TABLE 1

Adalimumab concentrations and clinical remission (at week 26 for pediatrics and week 24 for adults)

PopulationCtrough at Week 26a (Mean ± S.D.)Clinical Remission at Week 26
µg/ml
Pediatrics
 <40 kg (N = 39)
  10 mg EOW (N = 19)2.0 ± 1.45/19 (26.3%)
  20 mg EOW (N = 20)7.6 ± 3.68/20 (40.0%)
 ≥40 kg (N = 94)
  20 mg EOW (N = 47)3.7 ± 2.7120/47 (42.6%)
  40 mg EOW (N = 47)10.7 ± 4.623/47 (48.9%)
Adultsb
 N = 94
  40 mg EOW6.8 ± 4.354/94 (57.4%)
 N = 260
  40 mg EOWNA87/260 (33.5%)
  • a Data from 42 subjects are missing.

  • b Data in adults were taken from the submission for adult CD, and the clinical remission was based on the Crohn’s Disease Activity Index (pediatrics clinical remission was based the PCDAI).