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https://www.readbyqxmd.com/read/28230450/characteristics-and-medication-use-of-psoriasis-patients-who-may-or-may-not-qualify-for-randomized-controlled-trials
#1
William Malatestinic, Beth Nordstrom, Jashin J Wu, Orin Goldblum, Kathleen Solotkin, Chen-Yen Lin, Kristin Kistler, Kathy Fraeman, Joseph Johnston, Lcdr Lesley Hawley, Nicholas Sicignano, Andre Araujo
BACKGROUND: Clinical trials impose exclusion criteria that may limit the generalizability of results. OBJECTIVES: To (a) determine the percentage of real-world patients who would qualify for psoriasis randomized controlled trials; (b) ascertain differences between moderate-to-severe psoriasis patients who would be eligible, ineligible, or potentially eligible for clinical trials; and (c) compare their biologic treatment patterns. METHODS: Moderate-to-severe psoriasis patients were identified from the U...
March 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28176188/adalimumab-for-treating-moderate-to-severe-hidradenitis-suppurativa-an-evidence-review-group-perspective-of-a-nice-single-technology-appraisal
#2
REVIEW
Paul Tappenden, Christopher Carroll, John W Stevens, Andrew Rawdin, Sabine Grimm, Mark Clowes, Eva Kaltenthaler, John R Ingram, Fiona Collier, Mohammad Ghazavi
As part of its single technology appraisal (STA) process, the UK National Institute for Health and Care Excellence (NICE) invited the manufacturer of adalimumab (AbbVie) to submit evidence on the clinical effectiveness and cost effectiveness of adalimumab for the treatment of moderate-to-severe hidradenitis suppurativa (HS). The appraisal assessed adalimumab as monotherapy in adult patients with an inadequate response to conventional systemic HS therapy. The School of Health and Related Research Technology Appraisal Group was commissioned to act as the independent Evidence Review Group (ERG)...
February 7, 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/28144917/impact-of-adalimumab-on-work-productivity-and-activity-impairment-in-japanese-patients-with-rheumatoid-arthritis-large-scale-prospective-single-cohort-anouveau-study
#3
Tsutomu Takeuchi, Ryo Nakajima, Shuichi Komatsu, Kiyotaka Yamazaki, Tomohiro Nakamura, Naoki Agata, Ataru Igarashi, Toshiro Tango, Yoshiya Tanaka
INTRODUCTION: The Adalimumab Non-interventional Trial for Up-verified Effects and Utility (ANOUVEAU) was a large-scale, multicenter, prospective, observational, single-cohort study that evaluated the effects of adalimumab (ADA) on rheumatoid arthritis (RA)-related work productivity and activity impairment (RA-related WPAI) and disease activity in routine rheumatology care in Japan. METHODS: Patients with RA were categorized as paid workers (PWs, ≥35 h/week), part-time workers (PTWs, <35 h/week), or homemakers (HMs, unemployed) and were administered the WPAI for RA (WPAI/RA) questionnaire...
January 31, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28138560/leukemia-cell-proliferation-and-death-in-chronic-lymphocytic-leukemia-patients-on-therapy-with-the-btk-inhibitor-ibrutinib
#4
Jan A Burger, Kelvin W Li, Michael J Keating, Mariela Sivina, Ahmed M Amer, Naveen Garg, Alessandra Ferrajoli, Xuelin Huang, Hagop Kantarjian, William G Wierda, Susan O'Brien, Marc K Hellerstein, Scott M Turner, Claire L Emson, Shih-Shih Chen, Xiao-Jie Yan, Dominik Wodarz, Nicholas Chiorazzi
BACKGROUND. Ibrutinib is an effective targeted therapy for patients with chronic lymphocytic leukemia (CLL) that inhibits Bruton's tyrosine kinase (BTK), a kinase involved in B cell receptor signaling. METHODS. We used stable isotopic labeling with deuterated water ((2)H2O) to measure directly the effects of ibrutinib on leukemia cell proliferation and death in 30 patients with CLL. RESULTS. The measured average CLL cell proliferation ("birth") rate before ibrutinib therapy was 0.39% of the clone per day (range 0...
January 26, 2017: JCI Insight
https://www.readbyqxmd.com/read/28130434/selective-progesterone-receptor-modulator-sprm-ulipristal-acetate-upa-and-its-effects-on-the-human-endometrium
#5
L H R Whitaker, A A Murray, R Matthews, G Shaw, A R W Williams, P T K Saunders, H O D Critchley
STUDY QUESTION: What is the impact of administration of the selective progesterone receptor modulator (SPRM), ulipristal acetate (UPA) on the endometrium of women with fibroids? SUMMARY ANSWER: UPA administration altered expression of sex-steroid receptors and progesterone-regulated genes and was associated with low levels of glandular and stromal cell proliferation. WHAT IS KNOWN ALREADY: Administration of all SPRM class members results in PAEC (progesterone receptor modulator associated endometrial changes)...
January 26, 2017: Human Reproduction
https://www.readbyqxmd.com/read/28089635/venetoclax-plus-rituximab-in-relapsed-or-refractory-chronic-lymphocytic-leukaemia-a-phase-1b-study
#6
John F Seymour, Shuo Ma, Danielle M Brander, Michael Y Choi, Jacqueline Barrientos, Matthew S Davids, Mary Ann Anderson, Anne W Beaven, Steven T Rosen, Constantine S Tam, Betty Prine, Suresh K Agarwal, Wijith Munasinghe, Ming Zhu, L Leanne Lash, Monali Desai, Elisa Cerri, Maria Verdugo, Su Young Kim, Rod A Humerickhouse, Gary B Gordon, Thomas J Kipps, Andrew W Roberts
BACKGROUND: Selective BCL2 inhibition with venetoclax has substantial activity in patients with relapsed or refractory chronic lymphocytic leukaemia. Combination therapy with rituximab enhanced activity in preclinical models. The aim of this study was to assess the safety, pharmacokinetics, and activity of venetoclax in combination with rituximab. METHODS: Adult patients with relapsed or refractory chronic lymphocytic leukaemia (according to the 2008 Modified International Workshop on CLL guidelines) or small lymphocytic lymphoma were eligible for this phase 1b, dose-escalation trial...
February 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28063066/high-prevalence-of-undiagnosed-axial-spondyloarthritis-in-patients-with-chronic-low-back-pain-consulting-non-rheumatologist-specialists-in-belgium-suspect-study
#7
Laure Tant, Nadine Delmotte, Maria Van den Enden, Valerie Gangji, Herman Mielants
INTRODUCTION: Diagnosis of axial spondyloarthritis (SpA) can be delayed for several years mainly because of low awareness of axial SpA among non-rheumatologists who are the first interlocutors of potential SpA patients. One strategy to decrease the delay between appearance of first symptoms and diagnosis of axial SpA and to allow early management of the disease is to provide the non-rheumatologists with tools to identify patients requiring prompt referral to rheumatologists. This study was designed to evaluate in a real-world setting whether screening patients with chronic low back pain who consult physical medicine and rehabilitation (PMR) physicians, orthopedists, and ophthalmologists is useful in detecting axial SpA...
January 6, 2017: Rheumatology and Therapy
https://www.readbyqxmd.com/read/28025919/amcp-partnership-forum-enabling-the-exchange-of-clinical-and-economic-information-pre-fda-approval
#8
(no author information available yet)
: Current federal laws and FDA regulations have significantly restricted the sharing of clinical and health economic information on biopharmaceuticals that have yet to receive FDA approval. Over the past several years, organizations that make health care coverage decisions, including those that set copayments, premiums, and formulary placement, have expressed a need for receiving this information before approval, as long as appropriate safeguards exist to prevent this information from reaching unintended entities...
January 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/27999526/cme-cne-article-a-framework-of-care-in-multiple-sclerosis-part-1-updated-disease-classification-and-disease-modifying-therapy-use-in-specific-circumstances
#9
Scott D Newsome, Philip J Aliotta, Jacquelyn Bainbridge, Susan E Bennett, Gary Cutter, Kaylan Fenton, Fred Lublin, Dorothy Northrop, David Rintell, Bryan D Walker, Megan Weigel, Kathleen Zackowski, David E Jones
: Activity Available Online: To access the article, post-test, and evaluation online, go to http://www.cmscscholar.org. TARGET AUDIENCE: The target audience for this activity is physicians, physician assistants, nursing professionals, and other health-care providers involved in the management of patients with multiple sclerosis (MS). LEARNING OBJECTIVES: Apply new information about MS to a comprehensive individualized treatment plan for patients with MSIntegrate the team approach into long-term planning in order to optimize rehabilitation care of patients with MSAccreditation Statement: This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the Consortium of Multiple Sclerosis Centers (CMSC), Nurse Practitioner Alternatives (NPA), and Delaware Media Group...
November 2016: International Journal of MS Care
https://www.readbyqxmd.com/read/27970810/economic-evaluation-of-abbvie-s-regimen-viekirax-for-patients-with-genotype-4-hcv-in-greece
#10
C Mylonas, G Kourlaba, A Vernadaki, M Kakouros, N Maniadakis
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/27970806/economic-evaluation-of-abbvie-s-regimen-viekirax-exviera-for-patients-with-genotype-1b-hcv-in-greece
#11
C Mylonas, G Kourlaba, A Vernadaki, M Kakouros, N Maniadakis
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/27970804/economic-evaluation-of-abbvie-s-regimen-viekirax-exviera-for-patients-with-genotype-1a-hcv-in-greece
#12
C Mylonas, G Kourlaba, A Vernadaki, M Kakouros, N Maniadakis
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/27956157/ibrutinib-for-patients-with-rituximab-refractory-waldenstr%C3%A3-m-s-macroglobulinaemia-innovate-an-open-label-substudy-of-an-international-multicentre-phase-3-trial
#13
Meletios A Dimopoulos, Judith Trotman, Alessandra Tedeschi, Jeffrey V Matous, David Macdonald, Constantine Tam, Olivier Tournilhac, Shuo Ma, Albert Oriol, Leonard T Heffner, Chaim Shustik, Ramón García-Sanz, Robert F Cornell, Carlos Fernández de Larrea, Jorge J Castillo, Miquel Granell, Marie-Christine Kyrtsonis, Veronique Leblond, Argiris Symeonidis, Efstathios Kastritis, Priyanka Singh, Jianling Li, Thorsten Graef, Elizabeth Bilotti, Steven Treon, Christian Buske
BACKGROUND: In the era of widespread rituximab use for Waldenström's macroglobulinaemia, new treatment options for patients with rituximab-refractory disease are an important clinical need. Ibrutinib has induced durable responses in previously treated patients with Waldenström's macroglobulinaemia. We assessed the efficacy and safety of ibrutinib in a population with rituximab-refractory disease. METHODS: This multicentre, open-label substudy was done at 19 sites in seven countries in adults aged 18 years and older with confirmed Waldenström's macroglobulinaemia, refractory to rituximab and requiring treatment...
February 2017: Lancet Oncology
https://www.readbyqxmd.com/read/27920089/world-endometriosis-society-consensus-on-the-classification-of-endometriosis
#14
Neil P Johnson, Lone Hummelshoj, G David Adamson, Jörg Keckstein, Hugh S Taylor, Mauricio S Abrao, Deborah Bush, Ludwig Kiesel, Rulla Tamimi, Kathy L Sharpe-Timms, Luk Rombauts, Linda C Giudice
STUDY QUESTION: What is the global consensus on the classification of endometriosis that considers the views of women with endometriosis? SUMMARY ANSWER: We have produced an international consensus statement on the classification of endometriosis through systematic appraisal of evidence and a consensus process that included representatives of national and international, medical and non-medical societies, patient organizations, and companies with an interest in endometriosis...
February 2017: Human Reproduction
https://www.readbyqxmd.com/read/27883347/-adalimumab-as-induction-therapy-for-crohn-s-disease-one-center-study
#15
Maciej Gonciarz, Aldona Mularczyk, Dawid Szkudłapski, Iwona Piątek, Marek Kopała
: Adalimumab is a subcutaneously administered recombinant fully human monoclonal antibody targeting tumor necrosis factor alpha. It has been approved for use in Poland to treat patients with Crohn's disease under the program of Polish National Health Found since 2010. AIM: The aim of this study was to evaluate the efficacy of adalimumab monotherapy for inducing clinical remission in patients with active Crohn's disease . The primary outcome assessment was the reduction in score to 150 or below on the Crohn's Disease Activity Index (CDAI) at 12 weeks and the secondary one was the reduction in ΔCDAI of at least 100 points...
November 25, 2016: Polski Merkuriusz Lekarski: Organ Polskiego Towarzystwa Lekarskiego
https://www.readbyqxmd.com/read/27882832/geographic-variation-in-the-quality-and-cost-of-care-for-patients-with-rheumatoid-arthritis
#16
Jason Shafrin, Arijit Ganguli, Yuri Sanchez Gonzalez, Jin Joo Shim, Seth A Seabury
BACKGROUND: There is considerable push to improve value in health care by simultaneously increasing quality while lowering or containing costs. However, for diseases that are best treated with comparatively expensive treatments, such as rheumatoid arthritis (RA), there could be tension between these aims. In this study, we measured geographic variation in quality, access, and cost for patients with RA, a disease with effective but costly specialty treatments. OBJECTIVE: To assess the geographic differences in the quality, access, and cost of care for patients with RA...
December 2016: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/27864751/defining-the-risk-and-associated-morbidity-and-mortality-of-severe-respiratory-syncytial-virus-infection-among-infants-with-chronic-lung-disease
#17
REVIEW
Bosco Paes, Brigitte Fauroux, Josep Figueras-Aloy, Louis Bont, Paul A Checchia, Eric A F Simões, Paolo Manzoni, Xavier Carbonell-Estrany
INTRODUCTION: The REGAL (RSV evidence-a geographical archive of the literature) series provide a comprehensive review of the published evidence in the field of respiratory syncytial virus (RSV) in Western countries over the last 20 years. This third publication covers the risk and burden of RSV infection in infants with chronic lung disease (CLD), formerly called bronchopulmonary dysplasia (BPD). METHODS: A systematic review was undertaken of publications between January 1, 1995 and December 31, 2015 across PubMed, Embase, The Cochrane Library, and Clinicaltrials...
December 2016: Infectious Diseases and Therapy
https://www.readbyqxmd.com/read/27854054/impact-of-treatment-related-beliefs-on-medication-adherence-in-immune-mediated-inflammatory-diseases-results-of-the-global-align-study
#18
Pierre Michetti, John Weinman, Ulrich Mrowietz, Josef Smolen, Laurent Peyrin-Biroulet, Edouard Louis, Dieter Schremmer, Namita Tundia, Pascal Nurwakagari, Nicole Selenko-Gebauer
INTRODUCTION: Medication adherence is critical in chronic immune-mediated inflammatory diseases (IMIDs) and could be affected by patients' treatment-related beliefs. The objective of this study was to determine beliefs about systemic medications in patients with IMIDs and to explore the association of those beliefs and other factors with adherence. METHODS: This was a multi-country, cross-sectional, self-administered survey study. Included were adults diagnosed with one of six IMIDs receiving conventional systemic medications and/or tumor necrosis factor inhibitors (TNFi)...
January 2017: Advances in Therapy
https://www.readbyqxmd.com/read/27845027/clinical-effectiveness-and-cost-effectiveness-of-use-of-therapeutic-monitoring-of-tumour-necrosis-factor-alpha-tnf-%C3%AE-inhibitors-lisa-tracker%C3%A2-enzyme-linked-immunosorbent-assay-elisa-kits-tnf-%C3%AE-blocker-elisa-kits-and-promonitor%C3%A2-elisa-kits-versus-standard-care
#19
Karoline Freeman, Martin Connock, Peter Auguste, Sian Taylor-Phillips, Hema Mistry, Deepson Shyangdan, Rachel Court, Ramesh Arasaradnam, Paul Sutcliffe, Aileen Clarke
BACKGROUND AND OBJECTIVES: Systematic reviews and economic modelling of clinical effectiveness and cost-effectiveness of therapeutic monitoring of tumour necrosis factor alpha (TNF-α) inhibitors [using LISA-TRACKER(®) enzyme-linked immunosorbent assay (ELISA) kits (Theradiag, Marne La Vallee, France, or Alpha Laboratories, Heriot, UK), TNF-α-Blocker ELISA kits (Immundiagnostik AG, Bensheim, Germany) and Promonitor(®) ELISA kits (Proteomika, Progenika Biopharma, Bizkaia, Spain)] versus standard care for Crohn's disease (CD)...
November 2016: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/27792008/of-patents-and-patent-disputes-the-tnf%C3%AE-patent-files-part-1-humira
#20
Ulrich Storz
This article discusses the patent strategy underlying the world's best selling drug, AbbVie's Humira®. Despite a non-optiimal starting position, AbbVie has established an extensive portfolio to fend off biosimilar competition. This article is the first part of a trilogy that discusses IP issues related to anti-Tumor Necrosis factor α (TNFα) biologics.
October 21, 2016: Human Antibodies
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