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EFFICACY AND SAFETY OF EXPERIMENTAL CHIMERIC ANTIGEN RECEPTOR (CAR) T-CELLS VERSUS AXICABTAGENE CILOLEUCEL (YESCARTA) FOR THE TREATMENT OF RELAPSED/REFRACTORY LARGE B-CELL LYMPHOMA: MATCHING ADJUSTED INDIRECT COMPARISONS AND SYSTEMATIC REVIEW

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Hematology, Transfusion and Cell Therapy 2021年 43卷 S256-S256页

作者： B Weinstein B Muresan S Solano AV Macedo Y Lee Y Su Y Ahn C Camargo G Kim D Carpenter Department of Environmental Health Sciences School of Public Health University at Albany Rensselaer United Kingdom Health Sciences Unit University of Groningen University Medical Center Groningen Groningen The Netherlands Principles and Practice of Clinical Research (PPCR) Program ECPE Harvard T.H. Chan School of Public Health Boston United Kingdom Hematology Clinic Hospital da Polícia Militar Belo Horizonte MG Brazil Department of Pharmaceutical Sciences School of Pharmacy Texas Tech University Health Sciences Center Amarillo United Kingdom Inari Medical Biostatistics and Programming Department Irvine United Kingdom Department of Plastic Surgery Faculdade de Medicina Universidade de São Paulo (FMUSP) São Paulo SP Brazil Institute of Experimental and Clinical Pharmacology and Toxicology Faculty of Medicine University of Freiburg Freiburg Germany Institute for Health and the Environment University at Albany Rensselaer United Kingdom

Introduction Despite the high response rates seen with Chimeric Antigen Receptor (CAR) T-cell therapy for relapsed/refractory Large B-cell lymphoma (R/R LBCL), post-therapy relapse remains a key challenge. To date, no study has evaluated the comparative efficacy and safety of experimental CAR T-cell products versus currently approved CAR T-cell therapies. Objective To indirectly compare the efficacy and safety of novel, experimental CAR T-cell products against the first FDA-approved CAR T-cell construct, Axicabtagene ciloleucel (Yescarta). Methods In compliance with the PRISMA guidelines, we performed a systematic review, which identified 16 independent, early-phase clinical trials consisting of 193 LBCL patients with individual patient data (IPD). We categorized eight pooled populations based on the target antigens (CD19, CD20), co-stimulatory domains (CD28, 4-1BB), and CAR T-cells administered with or without concomitant autologous stem cell transplant (ASCT). The pooled populations were categorized as follows: (1) dual targeting strategies, such as tandem ***20, n = 28; (2) co-infusion of CD19 and CD20 CARs, n = 21; (3) third-generation CARs, n = 26; (4) CD19 CARs with modified constructs for reduced toxicity, including ***.86, n = 21; and (5) ***828Z, n = 14; (6) CD19. 4-1BB.S manufactured in China, n = 24; (7) concomitant ASCT and ***28, n = 45; and (8) CD20 CARs with a 4-1BB co-stimulatory domain, n = 14. A Matching Adjusted Indirect Comparison (MAIC) statistical technique was applied to account for heterogeneity in the study population across trials. Estimates for the experimental CAR T-cell trials were adjusted using patient-level data to match the ZUMA-1 (Yescarta, n = 108) study population based on mutually reported key baseline covariates, including age, disease stage, histology, refractoriness, number of prior lines of therapy, and extranodal disease. The study endpoints for this study included progression-free survival (PFS), cytokine r

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2376. Incidence ofClostridioides difficileInfection Among United States Medicare Advantage Enrollees

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Open Forum Infectious Diseases 2019年第SUPPLEMENT_2期6卷 S819–S820页

作者： Heinrich, Kirstin Emir, Birol Ivanova, Jasmina Zhou, Jingying Yu, Holly Health Economics and Outcomes Research Pfizer Inc. Collegeville Pennsylvania Biostatistics Pfizer Inc. New York New York Real-World Data and Analytics Pfizer Inc. New York New York Statistical Programming Pfizer Inc. New York New York Outcome Research Heath Economics Pfizer Inc. Collegeville Pennsylvania

Background Clostridioides difficile infection (CDI) may be life-threatening, and individuals aged ≥ 65 years are at increased risk. CDI burden among Medicare fee-for-service enrollees and nursing home residents in the United States have been characterized previously. The present study aimed to describe the incidence of CDI among Medicare Advantage Enrollees (MAEs), who account for 34% of all Medicare beneficiaries with enrollment increasing annually since 2004. Methods De-identified claims data for this retrospective cohort study were collected from the Optum® Clinformatics® Data Mart and included MAEs aged ≥ 65 years with continuous enrollment for ≥ 1 year before January 1, 2016, followed through death or disenrollment. CDI incidence was defined using the International Classification of Diseases 9th Revision diagnosis code of 008.45 or 10th Revision code of A04.7 (other than admitting diagnosis) or by treatment with nontopical metronidazole, oral vancomycin, or fidaxomicin within 14 days of CDI test. Incident CDI cases were identified from January 1 to December 31, 2016, and required that no CDI occurred within the previous 60 days in 2016. Incidence in 2016 was calculated as CDI cases and CDI patients per 100,000 person-years (PY) of observation time. Results Of 2,542,341 MAEs analyzed, 15,201 patients (0.6%) experienced a total of 18,842 incident CDI episodes. Overall, incidence rates were 762.8 CDI cases and 616.5 CDI patients per 100,000 PY. Incidence increased with age (539.6, 847.3, and 1259.6 cases per 100,000 PY in patients aged 65‒74 years, 75‒84 years, and ≥ 85 years, respectively). Most episodes (50.9%) were community acquired; the remaining 37.7% and 11.4% of episodes were hospital acquired and indeterminate, respectively. CDI patients were more likely than non-CDI patients to be older (mean age, 78.3 vs. 76.1 years, P < 0.0001), be women (64.5% vs. 58.1%, P < 0.0001), or have comorbidities (mean Charlson comorbidity index score, 4.5 vs. 1.8, P < 0.0001

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K-groups: A generalization of k-means clustering

arXiv

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arXiv 2017年

作者： Li, Songzi Rizzo, Maria L. Biostatistics and Programming Department Pharmaceutical Product Deparment LLC WilmingtonNC28401 Dept. of Mathematics & Statistics Bowling Green State University Bowling GreenOH43403 United States

We propose a new class of distribution-based clustering algorithms, called k-groups, based on energy distance between samples. The energy distance clustering criterion assigns observations to clusters according to a multi-sample energy statistic that measures the distance between distributions. The energy distance determines a consistent test for equality of distributions, and it is based on a population distance that characterizes equality of distributions. The k-groups procedure therefore generalizes the k-means method, which separates clusters that have different means. We propose two k-groups algorithms: k-groups by first variation;and k-groups by second variation. The implementation of k-groups is partly based on Hartigan and Wong's algorithm for k-means. The algorithm is generalized from moving one point on each iteration (first variation) to moving m (m > 1) points. For univariate data, we prove that Hartigan and Wong's k-means algorithm is a special case of k-groups by first variation. The simulation results from univariate and multivariate cases show that our k-groups algorithms perform as well as Hartigan and Wong's k-means algorithm when clusters are well-separated and normally distributed. Moreover, both k-groups algorithms perform better than k-means when data does not have a finite first moment or data has strong skewness and heavy tails. For non-spherical clusters, both k-groups algorithms performed better than k-means in high dimension, and k-groups by first variation is consistent as dimension increases. In a case study on dermatology data with 34 features, both k-groups algorithms performed better than k-means. Copyright © 2017, The Authors. All rights reserved.

关键词： Cluster analysis

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277MO SAR439859, an oral selective estrogen receptor (ER) degrader (SERD), in ER+/ HER2- metastatic breast cancer (mBC): Biomarker analyses from a phase I/II study

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Annals of Oncology 2020年 31卷 S351-S351页

作者： S. Chandarlapaty A. Bardia S. Lord H. Linden V. Pelekanou N. Ternes J. Ming V. Boutet E. Boitier A. Gosselin J. Sang Lee W. Dos-Santos Bele A. Protopopov M. Celanovic A-L. Bauchet M. Campone Medicine Memorial Sloan Kettering Cancer Center New York NY USA Medical Oncology Massachusetts General Hospital Harvard Medical School Boston MA USA Department of Oncology University of Oxford Churchill Hospital Oxford UK Department of Medicine University of Washington Medical Center Seattle WA USA Clinical Precision Oncology-Tranlsational Medicine Early Development Sanofi Cambridge MA USA Biostatistics and Programming Sanofi Paris France Oncology Sanofi Bridgewater NJ USA TMED & Biomarkers & Clinical Bioanalyses Sanofi Paris France Precision Oncology Sanofi Cambridge MA USA Molecular Profiling Precision Oncology Sanofi Paris France Oncology-OMD Sanofi Cambridge MA USA Medical Oncology Institut de Cancérologie de l'Ouest Saint-Herblain France

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069 High baseline serum IL-6 identifies a subgroup of rheumatoid arthritis patients with rapid joint damage and clinical progression and predicts increased sarilumab treatment response

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Rheumatology 2019年第SUPPLEMENT_3期58卷

作者： Boyapati, Anita Msihid, Jérôme Schwartzman, Sergio Choy, Ernest Burmester, Gerd R Lam, Gordon Kimura, Toshio Sadeh, Jonathan Graham, Neil M H Precision Medicine Regeneron Pharmaceuticals Inc. Tarrytown NY Biostatistics and Programming Sanofi Chilly-Mazarin FRANCE Rheumatology Hospital for Special Surgery New York NY CREATE Center Cardiff University School of Medicine Cardiff UNITED KINGDOM Rheumatology and Clinical Immunology Charité University Medicine Berlin GERMANY Rheumatology Atrium Health Charlotte NC Medical Analytics Regeneron Pharmaceuticals Inc. Tarrytown NY Immunology and Inflammation Franchise Sanofi Genzyme Bridgewater NJ Immunology and Inflammation Regeneron Pharmaceuticals Inc. Tarrytown NY

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Performance evaluation of practice courses using fuzzy cognitive maps

Performance evaluation of practice courses using fuzzy cogni...

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International Conference on Information Technology Based Higher Education and Training, ITHET

作者： Ahmet Albayrak Muammer Albayrak Department of Computer Programming Karadeniz Technical University Trabzon Turkey Department of Biostatistics and Medical Informatics Karadeniz Technical University Trabzon Turkey

ISBN: (纸本)9781509007790

In this study, the effect of practical courses (especially robotics) on students' success is evaluated using fuzzy cognitive maps. This study particularly focuses on how practical courses increase the learning achievements in vocational schools. For this purpose, students and academicians were chosen as stakeholders for this study. Student were selected from departments of machine, electronic and computer. In total views of 30 students were taken and evaluated using fuzzy cognitive maps before the study. Students were studied on three projects within this study. These projects are autonomous cleaning robot, chameleon robot and sumo wrestler robot. Each robot was developed by a group consisting of ten students. Three main outputs determined to be gained by students in the robot development process as sensor calibration, improvement of mechanical systems and software optimization. These outputs are also among the output concepts of the fuzzy cognitive map. Sensor calibration, improvement of the mechanical systems and optimization of the software are the critical tasks respectively for the student groups of electronics, machine and computer. Each student group shared students of their departments homogeneously. Academicians were selected as one from each department. Fuzzy cognitive maps' survey applied to 15 academicians. After the design and development processes of robots, students and academicians views re-evaluated. It was observed clearly from the comparison of the results that, learning achievement, desire to learn, desire to interdisciplinary collaboration, self-confidence, interest in robotic technologies, satisfaction and desire to give priority to practical training in other subjects are increased by %45, %63, %42, %74, %85, %88 and %76 respectively.

关键词： Mathematical model Robot sensing systems Fuzzy cognitive maps Training Stakeholders

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222 Efficacy of sarilumab in patients with rheumatoid arthritis who previously received sarilumab or tocilizumab

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Rheumatology 2018年第SUPPL_3期57卷

作者： Emery, Paul van Hoogstraten, Hubert Jayawardena, Shyamalie Mangan, Erin Cejas, Paula Verschueren, Patrick Leeds Institute of Rheumatic and Musculoskeletal Medicine University of Leeds Leeds UNITED KINGDOM Global Medical Affairs Sanofi Genzyme Bridgewater NJ USA Biostatistics and Programming Sanofi Bridgewater NJ USA Medical Affairs Regeneron Pharmaceuticals Inc. Tarrytown NY USA Reumatología Hospital Quirónsalud Infanta Luisa Sevilla SPAIN Division of Rheumatology University Hospital Leuven Leuven BELGIUM.

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215 Efficacy of sarilumab in combination with csDMARDs in patients with rheumatoid arthritisand inadequate response to TNF inhibitors by baseline levels of diseaseactivity

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Rheumatology 2018年第SUPPL_3期57卷

作者： Fleischmann, Roy van Hoogstraten, Hubert Jayawardena, Shyamalie Mangan, Erin K Ching, Daniel Burmester, Gerd R Metroplex Clinical Research Center University of Texas Southwestern Medical Center Dallas TX USA Global Medical Affairs Sanofi Genzyme Bridgewater NJ USA Biostatistics and Programming Sanofi Bridgewater NJ USA Medical Affairs Regeneron Pharmaceuticals Inc Tarrytown NY USA Timaru Medical Specialists Ltd Altoona Center for Clinical Research Timaru NEW ZEALAND Department of Rheumatology and Clinical Immunology Charité - University Medicine Berlin Berlin GERMANY

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214 Efficacy and safety of switching from adalimumab to sarilumab in an open-label extensionof a phase III monotherapy trial in patients with active rheumatoid arthritis

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Rheumatology 2018年第SUPPL_3期57卷

作者： Burmester, Gerd R Fiore, Stefano Hu, Chih-Chi Fay, Jon Lee, Eun Bong Genovese, Mark C Department of Rheumatology and Clinical Immunology Charité—University Medicine Berlin Berlin GERMANY US Global Medical Affairs Sanofi Genzyme Bridgewater NJ USA Biostatistics and Programming Sanofi Bridgewater NJ USA Medical Affairs Regeneron Pharmaceuticals Inc. Tarrytown NY USA Division of Rheumatology Department of Internal Medicine Seoul National University College of Medicine Seoul KOREA REPUBLIC OF Rheumatology Department Stanford University Medical Center Palo Alto CA USA

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Adaptive design and timeline prediction for cardiovascular event trials for a non-inferiority/superiority claim

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Communications in Statistics Case Studies Data Analysis and Applications 2015年第2期1卷 71-84页

作者： Quan, Hui Mao, Xuezhou Wu, Yujun Cho, Meehyung Zhao, Peng-Liang Zhang, Ji Bauer, Deborah Biostatistics and Programming Sanofi Bridgewater NJ United States

Cardiovascular event trials can be designed to allow adaptation based on interim results. In this article, we first discuss a strategy either to accept noninferiority at an interim analysis or to continue the study to establish superiority. We demonstrate the overall type I error rate control even when the nominal significance level is applied to both assessments based on two different datasets. We also develop methodology for using blinded interim data for timeline prediction via the conditional probability for a future event given available information using a piecewise exponential distribution. A cardiovascular trial is used to illustrate the methods. © 2015, © 2015 Taylor & Francis.

关键词： Adaptive design conditional probability hazard rate intent-to-treat study duration

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