Jun 6, 2002

Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial

Lancet
Stephen B HanauerACCENT I Study Group

Abstract

We did a randomised controlled trial to assess the benefit of maintenance infliximab therapy in patients with active Crohn's disease who respond to a single infusion of infliximab. 573 patients with a score of at least 220 on the Crohn's disease activity index (CDAI) received a 5 mg/kg intravenous infusion of infliximab at week 0. After assessment of response at week 2, patients were randomly assigned repeat infusions of placebo at weeks 2 and 6 and then every 8 weeks thereafter until week 46 (group I), repeat infusions of 5 mg/kg infliximab at the same timepoints (group II), or 5 mg/kg infliximab at weeks 2 and 6 followed by 10 mg/kg (group III). The prespecified co-primary endpoints were the proportion of patients who responded at week 2 and were in remission (CDAI <150) at week 30 and the time to loss of response up to week 54 in patients who responded. Analyses of the co-primary endpoints were by intention to treat. 335 (58%) patients responded to a single infusion of infliximab within 2 weeks. At week 30, 23 of 110 (21%) group I patients were in remission, compared with 44 of 113 (39%) group II (p=0.003) and 50 of 112 (45%) group III (p=0.0002) patients. Thus, patients in groups II and III combined were more likely to sust...Continue Reading

  • References11
  • Citations1927

References

  • References11
  • Citations1927

Citations

Mentioned in this Paper

Septicemia
Monoclonal Antibodies
IIeocolitis
Immunomodulators
CDAN1 gene
Tuberculosis
Immunologic Adjuvants
Corticosteroid [EPC]
Digestants
CDAN1 wt Allele

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