Ananthakrishnan Ashwin N, Cagan Andrew, Cai Tianxi, Gainer Vivian S, Shaw Stanley Y, Savova Guergana, Churchill Susanne, Karlson Elizabeth W, Kohane Isaac, Liao Katherine P, Murphy Shawn N
*Division of Gastroenterology, Massachusetts General Hospital, Boston, Massachusetts; †Harvard Medical School, Boston, Massachusetts; ‡Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; §Research IS and Computing, Partners HealthCare, Charlestown, Massachusetts; ‖Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts; ¶Center for Systems Biology, Massachusetts General Hospital, Boston, Massachusetts; **Children's Hospital Informatics Program, Boston Children's Hospital, Boston, Massachusetts; ††Center for Biomedical Informatics, Harvard Medical School, Boston, Massachusetts; ‡‡Division of Rheumatology, Allergy and Immunology, Brigham and Women's Hospital, Boston, Massachusetts; §§Children's Hospital Boston, Boston, Massachusetts; and ‖‖Department of Neurology, Massachusetts General Hospital, Boston, Massachusetts.
Inflamm Bowel Dis. 2016 Apr;22(4):880-5. doi: 10.1097/MIB.0000000000000754.
The availability of monoclonal antibodies to tumor necrosis factor α has revolutionized management of Crohn's disease (CD) and ulcerative colitis. However, limited data exist regarding comparative effectiveness of these agents to inform clinical practice.
This study consisted of patients with CD or ulcerative colitis initiation either infliximab (IFX) or adalimumab (ADA) between 1998 and 2010. A validated likelihood of nonresponse classification score using frequency of narrative mentions of relevant symptoms in the electronic health record was applied to assess comparative effectiveness at 1 year. Inflammatory bowel disease-related surgery, hospitalization, and use of steroids were determined during this period.
Our final cohort included 1060 new initiations of IFX (68% for CD) and 391 of ADA (79% for CD). In CD, the likelihood of nonresponse was higher in ADA than IFX (odds ratio, 1.62 and 95% CI, 1.21-2.17). Similar differences favoring efficacy of IFX were observed for the individual symptoms of diarrhea, pain, bleeding, and fatigue. However, there was no difference in inflammatory bowel disease-related surgery, hospitalizations, or prednisone use within 1 year after initiation of IFX or ADA in CD. There was no difference in narrative or codified outcomes between the 2 agents in ulcerative colitis.
We identified a modestly higher likelihood of symptomatic nonresponse at 1 year for ADA compared with IFX in patients with CD. However, there were no differences in inflammatory bowel disease-related surgery or hospitalizations, suggesting these treatments are broadly comparable in effectiveness in routine clinical practice.
肿瘤坏死因子α单克隆抗体的出现彻底改变了克罗恩病(CD)和溃疡性结肠炎的治疗方式。然而,关于这些药物比较疗效的数据有限,难以指导临床实践。
本研究纳入了1998年至2010年间开始使用英夫利昔单抗(IFX)或阿达木单抗(ADA)治疗的CD或溃疡性结肠炎患者。使用电子健康记录中相关症状叙述提及频率的有效无反应分类评分可能性来评估1年时的比较疗效。在此期间确定炎症性肠病相关手术、住院情况及类固醇使用情况。
我们的最终队列包括1060例新开始使用IFX的患者(68%为CD患者)和391例使用ADA的患者(79%为CD患者)。在CD患者中,ADA无反应的可能性高于IFX(优势比为1.62,95%置信区间为1.21 - 2.17)。腹泻、疼痛、出血和疲劳等个体症状也观察到类似的有利于IFX疗效的差异。然而,在CD患者开始使用IFX或ADA后的1年内,炎症性肠病相关手术、住院或泼尼松使用情况并无差异。在溃疡性结肠炎患者中,两种药物在叙述性或编码结局方面没有差异。
我们发现CD患者中,ADA在1年时出现症状性无反应的可能性略高于IFX。然而,炎症性肠病相关手术或住院情况并无差异,这表明这些治疗在常规临床实践中的有效性大致相当。