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POS0051 dIFFErENTIAL PHArMACOdYNAMIC ALTErATIONS AFTEr TrEATMENT WITH ABATACEPT Or AdALIMUMAB IN MTX-INAdEQUATE rESPONdEr PATIENTS WITH EArLY rA: WHOLE BLOOd rNA-SEQ analysis OF THE EArLY AMPLE STUdY

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Annals of the rheumatic diseases 2022年 81卷 241-242页

作者： C. Wu Y. Li N. ray M.A. Maldonado P. Schafer S.L. Bridges W. rigby V. Bykerk J. Buckner J. Liu Bristol Myers Squibb Translational Bioinformatics Princeton United States of America Parexel International N/A Durham United States of America Bristol Myers Squibb (at the time of analysis) Global Drug Development Princeton United States of America Bristol Myers Squibb Clinical R&D Immunoscience Princeton United States of America Bristol Myers Squibb Translational Medicine Princeton United States of America Hospital for Special Surgery Department of Medicine New York United States of America Dartmouth-Hitchcock Medical Center Rheumatology Section Department of Medicine Lebanon United States of America Hospital for Special Surgery Division of Rheumatology New York United States of America Benaroya Research Institute at Virginia Mason Center for Translational Immunology Seattle United States of America

Background despite advances in available novel pharmacologic agents for rA, 1 the dearth of effective response predictors for specific therapies remains an unmet need. To inform clinical decision making, it is critica...

Background despite advances in available novel pharmacologic agents for rA, 1 the dearth of effective response predictors for specific therapies remains an unmet need. To inform clinical decision making, it is critical to define molecular signatures of these therapeutic agents by investigating their mechanisms of action (MoAs) and differential impacts on patients' immune systems. Adalimumab and abatacept are biologic dMArds with distinct MoAs used to treat rA. A better understanding of the differential pharmacodynamic (Pd) changes of these 2 agents may provide guidance for the selection of treatment options. 2 The Early AMPLE ( A batacept versus adali M umab com P arison in bio L ogic-naïv E rA subjects with background MTX) study compared treatment with abatacept or adalimumab in a population of patients with early rA to explore differential Pd effects; abatacept treatment resulted in numerically higher efficacy responses vs adalimumab after 24 weeks of treatment. 3 Objectives To investigate Pd changes in response to treatment with abatacept or adalimumab, and to identify and differentiate the impact of each drug on modulation of immune cells at the molecular level. Methods The phase 4 Early AMPLE trial ( NCT02557100 ) was a head-to-head comparison of treatment response to either abatacept or adalimumab in patients with early rA with an inadequate response to MTX, high anti-citrullinated protein antibody titers, and rF positivity, with or without shared epitope. Whole blood rNA sequencing (rNA-Seq) was conducted on samples collected from patients at different visits (day 1; weeks 4, 8, 16, 24, 28, 32, 40, 48). differential gene expression analyses were performed using Limma-voom pipeline in r, adjusting for batch effect and sex. Over-representation tests were used to identify enriched Gene Ontology pathways. xCell, a gene signatures–based method learned from thousands of pure cell types, was applied for immune cell type deconvolution and enrichment analysis. results

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682TiP A phase I, first-in-human study of dS-1471 in patients with advanced/metastatic solid tumors

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Annals of Oncology 2024年 35卷 S531-S531页

作者： S. Koganemaru N. Yoshizuka S. Mizuno S. Hirai N. Yamamoto Department of Experimental Therapeutics National Cancer Center Hospital East Chiba Japan Global Oncology R&D Daiichi Sankyo Inc. Basking Ridge NJ USA Clinical Science Daiichi Sankyo Co. Ltd. Tokyo Japan Data Intelligence Daiichi Sankyo Co. Ltd. Tokyo Japan Department of Experimental Therapeutics National Cancer Center Hospital Tokyo Japan

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disturbance of questionable publishing to academia

arXiv

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arXiv 2021年

作者： You, Taekho Park, Jinseo Lee, June Young Yun, Jinhyuk Jung, Woo-Sung School of AI Convergence Soongsil University 369 Sangdo-ro Dongjak-gu Seoul06978 Korea Republic of Department of Industrial and Management Engineering Pohang University of Science and Technology 77 Cheongam-ro Pohang Gyeongsangbukdo 37673 Korea Republic of Center for Global R&D Data Analysis Korea Institute of Science and Technology Information 66 Heogi-ro Dongdaemun-gu Seoul02456 Korea Republic of Department of Physics Pohang University of Science and Technology 77 Cheongam-ro Pohang Gyeongsangbukdo 37673 Korea Republic of

Questionable publications have been accused of "greedy" practices;however, their influence on academia has not been gauged. Here, we probe the impact of questionable publications through a systematic and com... 详细信息

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1240MO Quantitative radiomics for the detection of symptomatic pneumonitis following chemoradiotherapy in patients with stage III unresectable NSCLC

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Annals of Oncology 2024年 35卷 S794-S794页

作者： J. Naidoo V.d. Haakensen J. Bar F. Belmans A. Corsi M. Flechet L. Libert C.C. Meca N. Tsoutzidis P. Chander K.A. Patwardhan J. Faria d. de ruysscher Oncology Dept. Beaumont Hospital Dublin Ireland Department of Oncology and Institute for Cancer Research Oslo University Hospital Oslo Norway Institute of Oncology and Faculty of Medicine Sheba Medical Center and Tel Aviv University Ramat Gan/Tel Aviv Israel R&D and Department of Imaging and Pathology Radiomics.bio and KU Leuven Liège/Leuven Belgium Medical Oncology Radiomics.bio Liège Belgium Execution Radiomics.bio Liège Belgium R&D Radiomics.bio Liège Belgium Business Radiomics.bio Liège Belgium Global Medical Affairs AstraZeneca Gaithersburg MD USA Oncology Data Science AstraZeneca Waltham MA USA R&D Oncology AstraZeneca Cambridge UK Radiation Oncology Stichting Maastricht Radiation Oncology (“MAASTRO”) Maastricht Netherlands

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AB0107 CHANGES IN EXTrACELLULAr MATrIX BIOMArKEr C3M COrrELATE WITH ABATACEPT rESPONSE IN SErOPOSITIVE EArLY rA

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Annals of the rheumatic diseases 2021年 80卷 1081-1082页

作者： S.L. Bridges J. Buckner M.A. Maldonado V. Bykerk N. ray S. Mukherjee N. Ohtsuka Hospital for Special Surgery Department of Medicine New York United States of America Benaroya Research Institute at Virginia Mason Center for Translational Immunology Seattle United States of America Bristol Myers Squibb Clinical R&D Immunoscience Princeton United States of America Hospital for Special Surgery Rheumatology New York United States of America Bristol Myers Squibb Global Drug Development Princeton United States of America Bristol Myers Squibb (at the time of analysis) Translational Medicine Princeton United States of America Bristol Myers Squibb Japan Translational Medicine Research and Development Tokyo Japan

Background: Effective biomarkers are needed to guide rA treatment selection, and the importance of evaluating synovial tissue is increasingly recognised. 1 Markers of extracellular matrix (ECM) turnover (e.g. C3M, a m...

Background: Effective biomarkers are needed to guide rA treatment selection, and the importance of evaluating synovial tissue is increasingly recognised. 1 Markers of extracellular matrix (ECM) turnover (e.g. C3M, a marker of interstitial tissue degradation) 2 may have clinical utility as disease-relevant and surrogate biomarkers of synovial joint pathophysiology. Objectives: To evaluate baseline (BL) correlations of ECM biomarkers with disease activity and the predictive value of ECM biomarkers in patients (pts) with seropositive early rA in the exploratory head-to-head Early AMPLE study ( NCT02557100 ), and to explore the impact of shared epitope (SE) status. Methods: Biologic-naive, MTX-inadequate responder adults with early (≤12 months' duration), active, moderate-to-severe rA were enrolled if they were anti-cyclic citrullinated peptide 2+ and rF+. Pts were randomised 1:1 to receive SC abatacept (ABA) 125 mg weekly or SC adalimumab (AdA) 40 mg every 2 weeks (wks) for 24 wks (single-blind period). Linear correlations between levels of ECM serum biomarkers (Nordic Biosciences) and disease activity (dAS28 [CrP], SdAI) at BL and change from BL (CfB) at Wk 24 were assessed in the overall population and by SE status (+/–); early (Wk 4) changes in biomarkers were also assessed. results: For SE+ (n=61) and SE– (n=18) pts at BL, mean (Sd) dAS28 (CrP) was 5.3 (1.2) and 5.0 (1.0), and SdAI was 35.9 (16.2) and 34.0 (13.8), respectively. At BL in the overall population, significant medium correlations between C1M, C3M and C4M and disease activity were seen ( Table 1 ). Correlations were generally higher in SE+ vs SE– pts, with C1M highly correlated with dAS28 (CrP) in SE+; correlations between C1M, C3M and C4M and disease activity were all significant in SE+ but not SE– pts. At Wk 24, overall CfB in C3M showed higher correlation with CfB in disease activity in pts receiving ABA (n=36; dAS28 [CrP]: 0.66 [p<0.0001]; SdAI: 0.53 [p=0.0009]) vs AdA (n=32; dAS28 [CrP]: 0.33 [p=0.0

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POS0198 EFFICACY ANd SAFETY OF dEUCrAVACITINIB, AN OrAL, SELECTIVE TYrOSINE KINASE 2 INHIBITOr, IN PATIENTS WITH ACTIVE PSOrIATIC ArTHrITIS: rESULTS FrOM A PHASE 2, rANdOMIZEd, dOUBLE-BLINd, PLACEBO-CONTrOLLEd TrIAL

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Annals of the rheumatic diseases 2021年 80卷 314-315页

作者： P.J. Mease A. deodhar d. Van der Heijde F. Behrens A. Kivitz J. Kim S. Singhal M. Nowak S. Banerjee Swedish Medical Center/Providence St. Joseph Health and University of Washington Rheumatology Research Seattle United States of America Oregon Health & Science University Division of Arthritis and Rheumatic Diseases Portland United States of America Leiden University Medical Center Rheumatology Leiden Netherlands CIRI/Rheumatology and Fraunhofer Institute Goethe University Translational Medicine and Pharmacology ITMP Frankfurt Germany Altoona Center for Clinical Research Department of Rheumatology Duncansville United States of America Bristol Myers Squibb Global Biometrics Data Sciences Princeton United States of America Bristol Myers Squibb Rheumatology Princeton United States of America Bristol Myers Squibb Clinical R&D Princeton United States of America Bristol Myers Squibb Rheumatology and Dermatology Princeton United States of America

Background: Tyrosine kinase 2 (TYK2) is an intracellular kinase that mediates signaling by key cytokines involved in psoriatic arthritis (PsA) and plaque psoriasis (PsO) pathogenesis. deucravacitinib is a novel oral a...

Background: Tyrosine kinase 2 (TYK2) is an intracellular kinase that mediates signaling by key cytokines involved in psoriatic arthritis (PsA) and plaque psoriasis (PsO) pathogenesis. deucravacitinib is a novel oral agent that selectively inhibits TYK2 via an allosteric mechanism by binding to the nonconserved regulatory domain of the kinase. A previous Phase 2 trial in PsO had demonstrated that deucravacitinib was efficacious and well tolerated, with no laboratory abnormalities observed. Objectives: To evaluate the efficacy and safety of deucravacitinib in active PsA. Methods: This is an ongoing, 1-year, randomized, double-blind, placebo (PBO)-controlled (initial 16 weeks), multiregional, Phase 2 trial ( NCT03881059 ). Eligible patients had a PsA diagnosis for ≥6 months, met CASPAr criteria, and had active disease with ≥3 tender and ≥3 swollen joints, C-reactive protein ≥3 mg/L (ULN, 5 mg/L), and ≥1 psoriatic lesion (≥2 cm). Patients had failed or were intolerant to ≥1 nonsteroidal anti-inflammatory drug, corticosteroid, conventional synthetic disease-modifying antirheumatic drug (csdMArd), and/or 1 TNF inhibitor (TNFi; ≤30%). Patients were randomized 1:1:1 to deucravacitinib 6 mg once daily (Qd) or 12 mg Qd, or PBO. The primary endpoint was achievement of ACr 20 response at Week 16. Additional endpoints included the proportion of patients achieving ACr 50/70 response, Health Assessment Questionnaire-disability Index (HAQ-dI) response (≥0.35 improvement from baseline), enthesitis resolution (Leeds Index score of 0), minimal disease activity, change from baseline in SF-36 physical component score (SF-36 PCS) and mental component score (SF-36 MCS), Psoriasis Area and Severity Index (PASI) 75 response, adverse events (AEs), and laboratory parameters. results: Of 203 patients randomized, 180 (89%) completed 16 weeks of treatment (deucravacitinib 6 mg Qd, 63/70 [90%]; deucravacitinib 12 mg Qd, 59/67 [88%]; PBO, 58/66 [88%]). demographic and baseline disease characterist

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INTrOdUCTION

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Bulletin of the American Meteorological Society 2024年第8期105卷 S1-S11页

作者： Boyer, T. Blunden, J. dunn, r.J.H. NOAA/NESDIS National Centers for Environmental Information Silver Spring Maryland NOAA/NESDIS National Centers for Environmental Information Asheville North Carolina Met Office Hadley Centre Exeter United Kingdom European Centre for Medium-Range Weather Forecasts Reading United Kingdom University of Maryland College Park Maryland Scripps Institution of Oceanography University of California San Diego La Jolla California NOAA/NWS National Centers for Environmental Prediction Climate Prediction Center College Park Maryland Brandenburg University of Technology (BTU) Cottbus-Senftenberg Germany Servicio Meteorológico Nacional Buenos Aires Argentina NOAA/OAR Physical Sciences Laboratory Boulder Colorado European Centre for Medium-Range Weather Forecasts Bonn Germany Center for Geophysical Research and School of Physics University of Costa Rica San José Costa Rica Department of Meteorology and National Centre for Earth Observation University of Reading Reading United Kingdom Centro Nacional de Monitoramento e Alertas de Desastres Naturais CEMADEN São Paulo Brazil Université Grenoble Alpes Institut des Géosciences de l’Environnement IRD CNRS Grenoble INP Grenoble France Hampton University Hampton Virginia Seychelles Meteorological Authority Mahe Seychelles Section for Glaciers Ice and Snow Norwegian Water Resources and Energy Directorate Oslo Norway National Research Institute for Agriculture Food and Environment (INRAE) CARRTEL Université Savoie Mont Blanc Thonon les Bains France Graduate School of Agriculture Osaka Metropolitan University Sakai Japan Science Faculty Universidad Nacional de Colombia Bogotá Colombia University of Bremen Bremen Germany NOAA Global Monitoring Laboratory Boulder Colorado Servicio Nacional de Meteorología e Hidrología del Perú Lima Perú Centro de Investigaciones sobre Desertificación – Spanish National Research Council (CSIC-UV-GVA) Valencia Spain Hydro-Climate Extremes Lab (H-CEL) Ghent University Ghent Belgium Department o

In 2023, La Niña conditions that generally prevailed in the eastern Pacific Ocean from mid-2020 into early 2023 gave way to a strong El Niño by October. Atmospheric concentrations of Earth’s major greenhous...

In 2023, La Niña conditions that generally prevailed in the eastern Pacific Ocean from mid-2020 into early 2023 gave way to a strong El Niño by October. Atmospheric concentrations of Earth’s major greenhouse gases—carbon dioxide, methane, and nitrous oxide—all increased to record-high levels. The annual global average carbon dioxide concentration in the atmosphere rose to 419.3±0.1 ppm, which is 50% greater than the pre-industrial level. The growth from 2022 to 2023 was 2.8 ppm, the fourth highest in the record since the 1960s. The combined short-term effects of El Niño and the long-term effects of increasing levels of heat-trapping gases in the atmosphere contributed to new records for many essential climate variables reported here. The annual global temperature across land and oceans was the highest in records dating as far back as 1850, with the last seven months (June–december) having each been record warm. Over land, the globally averaged temperature was also record high. dozens of countries reported record or near-record warmth for the year, including China and continental Europe as a whole (warmest on record), India and russia (second warmest), and Canada (third warmest). Intense and widespread heatwaves were reported around the world. In Vietnam, an all-time national maximum temperature record of 44.2°C was observed at Tuong duong on 7 May, surpassing the previous record of 43.4°C at Huong Khe on 20 April 2019. In Brazil, the air temperature reached 44.8°C in Araçuaí in Minas Gerais on 20 November, potentially a new national record and 12.8°C above normal. The effect of rising temperatures was apparent in the cryosphere, where snow cover extent by June 2023 was the smallest in the 56-year record for North America and seventh smallest for the Northern Hemisphere overall. Heatwaves contributed to the greatest average mass balance loss for Alpine glaciers around the world since the start of the record in 1970. due to rapid volume loss beginning in 2021, St. A

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Integration of digital Phenotyping and Genomics for dry Eye disease: Protocol for a Prospective Cohort Study

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JMIr research protocols 2025年 14卷 e67862页

作者： Ken Nagino Yasutsugu Akasaki Nobuo Fuse Soichi Ogishima Atsushi Shimizu Akira Uruno Yoichi Sutoh Yayoi Otsuka-Yamasaki Fuji Nagami Jun Seita Tomohiro Nakamura Satoshi Nagaie Makiko Taira Tomoko Kobayashi ritsuko Shimizu Atsushi Hozawa Shinichi Kuriyama Atsuko Eguchi Akie Midorikawa-Inomata Masahiro Nakamura Akira Murakami Shintaro Nakao Takenori Inomata Department of Ophthalmology Juntendo University Graduate School of Medicine Tokyo Japan. Department of Digital Medicine Juntendo University Graduate School of Medicine Tokyo Japan. Department of Hospital Administration Juntendo University Graduate School of Medicine Tokyo Japan. Department of Telemedicine and Mobile health Juntendo University Graduate School of Medicine Tokyo Japan. Tohoku Medical Megabank Organization Tohoku University Sendai Japan. Advanced Research Center for Innovations in Next-Generation Medicine Tohoku University Sendai Japan. Division of Biomedical Information Analysis Iwate Tohoku Medical Megabank Organization Disaster Reconstruction Center Iwate Medical University Yahaba Japan. Advanced Data Science Project RIKEN Information R&D and Strategy Headquarters RIKEN Tokyo Japan. Division of Biomedical Information Analysis Institute for Biomedical Sciences Iwate Medical University Yahaba Japan. Department of Data Science Kyoto Women's University Kyoto Japan. Department of Neurology Neuroscience & Sensory Organs Tohoku University Graduate of Medicine Sendai Japan. Department of Neurology Tohoku University Hospital Sendai Japan. Data Science Juntendo University Graduate School of Medicine Tokyo Japan.

BACKGrOUNd:dry eye disease (dEd) is a common ocular condition with diverse and heterogeneous symptoms. Current treatment standards of dEd include the post facto management of associated symptoms through topical eye dr... 详细信息

BACKGrOUNd:dry eye disease (dEd) is a common ocular condition with diverse and heterogeneous symptoms. Current treatment standards of dEd include the post facto management of associated symptoms through topical eye drops. However, there is a need for predictive, preventive, personalized, and participatory medicine. The dryEyerhythm mobile health app enables real-time data collection on environmental, lifestyle, host, and digital factors in a patient's daily environment. Combining these data with genetic information from biobanks could enhance our understanding of individual variations and facilitate the development of personalized treatment strategies for dEd. OBJECTIVE:This study aims to integrate digital data from the dryEyerhythm smartphone app with the Tohoku Medical Megabank database to create a comprehensive database that elucidates the interplay between multifactorial factors and the onset and progression of dEd. METHOdS:This prospective observational cohort study will include 1200 participants for the discovery stage and 1000 participants for the replication stage, all of whom have data available in the Tohoku Medical Megabank database. Participants will be recruited from the Community Support center of Sendai, Miyagi Prefecture, Japan. Participant enrollment for the discovery stage was conducted from August 1, 2021, to June 30, 2022, and the replication stage will be conducted from August 31, 2024, to March 31, 2026. Participants will provide demographic data, medical history, lifestyle information, dEd symptoms, and maximum blink interval measurements at baseline and after 30 days using the dryEyerhythm smartphone app. Upon scanning a registration code, each participant's cohort Id from the Tohoku Medical Megabank database will be linked to their smartphone app, enabling data integration between the Tohoku Medical Megabank and dryEyerhythm database. The primary outcome will assess the association between genetic polymorphisms and dEd using a genome-wide as

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AB1523-HPr USABILITY ANd ACCEPTABILITY OF A NEW AUTOINJECTOr dEVICE ANd ITS ASSOCIATEd APP IN AUSTrALIAN, FrENCH, GErMANY ANd JAPANESE rHEUMATOLOGY PATIENTS

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Annals of the rheumatic diseases 2022年 81卷 1864-1864页

作者： r. Alten M. Latymer d.C. Gruben L. Gunther-Lavergne S. Moss H. Kameda Schlosspark-Klinik University Medicine Internal Medicine Rheumatology Berlin Germany Pfizer Ltd I&I Medical Affairs Sandwich United Kingdom Pfizer Global Biostatistics and Data Management Groton United States of America Farm Design A Flex Company Human Factors Engineering Hollis United States of America Pfizer R&D UK Devices Centre of Excellence Cambridge United Kingdom Toho University (Ohashi Medical Center) Division of Rheumatology Tokyo Japan

Background Smartclic/ClicWise is a new reusable autoinjector with a dose-dispensing cartridge for subcutaneous self-administration of biotherapeutics in development for patients with rheumatoid arthritis (rA) and othe...

Background Smartclic/ClicWise is a new reusable autoinjector with a dose-dispensing cartridge for subcutaneous self-administration of biotherapeutics in development for patients with rheumatoid arthritis (rA) and other diseases. The device can connect to an optional mobile phone app (Smartclic, or ClicNote in Japan) to aid in tracking injections and other treatment or symptom data. Objectives The study objective was to collect ease of use and usability data on the Smartclic injector and companion app from experienced patients. Methods After completing a patient profiling questionnaire, adult patients (≥18 yrs) from Australia, France, Germany, and Japan with rA, psoriatic arthritis, or an original diagnosis of juvenile idiopathic arthritis who were prescribed an injectable biologic were enrolled in this study. For Japan, only patients with rA were enrolled. Each patient received training individually on the use of the Smartclic injector device and insertable cartridge and gained experience by performing simulated injections. Participants completed a questionnaire with evaluations of the device categories (number of questions): ‘ease of use' (14), ‘usability effectiveness' (11), ‘benefit of features' (8), and ‘form factor' (7). Participants also separately received a storyboard presentation summarizing the key features of the app, during which patients could explore the app (on a phone with either an android or iOS operating system), and completed 16 questions on the connectivity, usability, and benefit. responses were recorded as Likert scale ratings from 1 (‘extremely negative') to 7 (‘extremely positive'). respondents also provided an estimate of patient training time for the device. Mean values were reported. The percentage of negative (Likert scale rating 1-2), neutral (3-5), and positive (6-7) responses for each category were determined. results A total of 139 patients (mean age [range], 52 [18-84] yrs; 73% female) participated in the study ( Table 1 ). Mean sco

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LBA82 Efficacy and safety of ponsegromab, a first-in-class, monoclonal antibody inhibitor of growth differentiation factor 15, in patients with cancer cachexia: A randomized, placebo-controlled, phase II study

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Annals of Oncology 2024年 35卷 S1269-S1269页

作者： J. Crawford J.d. Groarke S.M. Collins S. Lubaczewski E.J. roeland T. Naito A.E. Hendifar M.T. Fallon K. Takayama T.r. Asmis r.F. dunne M. rossulek r. Qiu A.r. Saxena Duke Cancer Institute Duke University Medical Center Durham NC USA Internal Medicine Research Unit Pfizer Inc Cambridge MA USA Global Biometrics and Data Management Pfizer R&D UK Ltd Kent UK Translational Clinical Sciences Pfizer Inc Collegeville PA USA Knight Cancer Institute Oregon Health and Science University Portland OR USA Cancer Supportive Care Center Shizuoka Cancer Center Shizuoka Japan Samuel Oschin Cancer Center Cedars-Sinai Medical Center Los Angeles CA USA Edinburgh Cancer Research Centre Institute of Genetics and Cancer University of Edinburgh Edinburgh UK Department of Pulmonary Medicine Kyoto Prefectural University of Medicine Kyoto Japan Medical Oncology Department The Ottawa Hospital Cancer Centre Ottawa ON Canada Wilmot Cancer Institute University of Rochester Medical Center Rochester NY USA Internal Medicine Research Unit Pfizer Inc Tampa FL USA Clinical Pharmacology Pfizer Inc Cambridge MA USA

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