TY - JOUR
T1 - Growth Improvement with Adalimumab Treatment in Children with Moderately to Severely Active Crohn's Disease
AU - Walters, Thomas D.
AU - Faubion, William A.
AU - Griffiths, Anne M.
AU - Baldassano, Robert N.
AU - Escher, Johanna
AU - Ruemmele, Frank M.
AU - Hyams, Jeffrey S.
AU - Lazar, Andreas
AU - Eichner, Samantha
AU - Huang, Bidan
AU - Li, Yao
AU - Thakkar, Roopal B.
N1 - Publisher Copyright:
Copyright © 2017 Crohn's & Colitis Foundation.
PY - 2017/6/1
Y1 - 2017/6/1
N2 - Background: Growth failure is common in children with Crohn's disease. The effect of adalimumab (ADA), a fully human antitumor necrosis factor antagonist, on height velocity in pediatric patients with baseline (BL) linear growth impairment in the IMAgINE 1 trial is presented. Methods: This analysis included female and male patients with growth potential (bone age ≤13 and ≤14 yr, respectively), with BL Pediatric Crohn's disease Activity Index >30, and who failed or were intolerant to conventional therapy. Patients received open-label induction ADA at weeks 0 and 2 by body weight (≥40 kg, 160 and 80 mg and <40 kg, 80 and 40 mg). At week 4, patients were randomized to double-blind high (40 or 20 mg for ≥40 kg or <40 kg) or low dose (20 or 10 mg for ≥40 kg or <40 kg) every other week ADA to week 52. Height velocity z-score was summarized at BL, week 26, and week 52 by patients with BL growth impairment (z-score ≤-1.0) or normal growth (z-score >-1.0). Results: ADA therapy significantly improved and normalized growth rate at weeks 26 and 52 in patients with BL growth impairment (median z-score, BL, -3.25; week 26, -0.34; and week 52, 0.21; P < 0.001 versus BL for both), but not in patients with normal growth. Growth improvement was significantly greater at week 26 in week 4 responders to induction therapy compared with nonresponders (median z-score 0.09 versus -2.92; P = 0.02). Conclusions: ADA treatment resulted in growth rate normalization as early as week 26 in children with moderately to severely active Crohn's disease and growth impairment.
AB - Background: Growth failure is common in children with Crohn's disease. The effect of adalimumab (ADA), a fully human antitumor necrosis factor antagonist, on height velocity in pediatric patients with baseline (BL) linear growth impairment in the IMAgINE 1 trial is presented. Methods: This analysis included female and male patients with growth potential (bone age ≤13 and ≤14 yr, respectively), with BL Pediatric Crohn's disease Activity Index >30, and who failed or were intolerant to conventional therapy. Patients received open-label induction ADA at weeks 0 and 2 by body weight (≥40 kg, 160 and 80 mg and <40 kg, 80 and 40 mg). At week 4, patients were randomized to double-blind high (40 or 20 mg for ≥40 kg or <40 kg) or low dose (20 or 10 mg for ≥40 kg or <40 kg) every other week ADA to week 52. Height velocity z-score was summarized at BL, week 26, and week 52 by patients with BL growth impairment (z-score ≤-1.0) or normal growth (z-score >-1.0). Results: ADA therapy significantly improved and normalized growth rate at weeks 26 and 52 in patients with BL growth impairment (median z-score, BL, -3.25; week 26, -0.34; and week 52, 0.21; P < 0.001 versus BL for both), but not in patients with normal growth. Growth improvement was significantly greater at week 26 in week 4 responders to induction therapy compared with nonresponders (median z-score 0.09 versus -2.92; P = 0.02). Conclusions: ADA treatment resulted in growth rate normalization as early as week 26 in children with moderately to severely active Crohn's disease and growth impairment.
KW - adalimumab
KW - anti-TNF antibody
KW - height velocity z-score
KW - linear growth
KW - pediatric Crohn's disease
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U2 - 10.1097/MIB.0000000000001075
DO - 10.1097/MIB.0000000000001075
M3 - Article
C2 - 28301428
AN - SCOPUS:85019714088
SN - 1078-0998
VL - 23
SP - 967
EP - 975
JO - Inflammatory bowel diseases
JF - Inflammatory bowel diseases
IS - 6
ER -