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临床缓解与功能缓解:尽管生物制剂总体上优于传统改善病情抗风湿药,但成功率仍然较低——来自德国生物制剂登记处RABBIT的结果。

Clinical and functional remission: even though biologics are superior to conventional DMARDs overall success rates remain low--results from RABBIT, the German biologics register.

作者信息

Listing Joachim, Strangfeld Anja, Rau Rolf, Kekow Jörn, Gromnica-Ihle Erika, Klopsch Thilo, Demary Winfried, Burmester Gerd-Rüdiger, Zink Angela

机构信息

German Rheumatism Research Centre, Berlin, Germany.

出版信息

Arthritis Res Ther. 2006;8(3):R66. doi: 10.1186/ar1933. Epub 2006 Apr 5.

Abstract

We investigated the frequency of remission according to the disease activity score (DAS28) definition, modified American Rheumatology Association (ARA) criteria, and the frequency of an achievement of a functional status above defined thresholds ('functional remission', 'physical independence') in rheumatoid arthritis (RA) patients treated with either biologics or conventional DMARDs. We used the data of a prospective cohort study, the German biologics register RABBIT (German acronym for Rheumatoid Arthritis--Observation of Biologic Therapy) to investigate the outcomes in RA patients with two or more DMARD failures who received new treatment with biologics (BIOL; n = 818) or a conventional DMARD (n = 265). Logistic regression analysis was applied to adjust for differences in baseline risks. Taking risk indicators such as previous DMARD failures or baseline clinical status into account, we found that biologics doubled the chance of remission compared to conventional DMARD therapies (DAS28 remission, adjusted odds ratio (OR) 1.95 (95% confidenece interval (CI) 1.2-3.2)); ARA remission, OR 2.05 (95% CI 1.2-3.5)). High remission rates (DAS28 remission, 30.6%; ARA remission, 16.9%) were observed in BIOL patients with a moderate disease activity (DAS28, 3.2 to 5.1) at the start of treatment. These rates decreased to 8.5% in patients with DAS28 > 6. Sustained remission at 6 and 12 months was achieved in <10% of the patients. Severely disabled patients (< or = 50% of full function) receiving biologic therapies were significantly more likely to achieve a status indicating physical independence (> or = 67% of full function) than controls (OR 3.88 (95% CI 1.7-8.8)). 'Functional remission' (> or = 83% of full function) was more often achieved in BIOL than in controls (OR 2.18 (95% CI 1.04-4.6)). In conclusion, our study shows that biologics increase the chance to achieve clinical remission and a status of functional remission or at least physical independence. However, temporary or even sustained remission remain ambitious aims, which are achieved in a minority of patients only.

摘要

我们根据疾病活动评分(DAS28)定义、改良的美国风湿病学会(ARA)标准,调查了使用生物制剂或传统改善病情抗风湿药(DMARDs)治疗的类风湿关节炎(RA)患者的缓解频率,以及达到高于规定阈值的功能状态(“功能缓解”、“身体独立”)的频率。我们使用了一项前瞻性队列研究的数据,即德国生物制剂登记处RABBIT(类风湿关节炎——生物治疗观察的德语首字母缩写),来调查接受生物制剂新治疗(BIOL;n = 818)或传统DMARD(n = 265)的有两次或更多次DMARD治疗失败的RA患者的结局。应用逻辑回归分析来调整基线风险的差异。考虑到先前DMARD治疗失败或基线临床状态等风险指标,我们发现与传统DMARD治疗相比,生物制剂使缓解的机会增加了一倍(DAS28缓解,调整后的优势比(OR)为1.95(95%置信区间(CI)1.2 - 3.2));ARA缓解,OR为2.05(95% CI 1.2 - 3.5))。在治疗开始时疾病活动度为中度(DAS28,3.2至5.1)的BIOL患者中观察到高缓解率(DAS28缓解,30.6%;ARA缓解,16.9%)。在DAS28 > 6的患者中,这些率降至8.5%。在不到10%的患者中实现了6个月和12个月的持续缓解。接受生物治疗的严重残疾患者(<或=全功能的50%)比对照组更有可能达到表明身体独立的状态(>或=全功能的67%)(OR 3.88(95% CI 1.7 - 8.8))。BIOL组比对照组更常实现“功能缓解”(>或=全功能的83%)(OR 2.18(95% CI 1.04 - 4.6))。总之,我们的研究表明,生物制剂增加了实现临床缓解以及功能缓解或至少身体独立状态的机会。然而,暂时甚至持续缓解仍然是远大目标,仅在少数患者中能够实现。

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