Division of Gastroenterology and Hepatology, Department of Medicine, University of Maryland School of Medicine, Baltimore, MD, USA.
Dig Dis Sci. 2013 Jan;58(1):209-15. doi: 10.1007/s10620-012-2323-0. Epub 2012 Sep 27.
The three Food and Drug Administration (FDA)-approved anti-tumor necrosis factor drugs (anti-TNFs) for Crohn's disease (CD) have not been directly compared.
To compare the efficacy of the three anti-TNFs for CD in clinical practice.
Retrospective review of patients initiated on anti-TNF between 2004 and 2008. Disease activity, quality of life, and remission rates were compared between groups over 1 year.
Sixty patients with CD were initiated on anti-TNF from 2004 to 2008: 31 on infliximab (IFX) and 29 on adalimumab (ADA) or certolizumab pegol (CTZ). More patients in the ADA/CTZ scores group had prior exposure to anti-TNF (76 versus 10%, p < 0.01). Mean Harvey-Bradshaw Index (HBI) scores in the IFX group were lower than in the ADA/CTZ group at 12 months (2.72 ± 3.34 versus 5.63 ± 5.33, p = 0.03). At 12 months, more IFX patients were in remission compared with those on ADA/CTZ (88 versus 53%, p ≤ 0.01). Mean short inflammatory bowel disease questionnaire (SIBDQ) scores were not different between the IFX and ADA/CTZ groups at 12 months. Stratified analyses and logistic regression based on prior anti-TNF use did not show differences in remission rates at any time point post-baseline between groups.
After adjustment for prior anti-TNF there was no difference in remission rates between the IFX and ADA/CTZ groups at any time point post-baseline. This suggests that differences between groups were accounted for by a higher rate of prior anti-TNF in the ADA/CTZ group. Our results should be reviewed with caution given the small sample size.
美国食品和药物管理局(FDA)批准的三种用于治疗克罗恩病(CD)的抗肿瘤坏死因子药物(抗 TNF)尚未进行直接比较。
比较三种抗 TNF 药物在临床实践中治疗 CD 的疗效。
回顾性分析 2004 年至 2008 年间开始使用抗 TNF 的患者。比较各组患者在 1 年内疾病活动度、生活质量和缓解率。
2004 年至 2008 年间,60 例 CD 患者开始使用抗 TNF,其中 31 例使用英夫利昔单抗(IFX),29 例使用阿达木单抗(ADA)或培塞利珠单抗(CTZ)。ADA/CTZ 评分组中更多的患者之前曾接触过抗 TNF(76%比 10%,p<0.01)。IFX 组的 Harvey-Bradshaw 指数(HBI)评分在 12 个月时低于 ADA/CTZ 组(2.72±3.34 比 5.63±5.33,p=0.03)。12 个月时,IFX 组患者缓解率高于 ADA/CTZ 组(88%比 53%,p≤0.01)。IFX 组和 ADA/CTZ 组在 12 个月时的短炎症性肠病问卷(SIBDQ)评分无差异。基于既往使用抗 TNF 的分层分析和逻辑回归分析显示,两组在基线后任何时间点的缓解率均无差异。
在调整既往抗 TNF 治疗后,IFX 组和 ADA/CTZ 组在基线后任何时间点的缓解率均无差异。这表明,两组之间的差异归因于 ADA/CTZ 组更高的既往抗 TNF 治疗率。鉴于样本量较小,我们的结果应谨慎解读。