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Poster presentations: Clinical: Therapy and Observation 2020

P479 The effect of adalimumab on linear growth in children with Crohn’s disease: a post hoc analysis of the PAILOT randomised control trial

M. Matar1, R. Shamir2, D. Turner3, E. Broide4, B. Weiss5, O. Ledder6, A. Guz-Mark2, F. Rinawi2, S. Cohen7, C. Topf-Olivestone8, R. Shaoul9, B. Yerushalmi10, S. Ben-Horin11, A. Assa2

1Institute of Gastroenterology- Nutrition and Liver Diseases, Shneider Children’s Medical Center, Petach Tikva, Israel, 2The Institute of Gastroenterology- Nutrition and Liver Diseases, Schneider Children’s Hospital, Petach-Tikva, Israel, 3The Juliet Keidan Institute of Pediatric Gastroenterology, Shaare Zedek Medical Center, Jerusalem, Israel, 4Pediatric Gastroenterology Unit, Shamir Assaf Harofeh Medical Center, Zerifin, Israel, 5Pediatric Gastroenterology Unit, Sheba Medical Center- Edmond and Lily Safra Children’s Hospital-Tel-Hashomer, Ramat-Gan, Israel, 6The Juliet Keidan Institute of Pediatric Gastroenterology, Shaare Zedek Medical Center-, Jerusalem, Israel, 7Pediatric Gastroenterology Unit, ‘Dana-Dwek’ Children’s Hospital- Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel, 8Pediatric Gastroenterology Unit, Kaplan Medical Center, Rehovot, Israel, 9Pediatric Gastroenterology Unit, Rambam Medical Center, Haifa, Israel, 10Pediatric Gastroenterology Unit, Saban Pediatric Medical Center- Soroka University Hospital and Faculty of Health Sciences, Beer-Sheva, Israel, 11Department of Gastroenterology, Sheba Medical Center- Tel-Hashomer, Ramat-Gan, Israel

Background

Growth impairment is common in children with Crohn’s disease. We aimed to assess the effect of adalimumab treatment on linear growth in children with Crohn’s disease in a post-hoc analysis of the PAILOT randomised controlled trial.

Methods

Children 6–17 years old with moderate-to-severe Crohn’s disease, naïve to biologic treatment, who responded to adalimumab induction, were assessed at week 4, 8 andevery8 weeks thereafter until week 72 for anthropometric parameters (height, weight and body mass index, BMI, Z-scores). We also analysed the associations of these parameters with clinical disease activity, inflammatory biomarkers, faecal calprotectin and adalimumab trough concentration.

Results

Overall, 66 patients had available anthropometric parameters between week 4 to 72(29% females, mean age 14.3 ± 2.6 years). The median improvement of height z–score /month was +0.014, 95% CI 0.004–0.024, p = 0.006 with an overall improvement during the study period from -0.62 (IQR −1.6–0.15) to −0.33 (IQR -1.3–0.5). The median increase of weight z- score/month was +0.025, 95% CI 0.015–0.034, p = 0.025 [overall increase from -0.54 (IQR −1.2–0.15) to −0.1, (IQR -0.9–0.6)], whereas the median increase in BMI z –score/month was +0.02, 95% CI 0.008–0.031, p = 0.001 [overall increase from −0.4 (IQR −1.0–0.5) to 0.0 (IQR −0.8–0.9)]. There was a significant correlation between paediatric Crohn’s disease activity index and erythrocyte sedimentation rate at week 4 and height z-score changes (p = 0.043 and p = 0.048), respectively, and a marginal correlation with C-reactive protein (p = 0.06). There was a significant correlation between sustained clinical and biologic remission (weeks 4–72) and changes in height z-score during follow-up (p = 0.001). Faecal calprotectin, adalimumab trough concentrations and combination therapy with an immunomodulator were not associated with height z-score changes.

Conclusion

Adalimumab treatment significantly improved linear growth, and normalised weight and BMI in children with moderate-to-severe Crohn’s disease.