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

Thomas D. Walters, William Alvis Faubion, Anne M. Griffiths, Robert N. Baldassano, Johanna Escher, Frank M. Ruemmele, Jeffrey S. Hyams, Andreas Lazar, Samantha Eichner, Bidan Huang, Yao Li, Roopal B. Thakkar

Research output: Contribution to journalArticle

6 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)967-975
Number of pages9
JournalInflammatory Bowel Diseases
Volume23
Issue number6
DOIs
StatePublished - Jun 1 2017

Fingerprint

Crohn Disease
Growth
Therapeutics
Adalimumab
Bone Development
Necrosis
Body Weight
Pediatrics

Keywords

  • adalimumab
  • anti-TNF antibody
  • height velocity z-score
  • linear growth
  • pediatric Crohn's disease

ASJC Scopus subject areas

  • Immunology and Allergy
  • Gastroenterology

Cite this

Growth Improvement with Adalimumab Treatment in Children with Moderately to Severely Active Crohn's Disease. / Walters, Thomas D.; Faubion, William Alvis; 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.

In: Inflammatory Bowel Diseases, Vol. 23, No. 6, 01.06.2017, p. 967-975.

Research output: Contribution to journalArticle

Walters, TD, Faubion, WA, Griffiths, AM, Baldassano, RN, Escher, J, Ruemmele, FM, Hyams, JS, Lazar, A, Eichner, S, Huang, B, Li, Y & Thakkar, RB 2017, 'Growth Improvement with Adalimumab Treatment in Children with Moderately to Severely Active Crohn's Disease', Inflammatory Bowel Diseases, vol. 23, no. 6, pp. 967-975. https://doi.org/10.1097/MIB.0000000000001075
Walters, Thomas D. ; Faubion, William Alvis ; 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. / Growth Improvement with Adalimumab Treatment in Children with Moderately to Severely Active Crohn's Disease. In: Inflammatory Bowel Diseases. 2017 ; Vol. 23, No. 6. pp. 967-975.
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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.",
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T1 - Growth Improvement with Adalimumab Treatment in Children with Moderately to Severely Active Crohn's Disease

AU - Walters, Thomas D.

AU - Faubion, William Alvis

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.

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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