Efficacy and safety of adalimumab in the treatment of Crohn´s disease in children.

نویسندگان

  • Víctor Manuel Navas-López
  • Javier Blasco-Alonso
  • Francisco Girón-Fernández-Crehuet
  • María Juliana Serrano-Nieto
  • Carlos Sierra-Salinas
چکیده

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 Pediatric 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-a. 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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Long-term Efficacy and Safety of Adalimumab in Pediatric Patients with Crohn's Disease

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عنوان ژورنال:
  • Revista espanola de enfermedades digestivas : organo oficial de la Sociedad Espanola de Patologia Digestiva

دوره 105 10  شماره 

صفحات  -

تاریخ انتشار 2013