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Apalutamide for patients with metastatic castrationsensitive prostate cancer in East Asia:a subgroup analysis of the TITAN trial

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Asian Journal of Andrology 2022年第2期24卷 161-166页

作者： Byung Ha Chung Jian Huang Zhang-Qun Ye Da-Lin He Hirotsugu Uemura Gaku Arai Choung Soo Kim Yuan-Yuan Zhang Yusoke Koroki SuYeon Jeong Suneel Mundle Spyros Triantos Sharon McCarthy Kim N Chi Ding-Wei Ye Department of Urology Gangnam Severance HospitalYonsei University College of Medicine211 Eonju-roGangnam-guSeoul 135-271Korea Sun Yat-Sen Memorial Hospital Sun Yat-sen UniversityGuangzhou 510120China Wuhan Tongji Hospital Tongji Medical CollegeWuhan 430030China First Affiliated Hospital of Xi’an Jiaotong University Xi’an 719054China Kindai University Hospital Ōsakasayama 589-8511Japan Dokkyo medical University Saitama medical Center Saitama 2-1-50Japan Asian medical Center University of UlsanSeoul 138-040Korea janssen medical affairs Department Beijing 100025China janssen medical affairs Department Tokyo 101-0065Japan janssen medical affairs Department Seoul 140-012Korea janssen Global medical affairs Department HorshamPA 08869USA janssen Research and Development Spring HousePA 19477USA janssen Research and Development RaritanNJ 08869USA BC Cancer and Vancouver Prostate Centre VancouverBC V5Z 1G1Canada Fudan University Shanghai Cancer Center Shanghai 200032China

Ethnicity might be associated with treatment outcomes in advanced prostate *** study aimed to evaluate the efficacy and safety of androgen deprivation therapy(ADT)combined with apalutamide in East Asians with metastatic castration-sensitive prostate cancer(mCSPC).The original phase 3 Targeted Investigational Treatment Analysis of Novel Anti-androgen(TITAN)trial was conducted at 260 sites in 23 *** subgroup analysis included patients enrolled in 62 participating centers in China,Japan,and *** progression-free survival(PFS),time to prostate-specific antigen(PSA)progression,and PSA changes from baseline were compared between groups in the East Asian *** intent-to-treat East Asian population included 111 and 110 participants in the apalutamide and placebo groups,*** 24-month radiographic PFS rates were 76.1%and 52.3%in the apalutamide and placebo groups,respectively(apalutamide vs placebo:hazard ratio[HR]=0.506;95%confidence interval[CI],0.302–0.849;P=0.009).Median time to PSA progression was more favorable with apalutamide than placebo(HR=0.210;95%CI,0.124–0.357;P<0.001).Median maximum percentages of PSA decline from baseline were 99.0%and 73.9%in the apalutamide and placebo groups,*** most common adverse event(AE)was rash in the apalutamide group,with a higher rate than that in the placebo group(37.3%vs 9.1%).The most common grade 3 or 4 AEs were rash(12[10.9%])and hypertension(12[10.9%])for *** efficacy and safety of apalutamide in the East Asian subgroup of the TITAN trial are consistent with the global results.

关键词： apalutamide East Asia metastasis prostatic neoplasm survival

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Factors associated with success of telaprevir-and boceprevir-based triple therapy for hepatitis C virus infection

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World Journal of Hepatology 2017年第11期9卷 551-561页

作者： Kian Bichoupan Neeta Tandon Valerie Martel-Laferriere Neal M Patel David Sachs Michel Ng Emily A Schonfeld Alexis Pappas James Crismale Alicia Stivala Viktoriya Khaitova Donald Gardenier Michael Linderman William Olson Ponni V Perumalswami Thomas D Schiano Joseph A Odin Lawrence U Liu Douglas T Dieterich Andrea D Branch Division of Liver Diseases Icahn School of Medicine at Mount Sinai Icahn Medical Instititute janssen Pharmaceuticals Com-panies Division of Janssen Scientific Affairs Inc. Genetics and Genomics Icahn School of Medicine at Mount Sinai

AIM To evaluate new therapies for hepatitis C virus(HCV), data about real-world outcomes are *** Outcomes of 223 patients with genotype 1 HCV who started telaprevir-or boceprevir-based triple therapy(May 2011-March 2012) at the Mount Sinai medical Center were analyzed. Human immunodeficiency viruspositive patients and patients who received a liver transplant were excluded. Factors associated with sustained virological response(SVR24) and relapse were analyzed by univariable and multivariable logistic regression as well as classification and regression trees. Fast virological response(FVR) was defined as undetectable HCV RNA at week-4(telaprevir) or week-8(boceprevir). RESULTS The median age was 57 years, 18% were black, 44% had advanced fibrosis/cirrhosis(FIB-4 ≥ 3.25). Only 42%(94/223) of patients achieved SVR24 on an intention-totreat basis. In a model that included platelets, SVR24 was associated with white race [odds ratio(OR) = 5.92, 95% confidence interval(CI): 2.34-14.96], HCV sub-genotype 1b(OR = 2.81, 95%CI: 1.45-5.44), platelet count(OR = 1.10, per x 104 cells/μL, 95%CI: 1.05-1.16), and IL28 B CC genotype(OR = 3.54, 95%CI: 1.19-10.53). Platelet counts > 135 x 103/μL were the strongest predictor of SVR by classification and regression tree. Relapse occurred in 25%(27/104) of patients with an end-oftreatment response and was associated with non-FVR(OR = 4.77, 95%CI: 1.68-13.56), HCV sub-genotype 1a(OR = 5.20; 95%CI: 1.40-18.97), and FIB-4 ≥ 3.25(OR = 2.77; 95%CI: 1.07-7.22). CONCLUSION The SVR rate was 42% with telaprevir-or boceprevirbased triple therapy in real-world practice. Low platelets and advanced fibrosis were associated with treatment failure and relapse.

关键词：持续 virologic 反应丙肝病毒恶化 Telaprevir Boceprevir 三倍治疗分类和回归不利事件真实世界

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Apalutamide for metastatic castration-sensitive prostate cancer:final analysis of the Asian subpopulation in the TITAN trial

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Asian Journal of Andrology 2023年第6期25卷 653-661页

作者： Byung Ha Chung Jian Huang Hiroji Uemura Young Deuk Choi Zhang-Qun Ye Hiroyoshi Suzuki Taek Won Kang Da-Lin He Jae Young Joung Sabine D Brookman-May Sharon McCarthy Amitabha Bhaumik Anildeep Singh Suneel Mundle Simon Chowdhury Neeraj Agarwal Ding-Wei Ye Kim N Chi Hirotsugu Uemura Gangnam Severance Hospital Yonsei University College of MedicineSeoul 06273South Korea Sun Yat-Sen Memorial Hospital Sun Yat-Sen UniversityGuangzhou 510123China Yokohama City University medical Center Minami-kuYokohamaKanagwa 232-0024Japan Severance Hospital Yonsei University College of MedicineSeoul 03722South Korea Tongji Hospital Tongji Medical CollegeHuazhong University of Science and TechnologyWuhan 430030China Toho University Sakura medical Center Chiba 285-0841Japan Chonnam National University Hospital and medical School Gwangju 61469South Korea Department of Urology The First Affiliated Hospital of Xi’an Jiaotong UniversityXi’an 710061China Prostate Cancer Center National Cancer CenterGoyang 10408South Korea janssen Research and Development Spring HousePA 19002USA Ludwig Maximilians University Munich 80539Germany janssen Research and Development RaritanNJ 08869USA janssen medical affairs Asia PacificSingapore 118222Singapore Guy’s and St Thomas’NHS Foundation Trust London SE14YBUK University of Utah Huntsman Cancer Institute Salt Lake CityUT 84112USA Fudan University Shanghai Cancer Center Shanghai 200032China Vancouver Prostate Centre University of British ColumbiaVancouverBritish Columbia V6H 3Z6Canada Kindai University Faculty of MedicineOsaka-Sayama 589-8511Japan

The final analysis of the phase 3 Targeted Investigational Treatment Analysis of Novel Anti-androgen(TITAN)trial showed improvement in overall survival(OS)and other efficacy endpoints with apalutamide plus androgen deprivation therapy(ADT)versus ADT alone in patients with metastatic castration-sensitive prostate cancer(mCSPC).As ethnicity and regional differences may affect treatment outcomes in advanced prostate cancer,a post hoc final analysis was conducted to assess the efficacy and safety of apalutamide in the Asian ***-driven endpoints were OS,and time from randomization to initiation of castration resistance,prostate-specific antigen(PSA)progression,and second progression-free survival(PFS2)on first subsequent therapy or *** endpoints were assessed using the Kaplan–Meier method and Cox proportional-hazards models without formal statistical testing and adjustment for *** Asian patients received once-daily apalutamide 240 mg(n=111)or placebo(n=110)plus *** a median follow-up of 42.5 months and despite crossover of 47 placebo recipients to open-label apalutamide,apalutamide reduced the risk of death by 32%(hazard ratio[HR]:0.68;95%confidence interval[CI]:0.42–1.13),risk of castration resistance by 69%(HR:0.31;95%CI:0.21–0.46),PSA progression by 79%(HR:0.21;95%CI:0.13–0.35)and PFS2 by 24%(HR:0.76;95%CI:0.44–1.29)relative to *** outcomes were comparable between subgroups with low-and high-volume disease at *** new safety issues were *** provides valuable clinical benefits to Asian patients with mCSPC,with an efficacy and safety profile consistent with that in the overall patient population.

关键词： apalutamide Asia event-driven analysis metastatic castration-sensitive prostate cancer overall survival

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Long-Term Clinical Outcome of Patients Using Risperidone Long-Acting Injectable: The Romanian e-STAR Database

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Open Journal of Psychiatry 2015年第2期5卷 153-164页

作者： Ioana Micluţia Madalina Vrabie Roxana Ciungu Department of Neurosciences Discipline of Psychiatry“Iuliu Hatieganu”University of Medicine&PharmacyEmergency County Hospital ClujSecond Psychiatric ClinicCluj-NapocaRomania medical affairs JanssenDivision of Johnson&Johnson RomaniaBucharestRomania

The objectives of e-STAR Romania (NCT00283517) were to collect clinical outcome data of Romania schizophrenia or schizo-affective disorder patients;prospectively to assess the reasons of treatment initiation, medication usage patterns;to document (long-term) clinical efficacy;and to collect safety data, as well as recording 2-year corresponding retrospective data. In total, 378 eligible subjects were enrolled who were initiated either on risperidone long-acting injectable (RLAI) (290) or on an oral antipsychotic (OA) (88) at baseline as required by the local Summary of the Product Characteristics. Data were collected from per patient both retrospectively and prospectively over a 24-month period at 3-month intervals after starting treatment. The results indicated that subjects suffering from schizophrenia or schizo-affective disorder initiated on RLAI were less likely to be hospitalized within the first 24 months after the initiation of treatment. Moreover, subjects treated with RLAI experienced significant improvements in their illness severity and functioning. Discontinuation rates for RLAI were low and doses were stable throughout the 24 months following the initiation of treatment. In addition, the necessity for supplementary concomitant medication was reduced. Adverse events were reported in 20.3% (RLAI) and 11.4% (OA) of the subjects. In general, patients initiated on RLAI and OA at baseline both clinically improved on all assessed parameters but a larger improvement was observed for patients on RLAI. Incidences of reported AEs during the use of RLAI in a naturalistic setting are comparable with those described in clinical studies;however, the incidence of extrapyramidal signs and weight gain was lower than expected.

关键词： Schizophrenia Registry Risperidone Long-Acting Injectable Hospitalizations Clinical Outcome Safety

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Real-world cure rates for hepatitis C virus treatments that include simeprevir and/or sofosbuvir are comparable to clinical trial results

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World Journal of Virology 2017年第4期6卷 59-72页

作者： Kian Bichoupan Neeta Tandon James F Crismale Joshua Hartman David Del Bello Neal Patel Sweta Chekuri Alyson Harty Michel Ng Keith M Sigel Meena B Bansal Priya Grewal Charissa Y Chang Jennifer Leong Gene Y Im Lawrence U Liu Joseph A Odin Nancy Bach Scott L Friedman Thomas D Schiano Ponni V Perumalswami Douglas T Dieterich Andrea D Branch Division of Liver Diseases Icahn School of Medicine at Mount Sinai janssen Scientific affairs LLC Division of General Internal Medicine Icahn School of Medicine at Mount Sinai

AIM To assess the real-world effectiveness and cost of simeprevir(SMV), and/or sofosbuvir(SOF)-based therapy for chronic hepatitis C virus(HCV) *** The real-world performance of patients treated with SMV/SOF ± ribavirin(RBV), SOF/RBV, and SOF/RBV with pegylated-interferon(PEG) were analyzed in a consecutive series of 508 patients with chronic HCV infection treated at a single academic medical center. Patients with genotypes 1 through 4 were included. Rates of sustained virological response-the absence of a detectable serum HCV RNA 12 wk after the end of treatment [sustained virological response(SVR) 12]-were calculated on an intention-to-treat basis. Costs were calculated from the payer's perspective using Medicare/Medicaid fees and Redbook Wholesale Acquisition Costs. Patient-related factors associated with SVR12 were identified using multivariable logistic *** SVR 12 rates were as follows: 86%(95%CI: 80%-91%)among 178 patients on SMV/SOF ± RBV; 62%(95%CI: 55%-68%) among 234 patients on SOF/RBV; and 78%(95%CI: 68%-86%) among 96 patients on SOF/PEG/RBV. Mean costs-per-SVR 12 were $174442(standard deviation: ± $18588) for SMV/SOF ± RBV; $223003(± $77946) for SOF/RBV; and $126496(± $31052) for SOF/PEG/RBV. Among patients on SMV/SOF ± RBV, SVR12 was less likely in patients previously treated with a protease inhibitor [odds ratio(OR): 0.20, 95%CI: 0.06-0.56]. Higher bilirubin(OR: 0.47, 95%CI: 0.30-0.69) reduced the likelihood of SVR12 among patients on SOF/RBV, while FIB-4 score ≥ 3.25 reduced the likelihood of SVR 12(OR: 0.18, 95%CI: 0.05-0.59) among those on SOF/PEG/RBV. CONCLUSION SVR 12 rates for SMV and/or SOF-based regimens in a diverse real-world population are comparable to those in clinical trials. Treatment failure accounts for 27% of costs.

关键词： Cirrhosis Cost Sustained virological response Protease inhibitor Polymerase inhibitor

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Understanding risk of thrombosis with thrombocytopenia syndrome after ***2.S vaccination

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Frontiers of Medicine 2021年第6期15卷 938-941页

作者： Prathit A.Kulkarni Vinay Prasad Infectious Diseases Section Department of MedicineBaylor College of MedicineHoustonTX77030USA medical Care Line Michael E.DeBakey Veterans Affairs Medical CenterHoustonTX77030USA Department of Epidemiology and Biostatistics School of MedicineUniversity of California-San FranciscoSan FranciscoCA94143USA

On April 13,2021,the US Centers for Disease Control and Prevention(CDC)and the US Food and Drug Administration(FDA)recommended a pause in administration of the ***2.S(Johnson&Johnson[janssen])coronavirus disease 2019(COVID-19)vaccine for all persons[1].At that time,approximately 6.8 million doses of vaccine had been administered around the United *** pause was prompted by 6 cases of cerebral venous sinus thrombosis(CVST)in combination with thrombocytopenia,a condition whose nomenclature is in flux but which we will refer to as thrombosis with thrombocytopenia syndrome(TTS),as used by CDC in describing the condition[2].All patients were women younger than 50 *** note,2 of 6 patients also had splanchnic and portal vein thrombosis.

关键词： thrombosis vaccine doses

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Control strategy and methods for continuous direct compression processes

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Asian Journal of Pharmaceutical Sciences 2021年第2期16卷 253-262页

作者： Yasuhiro Suzuki Hirokazu Sugiyama Manabu Kano Ryutaro Shimono Gosuke Shimada Ryoichi Furukawa Eichi Mano Keiichi Motoyama Tatsuo Koide Yasuhiro Matsui Kazuki Kurasaki Issei Takayama Shunin Hikage Noriko Katori Masahiko Kikuchi Hiroshi Sakai Yoshihiro Matsuda Formulation Technology Research Laboratories Daiichi Sankyo Co.Ltd.Kanagawa 254-0014Japan Department of Chemical System Engineering The University of TokyoTokyo 113-8656Japan Department of Systems Science Kyoto UniversityKyoto 606-8501Japan CMC Sciences Department Regulatory Affairs DivisionR&D DivisionJanssen Pharmaceutical K.K.Tokyo 101-0065Japan EuroTechno Ltd. Kanagawa 223-0057Japan Pharmaceutical Research Department Mitsubishi Tanabe Pharma CorporationOsaka 532-8505Japan Chemical Products CMC Regulatory Affairs Area Japan DevelopmentMSD K.K.Tokyo 102-8667Japan Graduate School of Pharmaceutical Sciences Kumamoto UniversityKumamoto 862-0973Japan Division of Drugs National Institute of Health SciencesKawasaki 210-9501Japan Technology Research&Development Sumitomo Dainippon Pharma Co.Ltd.Osaka 564-0053Japan Formulation Development Department Chugai pharmaceutical Co.Ltd.Tokyo 115-8543Japan Office of New Drug IV Pharmaceuticals and Medical Devices AgencyShin-Kasumigaseki Bldg.Tokyo 100-0013Japan Office of Generic Drugs Pharmaceuticals and Medical Devices AgencyShin-Kasumigaseki Bldg.Tokyo 100-0013Japan KOKANDO Co. Ltd.Toyama 930-8580Japan Pharmaceuticals and medical Devices Agency Shin-Kasumigaseki Bldg.Tokyo 100-0013Japan

We presented a control strategy for tablet manufacturing processes based on continuous direct *** work was conducted by the experts of pharmaceutical companies,machine suppliers,academia,and regulatory authority in *** different items in the process,the component ratio and blended powder content were selected as the items requiring the control method specific to continuous manufacturing different from the conventional batch *** control and management of the Loss in Weight(LIW)feeder were deemed the most important,and the Residence Time Distribution(RTD)model were regarded effective for setting the control range and for controlling of the LIW *** on these ideas,the concept of process control using RTD was summarized.

关键词： Continuous manufacturing Solid drug products Process control Residence time distribution Loss in weight feeder Regulatory science

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A Controlled Study on the Effect of Preoperative Nutritional Assessment and Intervention on the Clinical Efficacy of Patients with Esophageal Cancer

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Advances in Modern Oncology Research 2019年第6期5卷 15-19页

作者： Jaeho Cho Dr Sc Hum Department of Cardiovascular and Metabolism-medical affairs Janssen Pharmaceuticals Inc.New JerseyUSA Former Director General of Agricultural Research System Pakistan

The purpose of this study was to analyze the effect of preoperative nutritional assessment and intervention on the clinical efficacy of patients with esophageal ***,110 patients with esophageal cancer admitted to our hospital from December 2014 to December 2016 were selected,including 78 males and 27 female were randomly selected as the observation group and control *** the observation group,26 cases received nutritional support,22 cases did not receive nutritional support,15 cases in the control group,47 cases did not receive nutritional *** non-protein calories were no less than 41.8kj•kg-1•***(PAB),transferrin(TRF)and albumin(ALB)were tested before,1 and 5 days after ***,IgG and IgM were detected by immunosuspension *** cytometry was used to detect CD3 and *** incidence of postoperative complications(incision infection,pulmonary infection,anastomotic fistula,chylothorax,bleeding,esophagotracheal fistula,cardiovascular complications,and digestive tract diseases)was *** results showed that 48 patients(43.64%)in the observation group had nutritional risk(≥3 points),while 62 patients(56.36%)in the control group had no nutritional risk(0.05)postoperative indicators showed that all indicators continued to *** level of immune factors in the nutrition support group was higher than 1 day before surgery and close to the preoperative *** indicated that effective preoperative nutritional support for esophageal cancer patients with nutritional risk can inhibit the decomposition of immunoglobulin,which is conducive to the recovery of postoperative immune function and improve the tolerance of the body to comprehensive tumor *** the sam

关键词： Esophageal cancer Nutritional support Complications

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Recent developments in neuropsychological endophenotypes for schizophrenia: Development of the MATRICS battery, liability syndromes and the near future

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Chinese Science Bulletin 2011年第32期56卷 3385-3393页

作者： STONE William S HSI Xiaolu Department of Psychiatry Massachusetts Mental Health Center Division of Beth Israel Deaconess Medical Center Harvard Medical School Boston MA 02115-6092 USA MIT medical Massachusetts Institute of Technology (MIT) Cambridge MA 02139 USA

Cognitive deficits are now recognized widely as core features of schizophrenia, and as major contributors to the clinical outcome of the disorder. They are also studied widely as 'endophenotypes', reflecting a growing consensus that schizophrenia is a broader, more multidimensional illness than the diagnostic criteria required for its formal diagnosis. This evolving view of cognition underlies its utilization in recent initiatives for intervention and assessment in schizophrenia. Two of these initiatives are reviewed in this paper. The first focuses on the development and validation of the MATRICS Cognitive Consensus Battery, a standardized battery of neuropsychological tests developed to assess the effectiveness of cognitive enhancing treatments in schizophrenia. A part of this effort includes the identification of performance-based, 'co-primary' measures of functional capacity that are related to cognition, and that are likely to show improvement at least partly as a function of improved cognition. The second initiative involves efforts to utilize neuropsychological deficits in the identification, validation and remediation of a liability syndrome for schizophrenia ('schizotaxia'). The discussion of this effort focuses on the development of a syndrome that is both measurable and meaningful clinically, and that may provide useful intervention targets. The utilization of cognition in both of these initiatives underscores its functional importance in the clinical outcome of schizophrenia. Moreover, it helps to illuminate indicators of liability for schizophrenia that might be amenable to remediation.

关键词：精神分裂症心理测验综合征电池神经稳定责任认知功能

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Ustekinumab versus adalimumab for induction and maintenance therapy in biologic-naive patients with moderately to severely active Crohn's disease:a multicentre,randomised,double-blind,parallel-group,phase 3b trial

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四川生理科学杂志 2022年第5期44卷 940-940页

作者： Bruce E Sands Dr Henry D Janowitz Division of Gastroenterology Icahn School of Medicine at Mount Sinai New York NY USA Department of Gastroenterology Guy's and St Thomas’ NHS Foundation Trust London UK School of Immunology and Microbial Sciences King's College London London UK Immunology Global medical affairs Janssen Pharmaceutical Companies of Johnson & Johnson Horsham PA USA janssen Scientific affairs Horsham PA USA Gastroenterology Department Hôpital Saint-Louis Assistance Publique-Hôpitaux de Paris (AP-HP) INSERM U1160 Université de Paris Paris France Gastroenterology and Endoscopy IRCCS Ospedale San Raffaele and Università Vita-Salute San Raffaele Milan Italy Northwestern University Feinberg School of Medicine Chicago IL USA Division of Gastroenterology Department of Medicine University Hospital London ON Canada Division of Epidemiology and Biostatistics Western University London ON Canada Department of Internal Medicine Gastroenterology Diabetology Hemato-Oncology and Palliative Medicine Medius Clinic Nuertingen Nürtingen Germany Perelman School of Medicine at the University of Pennsylvania Philadelphia PA USA Division of Gastroenterology and Hepatology Mayo Clinic College of Medicine and Science Rochester MN USA Department of Internal Medicine and Hematology Semmelweis University Budapest Hungary Inflammatory Bowel Disease Unit Division of Gastroenterology and Hepatology University of Calgary Calgary AB Canada Weill Department of Medicine New York Presbyterian Hospital Weill Cornell Medicine New York NY USA Division The City Center for IBD Diagnosis and Treatment Saint Petersburg State Budgetary Health Institution City Clinical Hospital 31 Saint Petersburg Russia

Background:Active-comparator trials are important to inform patient and physician *** aimed to evaluate the efficacy and safety of monotherapy with either ustekinumab or adalimumab in biologic-naive patients with mode... 详细信息

关键词： patients centre moderately

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