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https://www.readbyqxmd.com/read/29290168/the-economic-burden-of-acpa-positive-status-among-patients-with-rheumatoid-arthritis
#1
Jason Shafrin, Mahlet Gizaw Tebeka, Kwanza Price, Chad Patel, Kaleb Michaud
BACKGROUND: Anticitrullinated protein antibodies (ACPAs) are serological biomarkers associated with early, rapidly progressing rheumatoid arthritis (RA), including more severe disease and joint damage. ACPA testing has become a routine tool for RA diagnosis and prognosis. Furthermore, treatment efficacy has been shown to vary by ACPA-positive status. However, it is not clear if the economic burden of patients with RA varies by ACPA status. OBJECTIVE: To determine if the economic burden of RA varies by patient ACPA status...
January 2018: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29278006/relationship-between-disease-activity-and-patient-reported-outcomes-in-rheumatoid-arthritis-post-hoc-analyses-of-overall-and-japanese-results-from-two-phase-3-clinical-trials
#2
Naoki Ishiguro, Maxime Dougados, Zhihong Cai, Baojin Zhu, Masato Ishida, Masayo Sato, Carol Gaich, Amanda Quebe, Ivaylo Stoykov, Yoshiya Tanaka
OBJECTIVE: To examine patient-reported outcomes (PROs) in patients with different rheumatoid arthritis (RA) disease activity levels and identify residual symptoms. METHODS: Post hoc analyses of overall and Japanese data from two randomized controlled trials including RA patients with previous inadequate responses to methotrexate (NCT01710358) or no/minimal previous disease-modifying antirheumatic drug treatment (NCT01711359) (sponsor: Eli Lilly and Company). Week 24 assessments were disease activity (Simplified Disease Activity Index, Disease Activity Score/Disease Activity Score 28 joints-erythrocyte sedimentation rate) and PROs (pain visual analog scale [VAS], morning joint stiffness [MJS], Health Assessment Questionnaire-Disability Index, Functional Assessment of Chronic Illness Therapy-Fatigue, and Medical Outcomes Study Short Form 36 Health Survey Physical and Mental Component Scores)...
December 26, 2017: Modern Rheumatology
https://www.readbyqxmd.com/read/29216806/an-industry-update-the-latest-developments-in-therapeutic-delivery
#3
Iain Simpson
This industry update covers the period from 1 September through 30 September 2017, and is based on information sourced from company press releases, scientific literature, patents and various news websites. The month saw the US FDA approve three new molecular entities, Aliqopa (copanlisib dihydrochloride) (Bayer Healthcare); Solosec (secnidazole) (Symbiomix Therapeutics) and Verzenio (abemaciclib) (Eli Lilly and Co). Intarcia Therapeutics Inc. has its application for approval of a novel drug device combination of exenatide for the treatment of diabetes rejected by FDA but said that it will work to address the concerns and refile the application...
January 2018: Therapeutic Delivery
https://www.readbyqxmd.com/read/29204894/the-development-of-the-genital-psoriasis-sexual-frequency-questionnaire-genps-sfq-to-assess-the-impact-of-genital-psoriasis-on-sexual-health
#4
Alice B Gottlieb, Brian Kirby, Caitriona Ryan, April N Naegeli, Russel Burge, Alison Potts Bleakman, Milena D Anatchkova, Jennifer Cather
INTRODUCTION: Patient-reported outcome measures (PROs) exist for psoriasis but not genital psoriasis (GenPs). METHODS: This cross-sectional, qualitative study in patients with moderate-to-severe GenPs was conducted to support development of a PRO for measuring the impact of GenPs on sexual activity and to establish content validity. The impacts of GenPs were identified in a literature review. Findings from the literature review were discussed with clinicians, and then patients with GenPs were interviewed...
December 4, 2017: Dermatology and Therapy
https://www.readbyqxmd.com/read/29204893/the-development-of-a-patient-reported-outcome-measure-for-assessment-of-genital-psoriasis-symptoms-the-genital-psoriasis-symptoms-scale-gpss
#5
Alice B Gottlieb, Brian Kirby, Caitriona Ryan, April N Naegeli, Russel Burge, Alison Potts Bleakman, Milena D Anatchkova, Gil Yosipovitch
INTRODUCTION: Patient-reported outcome measures (PROs) specific for genital psoriasis (GenPs) have not been described. METHODS: In this cross-sectional, qualitative study in patients with moderate-to-severe GenPs, we sought to develop a PRO useful for GenPs symptom assessment. A literature review was performed to identify relevant psoriasis or GenPs symptoms and existing PROs that may be useful in the evaluation of symptom severity in GenPs patients. The literature review findings were discussed with clinicians, and then patients with GenPs...
December 4, 2017: Dermatology and Therapy
https://www.readbyqxmd.com/read/29172978/application-of-the-fda-biosimilar-extrapolation-framework-to-make-off-label-determinations
#6
Edward Li, Ernesto Lobaina
BACKGROUND: The FDA's extrapolation framework allows for a biosimilar to obtain licensure for indications that were not explicitly studied in the context of a clinical trial by extending conclusions from studies in 1 population to make inferences in other populations. Within routine clinical care, drugs and biologics are routinely used for medically accepted off-label indications. The appropriateness of these products for off-label indications are typically curated by compendia and guidelines, which have established processes and criteria for reviewing and evaluating the evidence to make such determinations...
December 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29169877/cetuximab-plus-carboplatin-and-paclitaxel-with-or-without-bevacizumab-versus-carboplatin-and-paclitaxel-with-or-without-bevacizumab-in-advanced-nsclc-swog-s0819-a-randomised-phase-3-study
#7
Roy S Herbst, Mary W Redman, Edward S Kim, Thomas J Semrad, Lyudmila Bazhenova, Gregory Masters, Kurt Oettel, Perry Guaglianone, Christopher Reynolds, Anand Karnad, Susanne M Arnold, Marileila Varella-Garcia, James Moon, Philip C Mack, Charles D Blanke, Fred R Hirsch, Karen Kelly, David R Gandara
BACKGROUND: EGFR antibodies have shown promise in patients with advanced non-small-cell lung cancer (NSCLC), particularly with squamous cell histology. We hypothesised that EGFR copy number by fluorescence in-situ hybridisation (FISH) can identify patients most likely to benefit from these drugs combined with chemotherapy and we aimed to explore the activity of cetuximab with chemotherapy in patients with advanced NSCLC who are EGFR FISH-positive. METHODS: We did this open-label, phase 3 study (SWOG S0819) at 277 sites in the USA and Mexico...
November 20, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/29134607/the-cost-effectiveness-of-dulaglutide-1-5mg-versus-exenatide-qw-for-the-treatment-of-patients-with-type-2-diabetes-mellitus-in-france
#8
Mickael Basson, Dionysios Ntais, Ruba Ayyub, Donna Wright, Julia Lowin, Florence Chartier, Stéphane Roze, Kirsi Norrbacka
INTRODUCTION: Dulaglutide is a novel onceweekly administered glucagon-like peptide 1 receptor agonist (GLP-1 RA) for the management of type 2 diabetes mellitus (T2DM). The objective of this analysis was to estimate the cost-effectiveness of dulaglutide 1.5 mg versus exenatide QW for the management of T2DM in France. METHODS: The QuintilesIMS CORE Diabetes Model was used to estimate the expected lifetime direct medical costs and outcomes of T2DM from the perspective of the French National Health Service...
November 13, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/29128965/abemaciclib-first-global-approval
#9
Esther S Kim
Abemaciclib (Verzenio™) is an orally administered inhibitor of cyclin-dependent kinases 4 and 6 that is being developed by Eli Lilly and Company. Abemaciclib has been approved in the USA for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, in combination with fulvestrant in women with disease progression following endocrine therapy, and as monotherapy in adult patients with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting...
December 2017: Drugs
https://www.readbyqxmd.com/read/29116584/use-of-50-50-premixed-insulin-analogs-in-type-2-diabetes-systematic-review-and-clinical-recommendations
#10
REVIEW
Gary Deed, Gary Kilov, Trisha Dunning, Richard Cutfield, Jane Overland, Ted Wu
INTRODUCTION: Premixed insulin analogs represent an alternative to basal or basal-bolus insulin regimens for the treatment of type 2 diabetes (T2D). "Low-mix" formulations with a low rapid-acting to long-acting analog ratio (e.g., 25/75) are commonly used, but 50/50 formulations (Mix50) may be more appropriate for some patients. We conducted a systematic literature review to assess the efficacy and safety of Mix50, compared with low-mix, basal, or basal-bolus therapy, for insulin initiation and intensification...
December 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/29083977/examining-the-effect-of-medication-adherence-on-risk-of-subsequent-fracture-among-women-with-a-fragility-fracture-in-the-u-s-medicare-population
#11
Allison Keshishian, Natalie Boytsov, Russel Burge, Kelly Krohn, Louise Lombard, Xiang Zhang, Lin Xie, Onur Baser
BACKGROUND: In the United States, osteoporosis affects approximately 10 million people, of whom 80% are women, and it contributes a significant clinical burden to the community. Poor adherence to osteoporosis medications adds to the overall burden of illness. OBJECTIVE: To examine the association of osteoporosis medication adherence and the risk of a subsequent fracture among Medicare-enrolled women with a previous fragility fracture. METHODS: This study was a retrospective observational analysis of U...
November 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29083973/amcp-partnership-forum-advancing-value-based-contracting
#12
(no author information available yet)
During the past decade, payment models for the delivery of health care have undergone a dramatic shift from focusing on volume to focusing on value. This shift began with the Affordable Care Act and was reinforced by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), which increased the emphasis on payment for delivery of quality care. Today, value-based care is a primary strategy for improving patient care while managing costs. This shift in payment models is expanding beyond the delivery of health care services to encompass models of compensation between payers and biopharmaceutical manufacturers...
November 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29083969/personalized-care-and-the-role-of-insulin-as-a-vehicle-to-optimizing-treatments-in-diabetes-care
#13
Nella Bieszk, Michael Grabner, Wenhui Wei, John Barron, Ralph Quimbo, Tingjian Yan, Beth Biel, James W Chu
BACKGROUND: In patients with type 2 diabetes (T2D) with poor glycemic control, there is an unmet need for treatment optimization involving the initiation and/or intensification of insulin therapy, which is often delayed because of clinical inertia. Educational initiatives that target patients and physicians might be one way to address this need. OBJECTIVE: To evaluate the effectiveness of educational materials mailed to physicians and their patients in affecting initiation of insulin therapy and other health care outcomes...
November 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29081023/combined-treatment-with-pemetrexed-and-vinflunine-in-patients-with-metastatic-urothelial-cell-carcinoma-after-prior-platinum-containing-chemotherapy-results-of-an-exploratory-phase-i-study
#14
H Pappot, H von der Maase, A Ullén, M Agerbæk
Vinflunine is to date the only registered agent for second-line treatment of metastatic urothelial cell carcinoma (UCC) in Europe. However, the effect is modest. Pemetrexed has demonstrated some single-agent activity in this disease entity. In order to improve treatment possibilities for UCC patients, a phase I trial (VINTREX) was undertaken to assess the safety of vinflunine and pemetrexed in metastatic UCC patients. A dose escalation design was planned to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of a vinflunine/pemetrexed combination...
October 28, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/29079252/effect-of-an-intensified-multifactorial-intervention-on-cardiovascular-outcomes-and-mortality-in-type-2-diabetes-j-doit3-an-open-label-randomised-controlled-trial
#15
Kohjiro Ueki, Takayoshi Sasako, Yukiko Okazaki, Masayuki Kato, Sumie Okahata, Hisayuki Katsuyama, Mikiko Haraguchi, Ai Morita, Ken Ohashi, Kazuo Hara, Atsushi Morise, Kazuo Izumi, Naoki Ishizuka, Yasuo Ohashi, Mitsuhiko Noda, Takashi Kadowaki
BACKGROUND: Limited evidence suggests that multifactorial interventions for control of glucose, blood pressure, and lipids reduce macrovascular complications and mortality in patients with type 2 diabetes. However, safe and effective treatment targets for these risk factors have not been determined for such interventions. METHODS: In this multicentre, open-label, randomised, parallel-group trial, undertaken at 81 clinical sites in Japan, we randomly assigned (1:1) patients with type 2 diabetes aged 45-69 years with hypertension, dyslipidaemia, or both, and an HbA1c of 6·9% (52·0 mmol/mol) or higher, to receive conventional therapy for glucose, blood pressure, and lipid control (targets: HbA1c <6·9% [52·0 mmol/mol], blood pressure <130/80 mm Hg, LDL cholesterol <120 mg/dL [or 100 mg/dL in patients with a history of coronary artery disease]) or intensive therapy (HbA1c <6·2% [44·3 mmol/mol], blood pressure <120/75 mm Hg, LDL cholesterol <80 mg/dL [or 70 mg/dL in patients with a history of coronary artery disease])...
December 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/29076000/patients-perspectives-on-the-impact-of-genital-psoriasis-a-qualitative-study
#16
Jennifer Clay Cather, Caitriona Ryan, Kim Meeuwis, Alison J Potts Bleakman, April N Naegeli, Emily Edson-Heredia, Jiat Ling Poon, Cate Jones, Ashley N Wallace, Lyn Guenther, Scott Fretzin
INTRODUCTION: Plaque psoriasis is a chronic skin disease where genital involvement is relatively common. Yet health care providers do not routinely evaluate psoriasis patients for genital involvement and patients do not readily initiate discussion of it. METHODS: A qualitative study of 20 US patients with dermatologist-confirmed genital psoriasis (GenPs) and self-reported moderate-to-severe GenPs at screening was conducted to identify key GenPs symptoms and their impacts on health-related quality of life (HRQoL)...
December 2017: Dermatology and Therapy
https://www.readbyqxmd.com/read/29052427/the-joint-ispor-ispe-special-task-force-on-real-world-evidence-in-health-care-decision-making-an-interview-with-marc-berger
#17
Marc L Berger
Marc L Berger, MD, is a retired, part-time consultant. He recently became Chair of the Real World Evidence Advisory Board for SHYFT Analytics. Over a 25-year industry career, Marc has held senior-level positions at Pfizer, Inc., OptumInsight, Eli Lilly and Company, and Merck & Co., Inc. His professional activities have included serving on committees for Center for Medicare and Medicaid Services (CMS), Agency for Healthcare Research and Quality (AHRQ), Patient-Centered Outcomes Research Institute (PCORI), the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), Drug Information Association (DIA), and the editorial advisory boards of several journals...
October 20, 2017: Journal of Comparative Effectiveness Research
https://www.readbyqxmd.com/read/29035430/the-use-pattern-and-clinical-impact-of-new-antiplatelet-agents-including-prasugrel-and-ticagrelor-on-30-day-outcomes-after-acute-myocardial-infarction-in-korea-korean-health-insurance-review-and-assessment-data
#18
Choongki Kim, Dong Ho Shin, Chul Min Ahn, Jung Sun Kim, Byeong Keuk Kim, Young Guk Ko, Donghoon Choi, Myeong Ki Hong, Juhee Park, Hyeyeong Lee, Yoon Jung Choi, Youn Song Choi, Sang Kwon Oh, Yangsoo Jang
BACKGROUND AND OBJECTIVES: Despite the favorable efficacy of new antiplatelet agents demonstrated in randomized controlled trials, their clinical implications in Korea are unclear. The purpose of this study was to investigate trends in antiplatelet agent use for acute myocardial infarction (AMI) and their impact on 30-day clinical outcomes. METHODS: AMI patients undergoing percutaneous coronary intervention between 2010 and 2015 were assessed using claim data from the Health Insurance Review and Assessment Service...
September 12, 2017: Korean Circulation Journal
https://www.readbyqxmd.com/read/28959452/predicting-early-transition-from-sub-syndromal-presentations-to-major-mental-disorders
#19
Shane P M Cross, Jan Scott, Ian B Hickie
BACKGROUND: Transition from at-risk state to full syndromal mental disorders is underexplored for unipolar and bipolar disorders compared with psychosis. AIMS: Prospective, trans-diagnostic study of rates and predictors of early transition from sub-threshold to full syndromal mental disorder. METHOD: One-year outcome of 243 consenting youth aged 15-25 years with a sub-syndromal presentation of a potentially severe mental disorder. Survival analysis and odds ratio (OR) for predictors of transition identified from baseline clinical and demographic ratings...
September 2017: BJPsych Open
https://www.readbyqxmd.com/read/28916371/ramucirumab-plus-docetaxel-versus-placebo-plus-docetaxel-in-patients-with-locally-advanced-or-metastatic-urothelial-carcinoma-after-platinum-based-therapy-range-a-randomised-double-blind-phase-3-trial
#20
Daniel P Petrylak, Ronald de Wit, Kim N Chi, Alexandra Drakaki, Cora N Sternberg, Hiroyuki Nishiyama, Daniel Castellano, Syed Hussain, Aude Fléchon, Aristotelis Bamias, Evan Y Yu, Michiel S van der Heijden, Nobuaki Matsubara, Boris Alekseev, Andrea Necchi, Lajos Géczi, Yen-Chuan Ou, Hasan Senol Coskun, Wen-Pin Su, Miriam Hegemann, Ivor J Percent, Jae-Lyun Lee, Marcello Tucci, Andrey Semenov, Fredrik Laestadius, Avivit Peer, Giampaolo Tortora, Sufia Safina, Xavier Garcia Del Muro, Alejo Rodriguez-Vida, Irfan Cicin, Hakan Harputluoglu, Ryan C Widau, Astra M Liepa, Richard A Walgren, Oday Hamid, Annamaria H Zimmermann, Katherine M Bell-McGuinn, Thomas Powles
BACKGROUND: Few treatments with a distinct mechanism of action are available for patients with platinum-refractory advanced or metastatic urothelial carcinoma. We assessed the efficacy and safety of treatment with docetaxel plus either ramucirumab-a human IgG1 VEGFR-2 antagonist-or placebo in this patient population. METHODS: We did a randomised, double-blind, phase 3 trial in patients with advanced or metastatic urothelial carcinoma who progressed during or after platinum-based chemotherapy...
September 12, 2017: Lancet
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