Growth Improvement with Adalimumab Treatment in Children with Moderately to Severely Active Crohn's Disease. Issue 6 (15th March 2017)

• Record Type: Journal Article
• Authors: Walters, Thomas D.; Faubion, William A.; Griffiths, Anne M.; Baldassano, Robert N.; Escher, Johanna; Ruemmele, Frank M.; Hyams, Jeffrey S.; Lazar, Andreas; Eichner, Samantha; Huang, Bidan; Li, Yao; Thakkar, Roopal B.
• Is Part Of: Inflammatory bowel diseases. Volume 23:Issue 6(2017)
• Page Start: 967
• Page End: 975
• Publication Date: 2017-03-15
• Subjects: pediatric Crohn's disease -- anti-TNF antibody -- adalimumab -- linear growth -- height velocity z-score; Inflammatory bowel diseases -- Periodicals; Colitis, Ulcerative -- Periodicals; Crohn Disease -- Periodicals; Inflammatory Bowel Diseases -- Periodicals; 616.344
• DOI: 10.1097/MIB.0000000000001075
• Languages: English
• ISSNs: 1078-0998

Abstract

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.