Trinder Matthew W, Lawrance Ian C
Centre for inflammatory Bowel Diseases, University of Western Australia, Fremantle Hospital, Western Australia, Australia.
J Gastroenterol Hepatol. 2009 Jul;24(7):1252-7. doi: 10.1111/j.1440-1746.2009.05786.x. Epub 2009 Feb 12.
Anti-tumor necrosis factor (TNF)-alpha medications are effective in Crohn's Disease (CD) and efficacious in ulcerative colitis (UC). Adalimumab has been available through the Australian Pharmaceutical Benefits Scheme since August 2008, but clinical experience for inflammatory bowel disease (IBD) in Australia is limited.
To determine adalimumab efficacy for IBD in the Australian setting.
Crohn's disease or UC/IBD unclassified (UC/IBDU) patients received adalimumab after failure of disease control with conventional therapies or loss of control by infliximab. Response/remission at 8 and 12 weeks were determined by the Crohn's Disease Activity Index (CDAI) and Colitis Activity Index (CAI). All patients received 160 mg (week 0), 80 mg (week 2), followed by 40 mg every-other-week (eow). Patients with a limited response at 8 weeks were considered for weekly adalimumab.
Of 38 CD patients 86.8% (33/38) had active luminal and 23.7% (9/38) fistulising disease at inclusion. Response occurred in 81.8% and 84.4% of luminal CD at 8 and 12 weeks, while 54.5% and 63.6% remitted respectively. 77.8% of fistulising CD responded and 55.6% remitted at 12 weeks. Fifteen CD patients had previously lost response to infliximab, and 86.7% of these responded and 53.3% remitted at 12 weeks. Of the seven UC/IBDU patients 43% and 14% responded, while 29% and 0% remitted at 8 and 12 weeks.
In CD, adalimumab is as, if not more, effective in the clinical setting than in the trials, and is effective in patients with an attenuated response to infliximab. Its efficacy is not as good in UC, but this requires further clarification.
抗肿瘤坏死因子（TNF）-α药物对克罗恩病（CD）有效，对溃疡性结肠炎（UC）也有疗效。自2008年8月起，阿达木单抗已被纳入澳大利亚药品福利计划，但澳大利亚在炎性肠病（IBD）方面的临床经验有限。
确定在澳大利亚环境下阿达木单抗对IBD的疗效。
克罗恩病或未分类的UC/IBD（UC/IBDU）患者在传统疗法控制疾病失败或英夫利昔单抗失去控制后接受阿达木单抗治疗。在第8周和第12周时，通过克罗恩病活动指数（CDAI）和结肠炎活动指数（CAI）确定反应/缓解情况。所有患者在第0周接受160mg，第2周接受80mg，随后每隔一周（eow）接受40mg。在第8周反应有限的患者考虑每周使用阿达木单抗。
38例CD患者中，86.8%（33/38）在纳入时患有活动性肠腔疾病，23.7%（9/38）患有瘘管性疾病。在第8周和第12周时，81.8%和84.4%的肠腔CD患者出现反应，而分别有54.5%和63.6%的患者缓解。77.8%的瘘管性CD患者有反应，在第12周时55.6%的患者缓解。15例CD患者之前对英夫利昔单抗失去反应，其中86.7%的患者有反应，在第12周时53.3%的患者缓解。7例UC/IBDU患者中，43%和14%的患者有反应，在第8周和第12周时分别有29%和0%的患者缓解。
在CD中，阿达木单抗在临床环境中的效果即使不比试验中的更好，也至少相当，并且对英夫利昔单抗反应减弱的患者有效。其在UC中的疗效不太理想，但这需要进一步阐明。
