V M Navas-López1, J Blasco Alonso2, M J Serrano Nieto3, F Girón Fernández-Crehuet4, M D Argos Rodriguez5, C Sierra Salinas6. 1. Pediatric Gastroentrology and Nutrition Unit, Hospital Materno Infantil, Málaga, Spain. Electronic address: victor.navas@gmail.com. 2. Pediatric Gastroentrology and Nutrition Unit, Hospital Materno Infantil, Málaga, Spain. Electronic address: javierblascoalonso@yahoo.es. 3. Pediatric Gastroentrology and Nutrition Unit, Hospital Materno Infantil, Málaga, Spain. Electronic address: serranonieto@hotmail.com. 4. Pediatric Gastroentrology and Nutrition Unit, Hospital Materno Infantil, Málaga, Spain. Electronic address: currogiron@gmail.com. 5. Pediatric Gastroentrology and Nutrition Unit, Hospital Materno Infantil, Málaga, Spain. Electronic address: mdargos@gmail.com. 6. Pediatric Gastroentrology and Nutrition Unit, Hospital Materno Infantil, Málaga, Spain. Electronic address: csierra@wanadoo.es.
Abstract
BACKGROUND: Ulcerative colitis (UC) occurring during childhood is generally extensive and is associated with severe flares that may require intravenous steroid treatment. In cases of corticosteroid resistance is necessary to introduce a second-line treatment to avoid or delay surgery. AIMS: To describe the efficacy and safety of oral tacrolimus for the treatment of severe steroid-resistant UC. METHODS: We performed a retrospective study that included all patients under age 18 suffering from severe steroid-resistant UC treated with oral tacrolimus during the period January 1998 to October 2012 and with a follow-up period after treatment of 24 months or more. RESULTS: A total of ten patients were included. The age at baseline was 9.4±4.9 years, and the time from diagnosis was 1.3 months (IQR, 1-5.7). Seven of the patients were in their first flare of disease. All of them received an oral dose of 0.12 mg/kg/day of tacrolimus divided in two doses. Trough plasma levels of tacrolimus were maintained between 4 and 13 ng/ml. Response was seen in 5/10 patients at 12 months, colectomy was eventually performed in 60% of patients during the follow-up period. CONCLUSIONS: Tacrolimus is useful in inducing remission in patients with severe steroid-resistant UC, preventing or delaying colectomy, and allowing the patient and family to prepare for a probable surgery. Tacrolimus may also be used as a treatment bridge for corticosteroid-dependent patients until the new maintenance therapy takes effect.
BACKGROUND:Ulcerative colitis (UC) occurring during childhood is generally extensive and is associated with severe flares that may require intravenous steroid treatment. In cases of corticosteroid resistance is necessary to introduce a second-line treatment to avoid or delay surgery. AIMS: To describe the efficacy and safety of oral tacrolimus for the treatment of severe steroid-resistant UC. METHODS: We performed a retrospective study that included all patients under age 18 suffering from severe steroid-resistant UC treated with oral tacrolimus during the period January 1998 to October 2012 and with a follow-up period after treatment of 24 months or more. RESULTS: A total of ten patients were included. The age at baseline was 9.4±4.9 years, and the time from diagnosis was 1.3 months (IQR, 1-5.7). Seven of the patients were in their first flare of disease. All of them received an oral dose of 0.12 mg/kg/day of tacrolimus divided in two doses. Trough plasma levels of tacrolimus were maintained between 4 and 13 ng/ml. Response was seen in 5/10 patients at 12 months, colectomy was eventually performed in 60% of patients during the follow-up period. CONCLUSIONS:Tacrolimus is useful in inducing remission in patients with severe steroid-resistant UC, preventing or delaying colectomy, and allowing the patient and family to prepare for a probable surgery. Tacrolimus may also be used as a treatment bridge for corticosteroid-dependent patients until the new maintenance therapy takes effect.
Authors: Víctor Manuel Navas-López; Javier Blasco-Alonso; Francisco Girón Fernández-Crehuet; Maria Juliana Serrano Nieto; Silvia Gallego-Gutiérrez; Silvia Luque Pérez; Carlos Sierra Salinas Journal: Clin J Gastroenterol Date: 2014-06-25