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Secukinumab provided significant and sustained improvement in the signs and symptoms of ankylosing spondylitis: results from the 52-week, Phase III China-centric study, MEASURE 5

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收录情况: ◇ SCIE ◇ 统计源期刊 ◇ CSCD-C ◇ 卓越:领军期刊 ◇ 中华系列

单位: [1]Chinese Peoples Liberat Army Gen Hosp, Dept Rheumatol, 28 Fuzing Rd, Beijing 100853, Peoples R China [2]Fudan Univ, Huashan Hosp, Dept Rheumatol, Shanghai 200040, Peoples R China [3]Peoples Hosp Xinjiang Uygur Autonomous Reg, Dept Rheumatol & Immunol, Urumqi 830001, Xinjiang, Peoples R China [4]Huazhong Univ Sci & Technol, Tongji Hosp, Dept Rheumatol & Immunol, Tongji Med Coll, Wuhan 430030, Hubei, Peoples R China [5]Guangdong Gen Hosp, Dept Rheumatol & Immunol, Guangzhou 510000, Guangdong, Peoples R China [6]Hanyang Univ, Hosp Rheumat Dis, Seoul, South Korea [7]Royal Natl Hosp Rheumat Dis, Bath BA1 1RL, Avon, England [8]Inst Rheumatol, Prague, Czech Republic [9]Novartis Pharmaceut, E Hanover, NJ USA [10]China Novartis Inst Biomed Res, Shanghai 201203, Peoples R China [11]Novartis Pharma AG, Basel, Switzerland
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关键词: Ankylosing spondylitis Biologics Cytokines Interleukin 17A Tumor necrosis factor

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Background: Secukinumab demonstrated sustained efficacy in patients with ankylosing spondylitis (AS) through 5 years in pivotal Phase III studies. Here, we present efficacy and safety results (52-week) of secukinumab in patients with AS from the MEASURE 5 study. Methods: MEASURE 5 was a 52-week, Phase III, China-centric study. Eligible patients were randomly assigned (2:1) to receive subcutaneous secukinumab 150 mg or placebo weekly for the first five doses and then once every 4 weeks (q4w). All placebo patients switched to secukinumab 150 mg q4w starting at Week 16. Primary endpoint was Assessments of SpondyloArthritis international Society (ASAS) 20 at Week 16. Randomization was stratified by region (China vs. non-China). Results: Of 458 patients (secukinumab 150 mg, N = 305; placebo, N = 153) randomized, 327 (71.4%) were from China and 131 (28.6%) were not from China. Of these, 97.7% and 97.4% patients completed Week 16 and 91.1% and 95.3% (placebo-secukinumab) patients completed Week 52 of treatment. The primary endpoint was met; secukinumab significantly improved ASAS20 response at Week 16 vs. placebo (58.4% vs. 36.6%; P < 0.0001); corresponding rate in the Chinese population was 56.0% vs. 38.5% (P < 0.01). All secondary efficacy endpoints significantly improved with secukinumab 150 mg in the overall population at Week 16; responses were maintained with a trend toward increased efficacy from Week 16 to 52. No new or unexpected safety signals were reported up to Week 52. Conclusions: Secukinumab 150 mg demonstrated rapid and significant improvement in signs and symptoms of AS. Secukinumab was well tolerated and the safety profile was consistent with previous reports. Efficacy and safety results were comparable between the overall and Chinese populations.

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出版当年[2019]版:
大类 | 3 区 医学
小类 | 3 区 医学:内科
最新[2025]版:
大类 | 2 区 医学
小类 | 2 区 医学:内科
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出版当年[2018]版:
Q3 MEDICINE, GENERAL & INTERNAL
最新[2023]版:
Q1 MEDICINE, GENERAL & INTERNAL

影响因子: 最新[2023版] 最新五年平均 出版当年[2018版] 出版当年五年平均 出版前一年[2017版] 出版后一年[2019版]

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第一作者单位: [1]Chinese Peoples Liberat Army Gen Hosp, Dept Rheumatol, 28 Fuzing Rd, Beijing 100853, Peoples R China
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