ABSTRACT
BACKGROUND/AIMS: Tacrolimus is effective for refractory ulcerative colitis in adults, while data for children is sparse. We aimed to evaluate the effectiveness and safety of tacrolimus for induction and maintenance therapy in Japanese children with ulcerative colitis.METHODS: We retrospectively reviewed the multicenter survey data of 67 patients with ulcerative colitis aged < 17 years treated with tacrolimus between 2000 and 2012. Patients’ characteristics, disease activity, Pediatric Ulcerative Colitis Activity Index (PUCAI) score, initial oral tacrolimus dose, short-term (2-week) and long-term (1-year) outcomes, steroid-sparing effects, and adverse events were evaluated. Clinical remission was defined as a PUCAI score < 10; treatment response was defined as a PUCAI score reduction of ≥ 20 points compared with baseline.RESULTS: Patients included 35 boys and 32 girls (median [interquartile range] at admission: 13 [11–15] years). Thirty-nine patients were steroid-dependent and 26 were steroidrefractory; 20 had severe colitis and 43 had moderate colitis. The initial tacrolimus dose was 0.09 mg/kg/day (range, 0.05–0.12 mg/kg/day). The short-term clinical remission rate was 47.8%, and the clinical response rate was 37.3%. The mean prednisolone dose was reduced from 19.2 mg/day at tacrolimus initiation to 5.7 mg/day at week 8 (P< 0.001). The adverse event rate was 53.7%; 6 patients required discontinuation of tacrolimus therapy.CONCLUSIONS: Tacrolimus was a safe and effective second-line induction therapy for steroid-dependent and steroid-refractory ulcerative colitis in Japanese children.
Subject(s)
Adult , Child , Female , Humans , Asian People , Biological Factors , Colectomy , Colitis , Colitis, Ulcerative , Immunologic Factors , Japan , Prednisolone , Remission Induction , Retrospective Studies , Tacrolimus , UlcerABSTRACT
BACKGROUND/AIMS: Enteral nutrition (EN) is recommended for the treatment of pediatric Crohn's disease (CD) in Japan. However, the indications and treatment protocols for EN vary among hospitals. In the present study, we aimed to determine how EN was administered to pediatric patients and whether physicians followed treatment guidelines in their practices. METHODS: Two types of questionnaires were administered to 32 physicians who were involved in the treatment of pediatric CD. The consensus questionnaire evaluated the physicians' attitudes towards EN, whereas the efficacy questionnaire collected data on patients with CD, aged <17 years, who had undergone induction therapy between 2006 and 2011. RESULTS: A total of 23 physicians responded to the questionnaires. The results of the consensus questionnaire indicated that 82% and 59% of study participants recommended EN treatment for all newly diagnosed pediatric patients with CD and all relapsed patients, respectively. Exclusive EN (EEN) and elemental formula were recommended by 84% and 85% of physicians, respectively. The efficacy questionnaire revealed that 57 of the 58 patients received EN. Elemental formula was used in 39 of 40 patients who were treated with EEN. Of these 40 patients, 27 were treated with EEN alone; of these, 22 (81%) achieved remission without any other treatment. The mean duration of EEN was 15.9 days. CONCLUSIONS: EN is widely recommended by physicians treating pediatric CD in Japan. In contrast to Western countries, clinicians used elemental formula more often and with a shorter EEN treatment duration.