Efficacy and safety of adalimumab in the treatment of Crohn's disease in children
Objectives: to describe the efficacy and safety of adalimumab (ADA) in inducing clinical remission and reducing inflammation of intestinal mucosa in children with Crohn's disease (CD). Methods: we carried out a descriptive, observational study with all patients diagnosed with CD and treated with ADA between January 2007 and March 2013. Disease activity was determined using the Pdiatric Crohn's Disease Activity Index (PCDAI), and the degree of mucosa inflammation by fecal calprotectin (FC). Results: sixteen patients were included. Mean age at diagnosis was 10.6 ± 2.5 years, with a mean age at start of ADA treatment of 12.4 ± 1.8 years, and a median of 1.4 years (IQR 0.5-3) duration from CD diagnosis to start of treatment. Twelve patients were naïve to anti-TNF-α. The PCDAI score at start of ADA treatment was significantly reduced at 12 weeks of follow-up (31.25 IQR 26.8-37.5 vs. 1.2 IQR 0.0-5.0; p = 0.001). Similarly, the FC level decreased at 12 weeks (749 µg/g IQR 514-898 vs. 126 µg/g IQR 67.7-239.2; p = 0.02). Surgery was performed in 4 patients. Adverse events were reported in 4 patients. One patient developed lymphoma at 4 years of ADA treatment in monotherapy. Conclusions: ADA has been shown to be effective in children with moderate-to-severe CD. Treatment benefits should be weighed against side effects. Multicenter longitudinal studies with longer follow-up periods are required to determine the true efficacy and safety of long-term ADA treatment.
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Sociedad Española de Patología Digestiva
2013
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oai:scielo:S1130-010820130010000022014-04-30Efficacy and safety of adalimumab in the treatment of Crohn's disease in childrenNavas-López,Víctor ManuelBlasco-Alonso,JavierGirón-Fernández-Crehuet,FranciscoSerrano-Nieto,María JulianaSierra-Salinas,Carlos Adalimumab Crohn's disease Inflammatory bowel disease Children Objectives: to describe the efficacy and safety of adalimumab (ADA) in inducing clinical remission and reducing inflammation of intestinal mucosa in children with Crohn's disease (CD). Methods: we carried out a descriptive, observational study with all patients diagnosed with CD and treated with ADA between January 2007 and March 2013. Disease activity was determined using the Pdiatric Crohn's Disease Activity Index (PCDAI), and the degree of mucosa inflammation by fecal calprotectin (FC). Results: sixteen patients were included. Mean age at diagnosis was 10.6 ± 2.5 years, with a mean age at start of ADA treatment of 12.4 ± 1.8 years, and a median of 1.4 years (IQR 0.5-3) duration from CD diagnosis to start of treatment. Twelve patients were naïve to anti-TNF-α. The PCDAI score at start of ADA treatment was significantly reduced at 12 weeks of follow-up (31.25 IQR 26.8-37.5 vs. 1.2 IQR 0.0-5.0; p = 0.001). Similarly, the FC level decreased at 12 weeks (749 µg/g IQR 514-898 vs. 126 µg/g IQR 67.7-239.2; p = 0.02). Surgery was performed in 4 patients. Adverse events were reported in 4 patients. One patient developed lymphoma at 4 years of ADA treatment in monotherapy. Conclusions: ADA has been shown to be effective in children with moderate-to-severe CD. Treatment benefits should be weighed against side effects. Multicenter longitudinal studies with longer follow-up periods are required to determine the true efficacy and safety of long-term ADA treatment.Sociedad Española de Patología DigestivaRevista Española de Enfermedades Digestivas v.105 n.10 20132013-12-01journal articletext/htmlhttp://scielo.isciii.es/scielo.php?script=sci_arttext&pid=S1130-01082013001000002en |
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Navas-López,Víctor Manuel Blasco-Alonso,Javier Girón-Fernández-Crehuet,Francisco Serrano-Nieto,María Juliana Sierra-Salinas,Carlos |
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Navas-López,Víctor Manuel Blasco-Alonso,Javier Girón-Fernández-Crehuet,Francisco Serrano-Nieto,María Juliana Sierra-Salinas,Carlos Efficacy and safety of adalimumab in the treatment of Crohn's disease in children |
author_facet |
Navas-López,Víctor Manuel Blasco-Alonso,Javier Girón-Fernández-Crehuet,Francisco Serrano-Nieto,María Juliana Sierra-Salinas,Carlos |
author_sort |
Navas-López,Víctor Manuel |
title |
Efficacy and safety of adalimumab in the treatment of Crohn's disease in children |
title_short |
Efficacy and safety of adalimumab in the treatment of Crohn's disease in children |
title_full |
Efficacy and safety of adalimumab in the treatment of Crohn's disease in children |
title_fullStr |
Efficacy and safety of adalimumab in the treatment of Crohn's disease in children |
title_full_unstemmed |
Efficacy and safety of adalimumab in the treatment of Crohn's disease in children |
title_sort |
efficacy and safety of adalimumab in the treatment of crohn's disease in children |
description |
Objectives: to describe the efficacy and safety of adalimumab (ADA) in inducing clinical remission and reducing inflammation of intestinal mucosa in children with Crohn's disease (CD). Methods: we carried out a descriptive, observational study with all patients diagnosed with CD and treated with ADA between January 2007 and March 2013. Disease activity was determined using the Pdiatric Crohn's Disease Activity Index (PCDAI), and the degree of mucosa inflammation by fecal calprotectin (FC). Results: sixteen patients were included. Mean age at diagnosis was 10.6 ± 2.5 years, with a mean age at start of ADA treatment of 12.4 ± 1.8 years, and a median of 1.4 years (IQR 0.5-3) duration from CD diagnosis to start of treatment. Twelve patients were naïve to anti-TNF-α. The PCDAI score at start of ADA treatment was significantly reduced at 12 weeks of follow-up (31.25 IQR 26.8-37.5 vs. 1.2 IQR 0.0-5.0; p = 0.001). Similarly, the FC level decreased at 12 weeks (749 µg/g IQR 514-898 vs. 126 µg/g IQR 67.7-239.2; p = 0.02). Surgery was performed in 4 patients. Adverse events were reported in 4 patients. One patient developed lymphoma at 4 years of ADA treatment in monotherapy. Conclusions: ADA has been shown to be effective in children with moderate-to-severe CD. Treatment benefits should be weighed against side effects. Multicenter longitudinal studies with longer follow-up periods are required to determine the true efficacy and safety of long-term ADA treatment. |
publisher |
Sociedad Española de Patología Digestiva |
publishDate |
2013 |
url |
http://scielo.isciii.es/scielo.php?script=sci_arttext&pid=S1130-01082013001000002 |
work_keys_str_mv |
AT navaslopezvictormanuel efficacyandsafetyofadalimumabinthetreatmentofcrohnsdiseaseinchildren AT blascoalonsojavier efficacyandsafetyofadalimumabinthetreatmentofcrohnsdiseaseinchildren AT gironfernandezcrehuetfrancisco efficacyandsafetyofadalimumabinthetreatmentofcrohnsdiseaseinchildren AT serranonietomariajuliana efficacyandsafetyofadalimumabinthetreatmentofcrohnsdiseaseinchildren AT sierrasalinascarlos efficacyandsafetyofadalimumabinthetreatmentofcrohnsdiseaseinchildren |
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