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

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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Effects of a specialized oral nutritional supplement with dietary counseling on nutritional outcomes in community-dwelling older adults at risk of malnutrition: A randomized controlled trial

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Clinical Nutrition ESPEN 2024年 63卷 1318-1318页

作者： Muangpaisan, W. Wichansawakun, S. Huynh, D.T.T. Intalapaporn, S. Chalermsri, C. Thititagul, O. Chupisanyarote, K. Chuansangeam, M. Laiteerapong, A. Yalawar, M. Huang, C. Tey, S.L. Liu, Z. Faculty of Medicine Siriraj Hospital Mahidol University Bangkok Faculty of Medicine Thammasat University Pathum Thani Thailand Abbott Nutrition Research and Development Asia-Pacific Center Singapore Singapore Thammasat University Hospital Pathum Thani Abbott Nutrition Research and Development Bangkok Thailand Biostatistics and Statistical Programming Cognizant Technologies Solution Pvt. Ltd Bangalore India Abbott Nutrition Research and Development Shanghai China

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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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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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Palmitate de palipéridone à doses flexibles – Réponse thérapeutique, tolérance et sécurité d’emploi: une étude prospective chez des patients en période d’exacerbation aiguë d’un trouble schizophrénique 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： Schreiner, A. Bergmans, P. Cherubin, P. Rancans, E. Bez, Y. Parellada, E. Carpiniello, B. Vidailhet, P. Hargater, L. EMEA Medical Affairs Janssen Cilag Neuss Allemagne Biostatistics & Programming Janssen Cilag Benelux Tilburg Pays-Bas EMEA Medical Affairs Janssen Cilag Issy-lès-Moulineaux France Dpt. 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 CHU de Strasbourg Strasbourg

ObjectifsÉvaluer la tolérance, la sécurité d’emploi et l’efficacité de doses flexibles de PP chez des patients adultes en période d’exacerbation aiguë d’une schizophrénie, après échec d’un traitement par antipsychotiques oraux.MéthodesÉtude internationale, prospective, ouverte, de six ***ères d’évaluationPositive and Negative Syndrome Scale (PANSS), Clinical Global Impression-Severity (CGI-S), événements indésirables (EI), changement de poids.RésultatsDeux cent douze patients (population en intention de traiter) : âge moyen 36,4 ± 12,1 ans, 59,0 % d’hommes, 85,4 % souffrant de schizophrénie paranoïde ont été inclus. La principale raison de la substitution d’un antipsychotique oral par le PP était un manque d’efficacité (45,8 %). 70,3 % des patients ont terminé l’étude de six mois. Les raisons les plus fréquentes d’arrêt précoce ont été : le choix du patient (9,4 %), des EI (9,0 %), les perdus de vue (4,7 %), le manque d’efficacité (2,8 %). Le score total moyen à la PANSS initiale (98,5 ± 20,1) a diminué, et ce dès j8, pour atteindre 67,4 ± 24,0 à la fin de l’étude (diminution de −31,0 ± 29,0, p < 0,0001). 66,7 % des patients ont eu une amélioration de plus de 30 % du score PANSS total et le pourcentage de patients jugés manifestement malades ou pire (CGI-S) a diminué de 75,1 % à 20,5 %. Les EIs (≥ 5 % patients) : douleur au site d’injection (13,7 %), insomnie (10,8 %), trouble psychotique (10,4 %), céphalées (6,1 %) et anxiété (6,1 %). Le changement moyen de poids a été de 2,6 ± 5,6 kg (IC 95 % [1,8; 3,4]).ConclusionsCes résultats confirment que le PP à doses flexibles est bien toléré et permet une réponse clinique précoce et cliniquement significative chez des patients en période d’exacerbation aiguë de leur trouble schizophrénique, après échec d’un traitement par antipsychotiques oraux.

关键词： Schizophrénie Thérapeutique Antipsychotiques Palipéridone

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P0054 - An integrated analysis of the efficacy of desvenlafaxine succinate compared with placebo in the treatment of major depressive disorder

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European Psychiatry 2020年第S2期23卷 S208-S208页

作者： M.E. Thase S.G. Kornstein R. Tummala J.M. Germain Q. Jiang S. Ahmed P.T. Ninan Department of Psychiatry Mood and Anxiety Disorders Treatment and Research Program University of Pennsylvania Philadelphia PA USA Department of Psychiatry and Obstetrics and Gynecology Mood Disorders Institute and The Institute for Womens Health Virginia Commonwealth University School of Medicine Virginia Commonwealth University Richmond VA USA Department of Global Medical Affairs Wyeth Research Collegeville PA USA Department of Neuroscience Wyeth Research Paris France Department of Global Biostatistics and Programming Wyeth Research Collegeville PA USA

Objective:To assess the efficacy of desvenlafaxine succinate (DVS) treatment in patients with major depressive disorder (MDD).Methods:Seven randomized, double-blind, placebo-controlled, short-term studies were pooled to evaluate the efficacy of DVS in MDD. Adult outpatients with DSM-IV MDD were enrolled in all studies. Eligible patients were randomly assigned to DVS (n=1186) at doses of 100–400 mg/d, or placebo (n=797) for 8 weeks. The 17-item Hamilton Depression Rating Scale (HAM-D17) was the primary efficacy variable. Other efficacy variables were the Clinical Global Impressions scale (CGI), HAM-D6, Montgomery Åsberg Depression Rating Scale (MADRS), Covi Anxiety scale, Sheehan Disability Scale (SDS), WHO-5 Well-Being Index, and the Visual Analog Scale–Pain Intensity (VAS-PI). A mixed-effect model for repeated measures (MMRM) analysis was used to analyze continuous variables. Logistic regression was used to analyze response and remission ***:An adjusted mean difference of –2.8 points on HAM-D17 total score at end point for DVS vs placebo (95% confidence limits: –2.2, –3.4; P<0.001) was demonstrated. Response and remission rates were significantly elevated for DVS-treated patients compared with placebo (P<0.001) across rating scales (HAM-D17, MADRS, and CGI). For other secondary measures at end point, including the CGI, HAM-D6, MADRS, Covi, SDS, WHO-5, and VAS-PI, significant differences from placebo were also observed. No additional benefit was observed for DVS doses above 100 mg/d in analyses of fixed-dose ***:DVS was efficacious in treating MDD based on standard depression rating scales and measures of anxiety, global severity/improvement, functioning, well being, and pain.

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EPA-1550 - Paliperidone palmitate in acute patients with schizophrenia: treatment response, safety and tolerability ? a prospective flexible-dose study in patients previously unsuccessfully treated with oral antipsychotics

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European Psychiatry 2014年第S1期29卷 1-1页

作者： Schreiner, A. Bergmans, P. Cherubin, P. Rancans, E. Bez, Y. Parellada, E. Carpiniello, B. Vidailhet, P. Hargarter, L. 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 de Strasbourg Strasbourg France

Introduction This study explores tolerability, safety and treatment response of flexible doses of the atypical long-acting antipsychotic paliperidone palmitate (PP) in adult patients with an acute exacerbation of schizophrenia previously unsuccessfully treated with oral antipsychotics. Methods International prospective open-label 6-month study. Outcome parameters were change in Positive and Negative Syndrome Scale (PANSS) total score, Clinical Global Impression-Severity Scale (CGI-S), treatment-emergent adverse events (TEAEs) and weight change. Results 212 acute patients, 59.0% male, mean age 36.4 ±12.1 years, 85.4% paranoid schizophrenia were enrolled. 70.3% of patients completed the study. Most frequent reasons for early discontinuation were subject choice (9.4%), or an adverse event (9.0%). Recommended initiation regimen of PP (150 mg eq on day 1 and 100 mg eq on day 8) was administered in 92.9% of subjects. Mean baseline PANSS total score decreased from 98.5±20.1 as of day 8 of treatment to 67.4±24.0 at endpoint (mean change -31.0±28.97; 95% confidence interval [CI]-35.0;-27.1; p<0.0001). 66.7% of patients improved ≥30% in PANSS total score and percentage of patients rated markedly ill or worse in CGI-S decreased from 75.1% at baseline to 20.5% at endpoint. TEAEs reported in ≥5% were injection site pain (13.7%), insomnia (10.8%), psychotic disorder (10.4%), headache (6.1%) and anxiety (6.1%). Mean weight change at endpoint was 2.6±5.6 kg (95%CI 1.8; 3.4). Conclusions These data support results from previous randomized controlled studies that flexibly dosed paliperidone palmitate is well tolerated and associated with an early and clinically relevant treatment response in acute schizophrenia patients previously unsuccessfully treated with oral antipsychotics.

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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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