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https://www.readbyqxmd.com/read/28025919/amcp-partnership-forum-enabling-the-exchange-of-clinical-and-economic-information-pre-fda-approval
#1
(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/28017406/bortezomib-with-lenalidomide-and-dexamethasone-versus-lenalidomide-and-dexamethasone-alone-in-patients-with-newly-diagnosed-myeloma-without-intent-for-immediate-autologous-stem-cell-transplant-swog-s0777-a-randomised-open-label-phase-3-trial
#2
Brian G M Durie, Antje Hoering, Muneer H Abidi, S Vincent Rajkumar, Joshua Epstein, Stephen P Kahanic, Mohan Thakuri, Frederic Reu, Christopher M Reynolds, Rachael Sexton, Robert Z Orlowski, Bart Barlogie, Angela Dispenzieri
BACKGROUND: Lenalidomide plus dexamethasone is a reference treatment for patients with newly diagnosed myeloma. The combination of the proteasome inhibitor bortezomib with lenalidomide and dexamethasone has shown significant efficacy in the setting of newly diagnosed myeloma. We aimed to study whether the addition of bortezomib to lenalidomide and dexamethasone would improve progression-free survival and provide better response rates in patients with previously untreated multiple myeloma who were not planned for immediate autologous stem-cell transplant...
December 22, 2016: Lancet
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
#3
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/27752999/azacitidine-for-treating-acute-myeloid-leukaemia-with-more-than-30%C3%A2-bone-marrow-blasts-an-evidence-review-group-perspective-of-a-national-institute-for-health-and-care-excellence-single-technology-appraisal
#4
Irina A Tikhonova, Martin W Hoyle, Tristan M Snowsill, Chris Cooper, Joanna L Varley-Campbell, Claudius E Rudin, Ruben E Mujica Mota
The National Institute for Health and Care Excellence (NICE) invited the manufacturer of azacitidine (Celgene) to submit evidence for the clinical and cost effectiveness of this drug for the treatment of acute myeloid leukaemia with more than 30 % bone marrow blasts in adults who are not eligible for haematopoietic stem cell transplantation, as part of the NICE's Single Technology Appraisal process. The Peninsula Technology Assessment Group was commissioned to act as the Evidence Review Group (ERG). The ERG produced a critical review of the evidence contained within the company's submission to NICE...
October 17, 2016: PharmacoEconomics
https://www.readbyqxmd.com/read/27747516/psoriatic-arthritis-and-burden-of-disease-patient-perspectives-from-the-population-based-multinational-assessment-of-psoriasis-and-psoriatic-arthritis-mapp-survey
#5
Arthur Kavanaugh, Philip Helliwell, Christopher T Ritchlin
INTRODUCTION: Psoriatic arthritis (PsA) is underdiagnosed and has a substantial impact on quality of life, disability, and work productivity. The population-based Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) survey examined the impact of PsA on patients' activities of daily living and unmet treatment needs. METHODS: This large-scale, random digit dialing, telephone survey of patients self-reporting a diagnosis of psoriasis and/or PsA was conducted in North America and Europe...
June 2016: Rheumatology and Therapy
https://www.readbyqxmd.com/read/27606446/jounce-checkpoint-lures-celgene
#6
(no author information available yet)
No abstract text is available yet for this article.
September 8, 2016: Nature Biotechnology
https://www.readbyqxmd.com/read/27590615/pruritus-reduction-with-systemic-anti-lymphoma-treatments-in-patients-with-cutaneous-t-cell-lymphoma-a-narrative-review
#7
REVIEW
Halle Field, Ling Gao, Pooja Motwani, Henry K Wong
: Cutaneous T-cell lymphomas (CTCL) are a heterogeneous and relatively rare group of non-Hodgkin lymphomas arising from neoplastic skin-homing memory T cells. There is no known cure for CTCL, and current treatments focus on achieving and maintaining remission, controlling symptoms, limiting toxicities and maintaining or improving quality of life. Patients with CTCL often suffer from pruritus (itching), which can be debilitating and can have a significant impact on physical well-being and quality of life...
December 2016: Dermatology and Therapy
https://www.readbyqxmd.com/read/27503082/patients-perspective-of-medication-adherence-in-chronic-conditions-a-qualitative-study
#8
Neus Pagès-Puigdemont, Maria Antònia Mangues, Montserrat Masip, Giovanna Gabriele, Laura Fernández-Maldonado, Sergi Blancafort, Laura Tuneu
INTRODUCTION: About 50% of patients do not take their long-term therapy for chronic conditions as prescribed. Many studies have centered on patients' adherence to a specific treatment or single conditions, but few have taken all chronic conditions into consideration from a patient's perspective. This study aims to explore factors that impact on drug compliance and to identify strategies to improve this from the perspective of patients with at least one chronic condition. METHODS: Patients were recruited by healthcare professionals from a hospital pharmacy, four community pharmacies, patient associations, and a primary care center in Barcelona...
October 2016: Advances in Therapy
https://www.readbyqxmd.com/read/27459662/estimating-the-economic-impact-of-adding-panobinostat-to-a-u-s-formulary-for-relapsed-and-or-refractory-multiple-myeloma-a-budget-impact-and-cost-benefit-model
#9
Lisa Bloudek, Anuja Roy, Jonathan K Kish, David S Siegel, Sundar Jagannath, Denise Globe, Laurie Orloski, Emil T Kuriakose
BACKGROUND: Multiple myeloma is an incurable B-cell malignancy with a natural history that involves alternating periods of remission and subsequent relapse. For relapsed and/or refractory multiple myeloma (RRMM), the typical patient currently receives more lines of therapy than has been feasible in the past, translating into longer progression-free survival (PFS). Consequently, cost issues have become more prominent because patients may be offered newer and more expensive therapies during a more prolonged overall treatment course...
August 2016: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/27263779/discovery-of-the-target-for-immunomodulatory-drugs-imids
#10
Takumi Ito, Hideki Ando, Hiroshi Handa
Half a century ago, the sedative thalidomide caused a serious drug disaster because of its teratogenicity and was withdrawn from the market. However, thalidomide, which has returned to the market, is now used for the treatment of leprosy and multiple myeloma (MM) under strict control. The mechanism of thalidomide action had been a long-standing question. We developed a new affinity bead technology and identified cereblon (CRBN) as a thalidomide-binding protein. We found that CRBN functions as a substrate receptor of an E3 cullin-Ring ligase complex 4 (CRL4) and is a primary target of thalidomide teratogenicity...
May 2016: [Rinshō Ketsueki] the Japanese Journal of Clinical Hematology
https://www.readbyqxmd.com/read/27085323/nab-paclitaxel-plus-gemcitabine-versus-gemcitabine-in-patients-with-metastatic-pancreatic-adenocarcinoma-canadian-subgroup-analysis-of-the-phase-3-mpact-trial
#11
Mustapha Tehfe, Scot Dowden, Hagen Kennecke, Robert El-Maraghi, Bernard Lesperance, Felix Couture, Richard Letourneau, Helen Liu, Alfredo Romano
INTRODUCTION: The phase III MPACT trial in patients with metastatic pancreatic cancer (MPC) demonstrated superior efficacy of nab-paclitaxel (nab-P) plus gemcitabine (Gem) compared with Gem monotherapy, including the primary endpoint of overall survival (OS; median 8.7 vs. 6.6 months; hazard ratio [HR] 0.72; P < 0.001). A significant treatment difference favoring nab-P + Gem over Gem was observed for OS in patients treated in North America. The majority of patients were from the US (88%) with only 12% from Canada...
May 2016: Advances in Therapy
https://www.readbyqxmd.com/read/27034790/patient-and-caregiver-awareness-of-pancreatic-cancer-treatments-and-clinical-trials
#12
Anitra Engebretson, Lynn Matrisian, Cara Thompson
BACKGROUND: The poor prognosis of pancreatic cancer has been well established. For many patients, active treatments can improve patient outcomes, such as overall survival and symptom control. Nevertheless, there is evidence that pancreatic cancer is undertreated, even in patients with resectable disease. In addition, although participation in a clinical trial is recommended by current pancreatic cancer treatment guidelines, recent data suggest that patient participation in ongoing trials is below overall target accrual...
April 2016: Journal of Gastrointestinal Oncology
https://www.readbyqxmd.com/read/27023693/patient-characteristics-health-care-resource-utilization-and-costs-associated-with-treatment-regimen-failure-with-biologics-in-the-treatment-of-psoriasis
#13
Shonda A Foster, Baojin Zhu, Jiaying Guo, Enkeleida Nikai, Clement Ojeh, William Malatestinic, Orin Goldblum, Lori J Kornberg, Jashin J Wu
BACKGROUND: Psoriasis is a chronic, incurable, and immune-mediated skin disorder that is characterized by erythematous scaly papules and plaques. Understanding of psoriasis at the molecular level has led to the development of biologic agents that target disease-specific inflammatory mediators in psoriatic lesions. Biologic agents have become important components of the psoriasis armamentarium, but some patients become refractory to these agents over time or fail to respond to subsequent biologics...
April 2016: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/26947199/lenalidomide-in-relapsed-adult-t-cell-leukaemia-lymphoma-or-peripheral-t-cell-lymphoma-atll-001-a-phase-1-multicentre-dose-escalation-study
#14
Michinori Ogura, Yoshitaka Imaizumi, Naokuni Uike, Norio Asou, Atae Utsunomiya, Toshiki Uchida, Tomohiro Aoki, Kunihiro Tsukasaki, Jun Taguchi, Ilseung Choi, Dai Maruyama, Kisato Nosaka, Nianhang Chen, Shuichi Midorikawa, Tomoko Ohtsu, Kensei Tobinai
BACKGROUND: Patients with adult T-cell leukaemia-lymphoma have few treatment options after relapse and poor survival outcomes with current therapies. We aimed to determine the maximum tolerated dose of lenalidomide, an oral immunomodulator, in Japanese patients with relapsed adult T-cell leukaemia-lymphoma and other peripheral T-cell lymphomas. METHODS: In this phase 1 study, we enrolled patients aged 20 years or older with Eastern Cooperative Oncology Group performance status 0-2, documented diagnosis of aggressive adult T-cell leukaemia-lymphoma or other peripheral T-cell lymphoma subtypes, and at least one previous antilymphoma therapy...
March 2016: Lancet Haematology
https://www.readbyqxmd.com/read/26899778/lenalidomide-versus-investigator-s-choice-in-relapsed-or-refractory-mantle-cell-lymphoma-mcl-002-sprint-a-phase-2-randomised-multicentre-trial
#15
RANDOMIZED CONTROLLED TRIAL
Marek Trněný, Thierry Lamy, Jan Walewski, David Belada, Jiri Mayer, John Radford, Wojciech Jurczak, Franck Morschhauser, Julia Alexeeva, Simon Rule, Boris Afanasyev, Kamil Kaplanov, Antoine Thyss, Alexej Kuzmin, Sergey Voloshin, Kazimierz Kuliczkowski, Agnieszka Giza, Noel Milpied, Caterina Stelitano, Reinhard Marks, Lorenz Trümper, Tsvetan Biyukov, Meera Patturajan, Marie-Laure Casadebaig Bravo, Luca Arcaini
BACKGROUND: Lenalidomide, an immunomodulatory drug with antineoplastic and antiproliferative effects, showed activity in many single-group studies in relapsed or refractory mantle cell lymphoma. The aim of this randomised study was to examine the efficacy and safety of lenalidomide versus best investigator's choice of single-agent therapy in relapsed or refractory mantle cell lymphoma. METHODS: The MCL-002 (SPRINT) study was a randomised, phase 2 study of patients with mantle cell lymphoma aged 18 years or older at 67 clinics and academic centres in 12 countries who relapsed one to three times, had Eastern Cooperative Oncology Group performance status of 0-2, at least one measurable lesion to be eligible, and who were ineligible for intensive chemotherpy or stem-cell transplantation...
March 2016: Lancet Oncology
https://www.readbyqxmd.com/read/26869049/nab-paclitaxel-versus-solvent-based-paclitaxel-in-neoadjuvant-chemotherapy-for-early-breast-cancer-geparsepto-gbg-69-a-randomised-phase-3-trial
#16
RANDOMIZED CONTROLLED TRIAL
Michael Untch, Christian Jackisch, Andreas Schneeweiss, Bettina Conrad, Bahriye Aktas, Carsten Denkert, Holger Eidtmann, Hermann Wiebringhaus, Sherko Kümmel, Jörn Hilfrich, Mathias Warm, Stefan Paepke, Marianne Just, Claus Hanusch, John Hackmann, Jens-Uwe Blohmer, Michael Clemens, Silvia Darb-Esfahani, Wolfgang Daniel Schmitt, Serban Dan Costa, Bernd Gerber, Knut Engels, Valentina Nekljudova, Sibylle Loibl, Gunter von Minckwitz
BACKGROUND: In metastatic breast cancer, nab-paclitaxel has been shown to significantly increase progression-free survival compared with solvent-based paclitaxel. The GeparSepto (GBG 69) trial assessed whether weekly nab-paclitaxel could increase the proportion of patients achieving pathological complete response compared with weekly solvent-based paclitaxel, both followed by epirubicin plus cyclophosphamide as neoadjuvant treatment. METHOD: In a phase 3 randomised trial, we enrolled patients with previously untreated unilateral or bilateral primary invasive breast cancer and randomly assigned them in a 1:1 ratio using dynamic allocation and Pocock minimisation by breast cancer subtype, Ki67 and SPARC expression...
March 2016: Lancet Oncology
https://www.readbyqxmd.com/read/26801772/the-effectiveness-of-an-educational-brochure-as-a-risk-minimization-activity-to-communicate-important-rare-adverse-events-to-health-care-professionals
#17
Nicolette Bester, Michelle Di Vito-Smith, Theresa McGarry, Michael Riffkin, Stefan Kaehler, Richard Pilot, Robert Bwire
INTRODUCTION: Educational brochures are an important tool for communicating risk to health-care professionals. It is important to evaluate the impact of any risk minimization tool to understand the effectiveness of the strategy. The objective of this study was to assess the effectiveness (i.e., respondents' awareness and understanding of the communication) of a targeted educational brochure distributed to health-care professionals (HCPs) as a risk minimization strategy for the communication of new rare and important adverse events (AEs)...
February 2016: Advances in Therapy
https://www.readbyqxmd.com/read/26687958/combination-of-romidepsin-with-cyclophosphamide-doxorubicin-vincristine-and-prednisone-in-previously-untreated-patients-with-peripheral-t-cell-lymphoma-a-non-randomised-phase-1b-2-study
#18
Jehan Dupuis, Franck Morschhauser, Hervé Ghesquières, Hervé Tilly, Olivier Casasnovas, Catherine Thieblemont, Vincent Ribrag, Céline Bossard, Fabien Le Bras, Emmanuel Bachy, Bénédicte Hivert, Emmanuelle Nicolas-Virelizier, Fabrice Jardin, Jean-Noel Bastie, Sandy Amorim, Julien Lazarovici, Antoine Martin, Bertrand Coiffier
BACKGROUND: Romidepsin is a histone deacetylase inhibitor approved in the USA for patients with recurrent or refractory peripheral T-cell lymphoma and has shown activity in this setting with mainly haematological and gastrointestinal toxicity. Although it has limited efficacy, cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy is widely used for treatment of de-novo peripheral T-cell lymphoma. We aimed to assess the safety, tolerability, and activity of romidepsin combined with CHOP in patients with previously untreated disease...
April 2015: Lancet Haematology
https://www.readbyqxmd.com/read/26687423/sequential-azacitidine-and-lenalidomide-in-patients-with-high-risk-myelodysplastic-syndromes-and-acute-myeloid-leukaemia-a-single-arm-phase-1-2-study
#19
Courtney D DiNardo, Naval Daver, Elias Jabbour, Tapan Kadia, Gautam Borthakur, Marina Konopleva, Naveen Pemmaraju, Hui Yang, Sherry Pierce, William Wierda, Carlos Bueso-Ramos, Keyur P Patel, Jorge E Cortes, Farhad Ravandi, Hagop M Kantarjian, Guillermo Garcia-Manero
BACKGROUND: The standard of care for myelodysplastic syndromes is hypomethylating agents such as azacitidine. However, responses to azacitidine are generally temporary, and outcomes after hypomethylating agent failure are dismal. Therefore, the development of more effective treatments is crucial to improve outcomes in patients with myelodysplastic syndromes. We aimed to assess azacitidine and lenalidomide in patients with high-risk myelodysplastic syndromes and acute myeloid leukaemia...
January 2015: Lancet Haematology
https://www.readbyqxmd.com/read/26659916/impact-of-renal-impairment-on-outcomes-with-lenalidomide-and-dexamethasone-treatment-in-the-first-trial-a-randomized-open-label-phase-3-trial-in-transplant-ineligible-patients-with-multiple-myeloma
#20
RANDOMIZED CONTROLLED TRIAL
Meletios A Dimopoulos, Matthew C Cheung, Murielle Roussel, Ting Liu, Barbara Gamberi, Brigitte Kolb, H Guenter Derigs, HyeonSeok Eom, Karim Belhadj, Pascal Lenain, Richard Van der Jagt, Sophie Rigaudeau, Mamoun Dib, Rachel Hall, Henry Jardel, Arnaud Jaccard, Axel Tosikyan, Lionel Karlin, William Bensinger, Rik Schots, Nicolas Leupin, Guang Chen, Jennifer Marek, Annette Ervin-Haynes, Thierry Facon
Renal impairment is associated with poor prognosis in myeloma. This analysis of the pivotal phase 3 FIRST trial examined the impact of renally adapted dosing of lenalidomide and dexamethasone on outcomes of patients with different degrees of renal impairment. Transplant-ineligible patients not requiring dialysis were randomized 1:1:1 to receive continuous lenalidomide and dexamethasone until disease progression (n=535) or for 18 cycles (72 weeks; n=541), or melphalan, prednisone, and thalidomide for 12 cycles (72 weeks; n=547)...
March 2016: Haematologica
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