Unit of Translational Medicine, Department of Immunology and Rheumatology, Graduate School of Biomedical Sciences, Nagasaki University, 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan.
Mod Rheumatol. 2009;19(5):488-92. doi: 10.1007/s10165-009-0187-8. Epub 2009 Jul 4.
We tried to determine which baseline variables are responsible for remission induction at 6 months in unselected rheumatoid arthritis (RA) patients of Japanese population treated with etanercept. One hundred forty-one patients with RA who were administered etanercept were registered. Thirty-four patients were started on etanercept monotherapy, 60 patients on cotherapy with methotrexate (MTX) (MTX cotherapy), and 47 patients on cotherapy with other non-MTX nonbiologic disease-modifying antirheumatic drugs (DMARDs) (non-MTX cotherapy). None of the patients were treated with both MTX and non-MTX nonbiologic DMARDs at entry. Outcome was set as achievement of disease activity score 28 (DAS28)-ESR remission at 6 months. We examined association of gender, DAS at baseline, MTX cotherapy at baseline, non-MTX cotherapy at baseline, and prednisolone use at baseline with achievement of remission at 6 months by logistic regression analysis. All subjects were classified as having high (N = 109) or moderate disease activity (N = 32) at entry. One hundred twenty out of 141 patients (85.1%) continued treatment with etanercept at 6 months. Continuation rate was statistically higher in MTX cotherapy (93.3%) compared with etanercept monotherapy (73.5%), and tended to be higher than with non-MTX cotherapy (85.1%). Logistic regression analysis identified that MTX cotherapy at entry and moderate disease activity at entry were independent variables for remission induction at 6 months. Accordingly, DAS28-ESR at 6 months was significantly lower with MTX cotherapy as compared with etanercept monotherapy or non-MTX cotherapy. To a lesser extent, DAS28-ESR with non-MTX cotherapy at 6 months was lower than with etanercept monotherapy. In this study of unselected patients, use of MTX and moderate disease activity at entry were associated with higher likelihood of response to etanercept. Non-MTX nonbiologic DMARDs may be an alternative in RA patients administrated etanercept who are intolerant to MTX.
我们试图确定哪些基线变量负责诱导日本人群中未经选择的类风湿关节炎（RA）患者在 6 个月时缓解。登记了 141 名接受依那西普治疗的 RA 患者。34 名患者开始接受依那西普单药治疗，60 名患者接受甲氨蝶呤（MTX）联合治疗（MTX 联合治疗），47 名患者接受其他非 MTX 非生物疾病修饰抗风湿药物（DMARDs）联合治疗（非 MTX 联合治疗）。在入组时，没有患者同时接受 MTX 和非 MTX 非生物 DMARDs 治疗。结果设定为在 6 个月时达到疾病活动评分 28（DAS28）-红细胞沉降率缓解。我们通过逻辑回归分析检查了性别、基线 DAS、基线 MTX 联合治疗、基线非 MTX 联合治疗和基线泼尼松使用与 6 个月时缓解的相关性。所有患者在入组时均被归类为高（N=109）或中度疾病活动（N=32）。141 名患者中的 120 名（85.1%）在 6 个月时继续接受依那西普治疗。MTX 联合治疗的持续率（93.3%）明显高于依那西普单药治疗（73.5%），且有高于非 MTX 联合治疗（85.1%）的趋势。逻辑回归分析确定，入组时 MTX 联合治疗和中度疾病活动是 6 个月时缓解诱导的独立变量。因此，与依那西普单药治疗或非 MTX 联合治疗相比，MTX 联合治疗时 6 个月时的 DAS28-ESR 明显更低。在较小程度上，与依那西普单药治疗相比，非 MTX 联合治疗时 6 个月时的 DAS28-ESR 也更低。在这项对未经选择的患者的研究中，使用 MTX 和入组时的中度疾病活动与对依那西普的更高反应可能性相关。在不耐受 MTX 的接受依那西普治疗的 RA 患者中，非 MTX 非生物 DMARDs 可能是一种替代方案。
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