Journal of Crohn's & colitis · 2025
Real-life durability and risk factors for biologic discontinuation in pediatric inflammatory bowel disease: results from the SIGENP IBD registry.
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Lega Sara, Dipasquale Valeria, D'arcangelo Giulia, Scarallo Luca, Ancona Silvana, Fedele Flora, Zuin Giovanna, Graziano Francesco, Norsa Lorenzo, Gatti Simona, Illiceto Maria T, Felici Enrico, Corpino Mara, Pavanello Paolo M, Cozzali Rita, Alvisi Patrizia, Pizzol Antonio, Banzato Claudia, Penagini Francesca, Marseglia Antonio, Faraci Simona, Luini Chiara, Strisciuglio Caterina, Moretti Chiara, Martinelli Massimo, Arrigo Serena, Lionetti Paolo, Aloi Marina, Romano Claudio, Giangreco Manuela, Bramuzzo Matteo, SIGENP IBD Study Group
Аннотация
BACKGROUND AND AIMS: This study aims to evaluate the real-life durability of biologic therapies and to identify factors associated with biologic persistence in pediatric inflammatory bowel disease (IBD).
METHODS: We analyzed data from the IBD-registry of the Italian Society of Pediatric Gastroenterology, Hepatology, and Nutrition (SIGENP) of patients initiating biologics between 2009 and 2022 and ≥1-year follow-up.
RESULTS: A total of 1184 patients (747 with Crohn's disease [CD], 437 with ulcerative colitis or IBD unclassified [UC/IBD-U]) were included, accounting for 1709 treatment courses. The median follow-up was 43 months (interquartile range 28-64). Overall, 33% received a second-line biologic, 9% third-line, and 2% fourth-line. First-line biologic durability was significantly lower in UC/IBD-U vs CD, with inferior persistence at 1, 2, and 3 years (61%, 51%, and 44% vs 88%, 75%, and 67%; hazard ratios [HR]: 1.5, 95% confidence interval [CI] 1.2-1.9, P = .002). In CD, infliximab had inferior durability then adalimumab (72%, 59%, and 50% vs 91%, 82%, and 77%; HR 2.0, 95% CI, 1.5-2.7, P < .0001). In both CD and UC/IBD-U, age <6 years was a risk factor for treatment discontinuation (HR 1.8, 95% CI, 1.2-2.7, P < .01) while therapeutic drug monitoring (TDM) emerged as protective (HR 0.5, 95% CI, 0.4-0.7, P < .0001). Combination with an immunomodulator had no significant impact on durability (HR 0.9, 95% CI, 0.8-1.2, P = .54).
CONCLUSIONS: Biologic persistence varied by disease type and biologic agent. TDM was associated with longer treatment durability, while combination therapy had a limited effect. Further prospective studies are needed to refine biologics optimization strategies in pediatric IBD.
METHODS: We analyzed data from the IBD-registry of the Italian Society of Pediatric Gastroenterology, Hepatology, and Nutrition (SIGENP) of patients initiating biologics between 2009 and 2022 and ≥1-year follow-up.
RESULTS: A total of 1184 patients (747 with Crohn's disease [CD], 437 with ulcerative colitis or IBD unclassified [UC/IBD-U]) were included, accounting for 1709 treatment courses. The median follow-up was 43 months (interquartile range 28-64). Overall, 33% received a second-line biologic, 9% third-line, and 2% fourth-line. First-line biologic durability was significantly lower in UC/IBD-U vs CD, with inferior persistence at 1, 2, and 3 years (61%, 51%, and 44% vs 88%, 75%, and 67%; hazard ratios [HR]: 1.5, 95% confidence interval [CI] 1.2-1.9, P = .002). In CD, infliximab had inferior durability then adalimumab (72%, 59%, and 50% vs 91%, 82%, and 77%; HR 2.0, 95% CI, 1.5-2.7, P < .0001). In both CD and UC/IBD-U, age <6 years was a risk factor for treatment discontinuation (HR 1.8, 95% CI, 1.2-2.7, P < .01) while therapeutic drug monitoring (TDM) emerged as protective (HR 0.5, 95% CI, 0.4-0.7, P < .0001). Combination with an immunomodulator had no significant impact on durability (HR 0.9, 95% CI, 0.8-1.2, P = .54).
CONCLUSIONS: Biologic persistence varied by disease type and biologic agent. TDM was associated with longer treatment durability, while combination therapy had a limited effect. Further prospective studies are needed to refine biologics optimization strategies in pediatric IBD.