Long-Term Efficacy and Safety of Adalimumab in Pediatric Patients with Crohn's Disease

William A. Faubion, Marla Dubinsky, Frank M. Ruemmele, Johanna Escher, Joel Rosh, Jeffrey S. Hyams, Samantha Eichner, Yao Li, Nattanan Reilly, Roopal B. Thakkar, Anne M. Robinson, Andreas Lazar

Research output: Contribution to journalArticle

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Abstract

Background: IMAgINE 1 assessed 52-week efficacy and safety of adalimumab in children with moderate to severe Crohn's disease. Long-Term efficacy and safety of adalimumab for patients who entered the IMAgINE 2 extension are reported. Methods: Patients who completed IMAgINE 1 could enroll in IMAgINE 2. Endpoints assessed from weeks 0 to 240 of IMAgINE 2 were Pediatric Crohn's Disease Activity Index remission (Pediatric Crohn's Disease Activity Index ≤ 10) and response (Pediatric Crohn's Disease Activity Index decrease ≥15 from IMAgINE 1 baseline) using observed analysis and hybrid nonresponder imputation (hNRI). For hNRI, discontinued patients were imputed as failures unless they transitioned to commercial adalimumab (with study site closure) or adult care, where last observation was carried forward. Corticosteroid-free remission in patients receiving corticosteroids at IMAgINE 1 baseline, discontinuation of immunomodulators (IMMs) in patients receiving IMMs at IMAgINE 2 baseline, and linear growth improvement were reported as observed. Adverse events were assessed for patients receiving ≥1 adalimumab dose in IMAgINE 1 and 2 through January 2015. Results: Of 100 patients enrolled in IMAgINE 2, 41% and 48% achieved remission and response (hNRI) at IMAgINE 2 week 240. Remission rates were maintained by 45% (30/67, hNRI) of patients who entered IMAgINE 2 in remission. At IMAgINE 2 week 240, 63% (12/19) of patients receiving corticosteroids at IMAgINE 1 baseline achieved corticosteroid-free remission and 30% (6/20) of patients receiving IMMs at IMAgINE 2 baseline discontinued IMMs. Adalimumab treatment led to growth velocity normalization. No new safety signals were identified. Conclusions: Efficacy and safety profiles of prolonged adalimumab treatment in children with Crohn's disease were consistent with IMAgINE 1 and adult Crohn's disease adalimumab trials.

Original languageEnglish (US)
Pages (from-to)453-460
Number of pages8
JournalInflammatory bowel diseases
Volume23
Issue number3
DOIs
StatePublished - Mar 1 2017

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Crohn Disease
Pediatrics
Safety
Immunologic Factors
Adrenal Cortex Hormones
Adalimumab
Patient Safety
Growth
Observation
Therapeutics
Pediatric Crohn's disease

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Gastroenterology

Cite this

Faubion, W. A., Dubinsky, M., Ruemmele, F. M., Escher, J., Rosh, J., Hyams, J. S., ... Lazar, A. (2017). Long-Term Efficacy and Safety of Adalimumab in Pediatric Patients with Crohn's Disease. Inflammatory bowel diseases, 23(3), 453-460. https://doi.org/10.1097/MIB.0000000000001021
Faubion, William A. ; Dubinsky, Marla ; Ruemmele, Frank M. ; Escher, Johanna ; Rosh, Joel ; Hyams, Jeffrey S. ; Eichner, Samantha ; Li, Yao ; Reilly, Nattanan ; Thakkar, Roopal B. ; Robinson, Anne M. ; Lazar, Andreas. / Long-Term Efficacy and Safety of Adalimumab in Pediatric Patients with Crohn's Disease. In: Inflammatory bowel diseases. 2017 ; Vol. 23, No. 3. pp. 453-460.
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title = "Long-Term Efficacy and Safety of Adalimumab in Pediatric Patients with Crohn's Disease",
abstract = "Background: IMAgINE 1 assessed 52-week efficacy and safety of adalimumab in children with moderate to severe Crohn's disease. Long-Term efficacy and safety of adalimumab for patients who entered the IMAgINE 2 extension are reported. Methods: Patients who completed IMAgINE 1 could enroll in IMAgINE 2. Endpoints assessed from weeks 0 to 240 of IMAgINE 2 were Pediatric Crohn's Disease Activity Index remission (Pediatric Crohn's Disease Activity Index ≤ 10) and response (Pediatric Crohn's Disease Activity Index decrease ≥15 from IMAgINE 1 baseline) using observed analysis and hybrid nonresponder imputation (hNRI). For hNRI, discontinued patients were imputed as failures unless they transitioned to commercial adalimumab (with study site closure) or adult care, where last observation was carried forward. Corticosteroid-free remission in patients receiving corticosteroids at IMAgINE 1 baseline, discontinuation of immunomodulators (IMMs) in patients receiving IMMs at IMAgINE 2 baseline, and linear growth improvement were reported as observed. Adverse events were assessed for patients receiving ≥1 adalimumab dose in IMAgINE 1 and 2 through January 2015. Results: Of 100 patients enrolled in IMAgINE 2, 41{\%} and 48{\%} achieved remission and response (hNRI) at IMAgINE 2 week 240. Remission rates were maintained by 45{\%} (30/67, hNRI) of patients who entered IMAgINE 2 in remission. At IMAgINE 2 week 240, 63{\%} (12/19) of patients receiving corticosteroids at IMAgINE 1 baseline achieved corticosteroid-free remission and 30{\%} (6/20) of patients receiving IMMs at IMAgINE 2 baseline discontinued IMMs. Adalimumab treatment led to growth velocity normalization. No new safety signals were identified. Conclusions: Efficacy and safety profiles of prolonged adalimumab treatment in children with Crohn's disease were consistent with IMAgINE 1 and adult Crohn's disease adalimumab trials.",
author = "Faubion, {William A.} and Marla Dubinsky and Ruemmele, {Frank M.} and Johanna Escher and Joel Rosh and Hyams, {Jeffrey S.} and Samantha Eichner and Yao Li and Nattanan Reilly and Thakkar, {Roopal B.} and Robinson, {Anne M.} and Andreas Lazar",
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Faubion, WA, Dubinsky, M, Ruemmele, FM, Escher, J, Rosh, J, Hyams, JS, Eichner, S, Li, Y, Reilly, N, Thakkar, RB, Robinson, AM & Lazar, A 2017, 'Long-Term Efficacy and Safety of Adalimumab in Pediatric Patients with Crohn's Disease', Inflammatory bowel diseases, vol. 23, no. 3, pp. 453-460. https://doi.org/10.1097/MIB.0000000000001021

Long-Term Efficacy and Safety of Adalimumab in Pediatric Patients with Crohn's Disease. / Faubion, William A.; Dubinsky, Marla; Ruemmele, Frank M.; Escher, Johanna; Rosh, Joel; Hyams, Jeffrey S.; Eichner, Samantha; Li, Yao; Reilly, Nattanan; Thakkar, Roopal B.; Robinson, Anne M.; Lazar, Andreas.

In: Inflammatory bowel diseases, Vol. 23, No. 3, 01.03.2017, p. 453-460.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Long-Term Efficacy and Safety of Adalimumab in Pediatric Patients with Crohn's Disease

AU - Faubion, William A.

AU - Dubinsky, Marla

AU - Ruemmele, Frank M.

AU - Escher, Johanna

AU - Rosh, Joel

AU - Hyams, Jeffrey S.

AU - Eichner, Samantha

AU - Li, Yao

AU - Reilly, Nattanan

AU - Thakkar, Roopal B.

AU - Robinson, Anne M.

AU - Lazar, Andreas

PY - 2017/3/1

Y1 - 2017/3/1

N2 - Background: IMAgINE 1 assessed 52-week efficacy and safety of adalimumab in children with moderate to severe Crohn's disease. Long-Term efficacy and safety of adalimumab for patients who entered the IMAgINE 2 extension are reported. Methods: Patients who completed IMAgINE 1 could enroll in IMAgINE 2. Endpoints assessed from weeks 0 to 240 of IMAgINE 2 were Pediatric Crohn's Disease Activity Index remission (Pediatric Crohn's Disease Activity Index ≤ 10) and response (Pediatric Crohn's Disease Activity Index decrease ≥15 from IMAgINE 1 baseline) using observed analysis and hybrid nonresponder imputation (hNRI). For hNRI, discontinued patients were imputed as failures unless they transitioned to commercial adalimumab (with study site closure) or adult care, where last observation was carried forward. Corticosteroid-free remission in patients receiving corticosteroids at IMAgINE 1 baseline, discontinuation of immunomodulators (IMMs) in patients receiving IMMs at IMAgINE 2 baseline, and linear growth improvement were reported as observed. Adverse events were assessed for patients receiving ≥1 adalimumab dose in IMAgINE 1 and 2 through January 2015. Results: Of 100 patients enrolled in IMAgINE 2, 41% and 48% achieved remission and response (hNRI) at IMAgINE 2 week 240. Remission rates were maintained by 45% (30/67, hNRI) of patients who entered IMAgINE 2 in remission. At IMAgINE 2 week 240, 63% (12/19) of patients receiving corticosteroids at IMAgINE 1 baseline achieved corticosteroid-free remission and 30% (6/20) of patients receiving IMMs at IMAgINE 2 baseline discontinued IMMs. Adalimumab treatment led to growth velocity normalization. No new safety signals were identified. Conclusions: Efficacy and safety profiles of prolonged adalimumab treatment in children with Crohn's disease were consistent with IMAgINE 1 and adult Crohn's disease adalimumab trials.

AB - Background: IMAgINE 1 assessed 52-week efficacy and safety of adalimumab in children with moderate to severe Crohn's disease. Long-Term efficacy and safety of adalimumab for patients who entered the IMAgINE 2 extension are reported. Methods: Patients who completed IMAgINE 1 could enroll in IMAgINE 2. Endpoints assessed from weeks 0 to 240 of IMAgINE 2 were Pediatric Crohn's Disease Activity Index remission (Pediatric Crohn's Disease Activity Index ≤ 10) and response (Pediatric Crohn's Disease Activity Index decrease ≥15 from IMAgINE 1 baseline) using observed analysis and hybrid nonresponder imputation (hNRI). For hNRI, discontinued patients were imputed as failures unless they transitioned to commercial adalimumab (with study site closure) or adult care, where last observation was carried forward. Corticosteroid-free remission in patients receiving corticosteroids at IMAgINE 1 baseline, discontinuation of immunomodulators (IMMs) in patients receiving IMMs at IMAgINE 2 baseline, and linear growth improvement were reported as observed. Adverse events were assessed for patients receiving ≥1 adalimumab dose in IMAgINE 1 and 2 through January 2015. Results: Of 100 patients enrolled in IMAgINE 2, 41% and 48% achieved remission and response (hNRI) at IMAgINE 2 week 240. Remission rates were maintained by 45% (30/67, hNRI) of patients who entered IMAgINE 2 in remission. At IMAgINE 2 week 240, 63% (12/19) of patients receiving corticosteroids at IMAgINE 1 baseline achieved corticosteroid-free remission and 30% (6/20) of patients receiving IMMs at IMAgINE 2 baseline discontinued IMMs. Adalimumab treatment led to growth velocity normalization. No new safety signals were identified. Conclusions: Efficacy and safety profiles of prolonged adalimumab treatment in children with Crohn's disease were consistent with IMAgINE 1 and adult Crohn's disease adalimumab trials.

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U2 - 10.1097/MIB.0000000000001021

DO - 10.1097/MIB.0000000000001021

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