Search

Objectives: The aim of our study was to assess the effectiveness and side-effect profile of a combination of azithromycin and metronidazole (CD AZCRO) as alternative induction therapy for 8 weeks in mild to moderately active paediatric Crohn's disease (CD)., Methods: We performed a retrospective cohort study (November 2012 to July 2023) of a regional paediatric inflammatory bowel disease service. Disease activity, faecal calprotectin (FC), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), haematological parameters and albumin were collected at baseline, 8 and 16 weeks. At Week 8, patients were divided based on (paediatric Crohn's disease activity index) score and inflammatory markers (blood and stool) into: Group 1 clinical remission and Group 2 non-remission., Results: A total of 48 patients were initially identified of whom 44 were included in the intention-to-treat analysis. After 8 weeks, the overall remission rate was 64%. Of the 38 patients who completed the CD AZCRO course, 28 patients (74%) entered remission (Group 1) and 10 (26%) did not (Group 2). At baseline a shorter disease duration, low weight z score and higher inflammatory burden (ESR, platelets and FC levels) were observed in Group 2. After 8 weeks, Group 1 showed improved CRP levels and higher albumin and haemoglobin levels than Group 2. Median FC declined significantly from 650 mcg/g at baseline to 190 mcg/g at Week 8 in Group 1 (p < 0.001). At 16 weeks, 23/28 patients (82%) continued in clinical remission. Nausea and vomiting were reported in 4/44 patients., Conclusions: Our real-world data demonstrate that CD AZCRO represents an alternative induction therapy for mild to moderate paediatric CD., (© 2024 European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.)

No real-world data are available on subcutaneous infliximab (SC-IFX) in pediatric inflammatory bowel disease (PIBD). We report a single-center cohort experience of an elective switching program from biosimilar intravenous infliximab to SC-IFX, 120 mg fortnightly, as maintenance. Clinical and laboratory data were collected for 7 patients with infliximab trough levels collected prior and at 6 and 40 weeks after the switch. High treatment persistence was registered with a single patient discontinuing the treatment due to high IFX antibodies, already present before switching. All patients remained in clinical remission with no significant changes in laboratory markers and median infliximab trough levels (12.3 µg/mL at baseline; 13.9 and 14.0 µg/mL at 6 and 40 weeks respectively). No newly-developed IFX antibodies were detected and no adverse reactions or rescue therapies were recorded. Our real-world data support the feasibility of an elective switch to SC-IFX in PIBD as maintenance with potential advantages concerning medical resources and patient satisfaction., Competing Interests: R.K.R. has received consultation fees, research grants, royalties, or honorarium from Janssen, Pfizer, Nestle Health Sciences, AbbVie, Celltrion, Lilly, and Pharmacosmos. D.C.W. has received speaker fees and/or consultancy from Celltrion, AbbVie, and Nestle Health Sciences. The remaining authors report no conflicts of interest., (Copyright © 2023 by European Society for European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.)