Effectiveness and safety of biologics in pediatric inflammatory boweldisease: Real-life data from the Sicilian Network

Background: Biological therapies have modified the disease course of pediatric inflammatory bowel disease (IBD) and are routinely used in clinical practice. Our observational study aims to evaluate effectiveness and safety of biologics in IBD. Method: Clinical benefit and safety data of 93 children with IBD, receiving biologics (Infliximab – IFX, Adalimumab – ADA, Golimumab – GOL) from January 2013 to December 2017, were extracted from the cohort of the Sicilian Network of IBD. Results: Among 87 children aged 7–17 years (63 Crohn's disease [CD], 24 Ulcerative colitis [UC]), 101 out of 108 biologic treatments were considered. Evaluation of 74 biologic treatments in CD patients at 26, 52, 104 weeks showed clinical benefit rates of 84.2%, 93.3%, 66.7% with IFX (n = 38) and 88.9%, 84.4%, 65.2% with ADA (n= 36). Biologic treatments (n = 27) evaluated in the UC group at 26, 52, 104 weeks, led to clinical benefit rates of 85.7%, 83.3%, 50% in IFX subgroup (n = 21) and 40%, 50%, 33% in the ADA subgroup (n = 5), respectively. One patient treated with GOL showed 100% clinical benefit at 26 and 52 weeks. Overall adverse events (AEs) rate was 9.25%. Six younger children, < 6 years, receiving 8 treatments (4 ADA, 4 IFX) presented a clinical remission rate of 75% at 12 weeks and 25% at 52 weeks. AEs rate was 25% in this group. Conclusion: Our data show that biologic therapy in children, even at a younger age, is effective in allowing long-term remission with a good safety profile.