Using a patient chart review process, we conducted a retrospective study to describe the frequency of allergic reactions in individuals with haemophilia B receiving factor IX (FIX) replacement therapy. The number of allergic reactions in individuals receiving a recombinant FIX (rFIX) product (BeneFix(®)) was then compared with the number of reactions in patients receiving plasma-derived FIX (pdFIX) products. Of the 180 subjects in the study, 163 received rFIX, 88 received pdFIX; 71 received both product types. A total of seven (3.89%) subjects had a moderate or severe allergic reaction to a FIX product (95% confidence interval [CI], 1.06-6.71%). Among those receiving rFIX, four subjects (2.45%) had an allergic reaction (95% CI, 0.08-4.83%). Of individuals taking pdFIX products, three (3.41%) developed an allergic reaction (95% CI, 0-7.20%). It was noted that three (1.84%) of those taking rFIX developed an inhibitor to FIX (95% CI, 0-3.90%), while four (4.55%) of those receiving a pdFIX product developed an inhibitor (95% CI, 0.19-8.90%). Inhibitor development was frequently associated with allergic reaction. These results provide evidence that there is no difference in the frequency of allergic reactions or inhibitor development in individuals receiving rFIX compared with those receiving pdFIX concentrates. The current study and a previous study of similar design have now compared the rate of allergic reactions associated with rFIX and pdFIX concentrates has now been compared in a total of 414 subjects; this represents the largest collection of data to date on this rare complication of haemophilia B therapy.

Objective: To evaluate healthcare resource use and costs incurred during, as well as following hospitalization for major bleeding (MB), among atrial fibrillation (AF) patients treated with factor Xa inhibitors Methods: Patients with an AF diagnosis and MB hospitalization (index event) were identified from the MarketScan Commercial and Medicare databases (January 1, 2011-December 31, 2014. Patients were required to have 1 prescription for rivaroxaban or apixaban within 3 months prior to MB hospitalization. AF patients treated with Xa inhibitors, but who did not have any diagnosis of MB during the study period were identified. Hospital resource use and costs were evaluated for index MB hospitalizations. Healthcare resource use and associated costs were also evaluated for up to 12 months and compared between AF patients with and without MB. Results: Of the overall patient population with AF treated with factor Xa inhibitors (n ¼ 92,949), 3,081 (3.3%) were identified as patients with MB and 89,868 without MB. The mean hospital length of stay and hospital cost for index MB hospitalizations were 5.3 days and $28,059, respectively. Total all-cause healthcare costs were higher during the 12 months of follow-up for AF patients with MB vs without ($63,866 vs $37,916, p < .001). After adjusting for differences in patient characteristics, mean total healthcare costs were estimated at $58,169 for patients with MB vs $41,241 for patients without MB. Limitations: Since this was an observational study using a claims database analysis, a causal relationship between factor Xa inhibitor treatment and MB events cannot be inferred from the results of this study. Conclusion: In the real-world setting, the cost of initial hospitalizations for MB was substantial, and the incremental burden of total healthcare costs within 1 year following MB hospitalization was high. Approaches to better manage the continuum of care of AF patients with factor Xa inhibitor-associated MB may reduce the healthcare economic burden. ARTICLE HISTORY

BackgroundWe evaluated whether the duration of hospital stay influences venous thromboembolism (VTE) prophylaxis patterns and VTE risk during hospitalization and post-discharge among patients hospitalized for acute illnesses in the USA.MethodsPatients hospitalized for acute illnesses were identified from the US MarketScan Commercial and Medicare databases (January 1, 2012–June 30, 2015). Patients were stratified by index hospital length of stay (LOS), with study groups with 1–3 day, 4–6 day, and ≥7 day LOSs. Use of VTE prophylaxis and VTE event rates during and after hospitalization (6-month follow-up) were evaluated.ResultsOf the overall population, 8647 had a 1–3 day LOS, 5551 had a 4–6 day LOS, and 3697 had a ≥7 day LOS. A greater proportion of patients with a 1–3 day LOS (66.2%) did not receive any VTE prophylaxis in comparison to patients with a 4–6 day LOS (55.0%) and ≥7 day LOS (48.8%; p<0.001). Proportions of patients with VTE events during the index hospitalization increased with longer hospital LOS (1–3 day LOS: 0.5%; 4–6 day LOS: 1.3%; ≥7 day LOS: 5.4%), as did proportions of patients with VTE events during the 6-month follow-up (1–3 day LOS: 2.4%; 4–6 day LOS: 2.7%; ≥7 day LOS: 4.2%).ConclusionAmong this study population of hospitalized acutely ill patients in the USA, VTE pharmacologic prophylaxis was underutilized, regardless of the duration of hospital stay. However, the risk for VTE events was substantial, with nearly 10% of those with a ≥7 day LOS having suffered a VTE event within 6 months.

Objectives: This study evaluated the frequency of hospital readmissions for venous thromboembolism (VTE) and the associated costs and length of stay (LOS) among acute medically ill patients in the US using a real-world claims database analysis. Methods: Patients (!40 years of age) at risk of VTE due to hospitalization for acute medical illnesses, based on primary hospital discharge diagnosis codes, were identified from the MarketScan databases between July 1, 2011 and March 31, 2015. Patients were required to have continuous insurance enrollment in the 6 months prior to initial (index) hospitalizations (baseline period) and in the 6 months after hospital discharge (follow-up period). The proportions of patients with VTE-related (diagnosis at any position) and VTE as primary diagnosis hospital readmissions during the follow-up period were evaluated. The associated costs and LOS for such readmissions were also determined, as well as time to VTE-related readmissions. Results: Of the study population (n ¼ 12,785; mean age ¼ 68.3 years), most were hospitalized primarily for infectious diseases (35.2%), followed by respiratory diseases (27.9%), cancer (15.7%), heart failure (11.8%), ischemic stroke (8.1%), and rheumatic diseases (1.4%). Of the overall study population, 2.1% (n ¼ 268) had a VTE-related hospital readmission in the 6 months following discharge of their index hospitalization, of which 36.6% (n ¼ 98) were for a primary diagnosis of VTE. Approximately 25.4% of the VTE-related hospital readmissions occurred within the first 30 days of discharge and 58.2% within 90 days. The mean cost for a hospital readmission with a primary diagnosis of VTE was $18,681 (mean LOS ¼ 5.0 days); for readmissions with a primary diagnosis of DVT and PE, mean costs were $14,719 and $23,305, respectively. Conclusions: Among this study population of patients hospitalized for acute medical illnesses, some experienced a VTE event requiring re-hospitalization, with 25% occurring within the first 30 days after hospital discharge.

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