Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
Ruhr-University Bochum, Herne, Germany.
Ann Rheum Dis. 2018 May;77(5):699-705. doi: 10.1136/annrheumdis-2017-212377. Epub 2018 Jan 17.
To report 4-year imaging outcomes in the RAPID-axSpA (NCT01087762) study of patients with ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA), treated with certolizumab pegol (CZP).
This phase III, randomised trial was placebo-controlled and double-blind to week 24, dose-blind to week 48 and open-label to week 204. Patients fulfilling the Assessment of Spondyloarthritis International Society (ASAS) axSpA criteria with active disease were stratified (AS/nr-axSpA) according to the modified New York (mNY) criteria at randomisation. Spinal radiographs were assessed using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). MRI inflammation used the Spondyloarthritis Research Consortium of Canada (SPARCC) score for sacroiliac joints (SIJ) and the Berlin spinal score (remission defined as SPARCC <2 and Berlin ≤2, respectively).
MRI improvements from baseline (BL) to week 12 were maintained to week 204 (SPARCC BL: AS=8.5, nr-axSpA=7.5; SPARCC week 204: AS=1.3, nr-axSpA=2.4; Berlin BL: AS=7.4, nr-axSpA=4.4; Berlin week 204: AS=2.6, nr-axSpA=1.9). 66.7% of patients with AS and 69.6% of patients with nr-axSpA with BL SPARCC scores ≥2, and 65.4% of patients with AS and 57.3% of patients with nr-axSpA with BL Berlin score >2, achieved remission at week 204. Mean mSASSS change in AS from BL to week 204 was 0.98 (95% CI 0.34, 1.63); 0.67 (95% CI 0.21,1.13) from BL to week 96; and 0.31 (95% CI 0.02,0.60) from week 96 to week 204. Corresponding nr-axSpA changes were 0.06 (95% CI -0.17,0.28), -0.01 (95% CI -0.19,0.17) and 0.07 (95% CI -0.07,0.20). 4.5% of patients with nr-axSpA fulfilled the mNY criteria at week 204, while 4.3% of patients with AS no longer did so.
In patients with CZP-treated axSpA, rapid decreases in spinal and SIJ MRI inflammation were maintained to week 204. Overall, 4-year spinal progression was low, with less progression during years 2-4 than 0-2. Radiographic SIJ grading changes demonstrated limited progression.
NCT01087762; Post-results.
报告接受培塞利珠单抗（CZP）治疗的强直性脊柱炎（AS）和非放射学中轴型脊柱关节炎（nr-axSpA）患者的 RAPID-axSpA（NCT01087762）研究的 4 年影像学结果。
这是一项 III 期、安慰剂对照、双盲至第 24 周、第 48 周剂量盲、第 204 周开放标签的随机试验。符合强直性脊柱炎国际协会（ASAS）中轴型 SpA 标准且疾病活动的患者根据改良纽约（mNY）标准在随机分组时分层（AS/nr-axSpA）。脊柱 X 线片采用改良 Stoke 强直性脊柱炎脊柱评分（mSASSS）评估。磁共振成像炎症采用加拿大脊柱关节炎研究协会（SPARCC）评分评估骶髂关节（SIJ）和柏林脊柱评分（分别定义为 SPARCC <2 和柏林≤2 为缓解）。
从基线（BL）到第 12 周的 MRI 改善在第 204 周时得到维持（SPARCC BL：AS=8.5，nr-axSpA=7.5；SPARCC 第 204 周：AS=1.3，nr-axSpA=2.4；柏林 BL：AS=7.4，nr-axSpA=4.4；柏林第 204 周：AS=2.6，nr-axSpA=1.9）。BL SPARCC 评分≥2 的 AS 患者中有 66.7%和 nr-axSpA 患者中有 69.6%、BL 柏林评分>2 的 AS 患者中有 65.4%和 nr-axSpA 患者中有 57.3%在第 204 周时达到缓解。AS 从 BL 到第 204 周的平均 mSASSS 变化为 0.98（95%CI 0.34,1.63）；从 BL 到第 96 周为 0.67（95%CI 0.21,1.13）；从第 96 周到第 204 周为 0.31（95%CI 0.02,0.60）。相应的 nr-axSpA 变化为 0.06（95%CI -0.17,0.28）、-0.01（95%CI -0.19,0.17）和 0.07（95%CI -0.07,0.20）。第 204 周时，4.5%的 nr-axSpA 患者符合 mNY 标准，而 4.3%的 AS 患者不再符合该标准。
在接受 CZP 治疗的中轴型 SpA 患者中，脊柱和 SIJ 的 MRI 炎症迅速下降，并在第 204 周时得到维持。总体而言，4 年脊柱进展较低，0-2 年和 2-4 年期间的进展较少。放射学 SIJ 分级变化显示进展有限。
NCT01087762；Post-results。
