Switching Between Infliximab Originator and Biosimilar in Paediatric Patients with Inflammatory Bowel Disease. Preliminary Observations.

BACKGROUND AND AIMS: The growing incidence of inflammatory bowel disease (IBD) in children necessitates the use of biological treatments. Recently, an infliximab biosimilar was authorized in the European Union, which may result in switching patients. We present our preliminary experiences with such switches. METHODS: The prospective study included 32 paediatric patients diagnosed with Crohn's disease (CD) and 7 children with ulcerative colitis (UC) at 3 academic hospitals, who were switched from infliximab originator to its biosimilar (Remsima). Patient characteristics, disease severity, laboratory parameters and adverse events were recorded. Means, medians and ranges were calculated. RESULTS: Mean age at diagnosis of CD and UC was 11.1 (2.7-15.3) and 12.3 years (8.5-14.8), respectively. Mean number of infliximab originator infusions before switching to the biosimilar was 9.9 (median 8, range 4-29) and 5.1 (5, 1-12) for the CD and UC group, respectively. Evaluation efficacy of last biosimilar doses of all patients revealed rates of clinical remission of 88 and 57% for CD and UC patients, respectively. Last follow-up assessment of patients who continued with biosimilar therapy showed that 16/20 (80%) CD patients and all 4 UC individuals were in remission. One infusion reaction to infliximab biosimilar was observed in a CD patient, which led to treatment discontinuation. The incidence of sporadic mild adverse events prior to and after switching did not differ significantly and was consistent with the safety profile of the infliximab molecule. CONCLUSION: 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.

The nutritional status and factors contributing to malnutrition in children with chronic pancreatitis.

BACKGROUND/OBJECTIVES: The present study was undertaken to determine the prevalence of malnutrition among children with chronic pancreatitis (CP). Furthermore, we aimed to evaluate the relationship between etiological factors of CP, its clinical characteristics, and the severity of malnutrition. METHODS: The study included 208 children with CP (113 girls and 95 boys; mean age: 10.8 years, range: 1.6-18 years), hospitalized at our center between 1988 and 2012. The severity of malnutrition was graded on the basis of Cole's ratios, and its prevalence was analyzed according to the etiological factors of pancreatitis. Moreover, the analysis of discrimination was performed to identify the factors contributing to malnutrition among the following variables: age at CP onset, duration of CP, number of CP exacerbations, the number of ERCPs performed, the grade of pancreatic damage documented on imaging, co-occurrence of diabetes, and the results of 72-h fecal fat quantification. RESULTS: We documented features of malnutrition in 52 (25%) children with CP, including 36 (17.3%) patients with moderate malnutrition, and 2 (0.96%) with severe malnutrition. There was no significant difference in the prevalence of malnutrition between groups of patients with various etiological factors of chronic pancreatitis. The age at CP onset showed the best discrimination ability of malnourished patients: the mean age at disease onset in a subgroup of malnourished children was significantly higher than in children with Cole's index >85%. CONCLUSIONS: A considerable percentage of children with CP can suffer from clinically significant malnutrition. Later age at CP onset predisposes to development of malnutrition.