P1123 Baseline characteristics and nutrition in patients with moderately to severely active Inflammatory Bowel Disease: Results from the phase 3 UNITI Jr and UNIFI Jr trials
Authors: De Greef E , Kosaras É , Béres N , Cohen S , Conklin L , Strauss R , Godwin B , Damaraju L , Zhang R , Volger S , Kim L , Van Limbergen E 
Published: January 2025

Background

Few clinical trials investigating the efficacy of pediatric inflammatory bowel disease (IBD) treatments evaluate nutritional parameters and diet history of participants (pts) at enrollment. The pathophysiology of IBD may be influenced by nutritional factors. Moreover, IBD may impact nutrient absorption, loss, and contribute to a hypermetabolic state.1 Exclusive enteral nutrition (EEN) is an effective induction therapy, and along with CD-diet therapies may improve disease-related symptoms.2 Here we characterized the nutritional parameters (vitamin D, methylmalonic acid [MMA], iron) and growth status of pts in two phase 3 pediatric IBD studies and nutritional therapy usage in CD.

Methods

Pts enrolled in two ongoing phase 3 trials evaluating the efficacy and safety of ustekinumab (UST) in pts 2 to &lt;18 years with moderately to severely active CD (UNITI Jr) or UC (UNIFI Jr) and a history of inadequate response to corticosteroids, immunomodulators and/or biologics (BIO-IR). Pts receiving EEN had to have a stable regimen for ≥2 weeks prior to Week I-0 in UNITI Jr. In UNIFI Jr, pts previously receiving &gt;80% of their daily caloric needs via EEN had to stop or bring down the percentage of nutritional therapy ≥4 weeks prior to Week I-0. Baseline demographic data included height, weight, body mass index (BMI), nutritional parameters, disease characteristics, and nutritional history use (UNITI Jr only).

Results

Baseline demographics for UNITI Jr (n=101) and UNIFI Jr (n=102) are presented (Table). According to clinical guidelines,3 some pts in both UNITI Jr and UNIFI Jr exhibited mild malnourishment at enrollment (median BMI Z score [range]: -0.46 [-1.7, 4.1] and -0.18 [-1.7, 2.7], respectively). The majority of pts in UNITI Jr and UNIFI Jr were receiving disease-related medications at baseline (69.3% and 89.2%, respectively). BIO-IR pts represented 52.5% and 36.3% of the population in UNITI Jr and UNIFI Jr, respectively. Low vitamin D and elevated MMA were reported in both trials. In UNITI Jr, 61.4% of pts previously received EEN and 50% had followed the CD exclusion diet.

Conclusion

The cross-sectional data presented here offers insight into EEN usage and nutritional status of treatment refractory pediatric IBD pts in the UST pediatric IBD clinical studies. These data suggest that despite being at increased risk, a small portion of pts met the criteria for mild malnutrition and vitamin D deficiencies, suggesting appropriate use of international treatment guidelines for pediatric CD and UC.

References

1)Mitrev N, Huang H, Hannah B, et al. Review of exclusive enteral therapy in adult Crohn’s disease. BMJ Open Gastro. 2021; 8: e000745.

2)van Rheenen PF, Aloi M, Assa A, et al. The medical management of paediatric Crohn’s disease: an ECCO-ESPGHAN guideline update. J Crohns Colitis. 2021: 171-94.

3)Becker PJ, Carney LN, Corkins MR, et al. Consensus statement of the Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition: indicators recommended for the identification and documentation of pediatric malnutrition (undernutrition). Nutr Clin Pract. 2015; 30(1): 147-61.