Jennifer Whiteley

The burden of atopic dermatitis in US adults: results from the 2013 National Health and Wellness Survey

Abstract Objectives: To characterize comorbidities, health-related quality-of-life (HRQoL), productivity, and healthcare resource use in adults with atopic dermatitis (AD) relative to those without AD, and to evaluate the impact of patient-reported AD severity on these outcomes. Methods: Data were from the 2013 National Health and Wellness Survey (NHWS), which collected self-reported information on demographics, comorbidities, HRQoL (SF-36v2 Health Survey), productivity (Work Productivity and Impairment questionnaire [WPAI]), and healthcare utilization, which were weighted to the US general population. The AD cohort consisted of subjects who reported that they experienced AD within the past 12 months (n = 428), and the non-AD cohort included all subjects who did not report experiencing AD (n = 74,572); 366 AD subjects self-reported mild (n = 182) or moderate/severe (n = 184) disease. Univariable and multivariable analyses compared characteristics and outcomes between cohorts and between AD severity levels. Results: The AD cohort was younger than non-AD cohort (44.3 vs. 46.6 years; P = 0.0033), and had a higher proportion of females (64.4% vs. 51.8%; P < 0.0001). Relative to the non-AD cohort, the AD cohort had a significantly higher prevalence of atopic conditions including nasal allergies (46.4% vs. 19.8%) and asthma (22.4% vs. 7.9%), and neuropsychiatric conditions such as anxiety (42.5% vs. 21.3%) and depression (37.2% vs. 20.9%) (all P < 0.0001). Units of resource use (healthcare practitioner visits, emergency room, hospitalizations) were higher (all P < 0.05) and HRQoL was poorer (P < 0.0001) with AD. On the WPAI, AD employees reported almost twice as much lost work productivity as non-AD employees (30.0% vs. 16.3%; P < 0.0001). No clear differences in outcomes were observed among patient-reported AD severity categories, except greater impairment of work productivity and daily activities in those with moderate/severe AD relative to mild. Conclusions: The significant burden associated with AD relative to those without AD suggests an unmet need for more effective management strategies. There also appears to be a need for further characterization of disease severity and its impact on HRQoL.

Health-related quality of life in chronic myeloid leukemia

The increased survival associated with treatments for CML emphasize the importance of understanding the HRQOL of newly diagnosed and previously treated CML patients with all phases of disease. Functional Assessment of Cancer Therapy-Leukemia results from a phase 3 and a phase 2 trial are reported for over 900 1st, 2nd, 3rd line CP, AP, and BP patients. Physical Well-being and Leukemia symptoms were worse for patients in later lines of therapy. Individuals with AP and BP CML had poorer HRQOL than individuals with CP CML. HRQOL of CML patients was predominantly consistent with the longitudinal clinical trajectory of the disease.

Real-world Analysis of Tyrosine Kinase Inhibitor Treatment Patterns Among Patients With Chronic Myeloid Leukemia in the United States

PURPOSE The treatment of chronic myeloid leukemia (CML) has improved considerably since the introduction of the tyrosine kinase inhibitor (TKI) imatinib in 2001 and the approval of second-generation TKIs (dasatinib and nilotinib) beginning in 2006.The objective of this study was to explore treatment patterns of TKI therapy (adherence, duration, and switching) among patients with CML in the United States, following the availability of second-generation TKIs. METHODS This study used US health plan claims data from January 1, 2007, through December 31, 2011. Patients were required to be aged ≥18 years, have a prescription fill for a TKI, and a diagnosis of CML. Duration of TKI use was determined based on a gap in TKI coverage of ≥180 consecutive days after TKI initiation or switch to another TKI within the 180-day window. To account for censoring due to disenrollment from the health plan or end of the study period, median treatment duration was projected by using the Kaplan-Meier estimator. FINDINGS We identified 695 patients who started TKI treatment and had a CML diagnosis during the study time frame. The mean age of patients was 55 years, and 58% of patients were male. The most common first-line TKI was imatinib (82%), with dasatinib and nilotinib use equally distributed (9%). Among the 148 (21.3%) patients who initiated a second-line TKI, the majority had switched from imatinib to dasatinib or nilotinib (86%). The median duration of first-line TKI use was 39.8 months and second-line TKI use was 22.4 months. Median duration of treatment for first-line (P = 0.4342) and second-line (P = 0.1792) treatment did not differ significantly according to TKI. Mean adherence (ie, proportion of days covered) during the first line of therapy was 0.90. IMPLICATIONS For the US patients studied, we found that imatinib was used more frequently than other TKIs in the first-line setting, but there was an increased use of second-generation TKIs in the first-line setting over time (9% in 2008 vs 43% in 2011 were nilotinib or dasatinib users). Only about one fifth of patients switched to a second-line TKI during the period of data collection.

Health-related quality of life during bosutinib (SKI-606) therapy in patients with advanced chronic myeloid leukemia after imatinib failure

Abstract Objectives: The tyrosine kinase inhibitor (TKI) bosutinib has demonstrated activity in patients with advanced phase chronic myeloid leukemia (CML), but effects on health-related quality of life (HRQoL) remain unexplored. This study evaluated HRQoL in advanced CML patients receiving bosutinib in an ongoing phase 2 study following resistance or intolerance to prior imatinib therapy. Methods: This analysis included data from 76 accelerated-phase (AP) and 64 blast-phase (BP) patients resistant/intolerant to prior imatinib with or without prior exposure to other TKIs. Patient-reported HRQoL assessments completed at baseline; weeks 4, 8, and 12; every 12 weeks thereafter; and at treatment completion included the Functional Assessment of Cancer Therapy–Leukemia (FACT-Leu); general health status was assessed using the 5-item EuroQol (EQ-5D) instrument and a visual analog scale (VAS). Results: HRQoL at baseline was somewhat worse in BP versus AP CML patients. There was a significant improvement in the mean FACT-Leu Total scale at weeks 24, 36, and 48 in AP CML patients and at weeks 4, 8, 12, 24, 36, 48, and 96 in BP CML patients compared with baseline. EQ-5D Utility scores were stable throughout treatment in AP CML patients but significantly improved versus baseline in BP CML patients at weeks 4, 8, 12, and 36. Mean VAS scores were significantly improved at weeks 8, 36, and 48 in AP CML patients and at weeks 4, 8, 12, 24, 36, and 96 in BP CML patients. The lack of a comparison group limits attribution of improvements in HRQoL specifically to bosutinib treatment; potential bias due to non-ignorable dropout may limit the ability to generalize these findings to situations where durations of therapy exceed the 96-week follow-up duration of the present study. Conclusion: These findings suggest that bosutinib therapy is associated with improved HRQoL in advanced phase CML patients. Clinical trial registration: NCT00261846.

Treatment patterns and prognostic indicators of response to therapy among patients with chronic myeloid leukemia in Australia, Canada, and South Korea

Abstract Objective: Given the multiple options for treatment of chronic-phase chronic myeloid leukemia (CML) with tyrosine kinase inhibitors, our objective was to understand treatment patterns in routine practice and prognostic indicators of response. Research design and methods: We conducted a retrospective medical record review of 681 patients with CML in Australia, Canada, and South Korea. Eligible patients had a diagnosis of chronic-phase CML, were Philadelphia chromosome and/or BCR-ABL positive, were aged 18 years or older, and had been treated with first-line imatinib therapy between January 2005 and September 2010. Data on patient demographics, medical history (e.g., comorbidities, Sokal score), and treatment characteristics (e.g., time to initiation, therapy duration) were abstracted. Descriptive analyses were stratified by country and therapy line. Prognostic indicators of response to imatinib were evaluated using multivariable logistic regression, adjusting for country, patient demographics, medical history, treatment characteristics, and side effects. Main outcome measures: Hematologic, cytogenetic, and molecular responses at 3, 6, 12, and 18 months following initiation of each therapy line. Results: Patients’ average age was 57 years, and 59% were male. Overall, imatinib was initiated approximately 4 months following CML diagnosis. Complete or major molecular response (C/MMR) at 6 months following imatinib initiation was 54% in Australia, 22% in Canada, and 38% in South Korea. At 18 months, over 60% of patients achieved C/MMR. Approximately 30% of patients discontinued imatinib primarily due to intolerance and lack of response. Among patients who received second-line treatment, dasatinib was used more frequently than nilotinib. Multivariable regression results indicated Sokal score was identified as a prognostic indicator of response to imatinib therapy at several time points. Limitations: There are several limitations to this study. First, we selected a convenience sample of patients and physicians and therefore results may not be representative of the true population of patients with chronic-phase CML. Second, data were entered by the selected physician and could be subject to data entry errors or inaccuracies. Third, limited information was collected from the patient records, and it is possible that we did not capture additional prognostic or confounding factors related to the measured outcomes. Next, because this was an analysis of previously documented data (i.e., retrospective), we were unable to provide a priori definitions of response. Finally, multivariable analyses were limited to imatinib-related outcomes. Conclusions: Treatment patterns and prognostic indicators differed by country. Health care providers, payers, and patients can utilize these results to inform treatment and policies aimed at improving the effectiveness of care for patients with chronic-phase CML.