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• W2913063856 abstract "Purpose: This post-hoc analysis assessed the need for concomitant immunosuppressants (IMM) or corticosteroids (CS) for induction of response and remission with natalizumab (NAT) in the ENCORE and ENACT2 trials. Methods: In the ENCORE induction trial, 509 patients (pts) with CDAI scores ≥220 and ≤450 and CRP levels > 2.87 mg/L were randomized 1:1 to receive NAT 300 mg (N = 259) or placebo (PBO; N = 250) infusions at Mths 0, 1, and 2. In the ENACT2 maintenance trial, NAT-treated pts who responded in ENACT1 and had a CDAI score <220 were re-randomized 1:1 to receive monthly NAT (300 mg; N = 168) or placebo (N = 171) infusions for up to 12 mths. Results: In ENCORE, 188 pts were not receiving IMM or CS at baseline, with 90 and 98 randomized to receive NAT and PBO, respectively. A significantly greater proportion of NAT-treated pts were in clinical response at both Months 2 and 3, and, individually, at Mths 1 through 3, compared to the PBO group (Table 1). NAT treatment also resulted in a significantly greater proportion of pts in clinical remission at both Mths 2 and 3 and, individually, at Mths 1 and 3 compared to PBO (Table 1). In ENACT2, 138 pts were not receiving IMM or CS at baseline, and following randomization, 70 and 68 pts received NAT and PBO, respectively. At Mths 6 through 12, a significantly greater proportion of NAT-treated patients were in clinical response and remission, compared to the PBO group (Table 2).Table 1: ENCORE (Induction)Table 2: ENACT2 (Maintenance)Conclusion: Analyses of these trials suggest that NAT was effective in inducing response and sustaining remission in CD pts in the absence of concomitant IMM or CS therapy." @default.
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• W2913063856 date "2007-09-01" @default.
• W2913063856 modified "2023-09-26" @default.
• W2913063856 title "Natalizumab Does Not Require the Concomitant Use of Immunosuppressants or Corticosteriods for the Induction of Sustained Response and Remission in Patients with Crohnʼs Disease" @default.
• W2913063856 doi "https://doi.org/10.14309/00000434-200709002-01025" @default.
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