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4443. Efficacy and safety of garadacimab, a factor XIIa inhibitor for hereditary angioedema prevention (VANGUARD): a global, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.
作者: Timothy J Craig.;Avner Reshef.;H Henry Li.;Joshua S Jacobs.;Jonathan A Bernstein.;Henriette Farkas.;William H Yang.;Erik S G Stroes.;Isao Ohsawa.;Raffi Tachdjian.;Michael E Manning.;William R Lumry.;Inmaculada Martinez Saguer.;Emel Aygören-Pürsün.;Bruce Ritchie.;Gordon L Sussman.;John Anderson.;Kimito Kawahata.;Yusuke Suzuki.;Petra Staubach.;Regina Treudler.;Henrike Feuersenger.;Fiona Glassman.;Iris Jacobs.;Markus Magerl.
来源: Lancet. 2023年401卷10382期1079-1090页
Hereditary angioedema is a rare and potentially life-threatening genetic disease that is associated with kallikrein-kinin system dysregulation. Garadacimab (CSL312), a novel, fully-human monoclonal antibody that inhibits activated factor XII (FXIIa), is being studied for the prevention of hereditary angioedema attacks. The aim of this study was to evaluate the efficacy and safety of once-monthly subcutaneous administrations of garadacimab as prophylaxis for hereditary angioedema.
4446. Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 3 trial (SLE-BRAVE-II).
作者: Michelle Petri.;Ian N Bruce.;Thomas Dörner.;Yoshiya Tanaka.;Eric F Morand.;Kenneth C Kalunian.;Mario H Cardiel.;Maria E Silk.;Christina L Dickson.;Gabriella Meszaros.;Lu Zhang.;Bochao Jia.;Youna Zhao.;Conor J McVeigh.;Marta Mosca.
来源: Lancet. 2023年401卷10381期1011-1019页
Baricitinib is an oral selective inhibitor of Janus kinase 1 and 2 approved for the treatment of rheumatoid arthritis, atopic dermatitis, and alopecia areata. In a 24-week phase 2 study in patients with systemic lupus erythematosus (SLE), baricitinib 4 mg significantly improved SLE disease activity compared with placebo. In this Article, we report the evaluation of efficacy and safety of baricitinib in patients with SLE in a 52-week phase 3 study.
4447. Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 3 trial (SLE-BRAVE-I).
作者: Eric F Morand.;Edward M Vital.;Michelle Petri.;Ronald van Vollenhoven.;Daniel J Wallace.;Marta Mosca.;Richard A Furie.;Maria E Silk.;Christina L Dickson.;Gabriella Meszaros.;Bochao Jia.;Brenda Crowe.;Inmaculada de la Torre.;Thomas Dörner.
来源: Lancet. 2023年401卷10381期1001-1010页
Baricitinib is an oral selective inhibitor of Janus kinase 1 and 2 approved for the treatment of rheumatoid arthritis, atopic dermatitis, and alopecia areata. In a 24-week phase 2 study in patients with systemic lupus erythematosus (SLE), baricitinib 4 mg significantly improved SLE disease activity compared with placebo. The objective of this trial was to evaluate the efficacy and safety of baricitinib in patients with active SLE in a 52-week phase 3 study.
4450. Hyperfractionation compared with standard fractionation in intensity-modulated radiotherapy for patients with locally advanced recurrent nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase 3 trial.
作者: Rui You.;You-Ping Liu.;Yu-Long Xie.;Chao Lin.;Chong-Yang Duan.;Dong-Ping Chen.;Yi Pan.;Bin Qi.;Xiong Zou.;Ling Guo.;Jing-Yu Cao.;Yi-Nuan Zhang.;Zhi-Qiang Wang.;Yong-Long Liu.;Yan-Feng Ouyang.;Kai Wen.;Qi Yang.;Ruo-Qi Xie.;Hui-Feng Li.;Xiao-Tong Duan.;Xi Ding.;Lan Peng.;Si-Yuan Chen.;Jiong-Lin Liang.;Zheng-Kai Feng.;Tian-Liang Xia.;Rui-Ling Xie.;Rou Jiang.;Chen-Mei Gu.;Rong-Zeng Liu.;Rui Sun.;Xin Yang.;Li-Zhi Liu.;Li Ling.;Qing Liu.;Wai Tong Ng.;Yi-Jun Hua.;Pei-Yu Huang.;Ming-Yuan Chen.
来源: Lancet. 2023年401卷10380期917-927页
Reirradiation in standard fractionation for locally advanced recurrent nasopharyngeal carcinoma after a previous course of high-dose radiotherapy is often associated with substantial late toxicity, negating its overall benefit. We therefore aimed to investigate the efficacy and safety of hyperfractionation compared with standard fractionation in intensity-modulated radiotherapy.
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