P718 Combination therapy of adalimumab with an immunomodulator is not more effective than adalimumab monotherapy in children with Crohn’s disease
M. Matar1, R. Shamir1, D. Turner2, E. Broide3, B. Weiss4, O. Ledder2, A. Guz-Mark1, F. Rinawi1, S. Cohen5, C. Topf Olivestone6, R. Shaul7, S. Ben-Horin8, A. Assa1
1The Schneider Children’s Hospital, Petach-Tikva, Israel, The institute of Gastroenterology- Nutrition and Liver diseases, Petach Tikva, Israel, 2Shaare Zedek Medical Center- The Hebrew University, Jerusalem, Israel, The Juliet Keidan institute of Pediatric Gastroenterology, Jerusalem, Israel, 3Shamir Assaf Harofeh Medical Center, Pediatric Gastroenterology Unit, Zerifin, Israel, 4Edmond and Lily Safra Children’s Hospital, Pediatric Gastroenterology Unit, Ranat Gan, Israel, 5Dana-Dwek Children’s Hospital, Tel Aviv Sourasky Medical Center, Pediatric Gastroenterology Unit, Tel Aviv, Israel, 6Kaplan Medical Center, Pediatric Gastroenterology Unit, Rehovot, Israel, 7Rambam Medical Center, Pediatric Gastroenterology Unit, Haifa, Israel, 8Sheba Medical Center, Department of Gastroenterology, Ramat Gan, Israel
Background
The PAILOT trial was a randomised controlled trial aimed to evaluate proactive vs. reactive therapeutic drug monitoring in children with Crohn’s disease (CD) treated with adalimumab. Our aim, in this post-hoc analysis of the PAILOT trial, was to assess the efficacy and safety of adalimumab combination treatment in comparison to monotherapy at week 72 after adalimumab induction.
Methods
Participants were children 6–17 years old, biologic naïve, with moderate-to-severe CD, who responded to adalimumab induction at week 4. Patients receiving immunomodulators at baseline, maintained a stable dose until week 24; patients could then discontinue immunomodulators. At each visit patients were assessed for disease index, serum biomarkers, faecal calprotectin, adalimumab trough concentration and anti-adalimumab antibodies.
Results
Out of the 78 patients (29% female; mean age, 14.3 ± 2.6 years), 34 patients (44%) received combination therapy. During the study period there was no significant difference in the rates of sustained corticosteroid free clinical remission (25/34, 73% vs. 28/44, 63%;
Conclusion
Combination therapy of adalimumab and an immunomodulator was not more effective than adalimumab monotherapy in children with CD.