship with Astra Zeneca Please note: ongoing by Sanjay Sethi, value=Consulting fee Speaker/Speaker's Bureau relationship with Astra Zeneca Please note: 2019 by Sanjay Sethi, value=Honoraria Scientific Medical Advisor relationship with Nuvaira Please note: ongoing by Sanjay Sethi, value=Consulting Speaker/Speaker's Bureau relationship with Glaxo Smith Kline Please note: ongoing by Sanjay Sethi, value=Honoraria Advisory Committee Member relationship with Boehringer Ingelheim Please note: ongoing Added 04/06/2022 by Sanjay Sethi, value=Consulting fee Advisory Committee Member relationship with Theravance Please note: 2019 by Sanjay Sethi, value=Consulting fee Removed 04/06/2022 by Sanjay Sethi Consultant relationship with apellis Please note: 2021 Added 04/06/2022 by Sanjay Sethi, value=Consulting fee Consultant relationship with aerogen Please note: 2021 Added 04/06/2022 by Sanjay Sethi, value=Consulting fee No relevant relationships by Ann Xi