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• W2521055616 abstract "Purpose: It has been suggested that serum levels of infliximab (IFX) may be predictive of the loss of response to IFX in Crohn's disease patients treated with IFX. This post-hoc analysis assessed the relationship between week 14 IFX trough level, the change of clinical disease activity (CDAI) and of CRP from baseline to week 14 in patients with sustained benefit of IFX in the 5mg/kg treatment arm of the ACCENT1 study. Methods: Post-hoc analysis of data from the ACCENT1 trial assessed the associations of week 14 serum IFX trough level with change of clinical disease activity (CDAI) and CRP from baseline to week 14, and compared the association of these parameters with subsequent sustained response in patients enrolled in the 5mg/kg arm of ACCENT1 study (N=192). Per protocol, patients were considered in sustained response if their CDAI was decreased by ≥70 points and ≥25% relative to baseline at week 14, 22, 30, 38, 46, and 54. Results: In ACCENT1, 113/192 (59%) patients treated with 5mg/kg IFX were clinical responders at week 2. At week 14, median (IQR) serum IFX level was 2.2 μg/mL (0.5-5.4) (N=168). Higher week 14 serum IFX level was associated with greater CDAI improvement from baseline to week 14 in patients with initial response to IFX (Table). The median week 14 IFX trough level in patients with a sustained response to IFX was 4.0 μg/mL (1.7-6.8) compared with 1.9 μg/mL (0.4-4.1) in those without sustained response (p=0.0331). Median (IQR) % change of CRP from baseline to week 14 in initial responders with baseline CRP >0.8mg/dL was 65% (86-22). ROC analysis showed that best discrimination of sustained vs non-sustained response to 5mg/kg IFX through week 54 was achieved with a ≥3.5μg/mL IFX level at week 14, a ≥60% decrease of CRP, and a ≥50% decrease of CDAI from baseline to week 14. The AUC for prediction of sustained clinical response to IFX for these parameters was 0.6113, 0.6264, and 0.6840, respectively.Table: No Caption available.Conclusion: In this post-hoc ACCENT1 analysis, higher post-induction IFX trough levels at week 14 were associated with sustained response over one year. Further research is needed to prospectively assess whether early IFX trough levels in concert with the magnitude of CRP improvement, can be used in clinical practice to predict sustained benefit to IFX. Disclosure: F Cornillie: Employee, Janssen Biologics BV; S Hanauer: Investigator, Centocor Research and Development, Inc.; RH Diamond: Employee, Centocor Ortho Biotech Services, LLC; J Wang: Employee, Centocor Ortho Biotech Services, LLC; D Zelinger: Employee, Centocor Ortho Biotech Services, LLC; Z Xu: Employee, Centocor Research and Development, Inc.; S Vermeire: Investigator, Centocor Research and Development, Inc.; P Rutgeerts: Investigator, Centocor Research and Development, Inc. This research was supported by an industry grant from This study was sponsored by Centocor Research and Development, Inc." @default.
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• W2521055616 date "2011-10-01" @default.
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• W2521055616 title "Early Serum Infliximab Trough Level, Clinical Disease Activity and CRP as Markers of Sustained Benefit of Infliximab Treatment in Crohnʼs Disease: A Post-hoc Analysis of the ACCENT1 Trial" @default.
• W2521055616 doi "https://doi.org/10.14309/00000434-201110002-01226" @default.
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