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Aminosalicylate use Increases Corticosteroid Exposure and Decreases Biologic Durability in Pediatric Crohn's Disease
Perseus V Patel1, Jonathan Moses2, Sabina Ali3
1Division of Pediatric Gastroenterology, Stanford University School of Medicine, Palo Alto, CA.
Insights
Early 5-aminosalicylate (5-ASA) use in pediatric Crohn's Disease (pCD) is common but linked to worse outcomes. This approach leads to increased steroid use and delayed effective biologic therapy, highlighting the need for alternative treatments.
Area of Science:
- Pediatric Gastroenterology
- Inflammatory Bowel Disease Research
- Clinical Trial Analysis
Background:
- 5-aminosalicylates (5-ASA) are frequently prescribed for pediatric Crohn's Disease (pCD) despite limited evidence of efficacy.
- Current practice patterns and the impact of 5-ASA on clinical outcomes in pCD are not well-defined.
Purpose of the Study:
- To determine the prevalence of 5-ASA use in pediatric Crohn's Disease.
- To evaluate the association of early 5-ASA use with biologic durability, corticosteroid exposure, and disease complications.
Main Methods:
- Prospective, multicenter inception cohort study (Biologic dISContinuation sTudy - BISCUIT).
- Analysis of early therapy (<90 days) groups: biologics, immunomodulators, 5-ASA, and no therapy.
- Utilized stabilized inverse probability of treatment weighting and Cox regressions to adjust for baseline differences.
Main Results:
- 18% of 679 pCD patients received early 5-ASA monotherapy.
- Early 5-ASA was associated with increased corticosteroid use and delayed biologic initiation (median ~11 months).
- Early 5-ASA increased the risk of biologic discontinuation (HR 4.47) and did not prevent disease complications, while early anti-TNF therapy reduced perianal disease risk (OR 0.24).
Conclusions:
- Early 5-ASA use in pCD is common, indicates undertreatment, and is linked to inferior outcomes.
- Findings suggest avoiding 5-ASA in pCD and prioritizing early anti-TNF therapy for better long-term outcomes and reduced perianal disease.
- Early 5-ASA is associated with greater steroid exposure, delayed effective therapy, and decreased biologic durability.
Background And Aims:
Despite lack of evidence for efficacy, 5-aminosalicylates (5-ASA) continue to be prescribed for pediatric Crohn's Disease (pCD). There are limited data examining current practice patterns in pCD, and the impact of 5-ASA use on clinical outcomes. We aimed to determine the prevalence 5-ASA use in pCD and evaluate its association with biologic durability, corticosteroid exposure, and disease-related complications.
Methods:
We conducted a prospective, multicenter inception cohort study using data from the Biologic dISContinuation sTudy (BISCUIT). Early therapy (< 90 days from diagnosis) groups included biologics, immunomodulators, 5-ASA, and none of the above. The primary outcome was biologic durability. Secondary outcomes included corticosteroid use, therapy failure, and disease complications. Stabilized inverse probability of treatment weighting and Cox regressions were employed to equate for baseline differences among groups.
Results:
Of 679 patients, 18% received early 5-ASA monotherapy. Early 5-ASA was associated with greater systemic corticosteroid use (p=0.036) and delayed time-to-biologic (median ∼11 months), with 58.0% of patients escalating therapy. Among those who escalated, early 5-ASA increased risk of biologic discontinuation (hazard ratio 4.47 [1.28-15.65]; p=0.029). Furthermore, early 5-ASA and immunomodulator use did not prevent disease complications, whereas early anti-TNF therapy protected against perianal disease (odds ratio 0.24 [0.06-0.93]; p=0.039).
Conclusions:
Early 5-ASA use in pCD is common, represents undertreatment, and is associated with inferior outcomes, including greater steroid exposure, delayed initiation of effective biologic therapy, and decreased biologic durability, without protection against disease complications. These findings support avoidance of 5-ASA in pCD and prioritizing early anti-TNF therapy to improve long-term outcomes and reduce perianal disease risk.
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