Impact of 5‐Aminosalicylic Acid Discontinuation in Children with Ulcerative Colitis Receiving Biologic Therapy

G D’Arcangelo et al. J Pediatr Gastroenterol Nutr 2026; 83: 96-107. Open Access! Impact of 5-Aminosalicylic acid discontinuation in children with ulcerative colitis on biologic therapy: A propensity score-matched study

Background: Several adult-based studies have found that discontinuing 5-ASA at the initiation of anti-TNF therapy is not associated with worse clinical outcomes. “Ungaro et al. analyzed data from over 3500 patients in the United States and Denmark and found no increased risk of adverse outcomes following mesalamine discontinuation after the initiation of anti-TNF therapy.18 Based on this evidence, the American Gastroenterological Association recommends discontinuing mesalamine in patients with moderate-to-severe UC who are starting biologics or small molecules and achieve remission.19 However, this recommendation is based on low-quality evidence, and pediatric guidelines do not offer a similar directive.2

Methods: Retrospective, multicenter, case–control study which included 227 pediatric patients in the final analysis after matching (85 [37.5%] cases and 142 [62.5%] controls].

Key findings:

  • Children who discontinued 5-ASA were at higher risk of courses of steroids (Log-Rank p = 0.003) and hospitalization (p = 0.08). This finding persisted with multivariate Cox regression analysis.
  • “Fixed timepoint analyses showed a statistically significant increase in the odds of adverse outcomes at the 6-month follow-up (including hospitalizations and acute severe colitis), with no significant differences detected at 12, 18, or 24 months, and only a non-significant trend toward higher hospitalization risk over time.”

My take: This is an intriguing study with a small sample size of pediatric IBD patients. Given the findings in adults, it is customary to stop 5-ASA at the time of initiation of biologic therapy. However, this study indicates that pediatric patients—who often present with more extensive and severe disease—may have some benefit from overlapping these therapies, especially during the first six months. A prospective pediatric study would be helpful.

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Disclaimer: This blog, gutsandgrowth, assumes no responsibility for any use or operation of any method, product, instruction, concept or idea contained in the material herein or for any injury or damage to persons or property (whether products liability, negligence or otherwise) resulting from such use or operation. These blog posts are for educational purposes only. Specific dosing of medications (along with potential adverse effects) should be confirmed by prescribing physician. Because of rapid advances in the medical sciences, the gutsandgrowth blog cautions that independent verification should be made of diagnosis and drug dosages. The reader is solely responsible for the conduct of any suggested test or procedure. This content is not a substitute for medical advice, diagnosis or treatment provided by a qualified healthcare provider. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a condition

Is There Renal Toxicity with Mesalamine Therapy for IBD?

A recent study (V Jairath et al. AP&T 2019; https://doi.org/10.1111/apt.15408) provides evidence that 5-aminosalicylic acid therapy for IBD does NOT increase the risk of nephrotoxicity.  This paper’s findings run counter to more than thirty years of teaching on this medication.

Full Free Link: No increased risk of nephrotoxicity associated with 5‐aminosalicylic acid in IBD: a population‐based cohort and nested case‐control study

Abstract (bold highlighted by blog author):

Background

There is conflicting evidence about nephrotoxicity risk associated with 5‐aminosalicylates for treatment of IBD.

Methods

Retrospective cohort and nested case‐control study, using the Health Improvement Network primary care database linked to hospital discharge coding for patients in England, 1996‐2017. Nephrotoxicity risk analysis was a first recorded renal impairment diagnosis adjusted for key variables and was assessed between 2008 and 2017.

Results

A total of 35 601 patients with prevalent UC or CD were included. The proportion of patients prescribed 5‐aminosalicylates fell from 83% in 1996‐1999 to 71% in 2012‐2015 for UC patients and 64% to 45% for CD patients. Thirty per cent of patients had prolonged 5‐aminosalicylate use. Between 2008 and 2017, the incident rate of nephrotoxicity was similar and stable for UC (12.6/1000 person‐years) and CD (10.9/1000 person‐years) patients. Multivariate analysis showed no evidence for association between current prescription of 5‐aminosalicylate and nephrotoxicity in UC or CD patients, comparing ≤ 30 days prescription prior to index vs 31‐≤180 days. However, active disease, disease duration, concomitant cardiovascular disease or diabetes and nephrotoxic drug use were independently associated with development of nephrotoxicity in UC and CD.

Conclusions

Despite the paucity of evidence for their benefit, 5‐aminosalicylates were prescribed to approximately half of CD patients (30% prolonged therapy). Nephrotoxicity was rare in this patient cohort, and was not associated with 5‐aminosalicylate use, but rather with disease status, comorbidity and use of nephrotoxic drugs.

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Park Guell, Barcelona

Disclaimer: These blog posts are for educational purposes only. Specific dosing of medications/diets (along with potential adverse effects) should be confirmed by prescribing physician/nutritionist.  This content is not a substitute for medical advice, diagnosis or treatment provided by a qualified healthcare provider. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a condition