Prognostic factors for mortality in patients hospitalized with influenza complications, in Taiwan.

BACKGROUND: This study aims to assess factors associated with fatal hospitalized influenza with complications in Taiwan. METHODS: We identified reports of complications and illness onset in patients hospitalized with influenza between week 26, 2009 and week 25, 2012 from the National Notifiable Disease Surveillance System. We used a multivariate logistic regression model to evaluate covariates that can be associated with in-hospital mortality. RESULTS: Among 4735 patients (413 deaths), age ≥50 years (p<0.001), male (p=0.014), comorbidities (p<0.001), and delayed oseltamivir treatment (p<0.001) increased the likelihood of in-hospital mortality. CONCLUSIONS: We recommend influenza vaccination and early antiviral treatment for at-risk populations.

Telephone monitoring of adverse events during an MF59®-adjuvanted H5N1 influenza vaccination campaign in Taiwan.

This study was conducted to explore a telephone-based approach for identifying and quantifying the occurrence of adverse events following immunization (AEFIs) during an MF59®-adjuvanted H5N1 vaccination program in Taiwan. From March to August 2011, each H5N1 vaccine recipient who voluntarily registered as participants within 72 h of vaccination was phone interviewed at postvaccination 7-10 and 21-24 d. Among the 292 participants, 270 and 263 interviews were completed at 7-10 and 21-24 d. Overall, 127 (48%) respondents reported local and 86 (33%) reported systemic reactions. Females (odds ratio [OR] 2.06, 95% confidence interval [CI] 1.18-3.63), nonelderly adults aged 18-59 y (OR 3.08, 95% CI 1.11-9.45), and first-dose recipients (OR 2.16, 95% CI 1.22-3.86) were independently associated with having an AEFI within the first 7-10 d. None of the AEFIs reported were serious adverse events. In conclusion, most AEFIs to H5N1 vaccine were anticipated but varied with sex, age, and vaccine dose number. The use of modern information technologies will be a scalable alternative to efficiently enroll and monitor recipients with possible AEFIs in large campaigns involving influenza or other emerging vaccines. Further studies should compare the detection of AEFIs using telephone monitoring and standard pharmacovigilance reporting.

Application of the parallel line assay to assessment of biosimilar products based on binary endpoints.

Biological drug products are therapeutic moieties manufactured by a living system or organisms. These are important life-saving drug products for patients with unmet medical needs. Because of expensive cost, only a few patients have access to life-saving biological products. Most of the early biological products will lose their patent in the next few years. This provides the opportunity for generic versions of the biological products, referred to as biosimilar drug products. The US Biologic Price Competition and Innovation Act passed in 2009 and the draft guidance issued in 2012 provide an approval pathway for biological products shown to be biosimilar to, or interchangeable with, a Food and Drug Administration-licensed reference biological product. Hence, cost reduction and affordability of the biosimilar products to the average patients may become possible. However, the complexity and heterogeneity of the molecular structures, complicated manufacturing processes, different analytical methods, and possibility of severe immunogenicity reactions make evaluation of equivalence between the biosimilar products and their corresponding reference product a great challenge for statisticians and regulatory agencies. To accommodate the stepwise approach and totality of evidence, we propose to apply a parallel assay to evaluate the extrapolation of the similarity in product characteristics such as doses or pharmacokinetic responses to the similarity in binary efficacy endpoints. We also report the results of simulation studies to evaluate the performance, in terms of size and power, of our proposed methods. We present numerical examples to illustrate the suggested procedures.