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The aim of this study was to elicit utilities for radioactive iodine-refractory differentiated thyroid cancer (RR-DTC) and evaluate the impact of treatment response and toxicities on quality of life. RR-DTC health states were developed based on data from a previous qualitative study and iterative review by clinical experts. Following piloting, health states underwent valuation by 100 members of the UK public during time trade-off interviews. Mean utilities and descriptive distribution statistics were calculated, and a logistic regression analysis was conducted. The demographic characteristics of the study sample were generally reflective of the UK population. Clear differentiation in valuation between health states was observed. No response/stable disease had an adjusted utility value of 0.87, with a corresponding gain of +0.04 following a treatment response and a decline of -0.35 for disease progression. Adverse events were associated with utility decrements between -0.47 (grade III diarrhea) and -0.05 (grade I/II alopecia). The trade-off interviews derived utility weights show clear differentiation between RR-DTC health states in response to treatment. The values reported in this study are suitable for cost-effectiveness evaluations for new treatments in RR-DTC.

Biologics and apremilast have advanced psoriasis management by adding treatment options. This study evaluated persistence, adherence and healthcare costs among biologic-naive patients receiving apremilast or biologics. Administrative claims data for adults starting apremilast or biologics from 1 January 2013 to 30 June 2016 were matched based on demographics. Apremilast (n = 703) and biologics (n = 1378) had similar baseline characteristics. 12-month persistence and adherence rates were similar. Adjusted total healthcare costs were lower with apremilast versus biologics (p < 0.001) due to lower total outpatient pharmacy costs (p < 0.001). Real-world apremilast users had similar adherence and lower total healthcare costs versus biologic users. Apremilast's cost advantage was evident regardless of whether the patients were persistent or nonpersistent, or switched or did not switch treatments.

We evaluated treatment patterns and healthcare costs of initiating psoriatic arthritis (PsA) treatment with oral apremilast versus biologics. Claims data identified biologic-naive adults with PsA who initiated either apremilast or a biologic from 2013 to 2016. Medication adherence was similar at 12 months (76.9 vs 73.4%; p = 0.175) between apremilast (n = 381) and matched biologic (n = 761) patients. Apremilast users had $12,715 lower total costs per-patient-per-month (p < 0.001), largely due to outpatient pharmacy and medical costs. Commercially insured patients with PsA initiating apremilast had adherence similar to those initiating biologics but lower total healthcare costs.

Patients with differentiated thyroid cancer (DTC) often respond well to treatment but some become refractory to radioactive iodine (RAI) treatment, and treatment options are limited. Despite the humanistic and economic burden RAI refractory disease imposes on patients, published research concerning treatment patterns and health care resource utilization is sparse. Data were collected from an online retrospective chart review study in the US and five European Union (EU) countries (France, Germany, Italy, Spain, and UK) with physicians recruited from an online panel. Physicians (N=211) provided demographics, disease history, treatment information, and health care resource utilization for one to four of their patients with radioactive iodine refractory differentiated thyroid cancer (RR-DTC). The majority of the patients with RR-DTC (N=623) were female (56%), and their mean age was 58.2 years. In this sample, 63.2% had papillary thyroid cancer and 57.0% were in Stage IV when deemed RAI refractory. Patients with RR-DTC experienced regional recurrence in the thyroid bed/central neck area (25.3%) and had distant metastatic disease (53.6%). At the time data were collected, 50.7% were receiving systemic treatment. Of those, 78.5% were on first-line treatment and 62.7% were receiving multikinase inhibitors. Regional differences for prescribed treatments were observed; the US was more likely to have patients receiving multikinase inhibitors (79.2%) compared with UK (41.2%) and Italy (17.1%). Additional details regarding treatment patterns and resource utilization are discussed. The current study aimed to obtain a greater understanding of RR-DTC treatment globally. These results can assist in the development and implementation of treatment guidelines and ultimately enhance the care of patients with RR-DTC.

Aims: Lenvatinib and sorafenib have been evaluated in separate Phase III placebo-controlled trials in patients with radioiodine-refractory differentiated thyroid cancer; however, no head-to-head comparative studies are available. We performed an indirect comparison of these agents using matching-adjusted indirect comparison (MAIC) to adjust for differences in baseline characteristics, a technique allowing comparison of two studies with patient-level data available for one but only aggregate data available for the other. Patients and methods: Individual patient data were available for the SELECT trial (lenvatinib versus placebo) whereas only published summary data were available for the DECISION trial (sorafenib versus placebo); therefore the SELECT data were adjusted to closely match the DECISION data. Data for patients in SELECT were assigned weights so that weighted mean baseline characteristics of the SELECT population matched those reported for DECISION. Adjusted hazard ratios (HRs) for progression-free survival (PFS) and overall survival (OS; corrected for crossover using rank-preserving structural failure time models) were calculated using weighted Cox regression models. Adjusted HRs were used to calculate indirect HRs with 95% confidence intervals (CIs). Results: Indirect treatment comparison using unadjusted clinical trial data resulted in an HR for PFS of 0.36 (95% CI 0.22–0.57) for lenvatinib versus sorafenib; MAIC resulted in an HR of 0.33 (95% CI 0.20–0.53), suggesting a statistically significantly superior PFS for lenvatinib. The HR for crossover-corrected OS for lenvatinib versus sorafenib was 0.77 (95% CI 0.44–1.35); MAIC resulted in an OS HR of 0.73 (95% CI 0.40–1.35). Conclusion: After adjusting for differences in baseline characteristics using MAIC, lenvatinib was associated with statistically significantly superior PFS compared with sorafenib in patients with radioiodine-refractory differentiated thyroid cancer. This suggests lenvatinib may provide superior efficacy compared with sorafenib for patients with radioiodine-refractory differentiated thyroid cancer.

Significance Seeds are complex structures that are comprised of the embryo, endosperm, and seed coat. Despite their importance for food, fiber, and fuel, the cellular processes that characterize different regions of the seed are not known. We profiled gene activity genome-wide in every organ, tissue, and cell type of Arabidopsis seeds from fertilization through maturity. The resulting mRNA datasets provide unique insights into the cellular processes that occur in understudied seed regions, revealing unexpected overlaps in the functional identities of seed regions and enabling predictions of gene regulatory networks. This dataset is an essential resource for studies of seed biology.

Real-world analyses of treatments for patients with metastatic breast cancer are limited. We evaluated the comparative effectiveness of -paclitaxel vs. paclitaxel in patients with metastatic breast cancer using data from an electronic medical record database from community practices across the USA. We performed a retrospective cohort study using fully de-identified data from an independent US electronic medical record platform of patients with metastatic breast cancer initiating single-agent -paclitaxel or paclitaxel as a first- or second-line treatment from December 1, 2010 to October 6, 2014. The clinical efficacy objectives were time to treatment discontinuation (TTD) and time to next treatment (TTNT). Subgroup analyses were performed in patients with 2 types of metastatic breast cancer as follows: 1) hormone receptor-positive and human epidermal growth factor receptor 2 negative, and 2) triple-negative disease. This analysis included 925 patients. Patients receiving -paclitaxel vs. paclitaxel had significantly longer TTD (median 4.2 vs. 2.8 months, <0.0001) and TTNT (median 6.0 vs. 4.2 months, <0.0001); similar outcomes were observed for patients with hormone receptor-positive/human epidermal growth factor receptor 2 negative disease. Compared with paclitaxel, -paclitaxel was associated with significantly longer TTD in patients with triple-negative disease. -Paclitaxel was associated with significantly less all-grade neuropathy, anemia, pain, and diarrhea than paclitaxel. Antiemetic and antihistamine use were significantly less frequent with -paclitaxel vs. paclitaxel, whereas use of granulocyte colony-stimulating factor, hydrating agents, and bone-directed therapy to decrease skeletal-related events were more frequent. -Paclitaxel demonstrated improved clinical effectiveness compared with paclitaxel when examining TTD and TTNT in patients with metastatic breast cancer in a real-world setting.

Compare treatment switching rates and costs among biologic-naive psoriasis patients initiating apremilast or biologics. This retrospective claims analysis used IBM MarketScan Commercial and Medicare Supplemental databases to identify patients who initiated apremilast or a biologic (ie, tumor necrosis factor [TNF] or interleukin [IL] inhibitor) for psoriasis treatment between January 1, 2015, and December 31, 2016. A 1:1 propensity score matching was used to adjust for possible selection bias and maximize the number of patients available for analysis. Treatment switching, days to switch, and healthcare costs were assessed at 12 months. -test and chi-square test were used to evaluate differences between cohorts for continuous and categorical variables as appropriate; Wilcoxon rank-sum tests were used to assess cost differences. In total, 88,025 patients newly initiated apremilast, a TNF inhibitor, or an IL inhibitor. After inclusion/exclusion criteria were applied and patients were propensity score matched, 1645 (apremilast), 1207 (TNF inhibitor), and 438 (IL inhibitor) patients were included in this analysis. Twelve-month switch rates were significantly lower for apremilast initiators compared with TNF inhibitor initiators (14% vs 25%; p<0.01) and comparable to IL inhibitors (14% vs 11%; p>0.05). No statistical difference was observed in days to switch at 12 months for any treatment group. Total healthcare costs were lower for apremilast initiators compared with TNF and IL inhibitor initiators ($34,028 vs $55,973 and $64,430; p<0.0001). Per-patient per-month (PPPM) costs were significantly lower for apremilast initiators compared with TNF inhibitor and IL inhibitor initiators ($2834 vs $4662 and $5366; p<0.0001). Over a 12-month follow-up, biologic-naive psoriasis patients initiating apremilast had significantly lower switching rates compared with patients on TNF inhibitors and similar rates as patients on IL inhibitors. PPPM and total healthcare costs were significantly lower for patients initiating apremilast vs TNF or IL inhibitors, primarily due to lower pharmacy costs.

Ozanimod and fingolimod are sphingosine 1-phosphate receptor–modulating therapies for relapsing multiple sclerosis. Comparative effectiveness was assessed by matching adjusted indirect comparisons of safety and efficacy trial outcomes at first-dose cardiac monitoring, 1 year and 2 years. After adjustment, baseline characteristics were similar. Ozanimod was associated with a lower risk of extended first-dose monitoring, conduction abnormalities including atrioventricular block. One-year risks of any adverse event (AE), mean lymphocyte count reductions and abnormal liver enzymes were lower with ozanimod. Two-year risks of AEs leading to discontinuation, any AEs, herpetic infections, bradycardia and abnormal liver enzymes were lower with ozanimod. Analyses of efficacy outcomes were similar. Ozanimod appears to have a favorable benefit-risk profile versus fingolimod.

Background The combination chemotherapy regimens of nab-paclitaxel plus gemcitabine (nab-p + G) and FOLFIRINOX (FFX) have each demonstrated improved survival compared with gemcitabine monotherapy in clinical trials for metastatic pancreatic cancer; however, limited comparative data exist. Objective The objective of this study was to compare patient characteristics and clinical outcomes including time to treatment failure and overall survival in patients with metastatic pancreatic cancer receiving first-line chemotherapy in the community. Methods We conducted a retrospective, multi-site, observational cohort study of patients with metastatic pancreatic cancer receiving first-line nab-p + G, FFX, or gemcitabine monotherapy between April 2013 and October 2015, using data from the iKnowMed electronic health record database. Patients on clinical trials or with other cancer diagnoses were excluded. Time to treatment failure and overall survival were assessed by Kaplan–Meier methods. Results Four hundred and eighty-six patients met selection criteria, 255 nab-p + G, 159 FFX, and 72 gemcitabine patients. Median age was 61, 68, and 73 years for FFX, nab-p + G, and gemcitabine patients, respectively ( p  < 0.01 for nab-p + G vs. FFX). Eastern Cooperative Oncology Group performance status of 0–1 was 91% for FFX, 77% for nab-p + G, and 68% for gemcitabine patients ( p  < 0.01 for nab-p + G vs. FFX). For the nab-p + G vs. FFX cohorts, respectively, time to treatment failure was 3.7 vs. 4.3 months (log-rank p  = 0.25); and OS was 9.8 vs. 11.4 months (log-rank p  = 0.38). Among patients with Eastern Cooperative Oncology Group performance status 0–1, time to treatment failure was 4.2 vs. 4.3 months (log-rank p  = 0.47); and overall survival was 12.1 vs 11.4 months (log-rank p  = 0.68). Conclusions The nab-p + G patients were older and had worse performance status than FFX patients. Time to treatment failure and overall survival were not observed to be significantly different in first-line nab-p + G and FFX patients. Results were similar after stratifying by performance status.