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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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EPA-1547 - Once monthly paliperidone palmitate – tolerability and treatment response in recently diagnosed versus chronic non-acute schizophrenia patients switched from previously unsuccessful treatment with oral antipsychotics

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European Psychiatry 2014年 29卷 1-1页

作者： Hargarter, L. Bergmans, P. Cherubin, P. Rancans, E. Bez, Y. Parellada, E. Carpiniello, B. Vidailhet, P. Schreiner, A. EMEA MAF Janssen-Cilag GmbH Neuss Germany Biostatistics & Programming Janssen Cilag Benelux Tilburg Netherlands EMEA MAF Janssen Cilag France Issy-les-Moulineaux France Psychiatry and Narcology Riga Stradins University Riga Latvia Psychiatry Dicle University Medical Faculty Diyarbakir Turkey Psychiatry Hospital Clinic de Barcelona Barcelona Spain Psychiatry Universitá di Cagliari Cagliari Italy Psychiatry Centre Hopitalier Régional Universitaire de Strasbourg Strasbourg France

Introduction To explore tolerability and treatment response of flexibly dosed once-monthly paliperidone palmitate (PP) in recently diagnosed versus chronic adult non-acute schizophrenia patients previously unsuccessfully treated with oral antipsychotics. Methods International prospective 6-month open-label study. Patients were stratified by years since diagnosis [≤3 versus >3 years]. Outcomes were changes from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total score, Clinical Global Impression- Change Scale (CGI-C), Extrapyramidal Symptom Rating Scale (ESRS) and treatment-emergent adverse events (TEAEs). Results N=233 recently diagnosed (63.9% male, mean age 32.2±10.3 years, mean time since diagnosis 1.2±0.9 years) and n=360 chronic patients (62.5% male, mean age 42.4±11.0, mean time since diagnosis 13.9±9.3 years) were included. 71% of recently diagnosed and 59% of chronic patients showed a ≥20% improvement in PANSS total score at endpoint. Mean changes in PANSS total score at endpoint were - 15.1±15.6 and -9.6±15.7, respectively (between-group difference p<0.0001). Changes in PANSS positive, negative and general subscores were consistently higher in recently diagnosed patients (all p≤0.001). At endpoint, 52.4% of recently diagnosed patients were rated much or very much improved on CGI-C compared to 38.1% in the chronic group (p=0.0008). TEAEs ≥5% in both subgroups (recently diagnosed and chronic) were injection site pain (12.9% vs. 11.9%), insomnia (9.9% vs. 7.8%), anxiety (6.4% vs. 6.9%), and headache (6.0% vs.5.3%). Conclusions These data suggest that both recently diagnosed and chronic patients previously unsuccessfully treated with oral antipsychotics benefit from paliperidone palmitate, with recently diagnosed patients showing consistently higher treatment response and lower disease severity at endpoint.

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EPA-1548 - Flexibly dosed paliperidone palmitate in non-acute patients with schizophrenia switched from previously unsuccessful monotherapy with oral atypical antipsychotics

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European Psychiatry 2014年第S1期29卷 1-1页

作者： Hargarter, L. Bergmans, P. Cherubin, P. Rancans, E. Bez, Y. Parellada, E. Carpiniello, B. Vidailhet, P. Schreiner, A. EMEA MAF Janssen-Cilag GmbH Neuss Germany Biostatistics & Programming Janssen Cilag Benelux Tilburg Netherlands EMEA MAF Janssen Cilag France Issy-les-Moulineaux France Psychiatry and Narcology Riga Stradins University Riga Latvia Psychiatry Dicle University Medical Faculty Diyarbakir Turkey Psychiatry Hospital Clinic de Barcelona Barcelona Spain Psychiatry Clinica Psichiatrica Università di Cagliari Cagliari Italy Psychiatry Centre Hospitalier Régional Universitaire Strasbourg Strasbourg France

Introduction To explore tolerability, safety and treatment response of flexibly dosed paliperidone palmitate (PP) in adult non-acute schizophrenia patients previously unsuccessfully treated with oral antipsychotic monotherapy of risperidone (RIS), paliperidone ER (Pali ER), olanzapine (OLA), quetiapine (QUE) or aripiprazole (ARI). Methods International, prospective 6-month open-label study. Outcomes were response (≥20% improvement in Positive and Negative Syndrome Scale (PANSS) total score at endpoint), patient functioning (Personal and Social Performance scale (PSP)), treatment-emergent adverse events (TEAEs) and Extrapyramidal Symptom Rating Scale (ESRS). Results Intent-to-treat population: n=191 (RIS), n=104 (Pali ER), n=87 (OLA), n=46 (ARI), n=44 (QUE). Patients presented some differences in baseline demographics, e.g. in age, years since diagnosis and BMI. Baseline mean PANSS total scores ranged from 74.7±14.9 (ARI) to 70.8±13.1 (QUE) and 70.8±15.1 (RIS). Between 67.4% (ARI) and 83.2% (RIS) of patients completed the study. At endpoint, 74% (RIS), 58% (Pali ER), 61% (OLA), 66% (QUE) and 52% (ARI) of patients had improved ≥20% in PANSS total score. Mean PSP improvement at endpoint was: 10.4±13.8 (RIS), 7.0±13.8 (Pali ER), 4.5±15.9 (OLA), 7.9±12.4 (QUE) and 3.9±13.2 (ARI); all p<0.05. TEAEs reported at least once in all subgroups were injection site pain, insomnia and psychotic disorder. Mean change in ESRS from baseline to endpoint was -1.2±3.5 (RIS), - 0.7±4.1 (Pali ER), -1.3±4.4 (OLA), -0.3±3.2 (QUE) and -0.6±3.4 (ARI; p<0.05 for all except QUE). Conclusion PP was well tolerated and associated with clinically relevant treatment response in patients previously unsuccessfully treated with oral atypical antipsychotic monotherapy, regardless of the medication that was switched.

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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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Baseline Characteristics Of Patients With Chronic Myeloid Leukemia In a Prospective Observational Study (SIMPLICITY)

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BLOOD 2013年第21期122卷 4026-4029页

作者： Cortes, Jorge E. Hehlmann, Rudiger Gambacorti-Passerini, Carlo Goldberg, Stuart Khoury, H. Jean Mauro, Michael Michallet, Mauricette Paquette, Ron Simonsson, Bengt Foreman, Aimee Mohamed, Hesham Zyczynski, Teresa Hirji, Ishan Davis, Catherine Department of Leukemia The University of Texas MD Anderson Cancer Center Houston TX USA Department of Hematology/ Oncology University of Heidelberg Mannheim Germany Department of Internal Medicine and Clinical Research Unit University of Milano-Bicocca Monza Italy Division of Leukemia John Theurer Cancer Center at Hackensack University Medical Center Hackensack NJ USA Department of Hematology and Medical Oncology Winship Cancer Institute of Emory University Emory University Atlanta GA USA Memorial Sloan Kettering Cancer Center New York NY USA Centre Hospitalier Lyon Sud Pierre Benite France Ronald Reagan UCLA Medical Center University of California Los Angeles Los Angeles CA USA Department of Medical Sciences Hematology Uppsala University Hospital Uppsala Sweden ICON Clinical Research Biostatistics & Programming San Francisco CA USA Bristol-Myers Squibb Plainsboro NJ USA Global Health Economics and Outcomes Research Bristol-Myers Squibb Co. Princeton NJ USA Oncology Global Health Outcomes Bristol-Myers Squibb Co. Wallingford CT USA

4026

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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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Amélioration fonctionnelle sous palmitate de paliperidone à doses flexibles chez des patients aigus ou 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 108-108页

作者： Hargarter, L. Bergmans, B. Cherubin, P. Bjorner, A. Knegtering, H. Parellada, E. Carpiniello, B. Vidailhet, P. Mertens, C. Schreiner, A. EMEA Medical Affairs Janssen Cilag Neuss Allemagne Biostatistics & Programming Janssen Cilag Benelux Tilburg Pays-Bas EMEA Medical Affairs Janssen Cilag Issy-lès-Moulineaux Psykosmottagningen MÖLNDAL Suède Lentis Mental Health and University Medical Center of Groningen Groningen Pays-Bas Hospital Clínic de Barcelona Barcelone Espagne Clinica Psichiatrica Università di Cagliari Cagliari Italie Psychiatric Hospital Sint Camillus CHU de Strasbourg Strasbourg Sint-Denijs-Westrem Belgique

ObjectifsÉvaluer l’amélioration fonctionnelle chez des patients atteints de schizophrénie sous palmitate de paliperidone (PP) à doses flexibles après échec d’un traitement par antipsychotiques oraux.MéthodesAnalyse menée dans deux sous-groupes de patients atteints de schizophrénie : aigus (n = 202) et non aigus (n = 593) après échec d’un traitement par antipsychotiques oraux, inclus dans une étude internationale, prospective, de six ***ères d’évaluationChangement du score total à la PANSS (Positive and Negative Syndrome Scale), à la PSP (Personal and Psychosocial Performance scale), et à la Mini-ICF-APP (Mini International Classification of Functionality, Disability and Health Rating for Activity and Participation Disorders in Psychological Illnesses).RésultatsLes deux sous-groupes ont présenté une amélioration significative du score total à la PANSS : de 98,5 ± 20,1 à l’inclusion à 67,4 ± 24,0 à la fin de l’étude (diminution moyenne = −31,0 ± 29,0) chez les patients aigus et de 71,5 ± 14,6 à 59,7 ± 18,1 (diminution moyenne = −11,7 ± 15,9) chez les patients non aigus. Cette réponse thérapeutique était associée à une augmentation significative du score total à la PSP de 43,9 ± 15,0 à 62,9 ± 17,1 (amélioration moyenne = 19,0 ± 18,7, p <0,0001) chez les patients aigus, et de 58,1 ± 13,4 à 66,1 ± 15,7 (amélioration moyenne =8,0 ± 14,0, p < 0,0001) chez les patients non aigus. Il existait une amélioration significative du score à la Mini-ICF-APP qui diminuait de 26,8 ± 8,5 à 18,5 ± 9,8 (diminution moyenne = −8,0 ± 10,4, p < 0,0001) chez les patients aigus et de 19,8 ± 7,9 à 15,9 ± 8,8 (diminution moyenne = −4,0 ± 7,5, p < 0,0001) chez les patients non ***’amélioration symptomatique sous PP à doses flexibles chez des patients aigus ou non-aigus atteints de schizophrénie après échec d’un traitement par antipsychotique oral s’est accompagnée d’une amélioration fonctionnelle cliniquement significative.

关键词： Schizophrénie Thérapeutique Antipsychotiques Palipéridone

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EPA-1546 - Paliperidone palmitate in non-acute but symptomatic patients with schizophrenia previously unsuccessfully treated with oral aripiprazole

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European Psychiatry 2014年第S1期29卷 1-1页

作者： Hargarter, L. Bergmans, P. Cherubin, P. Rancans, E. Bez, Y. Parellada, E. Carpiniello, B. Vidailhet, P. Schreiner, A. EMEA MAF Janssen- Cilag GmbH Neuss Germany Biostatistics & Programming Janssen Cilag Benelux Tilburg Netherlands EMEA MAF Janssen Cilag France Issy-les-Moulineaux France Psychiatry and Narcology Riga Stradins University Riga Latvia Psychiatry Dicle University Medical Faculty Diyarbakir Turkey Psychiatry Hospital Clinic de Barcelona Barcelona Spain Psychiatry Clinica Psichiatrica Universitá die Cagliari Cagliari Italy Psychiatry Centgre Hospitalier Régional Universitaire Strasbourg Strasbourg France EMEA MAF Janssen-Cilag GmbH Neuss Germany

Introduction To explore tolerability, safety and treatment response of flexibly dosed once-monthly paliperidone palmitate (PP) in adult nonacute patients with schizophrenia previously unsuccessfully treated with oral aripiprazole. Methods International prospective open-label 6-month study. Outcomes were change in Positive and Negative Syndrome Scale (PANSS), patient functioning (Personal and Social Performance Scale; PSP), disease severity (CGI-S and CGI-C), Extrapyramidal Symptom Rating Scale (ESRS) and treatment-emergent adverse events (TEAEs). Results 46 patients (73.9% male, mean age 34.4±9.4 years, 78.3% paranoid schizophrenia) were analyzed. The mean prior oral aripiprazole dose was 22.7±10.7 mg/day. 67.4% of patients completed the study. Mean PANSS total score decreased from 74.7±14.9 at baseline to 62.6±16.5 at LOCF endpoint (mean change -12.2±16.7; 95% confidence interval -17.1;-7.2; p<0.0001). 52.2% of patients showed a ≥20% improvement in PANSS total score, the percentage of patients rated mildly ill or less in CGI-S increased from 23.9% to 56.5% and 75.5% of patients were rated improved in CGI-C. Patient functioning in PSP improved from 58.9±13.4 to 62.9±15.2 (p=0.041). TEAEs reported in ≥5% were anxiety (n=6), injection site pain, bronchitis, insomnia and akathisia (n=4 each), and weight increase, depression and pain in extremities (n=3 each). Extrapyramidal symptoms measured by ESRS total scores improved significantly in completers from baseline to month 6 by -1.4±2.7 (p<0.007) and by -0.6±3.4 from baseline to LOCF endpoint (p=0.046). Conclusions Flexibly dosed paliperidone palmitate was well tolerated and associated with a clinically relevant symptomatic treatment response, improved functioning and less EPS in non-acute patients with schizophrenia previously unsuccessfully treated with oral aripiprazole.

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EPA-1545 - Functional outcomes with once-monthly paliperidone palmitate in acute and in non-acute patients with schizophrenia previously unsuccessfully treated with oral antipsychotics

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European Psychiatry 2014年第S1期29卷 1-1页

作者： Hargarter, L. Bergmans, P. Cherubin, P. Björner, A. Knegtering, R. Parellada, E. Carpiniello, B. Vidailhet, P. Mertens, C. Schreiner, A. EMEA MAF Janssen-Cilag GmbH Neuss Germany Biostatistics & Programming Janssen Cilag Benelux Tilburg Netherlands EMEA MAF Janssen Cilag France Issy-les-Moulineaux France Psychiatry Psykosmottagningen Mölndal Sweden Psychiatry University Medical Center of Groningen Groningen Netherlands Psychiatry Hospital Clinic de Barcelona Barcelona Spain Psychiatry Clininca Psichiatrica Università di Cagliari Cagliari Italy Psychiatry Centre Hospitalier Régional Universitaire Strasbourg Strasbourg France Psychiatry Neuro- Psychiatrische Kliniek St-Camillu Sint Denijs Westrem Belgium

Introduction Effective antipsychotic treatment of schizophrenia should, beyond symptom control, translate into meaningful functional improvements. This study explored functional outcomes in patients with schizophrenia switched from previous unsuccessful treatment with oral antipsychotics to flexible doses of paliperidone palmitate (PP). Methods Two groups of acute (N=212) and non-acute (N=593) patients from an international prospective open-label 6-month study. Outcomes were change in Positive and Negative Syndrome Scale (PANSS) total score, Personal and Psychosocial Performance scale (PSP) and Mini International Classification of Functionality, Disability and Health Rating for Activity and Participation Disorders in Psychological Illnesses (Mini-ICF-APP). Results Both groups significantly improved from baseline to endpoint in mean PANSS total score from 98.5±20.1 to 67.4±24.0 (mean change -31.0±29.0) in acute and from 71.5±14.6 to 59.7±18.1 (mean change -11.7±15.9) in non-acute patients (all p<0.0001). Patient functioning in PSP total score increased from 43.9±15.0 at baseline to 62.9±17.1 at endpoint (mean change 19.0±18.7; 95% confidence interval [CI] 16.4;21.6) in the acute and from 58.1±13.4 at baseline to 66.1±15.7 at endpoint (mean change 8.0±14.0; 95%CI 6.8;9.1) in the non-acute group (both groups p<0.0001). Illness-related disabilities of activity and participation within groups improved significantly in Mini-ICF-APP global score decreasing from 26.8±8.5 to 18.5±9.8 (mean change -8.0±10.4; 95%CI -9.5;-6.5) in acute and from 19.8±7.9 to 15.9±8.8 (mean change: -4.0±7.5; 95%CI - 4.6;-3.3) from baseline to endpoint in non-acute patients (both groups p<0.0001). Conclusions Symptom reduction in acute and non-acute patients with schizophrenia treated with PP after previous unsuccessful treatment with oral antipsychotics was associated with clinically meaningful functional improvements.

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519P Cabazitaxel plus prednisolone with primary prophylaxis with pegfilgrastim (PEG) in Japanese patients with metastatic castration-resistant prostate cancer: An open label prospective phase 2 study

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Annals of Oncology 2017年第SUPPL_10期28卷

作者： H Uemura T Kosaka M Sumitomo K Harada M Sugimoto N Hayashi K Yoshimura S Fukasawa E B Ecstein-Fraisse Y Sunaga M Oya Department of Urology/Renal Transplantation Yokohama City University Medical Center Yokohama Japan Department of Urology Keio University Hospital Tokyo Japan Department of Urology Aichi Medical University Hospital Aichi Japan Department of Urology Kobe University Hospital Kobe Japan Department of Urology Kagawa University Hospital Kagawa Japan Department of Urology Yokohama City University Hospital Yokohama Japan Department of Urology Kindai University Hospital Osaka Japan Department of Urology/Prostate Cancer Chiba Cancer Center Chiba Japan Medical Sanofi France Paris France Biostatistics & Programming Sanofi Japan Tokyo Japan

519P Cabazitaxel plus prednisolone with primary prophylaxis with pegfilgrastim (PEG) in Japanese patients with metastatic castration-resistant prostate cancer: An open label prospective phase 2 study H Uemura Department of Urology/Renal Transplantation, Yokohama City University Medical Center, Yokohama, Japan Search for other works by this author on: Oxford Academic PubMed Google Scholar H Uemura T Kosaka Department of Urology, Keio University Hospital, Tokyo, Japan Search for other works by this author on: Oxford Academic PubMed Google Scholar T Kosaka M Sumitomo Department of Urology, Aichi Medical University Hospital, Aichi, Japan Search for other works by this author on: Oxford Academic PubMed Google Scholar M Sumitomo K Harada Department of Urology, Kobe University Hospital, Kobe, Japan Search for other works by this author on: Oxford Academic PubMed Google Scholar K Harada M Sugimoto Department of Urology, Kagawa University Hospital, Kagawa, Japan Search for other works by this author on: Oxford Academic PubMed Google Scholar M Sugimoto N Hayashi Department of Urology, Yokohama City University Hospital, Yokohama, Japan Search for other works by this author on: Oxford Academic PubMed Google Scholar N Hayashi K Yoshimura Department of Urology, Kindai University Hospital, Osaka, Japan Search for other works by this author on: Oxford Academic PubMed Google Scholar K Yoshimura S Fukasawa Department of Urology/Prostate Cancer, Chiba Cancer Center, Chiba, Japan Search for other works by this author on: Oxford Academic PubMed Google Scholar S Fukasawa E B Ecstein-Fraisse Medical, Sanofi France, Paris, France Search for other works by this author on: Oxford Academic PubMed Google Scholar E B Ecstein-Fraisse Y Sunaga biostatistics & programming, Sanofi Japan, Tokyo, Japan Search for other works by this author on: Oxford Academic PubMed Google Scholar Y Sunaga ... Show more M Oya Department of Urology, Keio University Hospital, Tokyo, Japan Search for other works by this

关键词： prostate cancer, androgen-independent prevention japanese

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