Eligibility of patients in routine care for major clinical trials of anti-tumor necrosis factor α agents in rheumatoid arthritis
Eligibility of patients in routine care for major clinical trials of anti-tumor necrosis factor α agents in rheumatoid arthritis
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DOI：
10.1002/art.10817
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发表时间：
2003-02-01
影响因子：
--
通讯作者：
Pincus, T
中科院分区：
文献类型：
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作者：
Sokka, T;Pincus, T
Objective.确定来自田纳西州纳什维尔的2个队列中符合纳入2项近期重要的抗肿瘤坏死因子α（抗TNF α）药物临床试验的基本标准的类风湿关节炎（RA）患者比例，这2项临床试验是依那西普与甲氨蝶呤的早期RA（ERA）试验，以及英夫利西单抗+甲氨蝶呤与甲氨蝶呤的RA伴随治疗（ATTRACT）研究。两个队列的患者，他们都符合美国风湿病学会标准的RA在某个时候，进行了研究。队列E（早期）包括232名患者，他们接受5名私人执业风湿病学家的治疗，RA的持续时间少于3年，并接受了ERA临床试验的基本入选标准审查。队列L（长期）包括152名连续患者，他们在每周一次的学术风湿病诊所接受平均4.5年的护理，并对ATTRACT研究的基本入选标准进行了审查。在队列E中，36例未服用甲氨蝶呤的患者中有11例（31%）符合ERA试验的基本入选标准，19例首次访视未服用甲氨蝶呤的患者中有8例（42%）符合ERA试验的基本入选标准，232例患者中有37例（16%）符合ERA试验的基本入选标准。在队列L中，5%的患者符合ATTRACT研究的基本入选标准。这2个队列中接受常规治疗的大多数患者不符合这2项重要的近期临床试验的入选标准。抗TNF α治疗比甲氨蝶呤疗效更好的结论可能仅适用于有限数量的最严重RA患者。大多数RA患者可能需要抗TNF α治疗，但这种可能性尚未得到正式研究。纳入RA临床试验的标准可能会被修改，以提高结果的普遍性。
Objective. To identify the proportion of patients with rheumatoid arthritis (RA) in 2 cohorts from Nashville, Tennessee, who met basic criteria for inclusion in 2 important recent clinical trials of anti-tumor necrosis factor alpha (anti-TNFalpha) agents, the early RA (ERA) trial of etanercept versus methotrexate, and the anti-TNFa trial in RA with concomitant therapy (ATTRACT) study of infliximab plus methotrexate versus methotrexate.Methods. Two cohorts of patients, all of whom had met the American College of Rheumatology criteria for RA at some time, were studied. Cohort E (early) comprised 232 patients who were under the care of 5 private practice rheumatologists, whose duration of RA was fewer than 3 years, and who were reviewed for basic inclusion criteria for the ERA clinical trial. Cohort L (long-term) comprised 152 consecutive patients who had been under care at a weekly academic rheumatology clinic for a mean of 4.5 years, and were reviewed for basic inclusion criteria for the ATTRACT study.Results. In cohort E, basic inclusion criteria for the ERA trial were met by 11 of 36 patients (31%) who had not taken methotrexate, 8 of 19 patients (42%) who were at their first visit and had not taken methotrexate, and 37 of all 232 patients (16%). In cohort L, 5% of patients met the basic inclusion criteria for the ATTRACT study.Conclusion. Most patients who were seen in routine care in these 2 cohorts did not meet the criteria for inclusion in these 2 important recent clinical trials. The conclusion that anti-TNFalpha therapy has greater efficacy than methotrexate may be valid only in a limited number of patients with the most severe RA. Anti-TNFalpha therapy may be desirable in most patients with RA, but this possibility has not been studied formally. Criteria for inclusion in RA clinical trials might be modified for greater generalizability of results.