Objectives: Retrospective, observational, single-center, cohort study investigating the safety profile of biological therapy in children with inflammatory bowel disease (IBD). Methods: Retrospective, observational, cohort study of pediatric patients with IBD, receiving infliximab, adalimumab, vedolizumab, or ustekinumab for at least 2 months. Data related to the immediate and delayed adverse events (AEs) were collected, focusing on the reaction type and severity, the time of onset, the outcome and the temporary or definitive therapy discontinuation secondary to the AE. Number of suspected and confirmed coronavirus disease-209 (COVID-19) cases and their outcomes, as well as flu vaccination coverage were collected. Results: One hundred eighty-five children were included (101 [55%] CD, 82 [44%] UC, and 2 [1%] IBDU): 149 received infliximab (IFX) (81%), 88 (48%) adalimumab (ADA), 18 (21%) vedolizumab, and 4 (2%) ustekinumab. The overall AE rates were 49%, 67% of whom likely medication-related. Eleven (6%) patients experienced more than 1 AE, 18 patients (10%) presented an immediate reaction, and 82 (45%) a delayed AE. Among the 90 patients experiencing at least 1 AE, 97% had mild-to-moderate AEs. Only 4 SAEs were reported (4%). Treatment discontinuation because of AE occurred in 25 patients (14%). Four COVID-19 cases were reported, all with a mild course. Conclusions: Our findings confirm a good safety profile of biologics. Infusion reactions to IFX administration remain one of the main issues, significantly linked to its immunogenicity and consequently with an impact on its efficacy and durability.
Introduction of AZA within 6 months of diagnosis seems not more effective than later treatment to achieve CS-free remission in pediatric ulcerative colitis. MH does not depend on the timing of AZA initiation; however, because of the incomplete comparability of the 2 groups at the diagnosis and the use of fecal calprotectin as a surrogate marker of MH, our results should be further confirmed by prospective studies.
The aim of this study was to define clusters of activity in a population-based cohort during the first 5 years after diagnosis and to identify early prognostic risk factors. Patients And Methods All UC patients from SIGENP IBD registry with a complete follow-up of at least 5 years were included. Active disease was defined every six months in the presence of at least 1 of the following: clinical activity (PUCAI≥35); endoscopic activity (Mayo≥1); fecal calprotectin >250 mcg/g; hospitalization; surgery; treatment escalation. Formula-based clusters were generated based on four published questionnaire-based activity patterns in adults , plus one additional cluster. Results 226 patients were identified. Forty-two (19%) had a moderate-severe chronically active disease, 31(14%) chronic-intermittent, 75 (33%) quiescent, 54 (24%) an active disease in the first 2 years after the diagnosis, then sustained remission, and 24 (11%) a remission in the first 2 years then an active disease. A mild disease onset along with a lower clinical severity not requiring the use of corticosteroids at 6 months were related with a quiescent disease course in the next follow-up [logistic model AUC 0.86 (95% CI 0.78-0.94); PPV 67%; NPV 70%]. Eight % of patients needed surgery, none in the quiescent group (p=0.04). Conclusions More than one-third of children with UC present a chronically active or intermittent course during the first 5 years of follow-up. A significant group of patients has an active disease in the first 2 years then a sustained remission. Interestingly, after initial treatment one-third of patients have a well-controlled disease throughout.
Objectives: Anemia is one of the most common extraintestinal manifestations of pediatric inflammatory bowel disease (IBD). We aimed to evaluate the prevalence of anemia in children newly diagnosed with IBD and assess the efficacy and safety of oral iron therapy over a 12-month follow-up period. Methods: This single-center, retrospective, observational cohort study included all children newly diagnosed with IBD at the Pediatric Gastroenterology Unit of Sapienza University of Rome from May 2015 to May 2019 presenting with anemia. At baseline, demographic, clinical, laboratory data (hemoglobin, mean corpuscular volume, serum iron, ferritin, transferrin levels, erythrocyte sedimentation rate, and C-reactive protein), and treatment received, were recorded. Clinical and laboratory data, as well as anemia therapy and adverse events (AEs), were collected every 3 months during the 1-year follow-up. Results: Eighty-nine out of 140 patients newly diagnosed with IBD presented with anemia (64%); 13 were excluded due to incomplete follow-up, thus 76 were included [median age 12.7 (interquartile range 9.8–15), 25 (33%) Crohn disease, 51 (67%) ulcerative colitis]. All patients received sucrosomial iron (SI) alone or in combination with intravenous ferric carboxymaltose. Treatment with SI was effective in 67 (88%) patients at the end of follow-up [37 (48%) within 3 months], regardless of anemia severity at baseline. No serious AEs related to SI treatment were reported. Conclusions: We confirmed a high prevalence of anemia at the time of the diagnosis of pediatric IBD. Our data suggest that SI is safe and effective, leading to anemia resolution in approximately half of the patients within 3 months.
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