阿达木单抗在非放射学中轴型脊柱关节炎中的疗效：单中心队列的临床和磁共振成像结果评估
Effectiveness of Adalimumab in Non-radiographic Axial Spondyloarthritis: Evaluation of Clinical and Magnetic Resonance Imaging Outcomes in a Monocentric Cohort.
作者信息
Cantarini Luca, Fabbroni Marta, Talarico Rosaria, Costa Luisa, Caso Francesco, Cuneo Gian Luca, Frediani Bruno, Faralli Gabriele, Vitale Antonio, Brizi Maria Giuseppina, Sabadini Luciano, Galeazzi Mauro
机构信息
From the Rheumatology Unit (LC, MF, BF, AV, MGB, MG), Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Siena; Rheumatology Unit (RT), Department of Clinical and Experimental Medicine, University of Pisa, Pisa; Rheumatology Research Unit (LC), Department of Clinical and Experimental Medicine, University Federico II, Naples; Rheumatology Unit (FC), Department of Medicine DIMED, University of Padua, Padua; Neuroradiology Unit (GLC), S. Donato Hospital, Cardiovascular and Neurologic Department, Arezzo; Radiology Unit (GF), S. Donato Hospital, Department of Diagnostic and Clinical Pathology, Arezzo; and Rheumatology Unit (LS), Department of Internal Medicine, Arezzo, Italy.
出版信息
Medicine (Baltimore). 2015 Jul;94(30):e1170. doi: 10.1097/MD.0000000000001170.
The primary aim of the study was to evaluate the long-term effectiveness of adalimumab (ADA) in a cohort of non-radiographic axial spondyloarthritis (nr-axSpA), and the secondary aims were to identify predictive factors of response and evaluate radiological progression.We evaluated 37 patients (male/female: 12/25; mean age 49 ± 14; mean disease duration: 6.3 ± 5.8) with active nr-axSpA (Assessment of SpondyloArthritis International Society criteria), despite the treatment with ≥1 nonsteroidal anti-inflammatory drug for at least 3 months, initiating the treatment with ADA 40 mg every other week. Patients were treated for 24 months, and evaluated at baseline, 6, 12, and 24 months. Outcome measures included Ankylosing Spondylitis Disease Activity Score, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Bath Ankylosing Spondylitis Functional Index. Radiograph of the spine and sacroiliac joints and magnetic resonance of the sacroiliac joints were performed at baseline and according to the standard of assessment for the disease.The proportion of patients that achieved a BASDAI50 response at 6, 12 and 24 months was 51.3%, 70.3%, and 76.8%, respectively. Treatment was well tolerated with no unexpected adverse events and/or serious adverse events. All patients remained on treatment for 2 years, with a good compliance. We did not identify any predictive factor of response to therapy. Moreover, modified Stoke Ankylosing Spondylitis Spine Score and Spondyloarthritis Research Consortium of Canada scores showed a trend of improvement during the study period.ADA was effective on clinical and radiological outcomes at 2-year follow-up; thus, early treatment with ADA may prevent radiographic damage and be associated with low disease activity or remission. Moreover, data from this cohort study have confirmed safety and tolerability profile of ADA in nr-axSpA in the long term.
本研究的主要目的是评估阿达木单抗（ADA）在一组非放射学中轴型脊柱关节炎（nr-axSpA）患者中的长期疗效，次要目的是确定反应的预测因素并评估放射学进展。我们评估了37例活动性nr-axSpA患者（男/女：12/25；平均年龄49±14岁；平均病程：6.3±5.8年），这些患者符合国际脊柱关节炎评估协会标准，尽管使用了至少一种非甾体抗炎药治疗至少3个月，但病情仍未得到控制，遂开始每隔一周皮下注射40 mg ADA治疗。患者接受治疗24个月，并在基线、6个月、12个月和24个月时进行评估。疗效指标包括强直性脊柱炎疾病活动评分、巴斯强直性脊柱炎疾病活动指数（BASDAI）和巴斯强直性脊柱炎功能指数。在基线时以及根据疾病评估标准对脊柱和骶髂关节进行了X线检查，并对骶髂关节进行了磁共振成像检查。在6个月、12个月和24个月时达到BASDAI改善50%的患者比例分别为51.3%、70.3%和76.8%。治疗耐受性良好，未出现意外不良事件和/或严重不良事件。所有患者均持续治疗2年，依从性良好。我们未发现任何治疗反应的预测因素。此外，改良斯托克强直性脊柱炎脊柱评分和加拿大脊柱关节炎研究联盟评分在研究期间呈改善趋势。在2年随访中，ADA对临床和放射学结局均有效；因此，早期使用ADA治疗可能预防放射学损伤，并与低疾病活动度或病情缓解相关。此外，该队列研究的数据证实了ADA在nr-axSpA患者中长期的安全性和耐受性。
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