Relationship between clinical and patient-reported outcomes in a phase 3 trial of tofacitinib or MTX in MTX-naïve patients with rheumatoid arthritis.
Relationship between clinical and patient-reported outcomes in a phase 3 trial of tofacitinib or MTX in MTX-naïve patients with rheumatoid arthritis.
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DOI：
10.1136/rmdopen-2015-000232
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发表时间：
2016
期刊：
影响因子：
6.2
通讯作者：
Bananis E
中科院分区：
文献类型：
--
作者：
Fleischmann R;Strand V;Wilkinson B;Kwok K;Bananis E
比较托法替尼或甲氨蝶呤（MTX）治疗类风湿关节炎（RA）患者的临床指标与患者报告结局（PRO）之间的关系。在一项III期随机对照试验中，MTX初治或接受≤3次给药的患者（N=956）随机接受托法替布5或10 mg每日2次或MTX滴定至20 mg/周。 成果包括：根据简化疾病活动指数，达到美国风湿病学会70%缓解（ACR 70）、ACR 50、低疾病活动（LDA）的患者百分比（SDAI ≤11）和临床疾病活动指数（CDAI ≤10），SDAI评估的缓解（≤3.3）和CDAI（≤2.8），患者报告的健康评估量表-残疾指数（HAQ-DI评分<0.5），疼痛和疾病活动的总体评估。第6个月时，大多数根据一种定义达到LDA/缓解的患者根据其他定义达到LDA/缓解;然而，MTX组指标之间的不一致性大于托法替尼组。正如预期的那样，CDAI和SDAI应答之间的一致性很高。总体而言，与临床指标（压痛和肿胀关节计数）相比，达到LDA或ACR 50缓解的患者报告的PRO（HAQ-DI、疼痛和患者总体评估）改善较少。在RA患者中设定达标治疗目标时，应考虑临床结局和PRO之间应答水平的变异性。NCT 01039688;后结果。
To compare the relationship between clinical measures and patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA) treated with tofacitinib or methotrexate (MTX). In a phase 3 randomised controlled trial, patients (N=956) who were MTX-naïve or had received ≤3 doses were randomised and received tofacitinib 5 or 10 mg twice daily or MTX titrated to 20 mg/week. Outcomes included: per cent of patients achieving American College of Rheumatology 70% responses (ACR70), ACR50, low disease activity (LDA) by Simplified Disease Activity Index (SDAI ≤11) and Clinical Disease Activity Index (CDAI ≤10), remission by SDAI (≤3.3) and CDAI (≤2.8), patient-reported Health Assessment Questionnaire-Disability Index (HAQ-DI scores <0.5), pain and global assessment of disease activity. At month 6, most patients who achieved LDA/remission by one definition achieved LDA/remission with others; however, discordance between measures was greater with MTX than with tofacitinib. As expected, concordance between CDAI and SDAI responses was high. Overall, patients achieving LDA or ACR50 responses reported less improvement in PROs (HAQ-DI, pain and patient global assessment) compared with clinical measures (tender and swollen joint counts). Variability in levels of responses between clinical outcomes and PROs should be considered when setting treat-to-target goals in patients with RA. NCT01039688; Post-results.