Clinical, functional and radiographic consequences of achieving stable low disease activity and remission with adalimumab plus methotrexate or methotrexate alone in early rheumatoid arthritis: 26-week results from the randomised, controlled OPTIMA study.
Clinical, functional and radiographic consequences of achieving stable low disease activity and remission with adalimumab plus methotrexate or methotrexate alone in early rheumatoid arthritis: 26-week results from the randomised, controlled OPTIMA study.
复制标题
DOI：
10.1136/annrheumdis-2011-201247
复制
发表时间：
2013-01
影响因子：
27.4
通讯作者：
Smolen JS
中科院分区：
文献类型：
--
作者：
Kavanaugh A;Fleischmann RM;Emery P;Kupper H;Redden L;Guerette B;Santra S;Smolen JS
评估阿达木单抗+甲氨蝶呤（ADA+MTX）与甲氨蝶呤单药治疗相比，在早期类风湿关节炎（RA）未接受过甲氨蝶呤治疗的患者中实现稳定的低疾病活动度（LDA;第22周和第26周疾病活动度评分（DAS 28（CRP））<3.2）以及临床、影像学和功能结局的疗效和安全性。1032例活动性RA患者按1：1随机分为ADA+MTX组和安慰剂+甲氨蝶呤组（PBO+MTX），治疗26周。根据第22周和第26周DAS 28（CRP）<3.2的结果，在随后的研究阶段进行治疗调整。事后分析比较了使用DAS 28和2010 ACR/EULAR标准实现稳定缓解的患者与实现LDA但未缓解的患者。在完成6个月的患者中，44%（207/466）ADA+MTX与24%（112/460）PBO+MTX患者在第22周和第26周达到稳定的LDA（p<0.001）。联合治疗在获得更高的ACR 20/50/70应答、更多的临床缓解、更大的DAS 28（CRP）平均降低、无放射学进展和第26周时正常功能状态方面在统计学上上级优于甲氨蝶呤（均p<0.001）。预测稳定LDA的唯一因素是第12周的疾病活动。达到ACR/EULAR缓解的患者，特别是PBO+MTX组，与仅达到LDA（但未缓解）的患者相比，在影像学结局方面具有一定优势。两组不良事件的总体频率相当。ADA+MTX组有更多严重感染和死亡，可能存在年龄效应。在早期活动性RA患者的临床、影像学和功能结局方面，ADA+MTX治疗显著优于单用甲氨蝶呤上级。在开始阿达木单抗治疗前，应仔细考虑个体患者的获益/风险比评价。
To assess the efficacy and safety of adalimumab plus methotrexate (ADA+MTX) compared with methotrexate monotherapy in achieving stable low disease activity (LDA; disease activity score (DAS28(CRP)) <3.2 at weeks 22 and 26) and clinical, radiographic and functional outcomes in methotrexate-naive patients with early rheumatoid arthritis (RA). 1032 patients with active RA were randomly assigned 1:1 to ADA+MTX or placebo plus methotrexate (PBO+MTX) for 26 weeks. Treatment modifications were to be made in a subsequent study period based on the achievement of DAS28(CRP) <3.2 at weeks 22 and 26. Post-hoc analyses compared patients achieving stable remission using DAS28 and 2010 ACR/EULAR criteria with those achieving LDA but not remission. Among patients completing 6 months, 44% (207/466) ADA+MTX versus 24% (112/460) PBO+MTX patients achieved stable LDA at weeks 22 and 26 (p<0.001). Combination therapy was statistically superior to methotrexate in obtaining higher ACR20/50/70 responses, more clinical remissions, greater mean reductions in DAS28(CRP), no radiographic progression, and normal functional status at week 26 (p<0.001 for all). The only factor predicting stable LDA was disease activity at week 12. Patients achieving ACR/EULAR remission, particularly in the PBO+MTX group, had some advantage in radiographic outcomes compared with patients who only achieved LDA (but not remission). The overall frequency of adverse events was comparable between groups. There were more serious infections and deaths in the ADA+MTX group, with a possible age effect. Treatment with ADA+MTX was significantly superior to methotrexate alone with respect to clinical, radiographic and functional outcomes in patients with early active RA. Before initiating treatment with adalimumab, individual patient evaluation of the benefit/risk ratio should be carefully considered.
登录
查看更多内容
影响因子：
27.4
作者：
Curtis, Jeffrey R.;Yang, Shuo;Kavanaugh, Arthur
通讯作者：
Kavanaugh, Arthur
影响因子：
--
作者：
Aletaha, Daniel;Funovits, Julia;Smolen, Josef S.
通讯作者：
Smolen, Josef S.
影响因子：
3.9
作者：
Emery, Paul;Genovese, Mark C.;Sasso, Eric H.
通讯作者：
Sasso, Eric H.
影响因子：
27.4
作者：
Burmester, G. R.;Mease, P.;Pangan, A. L.
通讯作者：
Pangan, A. L.
影响因子：
5.5
作者：
Galloway, James B.;Hyrich, Kimme L.;Symmons, Deborah P. M.
通讯作者：
Symmons, Deborah P. M.