AC-CUTE: An Open-Label Study to Evaluate Progression of Structural Joint Damage and Inflammation in Subjects with Moderate to Severe Rheumatoid Arthritis.

IF 2.3 Q2 RHEUMATOLOGY

International Journal of Rheumatology Pub Date : 2018-04-12 eCollection Date: 2018-01-01 DOI:10.1155/2018/8721753

Paul Bird, Charles Peterfy, Peter Countryman, Hedley Griffiths, Rina Barrett, Peter Youssef, Fredrick Joshua, Stephen Hall

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引用次数: 5

Abstract

Aim: Examine the efficacy of once-weekly subcutaneous tocilizumab (SC-TCZ) on joint damage at 24 weeks based on radiography of the hands and feet and magnetic resonance imaging (MRI) of the hand in subjects with moderate to severe rheumatoid arthritis (RA).

Methods: In this Australian open-label, multicentre, prospective, single-arm study, subjects received 162 mg SC-TCZ weekly. Primary endpoint was change in radiographic Genant-modified Total Sharp Score (TSS) between baseline and Week 24. Secondary endpoints included change from baseline to Week 24 in RA MRI scoring (RAMRIS) of erosions, synovitis, and osteitis and Cartilage Loss Score (CARLOS) in the dominant hand and disease activity score 28 (DAS28).

Results: 52 subjects were enrolled (80% female, mean (SD) age 57 (12) years). Radiography showed mild but not significant progression of joint damage (mean (SD) change in TSS 0.46 (1.29)). Synovitis reduced significantly on MRI; however, osteitis, erosion, and cartilage loss did not change significantly. DAS28 improved significantly by Week 24; 78% of subjects achieved DAS28 remission. SC-TCZ was generally well tolerated.

Conclusion: Synovitis and DAS28 decreased significantly; however, no significant change in osteitis or joint damage was observed at Week 24.

Trial registration: This trial is registered with Clinicaltrials.gov registration number NCT01951170 (ML28703).

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AC-CUTE:一项评估中度至重度类风湿关节炎患者结构性关节损伤和炎症进展的开放标签研究。

目的:通过对中度至重度类风湿性关节炎(RA)患者的手脚x线片和手部磁共振成像(MRI)，研究每周一次皮下tocilizumab (SC-TCZ)治疗24周关节损伤的疗效。方法:在这项澳大利亚开放标签、多中心、前瞻性单臂研究中，受试者每周接受162mg SC-TCZ。主要终点是放射学Genant-modified Total Sharp Score (TSS)在基线和第24周之间的变化。次要终点包括从基线到第24周RAMRI评分(RAMRIS)的变化，主要手的侵蚀，滑膜炎和骨炎，软骨损失评分(CARLOS)和疾病活动评分28 (DAS28)。结果:纳入52例受试者(80%为女性，平均(SD)年龄57(12)岁)。x线摄影显示关节损伤进展轻微但不明显(TSS平均(SD)变化0.46(1.29))。MRI上滑膜炎明显减轻;然而，骨炎、糜烂和软骨丢失没有明显变化。DAS28在第24周显著改善;78%的受试者达到DAS28缓解。SC-TCZ总体耐受良好。结论:滑膜炎、DAS28明显降低;然而，在第24周没有观察到骨炎或关节损伤的显著变化。试验注册:本试验在Clinicaltrials.gov注册，注册号为NCT01951170 (ML28703)。

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