PDF(Pubmed)
Abstract：
OBJECTIVE: There is a paucity of data on long-term clinical responses in patients with non-radiographic axial spondyloarthritis (nr-axSpA) based on their baseline objective signs of inflammation such as MRI or C-reactive protein (CRP) levels. This study reports clinical outcomes up to 3 years of the C-axSpAnd trial, including safety follow-up extension (SFE) from Weeks 52 to 156, stratified by patients\' baseline MRI and CRP status.
METHODS: C-axSpAnd (NCT02552212) was a phase 3, multicentre study that evaluated certolizumab pegol (CZP) in patients with active nr-axSpA who had active sacroiliitis on MRI and/or elevated CRP. In this post hoc analysis, efficacy outcomes are reported to Week 156 of C-axSpAnd for patients stratified according to their MRI and CRP status at Week 0 (MRI+/CRP-, MRI-/CRP+ and MRI+/CRP+).
RESULTS: Across all outcome measures, including major improvement in Ankylosing Spondylitis Disease Activity Score (ASDAS-MI) and Assessment of SpondyloArthritis international Society criteria ≥40% response (ASAS40), outcomes were generally sustained in SFE patients from Week 52 to Week 156. MRI+/CRP+ patients showed numerically higher or comparable responses relative to MRI-/CRP+ and MRI+/CRP- patients at Weeks 52 and 156; however, all three subgroups demonstrated substantial improvements from Week 0 (in CZP-randomised patients, ASDAS-MI at Week 156 [observed case]: MRI+/CRP+: 73.1%, MRI-/CRP+: 52.2%, MRI+/CRP-: 30.4%; ASAS40: MRI+/CRP+: 76.9%, MRI-/CRP+: 62.5%, MRI+/CRP-: 65.2%).
CONCLUSIONS: In patients with nr-axSpA and objective signs of inflammation, long-term clinical outcomes achieved after 1 year were generally sustained at 3 years across MRI+/CRP+, MRI-/CRP+ and MRI+/CRP- subgroups.
METHODS: C-axSpAnd (NCT02552212) was a phase 3, multicentre study that evaluated certolizumab pegol (CZP) in patients with active nr-axSpA who had active sacroiliitis on MRI and/or elevated CRP. In this post hoc analysis, efficacy outcomes are reported to Week 156 of C-axSpAnd for patients stratified according to their MRI and CRP status at Week 0 (MRI+/CRP-, MRI-/CRP+ and MRI+/CRP+).
RESULTS: Across all outcome measures, including major improvement in Ankylosing Spondylitis Disease Activity Score (ASDAS-MI) and Assessment of SpondyloArthritis international Society criteria ≥40% response (ASAS40), outcomes were generally sustained in SFE patients from Week 52 to Week 156. MRI+/CRP+ patients showed numerically higher or comparable responses relative to MRI-/CRP+ and MRI+/CRP- patients at Weeks 52 and 156; however, all three subgroups demonstrated substantial improvements from Week 0 (in CZP-randomised patients, ASDAS-MI at Week 156 [observed case]: MRI+/CRP+: 73.1%, MRI-/CRP+: 52.2%, MRI+/CRP-: 30.4%; ASAS40: MRI+/CRP+: 76.9%, MRI-/CRP+: 62.5%, MRI+/CRP-: 65.2%).
CONCLUSIONS: In patients with nr-axSpA and objective signs of inflammation, long-term clinical outcomes achieved after 1 year were generally sustained at 3 years across MRI+/CRP+, MRI-/CRP+ and MRI+/CRP- subgroups.
摘要：
目的：关于非影像学轴性脊柱关节炎（nr-axSpA）患者的长期临床反应的数据缺乏，这些数据基于他们的基线客观炎症体征，如MRI或C反应蛋白（CRP）水平。这项研究报告了C-axSpAnd试验长达3年的临床结果，包括第52至156周的安全性随访延长(SFE),按患者基线MRI和CRP状态分层。
方法：C-axSpAnd（NCT02552212）是一项3期，多中心研究，评估了在MRI和/或CRP升高的患有活动性nr-axSpA的患者中，赛托珠单抗pegol（CZP）。在这个事后分析中，根据第0周的MRI和CRP状态分层的患者的C-axSpAnd第156周报告疗效结果(MRI+/CRP-，MRI+/CRP+和MRI+/CRP+)。
结果：在所有结果测量中，包括强直性脊柱炎疾病活动评分（ASDAS-MI）的主要改善和脊柱炎国际学会标准≥40％反应（ASAS40）的评估，从第52周至第156周,SFE患者的结局通常持续.MRI+/CRP+患者在第52周和第156周表现出相对于MRI-/CRP+和MRI+/CRP-患者的数值更高或相当的反应;然而,从第0周开始，所有三个亚组均表现出实质性改善（在CZP随机患者中，第156周ASDAS-MI[观察病例]：MRI+/CRP+：73.1%，MRI-/CRP+：52.2%，MRI+/CRP-:30.4%;ASAS40:MRI+/CRP+:76.9%,MRI-/CRP+:62.5%,MRI+/CRP-：65.2%）。
结论：在患有nr-axSpA和炎症客观体征的患者中，1年后获得的长期临床结果通常在3年后通过MRI+/CRP+维持,MRI+/CRP+和MRI+/CRP-亚组。
方法：C-axSpAnd（NCT02552212）是一项3期，多中心研究，评估了在MRI和/或CRP升高的患有活动性nr-axSpA的患者中，赛托珠单抗pegol（CZP）。在这个事后分析中，根据第0周的MRI和CRP状态分层的患者的C-axSpAnd第156周报告疗效结果(MRI+/CRP-，MRI+/CRP+和MRI+/CRP+)。
结果：在所有结果测量中，包括强直性脊柱炎疾病活动评分（ASDAS-MI）的主要改善和脊柱炎国际学会标准≥40％反应（ASAS40）的评估，从第52周至第156周,SFE患者的结局通常持续.MRI+/CRP+患者在第52周和第156周表现出相对于MRI-/CRP+和MRI+/CRP-患者的数值更高或相当的反应;然而,从第0周开始，所有三个亚组均表现出实质性改善（在CZP随机患者中，第156周ASDAS-MI[观察病例]：MRI+/CRP+：73.1%，MRI-/CRP+：52.2%，MRI+/CRP-:30.4%;ASAS40:MRI+/CRP+:76.9%,MRI-/CRP+:62.5%,MRI+/CRP-：65.2%）。
结论：在患有nr-axSpA和炎症客观体征的患者中，1年后获得的长期临床结果通常在3年后通过MRI+/CRP+维持,MRI+/CRP+和MRI+/CRP-亚组。
