Safety and efficacy of subcutaneous iscalimab (CFZ533) in two distinct populations of patients with Sjögren's disease (TWINSS): week 24 results of a randomised, double-blind, placebo-controlled, phase 2b dose-ranging study.
作者:
Benjamin A,Fisher [1]
;
Xavier,Mariette [2]
;
Athena,Papas [3]
;
Thomas,Grader-Beck [4]
;
Hendrika,Bootsma [5]
;
Wan-Fai,Ng [6]
;
P L A,van Daele [7]
;
Stephanie,Finzel [8]
;
Ghaith,Noaiseh [9]
;
Sergio,Elgueta [10]
;
Josef,Hermann [11]
;
Sara S,McCoy [12]
;
Esen,Akpek [4]
;
Arthur,Bookman [13]
;
Monika,Sopala [14]
;
Michela,Montecchi-Palmer [15]
;
Wen-Lin,Luo [15]
;
Cornelia,Scheurer [14]
;
Wolfgang,Hueber [16]
;
TWINSS study group
作者单位:
Department of Rheumatology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK; NIHR Birmingham Biomedical Research Centre, Birmingham, UK.
[1]
Department of Rheumatology, Université Paris-Saclay, Assistance Publique - Hôpitaux de Paris, Hôpital Bicêtre, INSERM UMR1184, Le Kremlin Bicêtre, France.
[2]
Division of Oral Medicine, Tufts School of Dental Medicine, Boston, MA, USA.
[3]
Division of Rheumatology, Johns Hopkins School of Medicine, Baltimore, MD, USA.
[4]
Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Centre Groningen, Groningen, Netherlands.
[5]
NIHR Newcastle Clinical Research Facility, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK.
[6]
Department of Internal Medicine, Erasmus MC, Rotterdam, Netherlands.
[7]
Department of Rheumatology and Clinical Immunology, University Medical Center Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
[8]
Division of Allergy, Clinical Immunology and Rheumatology, Department of Medicine, University of Kansas, Kansas City, KS, USA.
[9]
Department of Rheumatology, Clinica Alemana de Valdivia, Valdivia, Chile; Clinical Research Chile SpA, Biomedical Research Centre, Valdivia, Chile.
[10]
Division of Rheumatology and Immunology, Department of Internal Medicine, Medical University Graz, Graz, Austria.
[11]
University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.
[12]
Toronto Western Hospital, Toronto, ON, Canada.
[13]
Novartis Pharma, Basel, Switzerland.
[14]
Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
[15]
Novartis Pharma, Basel, Switzerland. Electronic address: wolfgang.hueber@novartis.com.
[16]
期刊:
主题词:
人类(Humans);双盲法(Double-Blind Method);女(雌)性(Female);男(雄)性(Male);中年人(Middle Aged);干燥综合征(Sjogren's Syndrome);注射, 皮下(Injections, Subcutaneous);剂量效应关系, 药物(Dose-Response Relationship, Drug);成年人(Adult);治疗结果(Treatment Outcome);老年人(Aged);疾病严重程度指数(Severity of Illness Index);抗体, 单克隆(Antibodies, Monoclonal)
DOI:
10.1016/S0140-6736(24)01211-X
PMID:
39096929
发布时间:
2024-08-12
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