Switching from infliximab originator to its biosimilar seems to be a safe option in children with CD. After the switch the biosimilar was just as effective as the originator.
Induction therapy with CT-P13 in children with CD is effective. The profile appears similar to that reported for the reference infliximab. No unexpected adverse events occurred.
(1) Background: The CDED + PEN (partial enteral nutrition) is a promising method of nutritional treatment in active Crohn’s disease (CD). An increase in fecal calprotectin (FCP) level—a marker of mucosal inflammation—happens to be the first evidence of Crohn’s disease exacerbation that appears ahead of clinical symptoms and usually co-exists with them. In this study, we present our own experience with using the CDED + PEN in the treatment of children with CD and an increased FCP level. (2) Methods: In total, 48 children (male/female: 27/21) aged 4–17 years (median value = 13.43; IQR = 4.00) were treated with CDED + PEN between June 2019 and July 2021. The main inclusion criteria for the study was active CD defined as an FCP level ≥ 250.00 µg/g. Patients with severe clinical manifestation of CD (PCDAI >40.00), as well as ones who started any new concomitant CD treatment later than at least 4 weeks before the start of dietary intervention, were excluded from the analysis. The PCDAI and fecal calprotectin level were assessed at weeks 0 and 12. The primary endpoint was ITT normalization of FCP level, i.e., a result < 250.00 µg/g at week 12. The Wilcoxon Matched Pairs Test was used for statistical analysis. (3) Results: The normalization of the FCP level was obtained in 17 children (35.42%) and an FCP level decrease of at least 50% occurred in 26 patients (54.17%). The reduction in fecal calprotectin level between week 0 and week 12 was statistically significant with a median value of 1045.00 µg/g; IQR = 1188.00, and 363.00 µg/g; IQR = 665.00, respectively (p < 0.05). Among 29 patients who were not in clinical remission at baseline, 16 (55.17%) achieved clinical remission (PCDAI < 10.00) at week 12 and 20 (68.97%) obtained a clinical response defined as at least a 12.50 point drop in PCDAI or remission. In this group, the reduction in PCDAI between baseline and week 12 was statistically significant (median value = 20.00 points; IQR = 7.50 and 5.00 points; IQR = 5.00, respectively (p < 0.05)). All patients with a normal FCP level at week 12 were in clinical remission and 16 (94.13%) of them had a normal CRP (C-reactive protein) value. In 10 children (20.83%) the full course of 12 weeks with CDED + PEN was not completed or the concomitant therapy had been started before week 12 due to the lack of efficacy/intolerance of nutritional treatment. (4) Conclusions: The 12-week course of treatment with the CDED + PEN has a beneficial effect on the fecal calprotectin level in children with active CD. The dietary intervention led to a significant decrease in the FCP level in the studied group and to the normalization of this parameter in every third patient.
Infliximab was the first monoclonal antibody used in the treatment of inflammatory bowel disease (IBD). Over several years, this antitumour necrosis factor (TNF) treatment proved its efficacy in both induction and maintenance therapy. In many cases this biological treatment stopped the progression of the disease, probably also decreasing morbidity and hospitalization rates, and improving patients' comfort. When the patent on infliximab started to expire, the first biosimilar of a monoclonal antibody was introduced onto the pharmacological market. Biosimilar infliximab was studied in rheumatology and proved a high similarity to the reference drug. Based on extrapolation, biosimilars were approved to treat adult and paediatric IBD patients. Biosimilar infliximab, mainly because of its lower cost, has started to be in common use in Europe. The first studies have shown a similar efficacy and safety profile in comparison with reference drug. Biosimilar infliximab is raising hopes for improving the availability of this effective treatment.
Introduction: Undernutrition and growth failure are common problems in paediatric patients with active Crohn's disease (CD). Aim: The aim of exclusive enteral nutrition (EEN) commencement is not only to induce clinical remission and promote mucosal healing but also to initiate weight and growth gain, especially in patients with poor nutritional status. We assessed the effectiveness of treatment with EEN and its impact on nutritional status in children with active CD.Material and methods: Twenty children (male/female: 14/6) in median age of 14 years with active CD had EEN with polymeric industrial diet (Modulen IBD) applied for 6 weeks. The daily caloric intake was established according to the age and nutritional status. In patients with undernutrition, it was increased to 120-150% relative to recommendations for the healthy peers. The Paediatric CD activity index (PCDAI) -a marker of clinical remission, faecal calprotectin (FCP) -a marker of mucosal healing (MH), and nutritional status were assessed at baseline and 4 weeks following the end of the therapy (week 10).Results: In the studied group the mean decrease in PCDAI score was statistically significant (from 25.6 ±12 to 5.4 ±10, p < 0.05). Full remission (defined as PCDAI < 10) was achieved in 65% of patients, and clinical response in another 30% of them. Only 5% of children did not respond to the treatment. Mean decline in FCP level was statistically significant as well (from 3380 ±7746 to 1046.6 ±1219, p < 0.05). All patients, apart from one who was fed with a nasogastric tube, accepted oral intake of industrial formula. EEN was generally well tolerated. Initially, in 20% of patients the symptoms of intolerance to the industrial diet were observed, but they receded within the first days of the therapy. The recommended daily intake of the formula was achieved in 95% of children. Only one child was unable to intake the prescribed amount of the diet due to intolerance. At baseline, undernutrition was observed in 30% of patients, which was established by a body mass index (BMI) score below the third percentile according to the recommended charts for the Polish paediatric population. In all patients, improvement in BMI status was reported at the end of the treatment. The mean increase in BMI score was 0.91, and it was greater in the malnourished group compared to patients with normal nutritional status (1.19 vs. 0.62). After the treatment two-thirds of children with malnutrition achieved a BMI score within the normal range. In 25% of patients, growth deficit was observed (defined as growth below the third percentile according to the Polish charts) before the EEN introduction. An increase in body height was obtained generally in 55% of children and in 80% of those with initial growth failure. The mean increase in growth was 1 cm, and it was greater in the group with initial growth deficit relative to patients with baseline normal height (1.5 cm vs. 0.8 cm, respectively).Conclusions: A 6-week course of oral EEN was an effective and well-tolerated method of treatme...
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.