Kawalec Paweł, Pilc Andrzej
Drug Management Department, Institute of Public Health, Faculty of Health Sciences, Jagiellonian University Medical College, Krakow, Poland.
Institute of Pharmacology, Polish Academy of Sciences, Krakow, Poland.
Arch Med Sci. 2016 Oct 1;12(5):1097-1109. doi: 10.5114/aoms.2016.58682. Epub 2016 Mar 22.
The aim of the study was to compare adalimumab or golimumab with infliximab in patients with moderately-to-severely active ulcerative colitis (UC).
This paper was prepared according to the PRISMA guidelines. The systematic literature search was performed in PubMed, Embase, and Cochrane Library. No direct head-to-head comparisons for infliximab vs. adalimumab or golimumab were available so an indirect comparison according to the Bucher method was performed after a homogeneity evaluation of the included studies.
Six RCTs were included in the systematic review. An indirect comparison was performed, which revealed that infliximab was more effective in inducing clinical response compared with both doses of adalimumab (160/80 mg or 80/40 mg; < 0.05), and, in clinical remission, infliximab was more effective than adalimumab (only for a dosage regime of 80/40 mg; < 0.05). No statistically significant differences in clinical response and clinical remission were observed between infliximab and golimumab in the induction phase. A significant ( < 0.05) advantage only of infliximab compared with adalimumab at doses of 80/40 mg and 80/160 mg was seen in terms of clinical response in the maintenance phase (up to 52-54 weeks). The indirect comparison revealed that serious adverse events were significantly more frequent among patients treated with a maintenance dose of 100 mg of golimumab compared with those treated with infliximab ( < 0.05).
No significant differences in efficacy in the maintenance phase between infliximab and golimumab or adalimumab were revealed. Infliximab proved to be more effective than adalimumab but of similar efficacy to that of golimumab in the induction phase.
本研究旨在比较阿达木单抗或戈利木单抗与英夫利昔单抗治疗中度至重度活动性溃疡性结肠炎（UC）患者的疗效。
本文按照PRISMA指南撰写。在PubMed、Embase和Cochrane图书馆进行了系统的文献检索。由于没有英夫利昔单抗与阿达木单抗或戈利木单抗的直接头对头比较，因此在对纳入研究进行同质性评估后，根据Bucher方法进行了间接比较。
系统评价纳入了6项随机对照试验。进行了间接比较，结果显示，与两种剂量的阿达木单抗（160/80 mg或80/40 mg）相比，英夫利昔单抗在诱导临床缓解方面更有效（P<0.05）；在临床缓解方面，英夫利昔单抗比阿达木单抗更有效（仅对于80/40 mg的给药方案；P<0.05）。在诱导期，英夫利昔单抗和戈利木单抗在临床缓解和临床反应方面未观察到统计学显著差异。在维持期（长达52 - 54周），仅在80/40 mg和80/160 mg剂量下，英夫利昔单抗与阿达木单抗相比在临床反应方面具有显著（P<0.05）优势。间接比较显示，与接受英夫利昔单抗治疗的患者相比，接受100 mg戈利木单抗维持剂量治疗的患者严重不良事件明显更频繁（P<0.05）。
英夫利昔单抗与戈利木单抗或阿达木单抗在维持期疗效方面未显示出显著差异。在诱导期，英夫利昔单抗比阿达木单抗更有效，但与戈利木单抗疗效相似。
