赛库单抗对放射性和非放射性轴性脊柱关节炎的疗效:一项欧洲常规护理观察研究。

IF 5.1 2区 医学 Q1 RHEUMATOLOGY
Sara Nysom Christiansen, Simon Horskjær Rasmussen, Mikkel Ostergaard, Marion Pons, Brigitte Michelsen, Karel Pavelka, Catalin Codreanu, Adrian Ciurea, Bente Glintborg, Maria Jose Santos, Ismail Sari, Ziga Rotar, Bjorn Gudbjornsson, Gary J Macfarlane, Heikki Relas, Florenzo Iannone, Karin Laas, Johan K Wallman, Marleen van de Sande, Sella Aarrestad Provan, Isabel Castrejon, Jakub Zavada, Corina Mogosan, Michael J Nissen, Anne Gitte Loft, Anabela Barcelos, Yesim Erez, Katja Perdan Pirkmajer, Gerdur Grondal, Gareth T Jones, Anna-Mari Hokkanen, Maria Sole Chimenti, Sigrid Vorobjov, Daniela Di Giuseppe, Tore K Kvien, Lucia Otero-Varela, Irene van der Horst-Bruinsma, Merete Lund Hetland, Lykke Midtbøll Ørnbjerg
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引用次数: 0

摘要

目的比较secukinumab在欧洲常规治疗的放射性(r)与非放射性(nr)轴性脊柱关节炎(axSpA)患者中的治疗效果:根据患者报告结果(PROs;数字评分量表(0-10),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)非活动性疾病(ID))得出缓解率:总共纳入了1161名接受过赛库单抗治疗的患者(r-axSpA/nr-axSpA:922/239)。基线时,与nr-axSpA患者相比,r-axSpA患者的病程更长,C反应蛋白更高,男性和HLA-B27阳性者更多,既往接受过的生物或靶向合成修饰性抗风湿药物更少,而PRO指标基本相似。在随访期间,与 nr-axSpA 患者相比,r-axSpA 患者的 PRO 粗缓解率明显更高(6 个月:疼痛≤2:40%/28%,OR=1.7;BASDAI≤2:37%/25%,OR=1.8),药物保留率也更高(24 个月:66%/58%,HR 0.9):药物保留率也是如此(24 个月:66%/58%,HR 0.73(参考:R-axSpA))。两组患者达到ASDAS ID的比例均较低,尤其是nr-axSpA组(6个月:11%/8%)。然而,在对年龄+性别进行调整后,这些差异有所减小,在对多种混杂因素进行调整后,缓解率或药物保留率均无显著的组间差异:欧洲secukinumab治疗患者的粗缓解率/药物保留率在r-axSpA患者中高于nr-axSpA患者。在调整分析中,两组患者的secukinumab疗效相似,这表明观察到的差异与放射学状态以外的因素有关。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Effectiveness of secukinumab in radiographic and non-radiographic axial spondyloarthritis: a European routine-care observational study.

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.

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来源期刊
RMD Open
RMD Open RHEUMATOLOGY-
CiteScore
7.30
自引率
6.50%
发文量
205
审稿时长
14 weeks
期刊介绍: RMD Open publishes high quality peer-reviewed original research covering the full spectrum of musculoskeletal disorders, rheumatism and connective tissue diseases, including osteoporosis, spine and rehabilitation. Clinical and epidemiological research, basic and translational medicine, interesting clinical cases, and smaller studies that add to the literature are all considered.
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