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Dual Biologic or Small Molecule Therapy in Refractory Pediatric Inflammatory Bowel Disease (DOUBLE-PIBD): A
Anat Yerushalmy-Feler1, Christine Olbjorn2, Kaija-Leena Kolho3,4
1Pediatric Gastroenterology Institute, Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Insights
Dual biologic therapy shows promise for pediatric inflammatory bowel disease (IBD) patients who failed prior treatments. While effective, careful monitoring for serious adverse events is crucial.
Area of Science:
- Pediatric Gastroenterology
- Immunology
- Pharmacology
Background:
- Limited data exists on dual biologic therapy for pediatric inflammatory bowel disease (IBD).
- This study addresses the need for evidence on dual therapy effectiveness and safety in children with IBD.
Purpose of the Study:
- To evaluate the effectiveness and safety of dual biologic therapy in pediatric patients with IBD.
- To assess clinical remission rates and biochemical markers in children with IBD undergoing dual therapy.
Main Methods:
- Retrospective multicenter study involving 14 centers.
- Included children with IBD treated with combination biologic or biologic and small molecule therapy for ≥3 months.
- Collected demographic, clinical, laboratory, endoscopic, and imaging data; adverse events were recorded.
Main Results:
- 62 children (35 Crohn's disease, 27 ulcerative colitis) with prior biologic failure were included.
- Clinical remission rates at 3, 6, and 12 months were 35%, 50%, and 63%, respectively.
- 47% experienced adverse events, with 6 serious events leading to discontinuation.
Conclusions:
- Dual biologic therapy appears effective for refractory pediatric IBD.
- The potential benefits must be balanced against the risk of serious adverse events.
Background:
Current data on dual biologic therapy in children are limited. This multicenter study aimed to evaluate the effectiveness and safety of dual therapy in pediatric patients with inflammatory bowel disease (IBD).
Methods:
A retrospective study from 14 centers affiliated with the Pediatric IBD Interest and Porto Groups of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition. Included were children with IBD who underwent combinations of biologic agents or biologic and small molecule therapy for at least 3 months. Demographic, clinical, laboratory, endoscopic, and imaging data were collected. Adverse events were recorded.
Results:
Sixty-two children (35 Crohn's disease, 27 ulcerative colitis; median age 15.5 [interquartile range, 13.1-16.8] years) were included. They had all failed previous biologic therapies, and 47 (76%) failed at least 2 biologic agents. The dual therapy included an anti-tumor necrosis factor agent and vedolizumab in 30 children (48%), anti-tumor necrosis factor and ustekinumab in 21 (34%) children, vedolizumab and ustekinumab in 8 (13%) children, and tofacitinib with a biologic in 3 (5%) children. Clinical remission was observed in 21 (35%), 30 (50%), and 38 (63%) children at 3, 6, and 12 months, respectively. Normalization of C-reactive protein and decrease in fecal calprotectin to <250 µg/g were achieved in 75% and 64%, respectively, at 12 months of follow-up. Twenty-nine (47%) children sustained adverse events, 8 of which were regarded as serious and led to discontinuation of therapy in 6.
Conclusions:
Dual biologic therapy may be effective in children with refractory IBD. The potential efficacy should be weighed against the risk of serious adverse events.
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