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阿达木单抗和甲氨蝶呤治疗肥胖类风湿关节炎患者的临床反应和滑膜血管生成。

Clinical Responses and Synovial Vascularity in Obese Rheumatoid Arthritis Patients Treated with Adalimumab and Methotrexate.

机构信息

From the Division of Rheumatology and Clinical Immunology, University of Florida College of Medicine, Jacksonville, Florida; Department of Rheumatology, North Valley Hospital, Whitefish, Montana; Global Medical Affairs, AbbVie Inc., North Chicago, Illinois; Data and Statistical Sciences, AbbVie Inc., North Chicago, Illinois; Division of Rheumatology, University of California at Los Angeles, Los Angeles, California, USA; Pharmaceutical Development, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.

G.S. Kaeley, MD, Division of Rheumatology and Clinical Immunology, University of Florida College of Medicine; D.K. MacCarter, MD, Department of Rheumatology, North Valley Hospital; A.L. Pangan, MD, Immunology Clinical Development, AbbVie Inc.; X. Wang, PhD, Data and Statistical Sciences, AbbVie Inc.; J. Kalabic, MD, Pharmaceutical Development, AbbVie Deutschland GmbH & Co. KG; V.K. Ranganath, MD, Division of Rheumatology, University of California at Los Angeles.

出版信息

J Rheumatol. 2018 Dec;45(12):1628-1635. doi: 10.3899/jrheum.171232. Epub 2018 Sep 1.

Abstract

OBJECTIVE

Obese patients with rheumatoid arthritis (RA) report more joint swelling and tenderness and often have poorer responses to therapy than nonobese patients. The aim of this posthoc analysis of the MUSICA trial was to compare imaging and clinical disease activity measures in obese and nonobese patients with RA.

METHODS

MUSICA evaluated methotrexate (MTX) 20 mg/week versus 7.5 mg/week in combination with adalimumab (ADA) in RA patients with an inadequate response to MTX. Patients were categorized by baseline body mass index as normal (< 25), overweight (≥ 25 to < 30), or obese (≥ 30). Synovial vascularity and hypertrophy, swollen and tender joint counts (SJC and TJC), American College of Rheumatology (ACR) responses, and low disease activity (LDA), defined as Clinical Disease Activity Index < 10 and 28-joint count Disease Activity Score using C-reactive protein (DAS28-CRP) < 3.2, were assessed at weeks 12 and 24.

RESULTS

Patient characteristics were similar among groups at baseline. Obese patients had numerically smaller changes from baseline to weeks 12/24 in SJC, TJC, DAS28-CRP, and synovial hypertrophy and vascularity versus nonobese patients. Significantly fewer obese patients reached ACR20/50 at weeks 12 and 24, and LDA at Week 12; this difference was especially apparent in patients receiving 7.5 mg/week MTX but was no longer significant at Week 24.

CONCLUSION

Obese patients with RA had worse clinical and ultrasonographic responses than nonobese patients, which were partly overcome with time. Obese patients may experience better and faster clinical improvements if ADA is initiated with high-dose (20 mg/week) rather than low-dose MTX. [ClinicalTrials.gov: NCT01185288].

摘要

目的

肥胖的类风湿关节炎(RA)患者报告更多的关节肿胀和压痛,并且往往对治疗的反应较差。本 MUSICA 试验的事后分析旨在比较肥胖和非肥胖 RA 患者的影像学和临床疾病活动指标。

方法

MUSICA 评估了甲氨蝶呤(MTX)每周 20 毫克与每周 7.5 毫克联合阿达木单抗(ADA)在 MTX 治疗反应不足的 RA 患者中的疗效。根据基线体重指数将患者分为正常(<25)、超重(≥25 至<30)或肥胖(≥30)。评估了滑膜血管增生、肿胀和压痛关节计数(SJC 和 TJC)、美国风湿病学会(ACR)反应以及低疾病活动度(LDA),定义为临床疾病活动指数(CDAI)<10 和使用 C 反应蛋白(DAS28-CRP)的 28 关节疾病活动评分(DAS28-CRP)<3.2,分别在第 12 周和第 24 周进行评估。

结果

各组患者在基线时的特征相似。与非肥胖患者相比,肥胖患者在第 12 周/24 周时 SJC、TJC、DAS28-CRP 和滑膜增生及血管化的变化数值较小。在第 12 周和第 24 周时,达到 ACR20/50 和 LDA 的肥胖患者明显较少,这一差异在接受 7.5 毫克/周 MTX 的患者中更为明显,但在第 24 周时不再显著。

结论

肥胖的 RA 患者的临床和超声反应比非肥胖患者差,随着时间的推移这种差异部分得到了改善。如果 ADA 与高剂量(20 毫克/周)而非低剂量 MTX 一起开始治疗,肥胖患者可能会更快地获得更好的临床改善。[临床试验.gov:NCT01185288]。

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