Comparison of endoscopic healing and durability between infliximab originator and CT-P13 in pediatric patients with inflammatory bowel disease.

Background and aims: Favourable clinical data were published on the efficacy of CT-P13, the first biosimilar of infliximab (IFX), in pediatric inflammatory bowel disease (IBD); however, few studies have compared the effect on endoscopic healing (EH) and drug retention rate between the IFX originator and CT-P13. Therefore, we aimed to compare EH and the drug retention rate between the IFX originator and CT-P13. Methods: Children with Crohn's disease (CD) and ulcerative colitis (UC)/IBD-unclassified (IBD-U) at 22 medical centers were enrolled, with a retrospective review conducted at 1-year and last follow-up. Clinical remission, EH and drug retention rate were evaluated. Results: We studied 416 pediatric patients with IBD: 77.4% had CD and 22.6% had UC/IBD-U. Among them, 255 (61.3%) received the IFX originator and 161 (38.7%) received CT-P13. No statistically significant differences were found between the IFX originator and CT-P13 in terms of corticosteroid-free remission and adverse events. At 1-year follow-up, EH rates were comparable between them (CD: P=0.902, UC: P=0.860). The estimated cumulative cessation rates were not significantly different between the two groups. In patients with CD, the drug retention rates were 66.1% in the IFX originator and 71.6% in the CT-P13 group at the maximum follow-up period (P >0.05). In patients with UC, the drug retention rates were 49.8% in the IFX originator and 56.3% in the CT-P13 group at the maximum follow-up period (P >0.05). Conclusions: The IFX originator and CT-P13 demonstrated comparable therapeutic response including EH, clinical remission, drug retention rate and safety in pediatric IBD.

Accuracy of low dose CT in the diagnosis of appendicitis in childhood and comparison with USG and standard dose CT / Precisão de tomografia computadorizada (TC) de baixa dosagem no diagnóstico de apendicite na infância e comparação com ultrassonografia e TC de dosagem padrão

Abstract Objectives: Computed tomography should be performed after careful consideration due to radiation hazard, which is why interest in low dose CT has increased recently in acute appendicitis. Previous studies have been performed in adult and adolescents populations, but no studies have reported on the efficacy of using low-dose CT in children younger than 10 years. Methods: Patients (n = 475) younger than 10 years who were examined for acute appendicitis were recruited. Subjects were divided into three groups according to the examinations performed: low-dose CT, ultrasonography, and standard-dose CT. Subjects were categorized according to age and body mass index (BMI). Results: Low-dose CT was a contributive tool in diagnosing appendicitis, and it was an adequate method, when compared with ultrasonography and standard-dose CT in terms of sensitivity (95.5% vs. 95.0% and 94.5%, p = 0.794), specificity (94.9% vs. 80.0% and 98.8%, p = 0.024), positive-predictive value (96.4% vs. 92.7% and 97.2%, p = 0.019), and negative-predictive value (93.7% vs. 85.7% and 91.3%, p = 0.890). Low-dose CT accurately diagnosed patients with a perforated appendix. Acute appendicitis was effectively diagnosed using low-dose CT in both early and middle childhood. BMI did not influence the accuracy of detecting acute appendicitis on low-dose CT. Conclusion: Low-dose CT is effective and accurate for diagnosing acute appendicitis in childhood, as well as in adolescents and young adults. Additionally, low-dose CT was relatively accurate, irrespective of age or BMI, for detecting acute appendicitis. Therefore, low-dose CT is recommended for assessing children with suspected acute appendicitis.

Resumo Objetivos: A tomografia computadorizada deve ser feita após cautelosa consideração devido ao perigo de radiação, motivo pelo qual o interesse na TC de baixa dosagem tem aumentado recentemente em casos de apendicite aguda. Estudos anteriores foram feitos em populações adultas ou adolescentes, porém nenhum relatou a eficácia do uso da TC de baixa dosagem em crianças com menos de 10 anos. Métodos: Recrutamos pacientes (n = 475) com menos de 10 anos examinados com relação a apendicite aguda. Os indivíduos foram divididos em três grupos de acordo com os exames feitos: TC de baixa dosagem, ultrassonografia e TC de dosagem padrão. Os indivíduos foram categorizados de acordo com a idade e o índice de massa corporal. Resultados: A TC de baixa dosagem foi uma ferramenta de grande contribuição no diagnóstico de apendicite e um método adequado em comparação com a ultrassonografia e a TC de dosagem padrão em termos de sensibilidade (95,5% em comparação com 95% e 94,5%, p = 0,794), especificidade (94,9% em comparação com 80% e 98,8%, p = 0,024), valor preditivo positivo (96,4% em comparação com 92,7% e 97,2%, p = 0,019) e valor preditivo negativo (93,7% em comparação com 85,7% e 91,3%, p = 0,890). A TC de baixa dosagem diagnosticou de forma precisa pacientes com um apêndice perfurado. A apendicite aguda foi diagnosticada de maneira efetiva com a TC de baixa dosagem tanto na primeira quanto na segunda infância. O IMC não influenciou a precisão da detecção de apendicite aguda na TC de baixa dosagem. Conclusão: A TC de baixa dosagem é eficaz e precisa no diagnóstico de apendicite aguda na infância, bem como em adolescentes e jovens adultos. Além disso, a TC de baixa dosagem foi relativamente precisa, independentemente de idade ou IMC, na detecção de apendicite aguda. Assim, a TC de baixa dosagem é recomendada na avaliação de crianças com suspeita de apendicite aguda.