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- W2893343158 abstract "Certolizumab pegol is a PEGylated Fab' fragment of a humanized anti-tumor necrosis factor-α [TNFα] monoclonal antibody. In the PRECiSE 2 maintenance trial, certolizumab pegol demonstrated efficacy and safety in patients with active Crohn's disease (Crohn's Disease Activity Index [CDAI] score of 220-450). Patients with prior infliximab (IFX) use were eligible if they responded to the first dose and had no severe hypersensitivity or anaphylactic reaction. PRECiSE 2 efficacy data for certolizumab pegol in IFX-naïve patients and patients previously treated with IFX are presented here. At Weeks 0, 2, and 4, patients received open-label induction treatment with certolizumab pegol 400 mg administered subcutaneously. CDAI responders (decrease from baseline in CDAI score of ≥100 points) at Week 6 were randomized to certolizumab pegol 400 mg sc or placebo every 4 weeks over Weeks 8-24. CDAI and IBDQ scores were recorded at each visit and adverse events (AEs) were monitored throughout the trial. Of the 668 patients enrolled, 193 had received prior IFX; 474 were IFX-naïve; and IFX status was unknown for 1 patient. Response at Week6 was seen for 324 (68.4%) IFX-naïve patients and 104 patients (53.9%) with prior IFX use. At Week 26, significantly more patients maintained response and achieved remission (CDAI score ≤ 150 points) with certolizumab pegol than with placebo, irrespective of prior IFX use. This was also true for Inflammatory Bowel Disease Questionnaire (IBDQ) response (increase from baseline ≥16 points) (table). The proportions of patients with AEs and serious AEs are shown in the table. Irrespective of whether patients are IFX-naïve or have previously received IFX, certolizumab pegol is a safe and effective subcutaneous anti-TNF treatment for Crohn's disease." @default.
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- W2893343158 date "2007-05-01" @default.
- W2893343158 modified "2023-10-08" @default.
- W2893343158 title "Efficacy and safety of certolizumab pegol in patients with prior Influximab use" @default.
- W2893343158 doi "https://doi.org/10.1097/00054725-200705005-00016" @default.
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