Objectives 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). Methods 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). Results 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. Conclusions 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. Trial registration number NCT01087762; Post-results.

中文翻译：

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中轴型脊柱关节炎患者的放射学进展有限且 MRI 炎症持续减少：RAPID-axSpA III 期随机试验的 4 年成像结果


目的 报告 RAPID-axSpA (NCT01087762) 研究中接受聚乙二醇赛妥珠单抗 (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 4 年影像学结果。方法 这项 III 期随机试验在第 24 周进行安慰剂对照和双盲试验，在第 48 周进行剂量盲试验，在第 204 周进行开放标签试验。符合脊柱关节炎国际协会 (ASAS) axSpA 评估标准的活动性疾病患者根据修改后的纽约 (mNY) 标准随机分层 (AS/nr-axSpA)。使用改良的斯托克强直性脊柱炎脊柱评分（mSASSS）评估脊柱X光片。 MRI 炎症使用加拿大脊柱关节炎研究联盟 (SPARCC) 骶髂关节 (SIJ) 评分和柏林脊柱评分（缓解定义为 SPARCC <2 id=68>2，在第 204 周达到缓解。AS 相对于 BL 的平均 mSASSS 变化到第 204 周为 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)。变化分别为 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)，4.5% 的 nr-axSpA 患者在一周内满足 mNY 标准。 204，而 4.3% 的 AS 患者不再这样做。 结论 在接受 CZP 治疗的 axSpA 患者中，脊柱和 SIJ MRI 炎症的快速减少持续到第 204 周。总体而言，4 年脊柱进展较低，进展较少。 2-4 年期间，影像学 SIJ 分级变化显示进展有限；试验注册号 NCT01087762。