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Impact of 5-Aminosalicylic acid discontinuation in children with ulcerative colitis on biologic therapy: A propensity
Giulia D'Arcangelo1, Luca Scarallo2,3, Giulia Mancuso4
1Gastroenterology, Hepatology and Cystic Fibrosis Unit, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico di Milano, Milan, Italy.
Insights
Discontinuing 5-aminosalicylic acid (5-ASA) in children with moderate to severe ulcerative colitis (UC) on anti-tumor necrosis factor (anti-TNF) therapy increases the risk of steroid courses and hospitalization. Continuing 5-ASA is a prudent approach due to its safety profile.
Area of Science:
- Pediatric Gastroenterology
- Inflammatory Bowel Disease (IBD)
- Pharmacology
Background:
- 5-Aminosalicylic acid (5-ASA) is a first-line treatment for mild to moderate ulcerative colitis (UC).
- Limited evidence exists on 5-ASA use in pediatric patients with moderate to severe UC receiving biologic therapy, specifically anti-tumor necrosis factor (anti-TNF) agents.
- Understanding the impact of 5-ASA discontinuation in this population is crucial for optimizing treatment strategies.
Purpose of the Study:
- To evaluate the clinical impact of discontinuing 5-ASA in pediatric patients with UC undergoing anti-TNF therapy.
- To assess whether 5-ASA discontinuation affects disease flares, hospitalizations, or need for treatment escalation.
Main Methods:
- Retrospective, multicenter, case-control study involving pediatric UC patients initiating anti-TNF therapy (January 2018 - January 2023).
- Comparison between children who discontinued 5-ASA (cases) and those who continued mesalamine (controls), matched using Propensity Score analysis (1:2 ratio).
- Two-year follow-up recording disease flares, IBD-related hospitalizations, surgeries, need for step-up treatment, and acute severe colitis.
Main Results:
- The final analysis included 227 children (85 cases, 142 controls).
- Children who discontinued 5-ASA showed a significantly higher risk of requiring courses of steroids (Log-Rank p=0.003).
- A trend towards increased hospitalization risk was observed in the 5-ASA discontinuation group (p=0.08), identified as an independent predictor.
Conclusions:
- Discontinuation of 5-ASA may negatively influence the clinical course of pediatric UC patients treated with anti-TNF therapy.
- Continuing mesalamine (5-ASA) is advisable given its favorable safety profile and potential to maintain clinical stability.
- Further research may explore optimal 5-ASA dosing and duration in conjunction with biologic therapies for pediatric UC.
Objectives:
5-Aminosalicylic acid (5-ASA) is recommended as a first-line medication in mild to moderate ulcerative colitis (UC), but indications regarding its use in children with moderate to severe disease treated with biologics are lacking. We aimed to evaluate the impact of discontinuing 5-ASA in children with UC treated with anti-tumor necrosis factor (anti-TNF).
Methods:
Retrospective, multicenter, case-control study of the Italian Society of Pediatric Gastroenterology, Hepatology and Nutrition inflammatory bowel disease (IBD) study group. Children with UC starting anti-TNF therapy between January 2018 and January 2023 and with a minimum follow of 6 months were included. Those who discontinued 5-ASA (cases) were compared to those who continued mesalamine (controls). A Propensity Score analysis was used to match 1:2 with patients by baseline clinical and demographic characteristics. Every 6 months, during a 2-year follow-up, data on disease flares, IBD-related hospitalization, surgery, need for step-up treatment and acute severe colitis were recorded.
Results:
Data from 298 children were collected (92 [31%] cases and 206 [69%] controls) and 227 were included in the final analysis after matching (85 [37.5%] cases and 142 [62.5%] controls]. Children who discontinued 5-ASA were at higher risk of courses of steroids (Log-Rank p = 0.003) and hospitalization (p = 0.08). At the multivariate Cox regression analysis, 5-ASA discontinuation was identified as an independent predictor of courses of steroids (p = 0.003) and hospitalization (p = 0.08).
Conclusions:
5-ASA discontinuation might negatively impact the clinical course of children with UC treated with anti-TNF. Considering the good safety profile of the drug, continuing mesalamine can be suggested as a prudent approach.
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