在现实生活中，早期临床反应可预测接受赛妥珠单抗治疗的类风湿关节炎患者1年后的低疾病活动度。对意大利登记处GISEA的评估。

Early clinical response predicts low disease activity at one year in rheumatoid arthritis patients on treatment with certolizumab in real-life settings. An appraisal of the Italian registry GISEA.

作者信息

Iannone Florenzo, Carlino Giorgio, Marchesoni Antonio, Sarzi-Puttini Piercarlo, Gorla Roberto, Lapadula Giovanni

机构信息

Rheumatology unit, university of Bari, Policlinico, Piazza G. Cesare 11, 70124 Bari, Italy.

Rheumatology service DSS Casarano Gallipoli, ASL Lecce, Italy.

出版信息

Joint Bone Spine. 2016 Dec;83(6):721-725. doi: 10.1016/j.jbspin.2015.12.004. Epub 2016 Apr 23.

DOI:10.1016/j.jbspin.2015.12.004

PMID:27118021

Abstract

OBJECTIVES

The aim of this study was to assess whether good EULAR response assessed at 3months may predict the achievement of low disease activity (LDA) at 1year in rheumatoid arthritis (RA) patients on treatment with certolizumab pegol (CZP).

METHODS

From the nationwide Italian registry, we analysed 278 RA patients (age 54.8±12years, duration of disease 9.8±8years, female 84%) initiating CZP as first line (68%) or≥second line (32%) of biological treatment because of their active disease. Assessment of disease activity was based on 28 joint Disease Activity Score (DAS28). A reduction of DAS28>1.2 (good EULAR response) was assessed at 3months, and the achievement of LDA (DAS28≤3.2) was evaluated at 1year. Multiple regression models were used to estimate predictors of early good EULAR response or LDA.

RESULTS

The percentages of patients attaining good EULAR response were 52% at 3, 65% at 6, and 66% at 12months. Furthermore, 51.2% (98/192) of the patients reached LDA at 12months. Patients taking CZP as first biological treatment had adjusted odds ratios (OR) of good EULAR response at 3months 6 folds higher than in those with≥1 prior biological drug (OR 6.7, 95% CI 1.97-23.1). While, the strongest variable correlating with 12months LDA was the achievement of good EULAR response at 3months (OR 11.3, 95% CI 13.1-34.8).

CONCLUSIONS

Our findings showed that attaining good EULAR response at 3months strongly predicted 1year LDA in RA patients treated with CZP in real-life settings.

摘要

目的

本研究旨在评估接受聚乙二醇化赛妥珠单抗（CZP）治疗的类风湿关节炎（RA）患者在3个月时评估的良好欧洲抗风湿病联盟（EULAR）反应是否可预测1年时达到低疾病活动度（LDA）。

方法

从全国性的意大利登记处，我们分析了278例RA患者（年龄54.8±12岁，病程9.8±8年，女性占84%），由于疾病活动而开始将CZP作为生物治疗的一线（68%）或≥二线（32%）治疗。疾病活动度评估基于28个关节疾病活动评分（DAS28）。在3个月时评估DAS28降低>1.2（良好EULAR反应），并在1年时评估是否达到LDA（DAS28≤3.2）。使用多元回归模型估计早期良好EULAR反应或LDA的预测因素。

结果

达到良好EULAR反应的患者百分比在3个月时为52%，6个月时为65%，12个月时为66%。此外，51.2%（98/192）的患者在12个月时达到LDA。将CZP作为首次生物治疗的患者在3个月时良好EULAR反应的调整优势比（OR）比接受过≥1种先前生物药物治疗的患者高6倍（OR 6.7，95%可信区间1.97-23.1）。而与12个月LDA相关性最强的变量是3个月时达到良好EULAR反应（OR 11.3，95%可信区间13.1-34.8）。