在一项关于阿巴西普治疗银屑病关节炎的随机IIb期研究中实施OMERACT银屑病关节炎磁共振成像评分系统。
Implementation of the OMERACT Psoriatic Arthritis Magnetic Resonance Imaging Scoring System in a randomized phase IIb study of abatacept in psoriatic arthritis.
作者信息
Østergaard Mikkel, Bird Paul, Pachai Chahin, Du Shuyan, Wu Chun, Landis Jessica, Fuerst Thomas, Ahmad Harris A, Connolly Sean E, Conaghan Philip G
机构信息
Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Copenhagen University Hospital Rigshospitalet, Glostrup.
Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
出版信息
Rheumatology (Oxford). 2022 Nov 2;61(11):4305-4313. doi: 10.1093/rheumatology/keac073.
OBJECTIVES
To investigate if the OMERACT PsA MRI Scoring System (PsAMRIS), including a novel total inflammation score, shows sensitivity to change with an agent (abatacept) known to impact clinical outcomes in PsA.
METHODS
We performed a post hoc analysis of a randomized phase IIb study of abatacept in patients with PsA and inadequate DMARD response. Participants received one of three abatacept dosing regimens [ABA3, ABA10 or ABA30/10 mg/kg (30 mg/kg switched to 10 mg/kg after two doses)] or placebo until day 169, then ABA10 through day 365. MRIs at baseline and days 85, 169 and 365 were centrally evaluated by two readers blinded to chronological order and treatment arm. Synovitis, osteitis, tenosynovitis, periarticular inflammation, bone erosions, joint space narrowing and bone proliferation were assessed using the PsAMRIS. A novel total inflammation score was tested.
RESULTS
MRIs for 123 patients were included. On day 169, ABA10 and ABA30/10 significantly reduced MRI synovitis and tenosynovitis, respectively, vs placebo [differences -0.966 (P = 0.039) and -1.652 (P = 0.014), respectively]. Synovitis in the placebo group increased non-significantly from baseline to day 169, total inflammation and tenosynovitis decreased non-significantly and all measures improved significantly after a switch to ABA10 [-1.019, -0.940, -2.275 (P < 0.05), respectively, day 365 vs day 169]. Structural outcomes changed minimally across groups.
CONCLUSION
Adults with PsA receiving ABA10 and ABA30/10 demonstrated significant resolution of inflammatory components of disease, confirmed by MRI, with synovitis and tenosynovitis improvements consistent with previously reported clinical responses for these doses. Results indicate that a reduction in OMERACT PsAMRIS inflammation scores may provide proof of tissue-level efficacy in PsA clinical trials.
REGISTRATION
ClinicalTrials.gov (https://clinicaltrials.gov), NCT00534313.
目的
研究包括一种新型总炎症评分的OMERACT银屑病关节炎MRI评分系统（PsAMRIS）是否对已知会影响银屑病关节炎临床结局的药物（阿巴西普）的变化敏感。
方法
我们对一项阿巴西普治疗银屑病关节炎且疾病改善抗风湿药物（DMARD）反应不足患者的随机IIb期研究进行了事后分析。参与者接受三种阿巴西普给药方案之一[ABA3、ABA10或ABA30/10mg/kg（两剂后30mg/kg转换为10mg/kg）]或安慰剂至第169天，然后至第365天接受ABA10治疗。由两名对时间顺序和治疗组不知情的阅片者对基线、第85天、第169天和第365天的MRI进行集中评估。使用PsAMRIS评估滑膜炎、骨炎、腱鞘炎、关节周围炎症、骨侵蚀、关节间隙狭窄和骨增殖。对一种新型总炎症评分进行了测试。
结果
纳入了123例患者的MRI数据。在第169天，与安慰剂相比，ABA10和ABA30/10分别显著降低了MRI滑膜炎和腱鞘炎[差异分别为-0.966（P=0.039）和-1.652（P=0.014）]。安慰剂组的滑膜炎从基线到第169天无显著增加，总炎症和腱鞘炎无显著降低，转换为ABA10后所有指标均显著改善[-1.019、-0.940、-2.275（P<0.05），分别为第365天与第169天相比]。各组间结构结局变化极小。
结论
接受ABA10和ABA30/10治疗的银屑病关节炎成人患者经MRI证实疾病的炎症成分显著消退，滑膜炎和腱鞘炎的改善与先前报道的这些剂量的临床反应一致。结果表明，OMERACT PsAMRIS炎症评分的降低可能为银屑病关节炎临床试验中的组织水平疗效提供证据。
注册信息
ClinicalTrials.gov（https://clinicaltrials.gov），NCT00534313。
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