Efficacy and safety of escalation of adalimumab therapy to weekly dosing in pediatric patients with Crohn's disease

Marla C. Dubinsky, Joel Rosh, William A. Faubion, Jaroslaw Kierkus, Frank Ruemmele, Jeffrey S. Hyams, Samantha Eichner, Yao Li, Bidan Huang, Nael M. Mostafa, Andreas Lazar, Roopal B. Thakkar

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Background: The efficacy of adalimumab in inducing and maintaining remission in children with moderately to severely active Crohn's disease was shown in the IMAgINE 1 trial (NCT00409682). As per protocol, nonresponders or patients experiencing flare(s) on every other week (EOW) maintenance dosing could escalate to weekly dosing; we aimed to determine the therapeutic benefits of weekly dose escalation in this subpopulation. Methods: Week 52 remission and response rates were assessed in patients who escalated to weekly dosing from their previous EOW schedule, which was according to randomized treatment dose (higher dose [HD] adalimumab [≥40 kg, 40 mg EOW; <40 kg, 20 mg EOW] or lower dose [LD; ≥40 kg, 20 mg EOW; <40 kg, 10 mg EOW]). Adverse events were reported for patients remaining on EOW dosing and patients receiving weekly dosing. Results: Escalation to weekly dosing occurred in 48/95 (50.5%) patients randomized to LD and 35/93 (37.6%) patients randomized to HD adalimumab (P 0.076). Week 52 remission and response rates were 18.8% and 47.9% for patients receiving LD adalimumab weekly and 31.4% and 57.1% for patients receiving HD adalimumab weekly, respectively (LD versus HD, P 0.19 for remission; P 0.41 for response). Adverse event rates were similar for patients receiving EOW and weekly adalimumab. Conclusions: Weekly adalimumab dosing was clinically beneficial for children with Crohn's disease who experienced nonresponse or flare on EOW dosing. No increased safety risks were observed with weekly dosing.

Original languageEnglish (US)
Pages (from-to)886-893
Number of pages8
JournalInflammatory bowel diseases
Volume22
Issue number4
DOIs
StatePublished - Mar 9 2016

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Crohn Disease
Pediatrics
Safety
Therapeutics
Adalimumab
Appointments and Schedules
Maintenance

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Gastroenterology

Cite this

Dubinsky, Marla C. ; Rosh, Joel ; Faubion, William A. ; Kierkus, Jaroslaw ; Ruemmele, Frank ; Hyams, Jeffrey S. ; Eichner, Samantha ; Li, Yao ; Huang, Bidan ; Mostafa, Nael M. ; Lazar, Andreas ; Thakkar, Roopal B. / Efficacy and safety of escalation of adalimumab therapy to weekly dosing in pediatric patients with Crohn's disease. In: Inflammatory bowel diseases. 2016 ; Vol. 22, No. 4. pp. 886-893.
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title = "Efficacy and safety of escalation of adalimumab therapy to weekly dosing in pediatric patients with Crohn's disease",
abstract = "Background: The efficacy of adalimumab in inducing and maintaining remission in children with moderately to severely active Crohn's disease was shown in the IMAgINE 1 trial (NCT00409682). As per protocol, nonresponders or patients experiencing flare(s) on every other week (EOW) maintenance dosing could escalate to weekly dosing; we aimed to determine the therapeutic benefits of weekly dose escalation in this subpopulation. Methods: Week 52 remission and response rates were assessed in patients who escalated to weekly dosing from their previous EOW schedule, which was according to randomized treatment dose (higher dose [HD] adalimumab [≥40 kg, 40 mg EOW; <40 kg, 20 mg EOW] or lower dose [LD; ≥40 kg, 20 mg EOW; <40 kg, 10 mg EOW]). Adverse events were reported for patients remaining on EOW dosing and patients receiving weekly dosing. Results: Escalation to weekly dosing occurred in 48/95 (50.5{\%}) patients randomized to LD and 35/93 (37.6{\%}) patients randomized to HD adalimumab (P 0.076). Week 52 remission and response rates were 18.8{\%} and 47.9{\%} for patients receiving LD adalimumab weekly and 31.4{\%} and 57.1{\%} for patients receiving HD adalimumab weekly, respectively (LD versus HD, P 0.19 for remission; P 0.41 for response). Adverse event rates were similar for patients receiving EOW and weekly adalimumab. Conclusions: Weekly adalimumab dosing was clinically beneficial for children with Crohn's disease who experienced nonresponse or flare on EOW dosing. No increased safety risks were observed with weekly dosing.",
author = "Dubinsky, {Marla C.} and Joel Rosh and Faubion, {William A.} and Jaroslaw Kierkus and Frank Ruemmele and Hyams, {Jeffrey S.} and Samantha Eichner and Yao Li and Bidan Huang and Mostafa, {Nael M.} and Andreas Lazar and Thakkar, {Roopal B.}",
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Dubinsky, MC, Rosh, J, Faubion, WA, Kierkus, J, Ruemmele, F, Hyams, JS, Eichner, S, Li, Y, Huang, B, Mostafa, NM, Lazar, A & Thakkar, RB 2016, 'Efficacy and safety of escalation of adalimumab therapy to weekly dosing in pediatric patients with Crohn's disease', Inflammatory bowel diseases, vol. 22, no. 4, pp. 886-893. https://doi.org/10.1097/MIB.0000000000000715

Efficacy and safety of escalation of adalimumab therapy to weekly dosing in pediatric patients with Crohn's disease. / Dubinsky, Marla C.; Rosh, Joel; Faubion, William A.; Kierkus, Jaroslaw; Ruemmele, Frank; Hyams, Jeffrey S.; Eichner, Samantha; Li, Yao; Huang, Bidan; Mostafa, Nael M.; Lazar, Andreas; Thakkar, Roopal B.

In: Inflammatory bowel diseases, Vol. 22, No. 4, 09.03.2016, p. 886-893.

Research output: Contribution to journalArticle

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T1 - Efficacy and safety of escalation of adalimumab therapy to weekly dosing in pediatric patients with Crohn's disease

AU - Dubinsky, Marla C.

AU - Rosh, Joel

AU - Faubion, William A.

AU - Kierkus, Jaroslaw

AU - Ruemmele, Frank

AU - Hyams, Jeffrey S.

AU - Eichner, Samantha

AU - Li, Yao

AU - Huang, Bidan

AU - Mostafa, Nael M.

AU - Lazar, Andreas

AU - Thakkar, Roopal B.

PY - 2016/3/9

Y1 - 2016/3/9

N2 - Background: The efficacy of adalimumab in inducing and maintaining remission in children with moderately to severely active Crohn's disease was shown in the IMAgINE 1 trial (NCT00409682). As per protocol, nonresponders or patients experiencing flare(s) on every other week (EOW) maintenance dosing could escalate to weekly dosing; we aimed to determine the therapeutic benefits of weekly dose escalation in this subpopulation. Methods: Week 52 remission and response rates were assessed in patients who escalated to weekly dosing from their previous EOW schedule, which was according to randomized treatment dose (higher dose [HD] adalimumab [≥40 kg, 40 mg EOW; <40 kg, 20 mg EOW] or lower dose [LD; ≥40 kg, 20 mg EOW; <40 kg, 10 mg EOW]). Adverse events were reported for patients remaining on EOW dosing and patients receiving weekly dosing. Results: Escalation to weekly dosing occurred in 48/95 (50.5%) patients randomized to LD and 35/93 (37.6%) patients randomized to HD adalimumab (P 0.076). Week 52 remission and response rates were 18.8% and 47.9% for patients receiving LD adalimumab weekly and 31.4% and 57.1% for patients receiving HD adalimumab weekly, respectively (LD versus HD, P 0.19 for remission; P 0.41 for response). Adverse event rates were similar for patients receiving EOW and weekly adalimumab. Conclusions: Weekly adalimumab dosing was clinically beneficial for children with Crohn's disease who experienced nonresponse or flare on EOW dosing. No increased safety risks were observed with weekly dosing.

AB - Background: The efficacy of adalimumab in inducing and maintaining remission in children with moderately to severely active Crohn's disease was shown in the IMAgINE 1 trial (NCT00409682). As per protocol, nonresponders or patients experiencing flare(s) on every other week (EOW) maintenance dosing could escalate to weekly dosing; we aimed to determine the therapeutic benefits of weekly dose escalation in this subpopulation. Methods: Week 52 remission and response rates were assessed in patients who escalated to weekly dosing from their previous EOW schedule, which was according to randomized treatment dose (higher dose [HD] adalimumab [≥40 kg, 40 mg EOW; <40 kg, 20 mg EOW] or lower dose [LD; ≥40 kg, 20 mg EOW; <40 kg, 10 mg EOW]). Adverse events were reported for patients remaining on EOW dosing and patients receiving weekly dosing. Results: Escalation to weekly dosing occurred in 48/95 (50.5%) patients randomized to LD and 35/93 (37.6%) patients randomized to HD adalimumab (P 0.076). Week 52 remission and response rates were 18.8% and 47.9% for patients receiving LD adalimumab weekly and 31.4% and 57.1% for patients receiving HD adalimumab weekly, respectively (LD versus HD, P 0.19 for remission; P 0.41 for response). Adverse event rates were similar for patients receiving EOW and weekly adalimumab. Conclusions: Weekly adalimumab dosing was clinically beneficial for children with Crohn's disease who experienced nonresponse or flare on EOW dosing. No increased safety risks were observed with weekly dosing.

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DO - 10.1097/MIB.0000000000000715

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JO - Inflammatory Bowel Diseases

JF - Inflammatory Bowel Diseases

SN - 1078-0998

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