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Miguel J Lanz,1 Michael Pollack,2 Ileen A Gilbert,2 Hitesh N Gandhi,2 Joseph P Tkacz,3 Njira L Lugogo4 1Allergy and Immunology Division, Nicklaus Children’s Hospital, Miami, FL, USA; 2BioPharmaceuticals Medical, AstraZeneca, Wilmington, DE, USA; 3Health Economics and Outcomes Research, IBM Watson Health, Bethesda, MD, USA; 4Department of Medicine, Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor, MI, USACorrespondence: Ileen A Gilbert, BioPharmaceuticals, US Medical, AstraZeneca, 1800 Concord Pike, Wilmington, DE, 19803, USA, Tel +1 262-227-0686, Email ileen.gilbert@astrazeneca.comPurpose: To examine patterns of short-acting ß2-agonist (SABA) and maintenance therapy claims surrounding the subset of severe asthma exacerbations associated with outpatient, urgent care, or emergency department visits or hospitalization (termed serious exacerbations) in patients treated as intermittent or mild persistent asthma.Methods: This was a retrospective study of 2010– 2017 administrative claims from MerativeTM MarketScan® US databases for patients ≥ 12 years filling a SABA prescription for asthma (index). Patients had ≥ 12 months continuous insurance eligibility pre- and post-index and ≥ 1 additional SABA and/or maintenance medication fill appropriate for mild persistent asthma post-index. Prescription fills were assessed over 30 days before and after a serious exacerbation event.Results: Of 323,443 patients (mean [standard deviation] age: 34.9 [18.2] years; 62.0% female) treated as intermittent or mild persistent asthma, 51,690 (16.0%) experienced ≥ 1 serious exacerbation post-index. During the 30 days pre-event, a greater proportion of patients filled a SABA versus maintenance therapy (24.6% vs 19.0%; odds ratio [OR]: 1.39, 95% confidence interval [CI]: 1.35– 1.43; p < 0.001); during the 30 days post-event, patients were more likely to fill maintenance medication versus SABA (88.6% vs 67.0%; OR [95% CI]: 3.88 [3.75– 4.01]; p < 0.001). The closer in time prior to the event, the greater the likelihood of filling a SABA versus maintenance prescription (OR [95% CI]; 1– 7 days pre-event: 1.42 [1.36– 1.48]; 8– 14 days pre-event: 1.34 [1.27– 1.41]; 15– 30 days pre-event: 1.18 [1.12– 1.24]; all p < 0.001). Over 4.5 times more patients filled a maintenance therapy within 7 days post-event (45,014) versus all 30 days pre-event (9835) (OR [95% CI]: 28.7 [27.7– 29.7]; p < 0.001).Conclusion: These patterns of SABA rescue and maintenance fills suggest that a “window of opportunity” may exist to interrupt a serious exacerbation occurrence for patients treated as intermittent or mild persistent asthma if symptoms and inflammation are addressed concomitantly.Keywords: asthma, corticosteroid, inflammation, maintenance therapy, rescue therapy, short-acting ß2-agonist

Strange C, Tkacz J, Schinkel J, et al. Int J Chron Obstruct Pulmon Dis. 2023;18:2245–2256. The authors have advised that there are errors in the 95% CI interval values on page 2248. Results, Baseline and Follow-Up Exacerbation Rates, sentence 3, the text “Relative rates of total exacerbations for prompt were 0.76, 95% CI: (0.72 – 0.79) and 0.66, 95% CI: (0.63 – 0.69) versus delayed and very delayed” should read “Relative rates of total exacerbations for prompt were 0.76, 95% CI: (0.69 – 0.83) and 0.66, 95% CI: (0.60 – 0.72) versus delayed and very delayed”. Results, Baseline and Follow-Up Exacerbation Rates, sentence 5, the text “Relative rates of severe exacerbations for prompt were 0.75 (95% CI: 0.67-0.90) and 0.38 (95% CI: 0.29-0.47) versus delayed and very delayed” should read “Relative rates of severe exacerbations for prompt were 0.75 (95% CI: 0.45-1.15) and 0.38 (95% CI: 0.22-0.55) versus delayed and very delayed”. The authors apologize for these errors and confirm that the overarching interpretation of the results and conclusions of the study remain consistent with the originally published article and no other text or figures are affected.

Charlie Strange,1 Joseph Tkacz,2 Jill Schinkel,2 Benjamin Lewing,2 Barnabie Agatep,2 Sean Swisher,3 Sushma Patel,3 Devechio Edwards,3 Daniel R Touchette,4 Edward Portillo,5 Norbert Feigler,3 Michael Pollack3 1College of Medicine, The Medical University of South Carolina, Charleston, SC, USA; 2Data Solutions, Inovalon, Bowie, MD, USA; 3BioPharmaceuticals Medical, AstraZeneca, Wilmington, DE, USA; 4College of Pharmacy - Pharmacy Systems Outcomes and Policy, University of Illinois Chicago, Chicago, IL, USA; 5Pharmacy Practice & Translational Research Division, University of Wisconsin-Madison, Madison, WI, USACorrespondence: Michael Pollack, BioPharmaceuticals Medical, AstraZeneca, 1800 Concord Pike, Bldg A1C, Wilmington, DE, 19850, USA, Tel +1 302-886-1253, Email michael.pollack1@astrazeneca.comPurpose: Triple therapy to prevent exacerbations from chronic obstructive pulmonary disease (COPD) is associated with improved health compared to single and dual-agent therapy in some populations. This study assessed the benefits of prompt administration of budesonide/glycopyrrolate/formoterol fumarate (BGF) following a COPD exacerbation.Patients and methods: EROS was a retrospective analysis of people with COPD using the MORE2 Registry®. Inclusion required ≥ 1 severe, ≥ 2 moderate, or ≥ 1 moderate exacerbation while on other maintenance treatment. Within 12 months following the index exacerbation, ≥ 1 pharmacy claim for BGF was required. Primary outcomes were the rate of COPD exacerbations and healthcare costs for those that received BGF promptly (within 30 days of index exacerbation) versus delayed (31– 180 days) and very delayed (181– 365 days). The effect of each 30-day delay in initiation of BGF was estimated using a multivariable negative binomial regression model.Results: 2409 patients were identified: 434 prompt, 1187 delayed, and 788 very delayed. The rate (95% CI) of total exacerbations post-index increased as time to BGF initiation increased: prompt 1.52 (1.39– 1.66); delayed 2.00 (1.92– 2.09); and very delayed 2.30 (2.20– 2.40). Adjusting for patient characteristics, each 30-day delay in receiving BGF was associated with a 5% increase in the average number of subsequent exacerbations (rate ratio, 95% CI: 1.05, 1.01– 1.08; p< 0.05). Prompt initiation of BGF was also associated with lower post-index annualized COPD-related costs (&dollar;5002 for prompt vs &dollar;7639 and &dollar;8724 for the delayed and very delayed groups, respectively).Conclusion: Following a COPD exacerbation, promptly initiating BGF was associated with a reduction in subsequent exacerbations and reduced healthcare utilization and costs.Keywords: COPD, triple therapy, exacerbations, delayed therapy, budesonide/glycopyrrolate/formoterol fumarate

Njira Lugogo,1 Ileen Gilbert,2 Michael Pollack,2 Hitesh Gandhi,2 Joseph Tkacz,3 Miguel J Lanz4 1Department of Medicine, Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor, MI, USA; 2BioPharmaceuticals Medical, AstraZeneca, Wilmington, DE, USA; 3Inovalon, Bowie, MD, USA; 4Allergy and Asthma, AAADRS Clinical Research Center, Coral Gables, FL, USACorrespondence: Michael Pollack, BioPharmaceuticals Medical, AstraZeneca, 1800 Concord Pike, Wilmington, DE, 19850, USA, Tel +1-302-886-1253, Email Michael.pollack1@astrazeneca.com

Sanjay Sethi,1 Barry J Make,2 Scott B Robinson,3 Shambhavi Kumar,3 Michael Pollack,4 Chad Moretz,5 Jill Dreyfus,5 Ann Xi,5 Dakota Powell,5 Norbert Feigler4 1University at Buffalo, Buffalo, NY, USA; 2National Jewish Health, Denver, CO, USA; 3Avalere, Health Economics and Advanced Analytics, Washington, DC, USA; 4AstraZeneca, Biopharmaceuticals Medical, Wilmington, DE, USA; 5Formerly Avalere, Washington, DC, USACorrespondence: Michael Pollack, Health Economics and Payer Evidence-Global, 1800 Concord Pike, Wilmington, DE, 19850, USA, Tel +1 302-886-1253, Email michael.pollack1@astrazeneca.comPurpose: To quantify the effects of moderate and/or severe chronic obstructive pulmonary disease (COPD) exacerbations on future exacerbations and healthcare costs in Medicare Fee-For-Service beneficiaries.Patients and Methods: A retrospective cohort study of patients ≥ 40 years of age, with continuous enrollment from 2015 to 2018, with an index COPD diagnosis defined as first hospitalization, emergency department visit, or first of two outpatient visits (≥ 30 days apart) in 2015 with a claim for chronic bronchitis, emphysema, or chronic airway obstruction. Patients were stratified by baseline exacerbation categories in year one (YR1) and subsequently evaluated in YR2 and YR3: (A) none; (B) 1 moderate; (C) ≥ 2 moderate; (D) 1 severe; and (E) ≥ 2, one being severe. Moderate exacerbations were defined as COPD-related outpatient/ED visits with a corticosteroid/antibiotic claim within ± 7 days of the visit and severe exacerbations as hospitalizations with a primary COPD diagnosis. Total all-cause costs for Categories B-E were compared to reference Category A using generalized linear models and inflation adjusted to 2019 dollars.Results: A total of 1,492,108 patients met study criteria with a mean (±SD) age of 70.9± 10.9. In YR1, nearly 40% of patients experienced ≥ 1 moderate and/or severe exacerbations. Patients having multiple exacerbations, regardless of severity were 2– 4 times more likely to experience an exacerbation during YR2 and YR3. Adjusted costs ranged between $24,000 and $26,600 for all categories for YR2 and YR3. Adjusted YR2 costs for Category D and E were $1421 and $1548 higher than those without an exacerbation (Category A YR2 $25,084, YR3 $24,282; p< 0.0001). The respective YR3 adjusted costs were $2062 and $2117 higher than those without an exacerbation (Category A; p< 0.0001), representing an increase of 6– 8% and 8– 9% for YR2 and YR3.Conclusion: Medicare patients with recent moderate or severe exacerbations, or at least two exacerbations per year are at significant risk for future exacerbations and incur higher all-cause costs.Keywords: chronic obstructive pulmonary disease, exacerbations, medicare, maintenance therapy, costs