Search

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.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.COPD-associated outcomes after diagnosis were significantly worse in patients with influenza (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.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.

Christopher Wallick, Ibrahim M Abbass, Daniel Sheinson, Dalia Moawad Genentech, Inc, South San Francisco, CA, USACorrespondence: Christopher WallickGenentech, Inc., South San Francisco, CA, USATel +1 650-797-3006Fax +1 650-225-4630Email wallick.christopher@gene.comPurpose: 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.Keywords: claims, household, influenza, retrospective, observational, children

To determine the effect of antiviral agents on influenza-related complications, health care resource utilization (HRU), and costs over three influenza seasons (2014-2016).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.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%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.Antiviral influenza treatment is associated with a significant reduction in complications, HRU, and costs at 30 and 90 d after diagnosis.

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.

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.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.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.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.

Background Influenza remains a significant public health burden, resulting in serious morbidity and mortality globally. The National Institute for Health and Care Excellence (NICE) recommends treatment with antivirals for a broad range of high-risk influenza cases; however, anecdotal reports suggest treatment rates in the United Kingdom remain low. Real-world evidence on influenza treatment patterns in this region is limited. We therefore sought to investigate the proportion of influenza cases presenting to UK primary care facilities that receive antiviral treatment. Methods Data were obtained from the Clinical Practice Research Datalink (CPRD), a database of medical records from 674 primary care facilities in the UK. Cases were eligible for study inclusion if a diagnosis code for influenza or influenza-like illness (ILI) occurred between 1 January 2003 and 31 December 2018, and the medical record had sufficient data quality. Treatment was defined as prescription of an antiviral (oseltamivir, zanamivir, peramivir, or amantadine) within ±10 days of diagnosis. We examined (1) treatment rates, overall and by study year to understand time trends, (2) distribution of antiviral types prescribed, and (3) patient characteristics across treatment status. Results Of the 116,923 cases of influenza that met study inclusion criteria, 10,923 (9.3%) were treated with an antiviral. Treatment rates varied by study year, ranging from Conclusion We evaluated real-world estimates of influenza treatment rates over a 16-year period in UK primary care settings, where anecdotal reports suggested low treatment rates. Consistent with these reports, we observed low treatment rates, likely due in part to inclusion criteria and clinical guidelines specifying treatment only for high-risk cases. Subsequent analyses will investigate treatment patterns and patient characteristics in high-risk vs. low-risk cases to provide additional context for observed treatment rates. Disclosures All authors: No reported disclosures.

Aim: To test the hypothesis that a therapeutic dose of ocrelizumab (200 mg × 2), can be administered as a single-infusion (400 mg × 1) to achieve clinical efficacy and safety in patients with active rheumatoid arthritis. Patients & methods: Three hundred and fourteen patients were randomized to double-blind placebo, ocrelizumab single-infusion or dual-infusion. The primary end point is American College of Rheumatology (ACR)20 response at week 24 for single-infusion ocrelizumab versus placebo. Results: At 24 weeks, ACR20 responses for patients treated with single-infusion ocrelizumab were not statistically significantly superior to placebo (37.6% [95% CI: 28.8–46.4%] vs 28.1% [95% CI: 17.1–39.1%]; p = 0.2253). ACR20 for dual-infusion ocrelizumab was 52.7% (95% CI: 44.1–61.2%). Initial depletion of peripheral B cells appeared comparable after single and dual-infusions. However, subsequent B-cell repletion occurred earlier after single-infusion. Adverse events were comparable across groups. Conclusion: Ocrel...

Background Seasonal influenza is known to be a significant burden to patients and the healthcare system. Understanding how this highly contagious infection is spread, particularly among family members, is important for quantifying the burden of flu and potential impact of upcoming therapeutic agents that limit transmission. This study used real-world US claims data to understand families’ medical care seeking behavior for flu infection and the relationship between family size and days families are burdened with flu within their household. Methods This was a retrospective analysis of US commercial claims data from the 2014–2016 flu seasons. Patients with enrolled family members and a diagnosis code for flu were identified and required to have continuous coverage during each influenza episode (defined as 14 days from the first flu case in a family). Results We identified 1,224,808 primary cases of flu among families of 2 or more members. The median family size was 4 members (25th, 75th percentiles = 3, 4). Of these families with at least one case of flu, 119,883 (9.8%) had additional member(s) who sought care for flu within the same flu episode. 70.8% (84,903) of these cases occurred within 3 days after the first member’s claim for influenza (Figure 1). Increased family size was associated with a higher percentage of families where flu spread to other members of the family beyond the first member diagnosed (6.4% of families of size 2 or 3 vs. 12.6% of families of size 4 or greater, P < 0.001). Family size was also positively correlated with the number of days between the first and last flu-related office visit within a family (Spearman coefficient = 0.09, P < 0.001). The majority of family members who sought care for flu were children (n = 810,867; 59.5%), followed by employees (n = 323,277; 23.7%) and their spouses (n = 228,775; 16.8%). Conclusion In data for the last 3 available flu seasons, we identified a significant number of secondary cases of flu among families with a primary case. Larger families had higher likelihood for subsequent flu infections and more number of days for dealing with flu. Transmission of flu between family members represents a large burden on the healthcare system and reveals an unmet need for treatment options that limit transmission. Disclosures All Authors: Roche: Employee, Salary.

Background The CDC has reported that seasonal influenza in 2017–2018 has been one of the worst on record, with hospitalization rates among the highest recorded, especially among younger age groups (age 50–65, hospitalization rate of 63.1 per 100,000 people compared with 35.1 in last severe season, 2015–2016). Understanding how antiviral use affects rates and severity of complications is important to inform treatment decisions. This study used real-world US claims data for 3 flu seasons (2014–2016) to understand the frequency of flu complications and how intervention with antivirals may affect their occurrence. Methods This was a retrospective cohort study using US commercial claims data from the 2014–2016 flu seasons. Patients with a diagnosis code for flu were identified and required to have continuous coverage for at least 365 days before and 91 days after diagnosis. Patients who were prescribed antivirals within 48 hours of the first flu-related encounter during the flu season were identified and propensity score matched to a comparative cohort without antiviral use within 48 hours but comparable baseline health resource utilization (HRU) and comorbidities. All-cause and respiratory-related HRU and costs in the 30 and 91 days after flu diagnosis were analyzed and compared. Results A total of 989,530 cases of influenza were identified over 3 flu seasons, with 60.2 percent receiving antiviral therapy (Table 1). In the matched sample, greater HRU and costs was identified in the cohort that did not receive antiviral therapy, with 15% vs. 10.4% (P < 0.001) visiting the ER, and 2.8% vs. 0.9% (P < 0.001) being admitted for inpatient care within the first month (Table 2). Similarly, greater HRU was also seen in respiratory-related HRU and costs in the cohorts that did not receive antiviral therapy. Findings were similar in unmatched cohorts. Conclusion In data for the last 3 available flu seasons, flu patients treated with antivirals had less complications, healthcare resource utilization and overall costs than those who did not receive antiviral treatment. Limitations with this kind of study restrict the conclusions that can be made from this analysis, however suggest that treating flu can improve outcomes and resource utilization beyond symptom resolution. Disclosures C. Wallick, Roche: Employee, Salary. N. Wu, Roche: Collaborator and Consultant, Salary. T. M. Tu, Roche: Employee, Salary. D. Keebler, Roche: Employee, Salary. D. Moawad, Roche: Employee, Salary.