Impact of antiviral therapy on short- and long-term outcomes of patients with chronic obstructive pulmonary disease after influenza infection.

Background: Respiratory complications often accompany influenza in patients with chronic obstructive pulmonary disease (COPD). In this retrospective study, we quantified the impact of antiviral therapy on exacerbations, healthcare resource utilization (HRU), and costs in patients with COPD across 5 influenza seasons. Methods: Using claims data from US MarketScan® databases, we identified patients with COPD who had an influenza diagnosis during the 2012-2016 influenza seasons. Patients who received a neuraminidase inhibitor within 48 h of diagnosis (N = 4134) were identified and propensity score-matched 1:1 to a comparator cohort of untreated patients. We determined COPD- and pneumonia-related HRU and costs during month 1, each subsequent quarter, and months 2-13. Results: Antiviral-treated patients had a significantly lower frequency of COPD-related outcomes than untreated patients during all periods (exacerbations: 10.4% vs 18.2% [month 1] and 17.7% vs 24.2% [months 2-13]; inpatient visit: 2.5% vs 7.9% [month 1] and 3.8% vs 6.7% [months 2-13]; P < 0.0001, all comparisons). Treated patients also had significantly lower outpatient and emergency department (ED) visits beyond month 1. Pneumonia-related inpatient, ED, and outpatient visits were significantly lower in antiviral-treated patients than in untreated patients over all periods (P < 0.0001, all comparisons). In all HRU categories, COPD- and pneumonia-related costs were significantly lower in treated patients over all periods (month-1 ED visit costs were higher). Conclusions: Antiviral treatment in patients with COPD and influenza is associated with significantly lower HRU and costs in the postinfection month and for an entire year following infection compared with untreated patients.

Impact of influenza infection on the short- and long-term health of patients with chronic obstructive pulmonary disease.

BACKGROUND: Influenza is a common cause of acute respiratory infection that leads to exacerbation of underlying chronic obstructive pulmonary disease (COPD). To elucidate the short- and long-term effects of influenza in patients with COPD, we examined health care resource utilization (HRU) and costs up to 13 months following influenza infection. METHODS: We conducted a retrospective cohort study using U.S. insurance claims data from MarketScan. Patients with an influenza diagnosis during the 2012-2014 influenza seasons and continuous enrollment in a health plan from 12 months before to 13 months after the index influenza diagnosis were identified and propensity score-matched 1:5 to controls without evidence of influenza. COPD- and pneumonia-related outcomes were assessed over 13 months following influenza diagnosis. RESULTS: COPD-associated outcomes after diagnosis were significantly worse in patients with influenza (n = 7,087) vs. controls (n = 35,435) during the first month (exacerbation: 16.1 vs. 3.4%; outpatient visits: 57.1 vs. 35.2%; emergency department (ED) visits: 10.5 vs. 1.8%; and inpatient visits: 5.6 vs. 0.7%) and months 2-13 (exacerbation: 25.1 vs. 21.1%; outpatient visits: 86.1 vs. 85.8%; ED visits: 20.0 vs. 15.7%; and inpatient visits: 6.5 vs. 5.3%). COPD- and pneumonia-associated costs for months 1 and 2-13 were higher in patients with influenza. LIMITATIONS: The study was subject to a residual imbalance between cohorts despite propensity score matching. The use of diagnostic codes to select patients and identify complications could introduce inaccuracies in estimating events. CONCLUSIONS: HRU and costs were higher in COPD patients with influenza during the first month and over the entire year following infection. This suggests influenza has an impact on respiratory health in patients with COPD that lasts beyond the acute infection.

Healthcare Resource Use and Burden Associated with Influenza Transmission Among Household Members with a Primary Infection: Commercial Claims Data Analysis.

PURPOSE: To assess the burden of influenza transmission and care-seeking patterns over 3 influenza seasons among commercially insured households with a primary influenza infection. PATIENTS AND METHODS: This retrospective cohort study used commercial claims data from the US MarketScan® Commercial and Medicare Supplemental databases for the 2014, 2015, and 2016 influenza seasons. Patients with a billed diagnosis of influenza and with coverage for at least 1 household member under the same health plan policy were included. A secondary diagnosed case was defined as a diagnosis of influenza in a second household member occurring within 14 days of the index case in a household. RESULTS: Among 1,224,808 households with ≥2 members and a primary case of influenza, a secondary case of influenza was reported in 119,883 households (9.8%). A secondary diagnosed case of influenza occurred within 4 days of the primary diagnosis in 93,883 (78.3%) of those households. Both primary and secondary diagnosed influenza cases occurred most often among children (~60%). Household size was positively correlated to both the risk of a second case (6.4% of households with 2 or 3 members versus 12.6% of households with ≥4 members, P < 0.001) and the time to diagnosis of a second case (Spearman rank correlation coefficient = 0.09; P < 0.001). CONCLUSION: Claims data for 3 influenza seasons (2014, 2015, 2016) showed that intrahousehold transmission of influenza occurs in approximately 10% of households with a primary case and poses a higher burden on larger households. Intrahousehold transmission of influenza represents a large healthcare resource use burden, with an unmet need for interventions that limit transmission.

Antiviral use is associated with a decrease in the rate of influenza-related complications, health care resource utilization, and costs.

AIMS: To determine the effect of antiviral agents on influenza-related complications, health care resource utilization (HRU), and costs over three influenza seasons (2014-2016). METHODS: This retrospective cohort study used claims data from the U.S. MarketScan Research Databases. Patients with a diagnosis code for influenza during the 2014-2016 seasons in an outpatient setting, with continuous enrollment from 1 year before to 91 d after diagnosis, were included. Patients who received an antiviral within 48 h of diagnosis were identified and propensity score-matched to a comparator cohort of untreated patients on baseline demographics, comorbid conditions, and HRU. Outcomes were assessed at days 30 and 90 after diagnosis and included respiratory-related complications (all respiratory-related and selected respiratory-related conditions [influenza, asthma, chronic obstructive pulmonary disease, or infection]), HRU, and costs. RESULTS: Treated and matched untreated cohorts each consisted of 362,818 patients. HRU was significantly lower in the treated cohort compared with the untreated cohort at 30 and 90 d after diagnosis, respectively (hospitalizations: 0.6% vs. 0.8% and 1.2% vs. 1.6%; emergency department [ED] visits: 4.1% vs. 4.9% and 7.9% vs. 9.2%; intensive care unit/critical care unit (ICU/CCU) admissions: 0.2% vs. 0.4% and 0.4% vs. 0.6%). Respiratory-related HRU was lower in the treated cohort at both 30 and 90 d after diagnosis (p < .0001 for both periods). Mean all-cause total costs (including prescription costs) were significantly reduced in the treated group (day 30: $633 vs. $778; day 90: $1778 vs. $2119), despite higher prescription costs in the treated group. LIMITATIONS: The study was retrospective and subject to residual selection bias, despite propensity score matching. Additionally, despite its potential relevance to influenza severity, vaccination status was not available in our data. CONCLUSIONS: Antiviral influenza treatment is associated with a significant reduction in complications, HRU, and costs at 30 and 90 d after diagnosis.

Changes in Manufacturing Processes of Biologic Therapies Can Alter the Immunogenicity Profile of the Product.

Manufacturing process changes may alter the characteristics of a protein therapeutic. In 2009, somatropin (version 1.0), a recombinant human growth hormone therapeutic, underwent a manufacturing update (version 1.1). The immunogenicity of somatropin version 1.1 as a daily subcutaneous injection was evaluated in 2014 in a prospective, open-label, single-arm clinical study of treatment-naive pediatric patients with idiopathic human growth hormone deficiency for 1 year. The primary end point was the proportion of patients who developed antidrug antibodies (ADAs) after treatment. Eighty-two patients were enrolled. The mean (SD) treatment duration was 347 (53) days. The incidence of ADAs was 3.7%. No neutralizing antibodies were observed in the three patients with ADA-positive samples. Two patients (2.6%) had growth attenuation, but they were not ADA positive. The manufacturing changes for somatropin version 1.1 resulted in a similar safety and efficacy profile compared with somatropin version 1.0 and a different immunogenicity profile with a lower incidence of ADAs.

National Cooperative Growth Study: 25 Years of Growth Hormone Data, Insights, and Lessons for Future Registries.

BACKGROUND: The National Cooperative Growth Study (NCGS) data are reviewed from 1985-2010 to report on final demographic, efficacy, and safety findings, and to illustrate the value of long-term, real-world follow-up to physicians and patients. METHODS: The NCGS was a multicenter, open-label, observational, postmarketing surveillance study of Genentech growth hormone (GH) products for the treatment of children with growth failure in North America. FINDINGS: Data from 65,205 patients representing 240,951 patient-years of experience were collected. All etiological groups had clinically meaningful improvements in near-adult height SDS. Females and African Americans were under-represented in the NCGS with little change in accrual over time. The favorable safety profile of GH was validated through the registry. CONCLUSIONS: Twenty-five years of monitoring GH use through the NCGS yielded extensive insight into the utility of GH in various underlying etiologies. Demographic disparities were clear and became evident by analyzing data collected through the registry.