教員業績データベース |
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論文種別 | 原著 |
言語種別 | 英語 |
査読の有無 | 査読なし |
表題 | Circulating Interleukin 6 and Albumin, and Infliximab Levels Are Good Predictors of Recovering Efficacy After Dose Escalation Infliximab Therapy in Patients with Loss of Response to Treatment for Crohn's Disease: A Prospective Clinical Trial. |
掲載誌名 | 正式名:Inflammatory bowel diseases 略 称:Inflamm Bowel Dis ISSNコード:1536-4844(Electronic)1078-0998(Linking) |
巻・号・頁 | 21(9),pp.2114-22 |
著者・共著者 | Suzuki Yasuo, Matsui Toshiyuki, Ito Hiroaki, Ashida Toshifumi, Nakamura Shiro, Motoya Satoshi, Matsumoto Takayuki, to Noriko, Ozaki Kunihiko, Watanabe Mamoru, Hibi Toshifumi |
発行年月 | 2015/09 |
概要 | BACKGROUND:We aimed to clarify the efficacy, safety, and factors associated with remission on dose escalation in patients with Crohn's disease showing loss of response (LOR) to infliximab treatment of 5 mg/kg at 8-week intervals in a clinical trial.METHODS:Thirty-nine patients with LOR to 5 mg/kg infliximab therapy started treatment with 10 mg/kg per 8 weeks. LOR was defined as both a Crohn's Disease Activity Index of ≥175 at 8 weeks after infusioMETHODS:n of 5 mg/kg infliximab and a Crohn's Disease Activity Index increase of ≥50 from 4 to 8 weeks after infusion.RESULTS:At week 8 after the first infusion of 10 mg/kg, median (95% confidence interval) reduction in Crohn's Disease Activity Index of 33 patients evaluated was 95.0 (70.0-134.0), meeting the primary endpoint. Remission rate at week 40 was 41% (16 of 39), with correlation noted between remission achievement and serum infliximab level (P = 0.036). Univariate analysis revealed thatRESULTS:"RESULTS:infliximab trough level ≥1 µg/mL,RESULTS:"RESULTS:"RESULTS:interleukin 6 level ≤2.41 pg/mL,RESULTS:"RESULTS:andRESULTS:"RESULTS:albumin level ≥3.8 g/dLRESULTS:"RESULTS:before dose escalation were significantly associated with remission at week 40 (P = 0.017, P = 0.011, and P = 0.019, respectively), and these variables were correlated with each other (all: PRESULTS:<RESULTS:0.001). The cutoff infliximab level for remission was 0.42 µg/mL in receiver operating characteristic curve analysis. No adverse events related to dose escalation were observed.CONCLUSIONS:Doubling the infliximab dose safely led to remission in patients with Crohn's disease with LOR to 5 mg/kg treatment. Remission was associated with pre-escalation levels of infliximab, interleukin 6, and albumin. Our findings suggest that dose escalation while maintaining a certain level of infliximab is important in achieving remission. |
DOI | 10.1097/MIB.0000000000000475 |
PMID | 26218144 |