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OnabotulinumtoxinA improves spasticity related pain in post-stroke patients: Findings from a randomized controlled trial

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Annals of Physical and Rehabilitation Medicine 2014年 57卷 e44-e44页

作者： Wissel, J. Ganapathy, V. Ma, Y. Ward, A. Borg, J. Ertzgaard, P. Fulford-Smith, A. Gillard, P. Neurological Rehabilitation Department of Neurology Vivantes Klinkum Spandau Berlin Germany Global Health Outcomes Strategy and Research Allergan Inc Irvine CA USA Biostatistics & Programming Allergan Inc Bridgewater NJ USA North Staffordshire Rehabilitation Centre Haywood Hospital Stoke on Trent UK Department of Clinical Sciences Karolinska Institutet Rehabilitation Medicine Danderyd Hospital Stockholm Sweden Department of Rehabilitation Medicine Linköping University Linköping Sweden Allergan Ltd Marlow International The Parkway Marlow Buckinghamshire UK

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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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Réponse thérapeutique, tolérance et sécurité d’emploi du palmitate de palipéridone à dose flexible : une étude prospective chez des patients adultes non-aigus atteints de schizophrénie, après échec d’un traitement par antipsychotiques oraux

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European Psychiatry 2013年第8期28卷 107-107页

作者： Vidailhet, P. Schreiner, A. Bergmans, P. Cherubin, P. Rancans, E. Bez, Y. Parellada, E. Carpiniello, B. Hargater, L. CHU de Strasbourg Strasbourg France EMEA Medical Affairs Janssen Cilag Neuss Allemagne Biostatistics & programming Janssen Cilag Benelux Tilburg Pays-Bas EMEA medical affairs Janssen Cilag Issy-lès-Moulineaux France Department of Psychiatry et Narcology Riga Stradins University RIGA Lettonie Dicle University Medical Faculty Diyarbakir Turquie Hospital Clínic de Barcelona Barcelone Espagne Clinica Psichiatrica Università di Cagliari Cagliari Italie

ObjectifsÉvaluer la tolérance, la sécurité d’emploi et la réponse à un traitement mensuel par palmitate de paliperidone (PP) à doses flexibles chez des patients adultes atteints de schizophrénie, non-aigus mais symptomatiques, après échec d’un traitement par antipsychotiques oraux.MéthodesAnalyse d’un groupe de patients atteints de schizophrénie, non-aigus mais symptomatiques, inclus dans une étude internationale, ouverte, prospective de six mois, évaluant la symptomatologie clinique : PANSS (Positive and Negative Syndrome Scale) et CGIS-S (Clinical Global Impression-Severity Scale), les événements indésirables (EIs) et le changement de poids.RésultatsCinq cent quatre-vingt-treize patients (population en intention de traiter) : 63,1 % d’hommes, âge moyen 38,4 ± 11,8 ans, 78,6 % souffrant de schizophrénie paranoïde. La principale raison de la substitution d’un antipsychotique oral par le PP était un manque d’efficacité (24,3 %). 74,5 % des patients ont terminé l’étude de six mois. Les raisons les plus fréquentes d’arrêt précoce étaient : le choix du patient (9,3 %), des effets indésirables (EIs) (6,1 %), les perdus de vue (3,0 %) et le manque d’efficacité (2,5 %). Le score total moyen à l’échelle PANSS a diminué de 71,5 ± 14,6 à l’inclusion à 59,7 ± 18,1 à la fin de l’étude (soit une différence de −11,7 ± 15,9 points ; 95 % IC 95 % [−13,0 ; −10,5] ; p <0,0001). 64,0 % des patients ont eu une amélioration supérieure ou égale à 20 % du score total à la PANSS et le pourcentage de patients légèrement malades ou moins (CGI-S) est passé de 31,8 à 63,2 %. Les EIs touchant plus de 5 % des patients sont : douleur au site d’injection (12,3 %), insomnie (8,6 %), anxiété (6,7 %), trouble psychotique (6,1 %) et céphalées (5,6 %). Le changement moyen de poids a été de 1,2 ± 5,0 kg (IC 95 % [0,7 ; 1,6]).ConclusionsCes résultats confirment la bonne tolérance et l’efficacité thérapeutique du PP à doses flexibles chez des patients non aigus atteints de schizophrénie, après échec d’un

关键词： Schizophrénie Thérapeutique Antipsychotiques Palipéridone

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VP6-2022: Adjuvant pertuzumab and trastuzumab in patients with early HER-2 positive breast cancer in APHINITY: 8.4 years' follow-up

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Annals of Oncology 2022年第9期33卷 986-987页

作者： S. Loibl J. Jassem A. Sonnenblick D. Parlier E. Winer J. Bergh R.D. Gelber E. Restuccia Y-H. Im C. Huang F. Dalenc I. Calvo M. Procter C. Caballero E. Clark H.L. Gomez Moreno J. Bliss G. Viale J. Bines M. Piccart Medicine and Research Dept. German Breast Group (GBG) Forschungs GmbH Neu-Isenburg Germany Oncology & Radiotherapy Medical University of Gdansk Gdansk Poland Oncology Department Tel Aviv Sourasky Medical Center-(Ichilov) Tel Aviv Israel Clinical Trials Support Unit Institut Jules Bordet Brussels Belgium Yale Cancer Center Yale University School of Medicine - Yale Cancer Center New Haven CT USA Department of Oncology-Pathology Karolinska Institutet and Breast Cancer Centre Cancer Theme Karolinska University Hospital Stockholm Sweden Biostatistics Dana Farber Cancer Institute Boston MA USA Product Development Oncology F. Hoffmann-La Roche Ltd Basel Switzerland Medicine Dept. Hematology/Medical Oncology Division Samsung Medical Center (SMC) - Sungkyunkwan University School of Medicine Seoul Republic of Korea Surgery Dept. NTUH - National Taiwan University Hospital Taipei Taiwan Oncologie 1A Institut Universitaire du Cancer Toulouse - Oncopole Toulouse France Breast Cancer Unit MD Anderson Cancer Center Madrid Madrid Spain Statistics and Programming Frontier Science Scotland Kincraig UK Medical Department Breast International Group (BIG) - AISBL Brussels Belgium Data Sciences - Data & Statistical Sciences (DSS) Roche Products Limited Welwyn Garden City UK Medicine Department INEN - Instituto Nacional de Enfermedades Neoplasicas Lima Peru Clinical Trials and Statistics Unit ICR - Institute of Cancer Research London UK Department of Oncology Università degli Studi di Milano Milan Italy Medical Oncology Department Instituto Nacional de Cancer - Research Center Rio de Janeiro Brazil Institut Jules Bordet Brussels Belgium

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Durability of alirocumab effect: Data from an open-label extension to the ODYSSEY program for patients with heterozygous familial hypercholesterolemia

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Annales d'Endocrinologie 2017年第4期78卷 301-301页

作者： M. Farnier G.K. Hovingh G. Langset R. Dufour M. Baccara-Dinet C. Din-Bell G. Manvelian J.R. Guyton Lipid clinic – Point Médical Dijon France Department of Vascular Medicine Academic Medical Center Amsterdam The Netherlands Lipid Clinic Oslo University Hospital Oslo Norway Institut de recherches cliniques de Montréal Université de Montréal Montréal QC Canada Clinical Development R&D Sanofi Montpellier France Biostatistics and Programming Sanofi Chilly-Mazarin France Regeneron Pharmaceuticals Tarrytown NY USA Duke University Medical Center Durham NC USA

Purpose To evaluate the overall durability of the effect of alirocumab in patients with heterozygous familial hypercholesterolemia (HeFH) using data from the ODYSSEY open-label extension (OLE) of four phase 3 trials (FHI, FHII, LONG-TERM, HIGH-FH) assessing long-term efficacy and safety for up to 40 months. Methods Patients received alirocumab 75 mg (FHI, FHII, LONG-TERM) or 150 mg (HIGH-FH) once every 2 weeks. From Week 12, dose adjustment of alirocumab was allowed as per investigator's clinical judgement. Results A total of 985 patients (mean age 54.4 years, 55.8% male) were included in OLE safety population. At OLE enrollment, 978 patients were receiving statins with 627 other lipid-lowering therapy. At the time of analysis, 938 patients had completed ≥ 1 year of treatment; 5.7% had discontinued treatment (2.2% due to adverse events). Of those who started OLE on 75 mg dose, 537/909 (59.1%) were maintained on that dose throughout. At Week 48 of OLE, the mean LDL-C was 79.7 mg/dL, a mean reduction of 46.9% compared with baseline levels of the parent studies. Other lipid changes included reductions at Week 48 in non-high density lipoprotein cholesterol (40.3%), total cholesterol (29.7%), lipoprotein(a) (25.6%), and apolipoprotein B (37.5%). Overall, 762/985 (77.4%) patients reported treatment-emergent adverse events during OLE (up to 73 weeks). Injection site reactions reported by 49 patients (5.0%) were mild and self-limited. Conclusion In this OLE study of patients with HeFH, alirocumab demonstrated a durable and robust treatment effect, yielding a 47% reduction in LDL-C at Week 48 compared with baseline levels.

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7 Phase 3 Trial of an Oral CXCR4 Antagonist, Mavorixafor, for Treatment of Patients With WHIM Syndrome: Preliminary Results From Ongoing Open-Label Extension Period of Continuous Mavorixafor Treatment

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Clinical Immunology 2024年 262卷 109949-109949页

作者： Tarrant, Teresa Badolato, Raffaele Donadieu, Jean Dubuc, Susan Hu, Yanping Jiang, Honghua Li, Sunny Steiner, Deborah Yan, Tina Arbet-Engels, Christophe Associate Professor of Medicine Rheumatology and Immunology/Division of Rheumatology and Immunology Department of Medicine Duke University Durham NC USA Full Professor of Pediatrics Chair of Pediatrics ASST Spedali Civili Brescia/Department of Clinical and Experimental Sciences University of Brescia & ASST Spedali Civili Brescia Italy Pediatric Physician/CHU Paris Est - Hôpital d’Enfants Armand-Trousseau Paris France Senior Director Pharmacovigilance & Risk Management/X4 Pharmaceuticals Boston MA USA Director Clinical Research/X4 Pharmaceuticals Boston MA USA Senior Director Biostatistics/X4 Pharmaceuticals Boston MA USA Senior Director Statistical Programming/X4 Pharmaceuticals Boston MA USA Vice President Clinical Development/X4 Pharmaceuticals Boston MA USA Director Statistical Programming/X4 Pharmaceuticals Boston MA USA Chief Medical Officer/X4 Pharmaceuticals Boston MA USA

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POS1050 INCIDENCE RATES OF INTERSTITIAL LUNG DISEASE AMONG PATIENTS WITH RHEUMATOID ARTHRITIS TREATED WITH ABATACEPT: A POST HOC POOLED ANALYSIS FROM A COMPENDIUM OF CLINICAL TRIALS

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Annals of the Rheumatic Diseases 2023年 82卷 843-843页

作者： P. Dieudé J. Sparks A. Fischer L. Chen K. Lozenski S. Dahan M. Chaballa W. Little Paris Cité University Bichat Hospital APHP Department of Rheumatology Paris France Brigham and Women's Hospital Harvard Medical School Division of Rheumatology Inflammation and Immunity Boston United States of America Bristol Myers Squibb Lung Fibrosis Lawrenceville United States of America Syneos Health Biostatistics and Statistical Programming Richmond Canada Bristol Myers Squibb Rheumatology Pipeline and Early Assets Lawrenceville United States of America Bristol Myers Squibb Worldwide Medical Lawrenceville United States of America Bristol Myers Squibb US Medical Immunology and Fibrosis Lawrenceville United States of America Bristol Myers Squibb Worldwide Rheumatology Lawrenceville United States of America

Background Interstitial lung disease (ILD) is a recognized complication of RA. Prior studies have suggested stabilization or improvement of ILD in patients with RA (RA-ILD) treated with abatacept. [1,2] Few studies have evaluated the background incidence rate of RA-ILD. Objectives To determine the incidence rate of clinically significant ILD in a cohort of patients with RA receiving abatacept + MTX versus placebo + MTX from multiple clinical trials. Methods This retrospective analysis examined pooled safety data from ten phase 3 clinical trials of patients with RA treated with background MTX in combination with abatacept or placebo. The term ‘interstitial lung’ was used to identify incidences of ILD reported as AEs in the safety data. The exposure period for each patient was censored at first incidence of clinically significant ILD, 56 days after last study drug administration, or 1 day prior to commencement of another study drug, whichever occurred first. Poisson regression models were used to estimate crude incidence rates per 100 person-years for baseline risk factors within treatment groups, and to estimate incidence rate ratios for the placebo + MTX versus abatacept + MTX treatment groups. Disease activity parameters, DAS28 (CRP) and HAQ-DI, were estimated from baseline to the time of ILD diagnosis (as reported by AEs). Results In total, 3,708 patients (10,521 person-years) treated with abatacept + MTX and 999 patients (938 person-years) treated with placebo + MTX were included. Patients treated with placebo + MTX had a higher incidence rate of ILD per 100 person-years (95% CI) versus those treated with abatacept + MTX (0.43 [0.16–1.14] vs 0.10 [0.05–0.18], respectively; Figure 1). The incidence rate ratio of placebo + MTX versus abatacept + MTX treatment groups for the total population was 4.49 (95% CI, 1.23–13.42). For all subpopulations stratified by baseline risk factors (where ≥ 1 patient in each treatment group had an ILD event), incidence rate ratios wer

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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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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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1411P Tusamitamab ravtansine plus ramucirumab as 2L therapy or beyond in patients with metastatic NSq NSCLC and high CEACAM5 expression (CARMEN-LC04)

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Annals of Oncology 2023年 34卷 S807-S807页

作者： G.K. Dy B.C. Cho J. Oliveira M.D. Isla Casado A. Blasco Cordellat M. Zemanova J. Roubec L. Vila Martinez L. Charbonnier C. Soufflet J. de Castro Carpeño Department of Medicine Roswell Park Comprehensive Cancer Center Buffalo NY USA Division of Medical Oncology Yonsei Cancer Center Yonsei University College of Medicine Seoul Republic of Korea Medical Oncology Service Early Phase Clinical Trial Unit-IPO Porto/RISE@CI-IPOP (Health Research Network Experimental Pathology and Therapeutics Group Research Center (CI-IPOP)/RISE@CI-IPOP (Health Research Network) Portuguese Oncology Institute of Porto (IPO Porto)/Porto Comprehensive Cancer Center Porto Portugal Medical Oncology Department Hospital Clínico Universitario Lozano Blesa Zaragoza Spain Medical Oncology Department Hospital General de Valencia Valencia Spain Department of Oncology First Faculty of Medicine Charles University and General University Hospital in Prague Prague Czech Republic Pneumooncology Nemocnice AGEL Ostrava-Vítkovice Ostrava-Vítkovice Czech Republic Oncology Department Consorci Corporació Sanitària Parc Taulí de Sabadell Sabadell Spain Biostatistics & Programming Sanofi Chilly-Mazarin France Clinical Development Sanofi Vitry-sur-Seine France Medical Oncology Service Hospital Universitario La Paz Madrid Spain

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