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Efficacy of Ixekizumab in Chinese Patients with Radiographic Axial Spondyloarthritis by Baseline C-Reactive Protein Level

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机构: [1]Fudan Univ, Huashan Hosp, Dept Rheumatol, 12 Urumqi Middle Rd, Shanghai 2000400, Peoples R China [2]Pingxiang Peoples Hosp, Dept Rheumatol, Pingxiang, Jiangxi, Peoples R China [3]Jinan Univ, Shenzhen Peoples Hosp, Clin Med Coll 2, Dept Rheumatol, Shenzhen, Peoples R China [4]Cent South Univ, Zhuzhou Hosp, Xiangya Med Coll, Dept Rheumatol, Zhuzhou, Hunan, Peoples R China [5]Zhejiang Univ, Affiliated Hosp 2, Sch Med, Dept Rheumatol, Hangzhou, Zhejiang, Peoples R China [6]Nanjing Univ, Nanjing Drum Tower Hosp, Affiliated Hosp, Dept Rheumatol,Med Sch, Nanjing, Jiangsu, Peoples R China [7]Sun Yat Sen Univ, Sun Yat Sen Mem Hosp, Dept Rheumatol, Guangzhou, Guangdong, Peoples R China [8]Sichuan Univ, Dept Rheumatol, West China Hosp, Chengdu, Sichuan, Peoples R China [9]Bengbu Med Univ, Affiliated Hosp 1, Dept Rheumatol, Bengbu, Anhui, Peoples R China [10]Shantou Univ, Affiliated Hosp 1, Med Coll, Dept Rheumatol, Shantou, Guangdong, Peoples R China [11]Shenzhen Univ, South China Hosp, Dept Rheumatol, Shenzhen, Peoples R China [12]Beijing Hosp, Beijing, Peoples R China [13]Kunming Med Univ, Affiliated Hosp 1, Dept Rheumatol, Kunming, Yunnan, Peoples R China [14]Eli Lilly & Co, Shanghai, Peoples R China
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关键词: China C-reactive protein Inflammation Ixekizumab Radiographic axial spondyloarthritis

摘要:
Introduction Ixekizumab, an interleukin 17A inhibitor, improved the Assessment of SpondyloArthritis international Society 40 (ASAS40) response rates irrespective of baseline inflammation in international populations with radiographic axial spondyloarthritis (r-axSpA). We investigated the association of baseline inflammation (measured by serum C-reactive protein [CRP] levels) with ixekizumab efficacy in Chinese patients with r-axSpA. Methods This was a subgroup analysis of a Chinese phase 3 study. Adults with r-axSpA who were biologic-na & iuml;ve, or tumor necrosis factor inhibitor-experienced with baseline CRP > 5 mg/l, were randomized (1:1) to receive ixekizumab 80 mg every 4 weeks (IXEQ4W) or placebo, for 16 weeks. The following endpoints were analyzed by normal (<= 5 mg/l) or elevated (> 5 mg/l) baseline CRP levels: ASAS40; Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50); Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2.1; ASDAS clinically important improvement (CII; change from baseline >= 1.1); ASDAS major improvement (MI; change from baseline >= 2.0 or achievement of lowest possible score); Bath Ankylosing Spondylitis Metrology Index (BASMI) linear score; Bath Ankylosing Spondylitis Functional Index (BASFI); Short Form-36 Physical Component Score (SF-36 PCS). Results A total of 147 patients were randomized. At week 16, the ASAS40 response rate was greater with IXEQ4W versus placebo in the normal (50.0% vs. 15.0%; p < 0.05) and elevated (29.5% vs. 5.7%; p < 0.01) CRP subgroups. Significant improvements in BASDAI50 response rate, ASDAS < 2.1, and ASDAS CII with IXEQ4W versus placebo were observed in both subgroups (normal CRP: p < 0.05, p < 0.01, and p < 0.05, respectively; elevated CRP: p < 0.01, p < 0.001, and p < 0.001, respectively); IXEQ4W significantly improved ASDAS MI in the elevated CRP subgroup (p < 0.001). IXEQ4W significantly improved linear BASMI and BASFI scores in the normal CRP subgroup (p < 0.001 and p < 0.01, respectively), while SF-36 PCS improved in both subgroups (both p < 0.05). Conclusions Ixekizumab showed efficacy in Chinese patients with r-axSpA, irrespective of baseline CRP levels, consistent with results in international populations with r-axSpA. Trial Registration ClinicalTrials.gov identifier, NCT04285229.

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大类 | 3 区 医学
小类 | 3 区 风湿病学
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Q2 RHEUMATOLOGY

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第一作者机构: [1]Fudan Univ, Huashan Hosp, Dept Rheumatol, 12 Urumqi Middle Rd, Shanghai 2000400, Peoples R China
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