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Gastroenterology:克罗恩病患儿或可从阿达木单抗获益

来源:医脉通 2012-08-10 23:28

最新一期美国胃肠病学协会(AGA)官方杂志《胃肠病学》(Gastroenterology)上的一项新研究显示,阿达木单抗(一种抗肿瘤坏死因子(TNF)抗体)可有效维持某些儿童克罗恩病的缓解。

儿童克罗恩病的发病率正在升高,激素通常用于治疗克罗恩病,但有可能妨碍生长和延缓青春期的到来。

这项研究是在克罗恩病患儿中进行的关于抗TNF药的最大型双盲研究。结果表明,超过80%的中至重度克罗恩病儿童在1个月内对阿达木单抗有反应(反应定义为儿科克罗恩病活动性指数较基线≥15分)。到6个月时,大约34%的患儿临床缓解,1年后,28.4%患儿缓解。

研究者于2007年4月至2010年5月间对加拿大、欧洲和美国的45个中心的192例患者(年龄6~17岁)进行了研究。根据他们的体重,这些患者被分配至大剂量组,每隔一周接受40 mg或20 mg阿达木单抗,或被分配至小剂量组,每隔一周接受20 mg或10 mg阿达木单抗。在26周时,大剂量组的处于缓解期的儿童多于小剂量组,但两个剂量组之间的差异并无统计学意义。

使用阿达木治疗得到的有前景的结果使人们深受鼓舞,尤其是对传统疗法耐药的这一临床上极具挑战性的患者群体。治疗的目的不仅是为了诱导和维持临床缓解,还为了恢复和保留这些患者的正常生长和青春期发育。(生物谷Bioon.com)

Safety and Efficacy of Adalimumab for Moderate to Severe Crohn's Disease in Children

Hyams JS,Griffiths A,Markowitz J,Baldassano RN,Faubion WA Jr,Colletti RB,Dubinsky M,Kierkus J,Rosh J,Wang Y,Huang B,Bittle B,Marshall M,Lazar A

Background & Aims

The IMAgINE 1 study (NCT00409682) evaluated the safety and efficacy of adalimumab double-blind maintenance dosing regimens following open-label induction for pediatric patients with moderate to severe Crohn's disease (CD).

Methods

We studied 192 patients with Pediatric Crohn's Disease Activity Index (PCDAI) scores >30 for whom conventional treatment was unsuccessful. Patients received open-label induction therapy with subcutaneous adalimumab at weeks 0 and 2 (160 mg and 80 mg, or 80 mg and 40 mg, for body weight ≥40 kg or <40 kg). At week 4, 188 patients were assigned to groups based on achievement of clinical response (defined as decrease in PCDAI ≥15 points from baseline; 155/188 [82.4%]) and prior exposure to infliximab (82/188 [43.6%]). Groups were given double-blind maintenance therapy with adalimumab at high (40 mg or 20 mg for body weight ≥40 kg or <40 kg; n = 93) or low doses (20 mg or 10 mg for body weight ≥40 kg or <40 kg; n = 95) every other week for 48 weeks. Clinical remission (PCDAI ≤10) at week 26 (the primary end point) was compared between groups using the Cochran–Mantel–Haenszel test, adjusting for strata, with nonresponder imputation. Adverse events were monitored to evaluate safety.

Results

A total of 152 of 188 patients (80.9%) completed all 26 weeks of the study. At week 26, 63 patients (33.5%) were in clinical remission, with no significant difference between high- and low-dose groups (36/93 [38.7%] vs 27/95 [28.4%]; P = .075). No new safety signals were detected.

Conclusions

Adalimumab induced and maintained clinical remission of children with CD, with a safety profile comparable to that of adult patients with CD. More children who received high compared with low dose were in remission at week 26, but the difference between dose groups was not statistically significant.

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