Early treatment with 5-aminosalicylates (5-ASA) holds little benefit in children with newly diagnosed Crohn’s disease (CD), being associated with higher treatment failure rates, increased corticosteroid use, and reduced subsequent biologic therapy durability, according to a study.
Analysis of prospectively collected real-world data from the Biologic Discontinuation Study (BISCUIT) showed that paediatric patients who initiated treatment with 5-ASA monotherapy within 90 days of CD diagnosis had greater corticosteroid use compared with those who initiated therapy with a biologic. This was true across all time points examined: ≤90 days (49.6 percent vs 34.4 percent; p=0.036), ≤1 year (58.8 percent vs 35.5 percent; p=0.035), and ≤3 years (64.7 percent vs 37.9 percent; p=0.035). [Clin Gastroenterol Hepatol 2026;doi:10.1016/j.cgh.2026.08.008]
More than half of patients in the 5-ASA group (58 percent) escalated to biologic therapy after a median of 347 days. The most common reason for escalation was active disease (85.5 percent), followed by development of disease complication and poor growth.
Importantly, early 5-ASA monotherapy was associated with a fourfold greater risk of future biologic discontinuation (hazard ratio [HR], 4.47, 95 percent confidence interval [CI], 1.28–15.65; p=0.019). The durability of the initial biologic was reduced by a median of 438 days for patients with early 5-ASA treatment vs those with early biologic therapy (p<0.001).
Furthermore, early 5-ASA use did not prevent disease complications, whereas early anti-TNF therapy was protective against the development of perianal disease (odds ratio, 0.24, 95 percent CI, 0.06–0.93; p=0.039).
“These pragmatic, real-world differences were noted in both unadjusted and disease severity-adjusted analyses, suggesting that despite the practice of prescribing 5-ASA in less severely affected patients, the progressive nature of paediatric CD is most effectively addressed with first-line biologic therapy,” said first author Dr Perseus Patel from the Stanford University School of Medicine, Palo Alto, California, US, and colleagues.
“Despite evidence indicating lack of efficacy of 5-ASA use in children with CD, widespread use leads to undertreatment and leaves children susceptible to disease progression,” they added.
The authors pointed out that the delay in the initiation of appropriate therapy observed in patients who received early 5-ASA monotherapy is “clinically significant,” because it leads to increased corticosteroid exposure and preventable complications.
Furthermore, early 5-ASA exposure compromises subsequent biologic durability, which negatively affects long-term disease management in a population with limited US FDA-approved treatment options, they said.
Patel and colleagues emphasized that their work should serve as a call-to-action for more robust implementation of a biologic-first approach. [Lancet Gastroenterol Hepatol 2024;9:415-427]
“Given the substantial proportion of patients still being prescribed early 5-ASA therapy, our results advocate for a shift in real-world practice towards prioritizing early biologic therapy to improve long-term clinical outcomes and quality of life for paediatric patients with CD,” they said.
The analysis included 679 children (59.7 percent male, 81.7 percent White) with newly diagnosed inflammatory CD without perianal complications. Within 90 days from diagnosis, 119 patients (17.5 percent) received a prescription for 5-ASA monotherapy.
At baseline, patients who did vs did not receive a prescription for 5-ASA (regardless of other concomitant CD therapies) were 1-year younger (p=0.049), more likely to have colonic (p=0.013) rather than small bowel disease (p=0.005), and had higher weight-for-age z-scores (p<0.001) and lower physician global assessment scores (p=0.046).