一项关于重组人白细胞介素-1受体拮抗剂治疗类风湿关节炎患者的多中心、双盲、剂量范围、随机、安慰剂对照研究：影像学进展及Genant和Larsen评分的相关性

A multicenter, double-blind, dose-ranging, randomized, placebo-controlled study of recombinant human interleukin-1 receptor antagonist in patients with rheumatoid arthritis: radiologic progression and correlation of Genant and Larsen scores.

作者信息

Jiang Y, Genant H K, Watt I, Cobby M, Bresnihan B, Aitchison R, McCabe D

机构信息

University of California, San Francisco 94143-0628, USA.

出版信息

Arthritis Rheum. 2000 May;43(5):1001-9. doi: 10.1002/1529-0131(200005)43:5<1001::AID-ANR7>3.0.CO;2-P.

DOI:10.1002/1529-0131(200005)43:5<1001::AID-ANR7>3.0.CO;2-P

PMID:10817552

Abstract

OBJECTIVE

To evaluate radiographic progression and the relationship of radiologic scores obtained by the Genant and Larsen methods in a clinical trial of recombinant human interleukin-1 receptor antagonist (IL-1Ra).

METHODS

Patients with rheumatoid arthritis (RA) were randomized into 4 groups: placebo (n = 121) or IL-1Ra at a daily dosage of 30 mg (n = 119), 75 mg (n = 116), or 150 mg (n = 116). Hand radiographs obtained at baseline, 24 weeks, and 48 weeks were scored using both methods.

RESULTS

At 24 weeks, by the Genant method, there was significant reduction in the score for progression of joint space narrowing (JSN) and the total score (a combination of erosion and JSN) in all treatment groups. Least-squares mean changes in the Genant erosion score from baseline to 24 weeks were significantly reduced after treatment with IL-1Ra at 30 mg/day and for all IL-1Ra treatment groups combined. The changes corresponded to a reduction of 38% in erosion, 58% in JSN, and 47% in total score. Patients treated with IL-1Ra at 75 mg/day had a significant reduction in the Larsen erosive joint count (LEJC), and all IL-1RA-treated groups combined showed a 45% reduction. Correlations (r) between the Genant total and Larsen scores were 0.84 at baseline, 0.83 at week 24, and 0.83 at week 48 (P < 0.0001); correlations between the Genant erosion score and the LEJC were 0.83 (P < 0.0001) at all visits; correlations between the Genant total and the Larsen scores were 0.32 and 0.49 (P < 0.0001) for progression from baseline to week 24 and from baseline to week 48, respectively; correlations between the Genant erosion score and the LEJC were 0.36 and 0.41 (P < 0.0001) for progression to weeks 24 and 48, respectively.

CONCLUSION

IL-1Ra reduced radiologic progression of RA. Scores by the 2 methods correlated strongly for each individual time point, but much less strongly for assessments of disease progression.

摘要

目的

在一项重组人白细胞介素-1受体拮抗剂（IL-1Ra）的临床试验中，评估影像学进展以及通过Genant法和Larsen法获得的放射学评分之间的关系。

方法

类风湿关节炎（RA）患者被随机分为4组：安慰剂组（n = 121）或每日剂量为30 mg（n = 119）、75 mg（n = 116）或150 mg（n = 116）的IL-1Ra组。使用这两种方法对在基线、24周和48周时获得的手部X光片进行评分。

结果

在24周时，通过Genant法，所有治疗组关节间隙狭窄（JSN）进展评分和总分（侵蚀和JSN的组合）均显著降低。从基线到24周，Genant侵蚀评分的最小二乘均值变化在每日30 mg的IL-1Ra治疗后以及所有IL-1Ra治疗组合并后均显著降低。这些变化相当于侵蚀减少38%，JSN减少58%，总分减少47%。每日75 mg的IL-1Ra治疗的患者Larsen侵蚀性关节计数（LEJC）显著降低，所有IL-1RA治疗组合并后显示降低45%。Genant总分与Larsen评分之间的相关性（r）在基线时为0.84，在第24周时为0.83，在第48周时为0.83（P < 0.0001）；Genant侵蚀评分与LEJC之间在所有访视时的相关性为0.83（P < 0.0001）；从基线到第24周以及从基线到第48周，Genant总分与Larsen评分之间的相关性分别为0.32和0.49（P < 0.0001）；到第24周和第48周时，Genant侵蚀评分与LEJC之间的相关性分别为0.36和0.41（P < 0.0001）。