Fig 1.
CONSORT flow chart of patient dispositions.
AE, adverse event; IFX, infliximab.
Fig 2.
IFX, infliximab; PCDAI, Pediatric Crohn’s Disease Activity Index. Study period: period from the starting day of the screening period to the last day of the evaluation period. Screening period: period from the starting day of PCDAI evaluation to the start of the study period. Evaluation period: period from the start of IFX treatment to the evaluation day at Week 54. Evaluation period for non-responders at Week 10: the period from the start of IFX treatment to the end of evaluation at Week 14. Evaluation period for discontinued patients: the period from the start of IFX treatment to the end of evaluation after 8 weeks of the last treatment.
Table 1.
Patient characteristics (FAS population).
Fig 3.
Efficacy responses to IFX treatment over time in Japanese pediatric patients with CD.
(A) Median PCDAI score at Weeks 0–54 in the FAS population. Open circle represents the median PCDAI score at Week 54 (overall). (B) PCDAI response and remission rates at Weeks 2–54. (C) Corticosteroid dose at Weeks 0–54 in three patients with baseline corticosteroid use. Asterisk represents the start of dose escalation. (D) Rates of complete closure of draining fistulas at Weeks 10–54. CD, Crohn’s disease; FAS, full analysis set; IFX, infliximab; PCDAI, Pediatric Crohn’s Disease Activity Index.
Fig 4.
Trough serum IFX concentration at week 14 in patients who achieved PCDAI remission and in those who did not achieve PCDAI remission.
IFX, infliximab; PCDAI, Pediatric Crohn’s Disease Activity Index.
Fig 5.
Individual responses from five patients who met criteria for IFX dose increasing from 5 mg/kg to 10 mg/kg.
(A) PCDAI from dose-increase Weeks -48 to 24. (B) IFX serum concentrations from dose-increase Weeks -48 to 24. IFX, infliximab; PCDAI, Pediatric Crohn’s Disease Activity Index. The time point of dose increase was defined as Week 0 of dose increase.
Table 2.
Incidence of AEs following 5 mg/kg or 10 mg/kg IFX.