甲氨蝶呤治疗早期未用过DMARD的类风湿性关节炎的疗效预测:来自SWEFOT试验开放期初期的结果

原文

译文

Ann Rheum Dis. 2011 Mar;70(3):469-75. Epub 2010 Dec 13. Predictors of response to methotrexate in early DMARD naive rheumatoid arthritis: results from the initial open-label phase of the SWEFOT trial. Saevarsdottir S, Wallin H, Seddighzadeh M, Ernestam S, Geborek P, Petersson IF, Bratt J, van Vollenhoven RF; SWEFOT Trial Investigators Group. Collaborators (14) Cöster L, Waltbrand E, Zickert A, Theander J, Thörner Å, Hellström H, Teleman A, Dackhammar C, Akre F, Forslind K, Ljung L, Oding R, Chatzidionysiou K, Wörnert M. Rheumatology Unit, Department of Medicine, Karolinska University Hospital, 17176 Stockholm, Sweden. saedis.saevarsdottir@karolinska.se Abstract OBJECTIVE: To identify predictors of response to methotrexate (MTX) in early rheumatoid arthritis (RA). METHODS: In the SWEFOT trial, patients with RA with symptom duration <1 year started MTX monotherapy (20 mg/weekly) and 405/487 continued until the 3-4- month visit. The primary outcome measure was the DAS28-based European League against Rheumatism (EULAR) response criteria. Multivariate logistic regression was used to study the association between response and the following baseline characteristics: gender, age, symptom duration, cigarette smoking habits, autoantibody status, Health Assessment Questionnaire (HAQ) score, concurrent prednisolone and treatment with non-steroidal anti-inflammatory drugs. Secondary response and remission measures were the American College of Rheumatology and the Simple Disease Activity Index and Clinical Disease Activity Index (SDAI/CDAI)-derived criteria. RESULTS: After 3-4 months of MTX treatment, the frequency of EULAR good/moderate/no response was 34%/41%/25%, respectively. Parameters associated with a decreased likelihood of EULAR response were female gender (adjusted OR (adj OR) 0.50, 95% CI 0.31 to 0.81), symptom duration (adj OR per month increase 0.93, 95% CI 0.88 to 0.99), current smoking (adj OR 0.35, 95% CI 0.20 to 0.63) and higher HAQ (adj OR 0.56, 95% CI 0.40 to 0.80). Parameters associated with an increased likelihood of EULAR response were higher age (adj OR per 10-year increase 1.30, 95% CI 1.11 to 1.51) and prednisolone treatment (adj OR 2.84, 95% CI 1.43 to 5.63). The findings were similar when patients on prednisolone were excluded and other response criteria tested, although current smoking was the only significant predictor using all response criteria, while HAQ was the only significant predictor of all the remission criteria used. A matrix showed up to ninefold differences between subgroups stratified by the main predictors. CONCLUSION: Current smoking, female sex, longer symptom duration and younger age predict a worse response to MTX in patients with new-onset RA. TrialRegNo NCT00764725.

甲氨蝶呤治疗早期未用过DMARD的类风湿性关节炎的疗效预测:来自SWEFOT试验开放期初期的结果 Saevarsdottir S,et al.Ann Rheum Dis. 2011 Mar;70(3):469-75. Epub 2010 Dec 13. 目的:探索甲氨蝶呤对早期类风湿性关节炎的疗效预测因素。 方法: SWEFOT试验中，487例病程<1年的RA患者开始接受MTX单药治疗(20mg/周), 405例持续随访至3-4月。主要观察终点为欧洲风湿病协会（EULAR）制定的DAS28。应用多因素回归分析疗效与基线水平特征的相关性，包括性别，年龄，病程，抽烟习惯，自身抗体水平，健康评估问卷（HAQ）积分，合并强的松龙和非甾体抗炎药的应用。次要终点和缓解评价指标为ACR和简化的疾病活动指数和临床疾病活动指数（SDAI/CDAI）衍化而来的标准。   结果:甲氨蝶呤治疗3-4月后，EULAR疗效好、中等和无效的比例分别为34%、41%和25%。与EULAR疗效差相关的参数为女性(校正OR 0.50，95%CI 0.31-0.81)、病程（校正OR 每月增加0.93,95%CI 0.88-0.99）、当前吸烟（校正OR 0.35，95%CI 0.20-0.63）以及高HAQ（校正OR 0.56, 95% CI 0.40 - 0.80)。与EULAR疗效较好相关的参数则为年长（校正 OR 每10年增加1.30, 95% CI 1.11 to 1.51）和强的松龙治疗(校正 OR 2.84, 95% CI 1.43 to 5.63)。排除强的松龙治疗的患者并用其他疗效标准进行测试，得出的结果也与此相似，然而只有当前抽烟是所有疗效标准中都一致的相关因素，而HAQ是所有缓解标准中都一致的相关因素。矩阵显示了按主要预测值分组后的9倍差异。 结论: 当前抽烟、女性、病程长、年纪轻是MTX治疗初发RA疗效差的预测指标。  TrialRegNo NCT00764725.