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Takao Koike, Masayoshi Harigai, Naoki Ishiguro, Shigeko Inokuma, Syuji Takei, Tsutomu Takeuchi, Hisashi Yamanaka, Yoshinari Takasaki, Tsuneyo Mimori, Katsutoshi Hiramatsu, Shuichi Komatsu, Yoshiya Tanaka
INTRODUCTION: There is insufficient evidence regarding the appropriate dose of methotrexate (MTX) required to achieve specific treatment goals in patients with rheumatoid arthritis (RA) receiving biologic drugs in Japan. The present study aimed to assess the dose-response effect of MTX in combination with adalimumab (ADA) to achieve low disease activity (LDA) and/or remission at 24 weeks in RA patients. METHODS: This analysis used data of the ADA all-case survey in Japan (n = 7740), and 5494 patients who received ADA and MTX were classified into five groups by weighted average MTX dose (>0-<4, 4-<6, 6-<8, 8-< 10, and ≥10 mg/week)...
June 2016: Rheumatol Ther
Satoko Hayashi, Katsuya Suzuki, Keiko Yoshimoto, Masaru Takeshita, Takahiko Kurasawa, Kunihiro Yamaoka, Tsutomu Takeuchi
INTRODUCTION: Early prognostic factors for the clinical response in patients with rheumatoid arthritis (RA) after 1 year of treatment with infliximab (IFX) as part of routine clinical practice were investigated. METHODS: Thirty-five patients with RA with an inadequate response to methotrexate were enrolled and administered IFX (3-9 mg/kg, every 4-8 weeks). Serum trough levels of IFX and levels of 9 cytokines were measured at baseline and at 3, 6 months, and 1 year...
June 2016: Rheumatol Ther
Marco Mula, Josemir W Sander
SUMMARY: Epilepsy is one of the most serious neurological conditions and has an impact not only on the affected individual but also on the family and, indirectly, on the community. A global approach to the individual must take into account cognitive problems, psychiatric comorbidities and all psychosocial complications that often accompany epilepsy. We discuss psychosocial issues in epilepsy with special focus on the relationship between stigma and psychiatric comorbidities. Social barriers to optimal care and health outcomes for people with epilepsy result in huge disparities, and the public health system needs to invest in awareness programmes to increase public knowledge and reduce stigma in order to minimise such disparities...
July 2016: BJPsych Open
Patrick Schöffski, Sant Chawla, Robert G Maki, Antoine Italiano, Hans Gelderblom, Edwin Choy, Giovanni Grignani, Veridiana Camargo, Sebastian Bauer, Sun Young Rha, Jean-Yves Blay, Peter Hohenberger, David D'Adamo, Matthew Guo, Bartosz Chmielowski, Axel Le Cesne, George D Demetri, Shreyaskumar R Patel
BACKGROUND: A non-randomised, phase 2 study showed activity and tolerability of eribulin in advanced or metastatic soft-tissue sarcoma. In this phase 3 study, we aimed to compare overall survival in patients with advanced or metastatic soft-tissue sarcoma who received eribulin with that in patients who received dacarbazine (an active control). METHODS: We did this randomised, open-label, phase 3 study across 110 study sites in 22 countries. We enrolled patients aged 18 years or older with intermediate-grade or high-grade advanced liposarcoma or leiomyosarcoma who had received at least two previous systemic regimens for advanced disease (including an anthracycline)...
April 16, 2016: Lancet
Rob McMurray, Pasquale Striano
INTRODUCTION: Management of Lennox-Gastaut syndrome (LGS) in adulthood can be particularly challenging. Published reports describing the use of rufinamide specifically in adult patients with LGS are scarce. A post hoc subgroup analysis of data from a phase III trial was conducted to investigate the efficacy and safety/tolerability of rufinamide in adults with LGS. METHODS: A randomized, double-blind, placebo-controlled trial was conducted in patients with LGS, aged 4 years and above...
June 2016: Neurology and Therapy
Makoto Asada
The Pharmaceutical Industry is expected to play a proactive global role in combatting neglected tropical diseases (NTDs) and other tropical diseases affecting low-income countries. Such a role would include novel medicine R&D, manufacturing and distribution. In order to succeed in this role, several challenges need to be overcome: a) the economic challenge or cost benefit balance for the development of these medicines, and b) sparse in-house experience with these diseases within the Industry. During the last decade, the Product Development Partnership (PDP) model has become an effective strategy to address such challenges...
2016: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
Ana Bella de la Calle Gil, Isaac Peña Vergara, María Auxiliadora Cormane Bornacelly, Antonio Pajuelo Gallego
INTRODUCTION: Studies have shown that, at low doses and with careful titration, combination therapy with intrathecal ziconotide and morphine results in rapid control of opioid-refractory cancer pain. However, there is a lack of published data regarding the efficacy and safety of intrathecal ziconotide specifically for the treatment of neuropathic cancer pain. CASE SERIES: Case reports of ziconotide intrathecal infusion in eight patients (age 45-71 years; 75% male) with chronic, uncontrolled cancer pain during therapy with intrathecal morphine plus bupivacaine were reviewed...
December 2015: Neurology and Therapy
Robert J Motzer, Thomas E Hutson, Hilary Glen, M Dror Michaelson, Ana Molina, Timothy Eisen, Jacek Jassem, Jakub Zolnierek, Jose Pablo Maroto, Begoña Mellado, Bohuslav Melichar, Jiri Tomasek, Alton Kremer, Han-Joo Kim, Karen Wood, Corina Dutcus, James Larkin
BACKGROUND: Currently, metastatic renal cell carcinoma is treated with sequential single agents targeting VEGF or mTOR. Here, we aimed to assess lenvatinib, everolimus, or their combination as second-line treatment in patients with metastatic renal cell carcinoma. METHODS: We did a randomised, phase 2, open-label, multicentre trial at 37 centres in five countries and enrolled patients with advanced or metastatic, clear-cell, renal cell carcinoma. We included patients who had received treatment with a VEGF-targeted therapy and progressed on or within 9 months of stopping that agent...
November 2015: Lancet Oncology
Jörg Tomeczkowski, Ansgar Lange, Andreas Güntert, Pushpike Thilakarathne, Joris Diels, Liang Xiu, Peter De Porre, Christoph Tapprich
INTRODUCTION: Among patients with acute myeloid leukemia (AML), the DACO-016 randomized study showed reduction in mortality for decitabine [Dacogen(®) (DAC), Eisai Inc., Woodcliff Lake, NJ, USA] compared with treatment choice (TC): at primary analysis the hazard ratio (HR) was 0.85 (95% confidence interval 0.69-1.04; stratified log-rank P = 0.108). With two interim analyses, two-sided alpha was adjusted to 0.0462. With 1-year additional follow-up the HR reached 0.82 (nominal P = 0.0373)...
September 2015: Advances in Therapy
Abhilasha Nair, Steven J Lemery, Jun Yang, Anshu Marathe, Liang Zhao, Hong Zhao, Xiaoping Jiang, Kun He, Gaetan Ladouceur, Amit K Mitra, Liang Zhou, Emily Fox, Stephanie Aungst, Whitney Helms, Patricia Keegan, Richard Pazdur
The FDA approved lenvatinib (Lenvima, Eisai Inc.) for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory (RAI-refractory) differentiated thyroid cancer (DTC). In an international, multicenter, double-blinded, placebo-controlled trial (E7080-G000-303), 392 patients with locally recurrent or metastatic RAI-refractory DTC and radiographic evidence of disease progression within 12 months prior to randomization were randomly allocated (2:1) to receive either lenvatinib 24 mg orally per day (n = 261) or matching placebo (n = 131) with the option for patients on the placebo arm to receive lenvatinib following independent radiologic confirmation of disease progression...
December 1, 2015: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Jacqueline A French, Gregory L Krauss, Robert T Wechsler, Xue-Feng Wang, Bree DiVentura, Christian Brandt, Eugen Trinka, Terence J O'Brien, Antonio Laurenza, Anna Patten, Francesco Bibbiani
OBJECTIVE: To assess efficacy and safety of adjunctive perampanel in patients with drug-resistant, primary generalized tonic-clonic (PGTC) seizures in idiopathic generalized epilepsy (IGE). METHODS: In this multicenter, double-blind study ( identifier: NCT01393743; funded by Eisai Inc.), patients 12 years or older with PGTC seizures and IGE were randomized to placebo or perampanel during a 4-week titration period (perampanel up titrated from 2 to 8 mg/d, or highest tolerated dose) and 13-week maintenance period...
September 15, 2015: Neurology
Kazuo Hotta, Jun Ueyama, Yasuaki Tatsumi, Ikuto Tsukiyama, Yuka Sugiura, Hiroko Saito, Katsuhiko Matsuura, Takaaki Hasegawa
We investigated whether hepatic multidrug resistance-associated protein 2 (ABCC2) is involved in the hepatobiliary excretion of regorafenib, a novel multi-kinase inhibitor, using Sprague-Dawley (SD) rats and Eisai hyperbilirubinemic rats (EHBR) lacking the efflux transporter ABCC2. The involvement of organic anion-transporting polypeptide 1 (OATP1; OATP in humans) and OATP2 in the hepatic uptake of regorafenib and their protein levels in the liver were also investigated in the two rat groups. When regorafenib (5 mg/kg) was administered intravenously, the plasma concentrations of regorafenib were higher in EHBR than those in SD rats...
September 2015: Anticancer Research
Rachel Grossman, Peter Burger, Ethan Soudry, Betty Tyler, Kaisorn L Chaichana, Jon Weingart, Alessandro Olivi, Gary L Gallia, David Sidransky, Alfredo Quiñones-Hinojosa, Xiaobu Ye, Henry Brem
We examined the relationship between the O(6)-methylguanine-methyltransferase (MGMT) methylation status and clinical outcomes in newly diagnosed glioblastoma multiforme (GBM) patients who were treated with Gliadel wafers (Eisai, Tokyo, Japan). MGMT promoter methylation has been associated with increased survival among patients with GBM who are treated with various alkylating agents. MGMT promoter methylation, in DNA from 122 of 160 newly diagnosed GBM patients treated with Gliadel, was determined by a quantitative methylation-specific polymerase chain reaction, and was correlated with overall survival (OS) and recurrence-free survival (RFS)...
December 2015: Journal of Clinical Neuroscience: Official Journal of the Neurosurgical Society of Australasia
Heii Arai, Kenta Sumitomo, Yukinori Sakata, Kasumi Daidoji, Takao Takase, Tetsumi Toyoda
BACKGROUND: There have been very few long-term studies involving a large study population; existing studies usually have no more than a few hundred patients with Alzheimer's disease. For these reasons, there are no detailed investigations regarding changes in activities of daily living evaluated by the Functional Assessment Staging Test (FAST). METHODS: A long-term, large-scale observational study of donepezil hydrochloride (Aricept(®); Eisai Co., Ltd, Tokyo, Japan) is currently in progress...
March 2016: Psychogeriatrics: the Official Journal of the Japanese Psychogeriatric Society
Gary R Morrow, Lee Schwartzberg, Sally Y Barbour, Gianluca Ballinari, Michael D Thorn, David Cox
BACKGROUND: No clinical standard currently exists for the optimal management of nausea induced by emetogenic chemotherapy, 7particularly delayed nausea. OBJECTIVES: To compare the effcacy and safety of palonosetron with older 5-HT3 receptor antagonists (RAs) in preventing chemotherapy-induced nausea. METHODS: Data were pooled from 4 similarly designed multicenter, randomized, double-blind, clinical trials that compared single intravenous doses of palonosetron 0...
July 2014: Journal of Community and Supportive Oncology
Lesley J Scott
Lenvatinib (Lenvima™) is a multitargeted receptor kinase inhibitor that inhibits the kinase activities of vascular endothelial-derived growth factor receptors 1, 2 and 3, fibroblast growth factor receptors 1, 2, 3 and 4, platelet-derived growth factor receptor α, RET and KIT. In addition to their role in normal cellular function, these kinases have been implicated in pathogenic angiogenesis, tumour growth and cancer progression. Lenvatinib is being developed by Eisai Co. Ltd for the treatment of solid tumours, primarily for differentiated thyroid cancer, and other malignancies...
April 2015: Drugs
Martin Schlumberger, Makoto Tahara, Lori J Wirth, Bruce Robinson, Marcia S Brose, Rossella Elisei, Mouhammed Amir Habra, Kate Newbold, Manisha H Shah, Ana O Hoff, Andrew G Gianoukakis, Naomi Kiyota, Matthew H Taylor, Sung-Bae Kim, Monika K Krzyzanowska, Corina E Dutcus, Begoña de las Heras, Junming Zhu, Steven I Sherman
BACKGROUND: Lenvatinib, an oral inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, fibroblast growth factor receptors 1 through 4, platelet-derived growth factor receptor α, RET, and KIT, showed clinical activity in a phase 2 study involving patients with differentiated thyroid cancer that was refractory to radioiodine (iodine-131). METHODS: In our phase 3, randomized, double-blind, multicenter study involving patients with progressive thyroid cancer that was refractory to iodine-131, we randomly assigned 261 patients to receive lenvatinib (at a daily dose of 24 mg per day in 28-day cycles) and 131 patients to receive placebo...
February 12, 2015: New England Journal of Medicine
Keigo Kosaka, Tomoko Watanabe, Takeshi Susukida, Shigeki Aoki, Shuichi Sekine, Toshiyuki Kume, Kousei Ito
1. Raloxifene-6-glucuronide (R6G) is a substrate of rat multidrug resistance-associated protein 2 (Mrp2), a transporter responsible for biliary excretion of organic anions. 2. Pharmacokinetic modeling of R6G in Eisai hyperbilirubinemic rats (EHBRs), hereditary Mrp2-deficient rats, and wild-type Sprague-Dawley rats (SDRs) indicated that reduction in not only biliary excretion but also hepatic uptake of R6G influenced low clearance in EHBRs. 3. An integration plot study demonstrated that the hepatic uptake of R6G was 66% lower in EHBRs than that in SDRs...
2015: Xenobiotica; the Fate of Foreign Compounds in Biological Systems
Philip N Patsalos
The clinical pharmacology profile of a drug critically determines its therapeutics, and this review summarizes the characteristics associated with the antiepileptic drug (AED) perampanel. A PubMed literature search was performed for perampanel. Congress abstract data are included where necessary and Eisai Ltd provided access to unpublished data on file. After oral ingestion, perampanel is rapidly absorbed and peak plasma concentrations occur 0.5-2.5 h later; its bioavailability is ~100%. Although the rate of perampanel absorption is slowed by food co-ingestion, the extent absorbed remains unchanged; therefore, perampanel can be administered without regard to meal times...
January 2015: Epilepsia
Janette Greenhalgh, Adrian Bagust, Angela Boland, James Oyee, Nicola Trevor, Sophie Beale, Yenal Dundar, Juliet Hockenhull, Chris Proudlove, Susan O'Reilly
The National Institute for Health and Care Excellence (NICE) invited the manufacturer of eribulin (Eisai Ltd) to submit evidence for the clinical and cost effectiveness of eribulin as treatment for patients with locally advanced or metastatic breast cancer (LABC/MBC) pre-treated with at least two chemotherapy regimens. This article summarizes the review of evidence by the Evidence Review Group (ERG) and provides a summary of the NICE Appraisal Committee's (AC's) decision. The clinical evidence was derived from a multi-centred, open-label, randomized, phase III study comparing eribulin with treatment of physician's choice (TPC) in 762 patients with LABC/MBC...
February 2015: PharmacoEconomics
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