Yorkhill Hospital, Glasgow, UK.
Aliment Pharmacol Ther. 2011 Apr;33(8):946-53. doi: 10.1111/j.1365-2036.2011.04603.x. Epub 2011 Feb 22.
Adalimumab is efficacious therapy for adults with Crohn's disease (CD).
To summarise the United Kingdom and Republic of Ireland paediatric adalimumab experience.
British Society of Paediatric Gastroenterology, Hepatology and Nutrition (BSPGHAN) members with Inflammatory Bowel Disease (IBD) patients <18 years old commencing adalimumab with at least 4 weeks follow-up. Patient demographics and details of treatment were then collected. Response and remission was assessed using the Paediatric Crohn's Disease Activity Index (PCDAI)/Physicians Global Assessment (PGA).
Seventy-two patients [70 CD, 1 ulcerative colitis (UC), 1 IBD unclassified (IBDU)] from 19 paediatric-centres received adalimumab at a median age of 14.8 (IQR 3.1, range 6.1-17.8) years; 66/70 CD (94%) had previously received infliximab. A dose of 80 mg then 40 mg was used for induction in 41(59%) and 40 mg fortnightly for maintenance in 61 (90%). Remission rates were 24%, 58% and 41% at 1, 6 and 12 months, respectively. Overall 43 (61%) went into remission at some point, with 24 (35%) requiring escalation of therapy. Remission rates were higher in those on concomitant immunosuppression cf. those not on immunosuppression [34/46 (74%) vs. 9/24 (37%), respectively, (χ(2) 8.8, P=0.003)]. There were 15 adverse events (21%) including four (6%) serious adverse events with two sepsis related deaths in patients who were also on immunosuppression and home parenteral nutrition (3% mortality rate).
Adalimumab is useful in treatment of refractory paediatric patients with a remission rate of 61%. This treatment benefit should be balanced against side effects, including in this study a 3% mortality rate.
阿达木单抗对成人克罗恩病（CD）有效。
总结英国和爱尔兰共和国儿科阿达木单抗的经验。
英国儿科学会胃肠病学、肝病学和营养学分会（BSPGHAN）成员，对接受阿达木单抗治疗且至少有 4 周随访的 18 岁以下炎症性肠病（IBD）患者进行了回顾性研究。收集患者的人口统计学和治疗细节。采用儿科克罗恩病活动指数（PCDAI）/医生总体评估（PGA）评估缓解和缓解率。
19 家儿科中心的 72 名患者（70 例 CD、1 例溃疡性结肠炎（UC）、1 例未分类 IBD（IBDU））接受了阿达木单抗治疗，中位年龄为 14.8 岁（IQR 3.1，范围 6.1-17.8）；66/70 CD（94%）之前接受过英夫利昔单抗治疗。41 名（59%）患者诱导期使用 80mg 剂量，然后使用 40mg 剂量，61 名（90%）患者每两周使用 40mg 维持剂量。治疗 1、6 和 12 个月时缓解率分别为 24%、58%和 41%。总体上，43 名（61%）患者在某一时刻进入缓解期，其中 24 名（35%）需要升级治疗。同时使用免疫抑制剂的患者缓解率高于未使用免疫抑制剂的患者[34/46（74%）比 9/24（37%），（χ² 8.8，P=0.003）]。共有 15 例不良事件（21%），包括 4 例（6%）严重不良事件，其中 2 例与免疫抑制剂和家庭肠外营养相关的败血症相关死亡（3%的死亡率）。
阿达木单抗在治疗难治性儿童患者方面非常有效，缓解率为 61%。在考虑该治疗的获益时，应权衡其副作用，包括本研究中 3%的死亡率。
