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甲氨蝶呤在银屑病关节炎严格控制研究中的疗效

Methotrexate Efficacy in the Tight Control in Psoriatic Arthritis Study.

作者信息

Coates Laura C, Helliwell Philip S

机构信息

From the Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals National Health Service (NHS) Trust, Leeds, UK.L.C. Coates, NIHR Clinical Lecturer, MBChB, MRCP, PhD, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust; P.S. Helliwell, Senior Lecturer, MA, MD, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust.

出版信息

J Rheumatol. 2016 Feb;43(2):356-61. doi: 10.3899/jrheum.150614. Epub 2015 Dec 15.

Abstract

OBJECTIVE

Methotrexate (MTX) is a commonly used disease-modifying antirheumatic drug in psoriatic arthritis, but there is conflicting evidence to support its efficacy.

METHODS

Within the Tight Control of Psoriatic Arthritis (TICOPA) study, patients were treated with MTX as part of the tight control protocol or standard care. Outcomes were recorded at the 12-week visit, including joint counts, skin, nail, enthesitis, dactylitis, and patient-reported measures.

RESULTS

Of the 206 patients enrolled, 188 received MTX in the first 12 weeks of the trial with 104 receiving a mean dose > 15 mg/week. The proportions of patients achieving the American College of Rheumatology (ACR) outcomes at 12 weeks were ACR20 40.8%, ACR50 18.8%, and ACR70 8.6%, with 22.4% achieving minimal disease activity. Improvements were seen in psoriasis with 27.2% reaching a Psoriasis Area and Severity Index (PASI) 75. The proportion of patients with dactylitis and Leeds dactylitis instrument (LDI) scores decreased significantly (62.7% decrease in patients with dactylitis, median change LDI -59.7, -157.4 to -26.4, p = 0.033). The decrease in proportion of patients with enthesitis (25.7%) was significant, but the median change in enthesitis score was 0. There was a trend to higher proportions of patients receiving over 15 mg/week achieving ACR20, ACR50, and PASI75.

CONCLUSION

Despite the open-label design of the data, improvements in multiple clinical outcomes were seen. The proportion of patients reaching ACR20 in the TICOPA study was higher than in the Methotrexate in Psoriatic Arthritis study (41% vs 34%), but no comparative data are available for other outcomes. There is a suggestion of a dose response, but this is hard to assess when patients doing well may be maintained on lower doses.

摘要

目的

甲氨蝶呤(MTX)是银屑病关节炎中常用的改善病情抗风湿药,但支持其疗效的证据相互矛盾。

方法

在银屑病关节炎严格控制(TICOPA)研究中,患者接受MTX治疗,作为严格控制方案或标准治疗的一部分。在第12周访视时记录结果,包括关节计数、皮肤、指甲、肌腱端炎、指(趾)炎以及患者报告的指标。

结果

在纳入的206例患者中,188例在试验的前12周接受了MTX治疗,其中104例接受的平均剂量>15mg/周。在12周时达到美国风湿病学会(ACR)各项指标的患者比例分别为:达到ACR20的占40.8%,达到ACR50的占18.8%,达到ACR70的占8.6%,达到最小疾病活动度的占22.4%。银屑病病情有所改善,27.2%的患者达到银屑病面积和严重程度指数(PASI)75。指(趾)炎患者比例及利兹指(趾)炎评估工具(LDI)评分显著下降(指(趾)炎患者减少62.7%,LDI中位数变化为-59.7,范围-157.4至-26.4,p = 0.033)。肌腱端炎患者比例下降(25.7%)显著,但肌腱端炎评分的中位数变化为0。接受超过15mg/周MTX治疗的患者达到ACR20、ACR50和PASI75的比例有升高趋势。

结论

尽管数据采用开放标签设计,但仍观察到多项临床指标有所改善。TICOPA研究中达到ACR20的患者比例高于银屑病关节炎中甲氨蝶呤研究(41%对34%),但其他指标尚无对比数据。有剂量反应的迹象,但当病情好转的患者可能维持较低剂量时,这一点难以评估。

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