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司库奇尤单抗治疗影像学和非影像学中轴型脊柱关节炎的疗效:一项欧洲常规护理观察性研究。

Effectiveness of secukinumab in radiographic and non-radiographic axial spondyloarthritis: a European routine-care observational study.

机构信息

Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre for Head and Orthopedics, Rigshospitalet Glostrup, Glostrup, Denmark

Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre for Head and Orthopedics, Rigshospitalet Glostrup, Glostrup, Denmark.

出版信息

RMD Open. 2024 Jul 24;10(3):e004166. doi: 10.1136/rmdopen-2024-004166.

Abstract

OBJECTIVES

To compare the treatment effectiveness of secukinumab in radiographic (r) versus non-radiographic (nr) axial spondyloarthritis (axSpA) patients treated in routine care across Europe.

METHODS

Prospectively collected data on secukinumab-treated axSpA patients with known radiographic status were pooled from nine countries.Remission rates based on patient-reported outcomes (PROs; Numeric Rating Scale (0-10), for example, pain ≤2/Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≤2 and Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease (ID) <1.3 after 6/12/24 months of secukinumab treatment were calculated.Remission and drug retention rates in r-axSpA versus nr-axSpA patients were compared by logistic and Cox regression models (unadjusted/adjusted for age+sex/adjusted for multiple confounders).

RESULTS

Overall, 1161 secukinumab-treated patients were included (r-axSpA/nr-axSpA: 922/239). At baseline, r-axSpA patients had longer disease duration and higher C reactive protein, were more often male and HLA-B27 positive and had received fewer prior biological or targeted synthetic disease-modifying antirheumatic drugs compared with nr-axSpA patients, whereas PROs were largely similar.During follow-up, crude PRO remission rates were significantly higher in r-axSpA compared with nr-axSpA patients (6 months: pain≤2: 40%/28%, OR=1.7; BASDAI≤2: 37%/25%, OR=1.8), as were drug retention rates (24 months: 66%/58%, HR 0.73 (ref: r-axSpA)). Proportions of patients achieving ASDAS ID were low for both groups, particularly nr-axSpA (6 months: 11%/8%).However, when adjusting for age+sex, these differences diminished, and after adjusting for multiple confounders, no significant between-group differences remained for either remission or drug retention rates.

CONCLUSION

Crude remission/drug retention rates in European secukinumab-treated patients were higher in r-axSpA compared with nr-axSpA patients. In adjusted analyses, secukinumab effectiveness was similar in both groups, suggesting that observed differences were related to factors other than radiographic status.

摘要

目的

比较司库奇尤单抗治疗欧洲常规护理下放射学(r)和非放射学(nr)轴性脊柱关节炎(axSpA)患者的疗效。

方法

从九个国家前瞻性收集了已知放射学状况的司库奇尤单抗治疗 axSpA 患者的数据。基于患者报告的结果(PROs;例如,疼痛≤2/巴斯强直性脊柱炎疾病活动指数(BASDAI)≤2 和强直性脊柱炎疾病活动评分(ASDAS)无疾病活动(ID)<1.3)计算了接受司库奇尤单抗治疗 6/12/24 个月后的缓解率。通过逻辑回归和 Cox 回归模型(未调整/调整年龄+性别/调整多个混杂因素)比较 r-axSpA 和 nr-axSpA 患者的缓解率和药物保留率。

结果

共纳入 1161 例接受司库奇尤单抗治疗的患者(r-axSpA/nr-axSpA:922/239)。基线时,r-axSpA 患者的疾病病程较长,C 反应蛋白水平较高,男性和 HLA-B27 阳性的比例更高,接受的生物制剂或靶向合成的改善病情抗风湿药物治疗较少。然而,PROs 基本相似。在随访期间,r-axSpA 患者的缓解率明显高于 nr-axSpA 患者(6 个月时疼痛≤2:40%/28%,OR=1.7;BASDAI≤2:37%/25%,OR=1.8),药物保留率也较高(24 个月时:66%/58%,HR 0.73(参考:r-axSpA))。两组患者达到 ASDAS ID 的比例均较低,nr-axSpA 组尤其低(6 个月时:11%/8%)。然而,调整年龄+性别后,这些差异有所减小,调整多个混杂因素后,两组间缓解率和药物保留率均无显著差异。

结论

与 nr-axSpA 患者相比,欧洲接受司库奇尤单抗治疗的 axSpA 患者的缓解率和药物保留率在 r-axSpA 患者中更高。在调整分析中,两组的司库奇尤单抗疗效相似,这表明观察到的差异与放射学状况以外的因素有关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ea83/11284936/af7f59c87ca4/rmdopen-10-3-g001.jpg

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