Cargando…
Efficacy and Safety of Escalation of Adalimumab Therapy to Weekly Dosing in Pediatric Patients with Crohn's Disease
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 dosi...
Autores principales: | , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Lippincott Williams & Wilkins
2016
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4794130/ https://www.ncbi.nlm.nih.gov/pubmed/26950307 http://dx.doi.org/10.1097/MIB.0000000000000715 |
_version_ | 1782421437336780800 |
---|---|
author | 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. |
author_facet | 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. |
author_sort | Dubinsky, Marla C. |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-4794130 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Lippincott Williams & Wilkins |
record_format | MEDLINE/PubMed |
spelling | pubmed-47941302016-04-05 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. Inflamm Bowel Dis Original Clinical Articles 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. Lippincott Williams & Wilkins 2016-03-07 2016-04 /pmc/articles/PMC4794130/ /pubmed/26950307 http://dx.doi.org/10.1097/MIB.0000000000000715 Text en Copyright © 2016 Crohn's & Colitis Foundation of America, Inc. This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CC BY-NC-ND) (http://creativecommons.org/licenses/by-nc-nd/4.0/) , which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially. |
spellingShingle | Original Clinical Articles 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 |
title | Efficacy and Safety of Escalation of Adalimumab Therapy to Weekly Dosing in Pediatric Patients with Crohn's Disease |
title_full | Efficacy and Safety of Escalation of Adalimumab Therapy to Weekly Dosing in Pediatric Patients with Crohn's Disease |
title_fullStr | Efficacy and Safety of Escalation of Adalimumab Therapy to Weekly Dosing in Pediatric Patients with Crohn's Disease |
title_full_unstemmed | Efficacy and Safety of Escalation of Adalimumab Therapy to Weekly Dosing in Pediatric Patients with Crohn's Disease |
title_short | Efficacy and Safety of Escalation of Adalimumab Therapy to Weekly Dosing in Pediatric Patients with Crohn's Disease |
title_sort | efficacy and safety of escalation of adalimumab therapy to weekly dosing in pediatric patients with crohn's disease |
topic | Original Clinical Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4794130/ https://www.ncbi.nlm.nih.gov/pubmed/26950307 http://dx.doi.org/10.1097/MIB.0000000000000715 |
work_keys_str_mv | AT dubinskymarlac efficacyandsafetyofescalationofadalimumabtherapytoweeklydosinginpediatricpatientswithcrohnsdisease AT roshjoel efficacyandsafetyofescalationofadalimumabtherapytoweeklydosinginpediatricpatientswithcrohnsdisease AT faubionwilliama efficacyandsafetyofescalationofadalimumabtherapytoweeklydosinginpediatricpatientswithcrohnsdisease AT kierkusjaroslaw efficacyandsafetyofescalationofadalimumabtherapytoweeklydosinginpediatricpatientswithcrohnsdisease AT ruemmelefrank efficacyandsafetyofescalationofadalimumabtherapytoweeklydosinginpediatricpatientswithcrohnsdisease AT hyamsjeffreys efficacyandsafetyofescalationofadalimumabtherapytoweeklydosinginpediatricpatientswithcrohnsdisease AT eichnersamantha efficacyandsafetyofescalationofadalimumabtherapytoweeklydosinginpediatricpatientswithcrohnsdisease AT liyao efficacyandsafetyofescalationofadalimumabtherapytoweeklydosinginpediatricpatientswithcrohnsdisease AT huangbidan efficacyandsafetyofescalationofadalimumabtherapytoweeklydosinginpediatricpatientswithcrohnsdisease AT mostafanaelm efficacyandsafetyofescalationofadalimumabtherapytoweeklydosinginpediatricpatientswithcrohnsdisease AT lazarandreas efficacyandsafetyofescalationofadalimumabtherapytoweeklydosinginpediatricpatientswithcrohnsdisease AT thakkarroopalb efficacyandsafetyofescalationofadalimumabtherapytoweeklydosinginpediatricpatientswithcrohnsdisease |