期刊
INFLAMMATORY BOWEL DISEASES
卷 22, 期 4, 页码 886-893出版社
OXFORD UNIV PRESS INC
DOI: 10.1097/MIB.0000000000000715
关键词
adalimumab; pediatric Crohn's disease; dose adjustment; disease flare; dose escalation
资金
- AbbVie Inc.
- AbbVie
- Janssen
- Receptos
- Soligenix
- Prometheus
- Schering-Plough
- Nestle
- MeadJohnson
- Ferring
- MSD
- Johnson Johnson
- Centocor
- Janssen Orthobiotech
- TNI Biotech
- EnteraHealth
- Pfizer
- Takeda
- Avaxia
- Celgene
Background: The efficacy of adalimumab in inducing and maintaining remission in children with moderately to severely active Crohn's disease was shown in the IMAgINE 1 trial (NCT00409682). As per protocol, nonresponders or patients experiencing flare(s) on every other week (EOW) maintenance dosing could escalate to weekly dosing; we aimed to determine the therapeutic benefits of weekly dose escalation in this subpopulation. Methods: Week 52 remission and response rates were assessed in patients who escalated to weekly dosing from their previous EOW schedule, which was according to randomized treatment dose (higher dose [HD] adalimumab [>= 40 kg, 40 mg EOW; <40 kg, 20 mg EOW] or lower dose [LD; >= 40 kg, 20 mg EOW; <40 kg, 10 mg EOW]). Adverse events were reported for patients remaining on EOW dosing and patients receiving weekly dosing. Results: Escalation to weekly dosing occurred in 48/95 (50.5%) patients randomized to LD and 35/93 (37.6%) patients randomized to HD adalimumab (P = 0.076). Week 52 remission and response rates were 18.8% and 47.9% for patients receiving LD adalimumab weekly and 31.4% and 57.1% for patients receiving HD adalimumab weekly, respectively (LD versus HD, P = 0.19 for remission; P = 0.41 for response). Adverse event rates were similar for patients receiving EOW and weekly adalimumab. Conclusions: Weekly adalimumab dosing was clinically beneficial for children with Crohn's disease who experienced nonresponse or flare on EOW dosing. No increased safety risks were observed with weekly dosing.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据