Growth Improvement with Adalimumab Treatment in Children with Moderately to Severely Active Crohn’s Disease.

Growth Improvement with Adalimumab Treatment in Children with Moderately to Severely Active Crohn’s Disease.

Inflamm Bowel Dis. 2017 Mar 15;:

Authors: Walters TD, Faubion WA, Griffiths AM, Baldassano RN, Escher J, Ruemmele FM, Hyams JS, Lazar A, Eichner S, Huang B, Li Y, Thakkar RB

Abstract
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.

PMID: 28301428 [PubMed – as supplied by publisher]

PubMed Link: https://www.ncbi.nlm.nih.gov/pubmed/28301428?dopt=Abstract