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Effectiveness and safety of biologics in pediatric inflammatory boweldisease: Real-life data from the Sicilian
Anna Claudia Romeo1, Marco Ventimiglia1, Valeria Dipasquale1
1Pediatric Gastroenterology and Cystic Fibrosis Unit, Department of Human Pathology in Adulthood and Childhood "G. Barresi", University of Messina, Via Consolare Valeria 1, 98124 Messina, Italy.
Insights
Biologic therapies are effective for pediatric inflammatory bowel disease (IBD), including younger children, offering long-term remission and a good safety profile. This study evaluated Infliximab, Adalimumab, and Golimumab in children with Crohn's disease and Ulcerative Colitis.
Area of Science:
- Pediatric Gastroenterology
- Immunology
- Clinical Pharmacology
Background:
- Biological therapies have significantly altered the disease course for pediatric patients with inflammatory bowel disease (IBD).
- These advanced treatments are now a standard component of clinical practice for managing IBD in children.
- This study focuses on evaluating the real-world effectiveness and safety of these biologic agents in a pediatric IBD cohort.
Purpose of the Study:
- To assess the clinical effectiveness of biologic therapies in children diagnosed with IBD.
- To evaluate the safety profile and adverse events associated with biologic use in pediatric IBD patients.
- To analyze treatment outcomes across different biologic agents (Infliximab, Adalimumab, Golimumab) and IBD subtypes (Crohn's disease, Ulcerative Colitis).
Main Methods:
- An observational study analyzing clinical benefit and safety data from 93 children with IBD.
- Data were extracted from the Sicilian Network of IBD cohort, covering treatments from January 2013 to December 2017.
- Included biologics were Infliximab (IFX), Adalimumab (ADA), and Golimumab (GOL).
Main Results:
- In Crohn's disease (CD) patients (n=63), Infliximab (IFX) and Adalimumab (ADA) showed high clinical benefit rates at 26, 52, and 104 weeks (e.g., IFX: 84.2%, 93.3%, 66.7%; ADA: 88.9%, 84.4%, 65.2%).
- In Ulcerative Colitis (UC) patients (n=24), IFX demonstrated strong efficacy (85.7%, 83.3%, 50%), while ADA showed variable results (40%, 50%, 33%). Golimumab (GOL) showed 100% benefit at 26 and 52 weeks in one patient.
- Overall adverse events (AEs) were low (9.25%), though higher in younger children (<6 years) (25%), who still achieved significant remission rates (75% at 12 weeks, 25% at 52 weeks).
Conclusions:
- Biologic therapy is effective for pediatric IBD, including in younger children, promoting long-term remission.
- The safety profile of biologics in this pediatric cohort is generally good.
- These findings support the continued use of biologics as a valuable treatment option for pediatric IBD.
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.
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