P551 Safety and effectiveness of vedolizumab for the treatment of paediatric patients with Inflammatory Bowel Diseases
Fabiszewska, S.(1);Derda, E.(1);Szymańska, E.(1);Osiecki, M.(1);Kierkuś, J.(1);
(1)The Children’s Memorial Health Institute, Department of Gastroenterology- Hepatology- Feeding Disorders and Pediatrics, Warsaw, Poland;
Background
Vedolizumab is effective in induction and maintenance of remission in adults with inflammatory bowel diseases (IBD). Paediatric data are still limited. The aim of this study was to assess safety and efficacy of vedolizumab in paediatric patients with IBD.
Methods
Fifty one patients with paediatric IBD (24 female, 27 male), both Crohn’s Disease (CD) and Ulcerative colitis (UC) were included into this retrospective study. There were 8 patients with CD and 43 patients with UC.
At weeks 0, 2, 6 vedolizumab was administered intravenously in a dose of 300 mg as induction therapy followed by a maintenance phase, infusions every 8 weeks.
At 1st dose week, 4th dose week and 10th dose week of treatment clinical activity scores (PUCAI, PCDAI), nutritional and laboratory parameters were collected.
Primary outcome was clinical response after induction therapy after 3 doses of vedolizumab (4th dose week). Secondary outcome was clinical remission after induction phase (4th dose week) and maintenance phase after 9 doses of vedolizumab (10th dose week).
Results
Patients’ age at the time of diagnosis was 6 – 16,6 y.o. (median 12,4 y.o.), age at week 0 was 8,2 – 17,9 y.o. (median 16,1 y.o.).
There was 1/51 patient (2%) anti-TNF naive, 50/51 patients (98%) had failed at least one anti-TNF alfa agent, 12/51 patients (23,5%) had failed at least two anti-TNF alfa agents. Systemic steroid therapy had been used previously in 47/51 patients (92,2%). Previous budesonide MMX, 5-ASA, Azathioprine or Cyclosporine therapy were also commonly used in our patients.
Vedolizumab treatment is still continued in 28/51 patients (54,9%), 11 of these patients (21,6%) received at least 10 doses of the drug.
Twenty three out of 51 patients (45.1%) were disqualified from further treatment due to: allergic reactions, non-response, loss of response or others causes.
Clinical response at 4th dose week was observed in 43/51 patients (84,3%). Clinical remission at 4th dose week was achieved in 32/51 (62,7%). Mean baseline (1st dose week) PUCAI score was 50,6; decreased to 7,8 after induction therapy with vedolizumab (4th dose week) and to 5,5 after maintenance phase (10th dose week). Mean baseline PCDAI score was 46,4, decreased to 22,9 after induction therapy and to 13,8 after maintenance phase.
No serious adverse events were reported.
Conclusion
Vedolizumab was safe and effective in the treatment of paediatric patients with IBD.