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P386 Two year follow up of children with Inflammatory Bowel Disease (IBD) treated with vedolizumab and ustekinumab

Mardare, R.(1);Burgess, N.(1);Studart, D.(1);Deb, P.(1);Gasparetto, M.(1);Croft, N.(1);Naik, S.(1);Kadir, A.(1);

(1)Royal London Hospital, Paediatric Gastroenterology, London, United Kingdom

Background

In 2018, our Trust approved the use of vedolizumab in children with Ulcerative Colitis (UC) and ustekinumab in children with Crohn’s Disease (CD). At the time, access to these drugs for children was only possible through research studies.

Our aim was to assess the efficacy and safety of these novel treatments in our cohort.

Methods

We conducted an observational single centre cohort study. Data was obtained from our electronic system, Cerner Millennium, and Infoflex database. Analysis was performed using SPSS.

Results

27 children were treated with vedolizumab or ustekinumab with 1 receiving both. All patients had failed anti-TNF medication, except 1 research patient who commenced on vedolizumab at diagnosis. 

VedolizumabUstekinumab
N1710
Median age at diagnosis (years)9.1 (4.7 - 14.4)7.0 (4.0 - 12.4)
Diagnosis nUC 13/17
IBDU 2/17
CD (2/17 - research)
CD 10/10
Disease location (Paris classification) nE4 14/17
E2 1/17
L2L4apG0 2/17
L3 8/10
L2 2/10
Upper involvement 50%
Perianal disease 70%
Growth failure 70%
Length of prior anti-TNF treatment (months)4.8 (0 - 44.7)24.3 (6.8 - 50.3)
Treatment length (months)13.5 (2.6 - 41.2)22.0 (7.1 -28.1)
Follow up length (years)4.1 (2.0 - 12.4)8.0 (2.8 - 11.9)
Clinical Remission (%)  *Note that only part of the patients were assessed at week 52, 104 and end of study, as detailed.Week 12 76%
Week 52 9/9
Week 104 2/2
End of study 10/10
Week 8 50%
Week 52 4/8
Week 104 3/4
End of study 5/6
Endoscopic confirmation of remission1 patient (2, 3 years)
1 patient (3 months)
1 patient (1 and 2 years)

*Data expressed as median (range)


There were no serious adverse events apart from one patient who developed eosinophilic pneumonitis, but it is unclear whether this was due to vedolizumab or 5 ASA. Minor skin or upper respiratory tract infections were diagnosed in 5/10 patients on ustekinumab and 1/10 patient developed Clostridium difficile. Adrenal insufficiency, as a result of prolonged courses of steroids, was detected in 7/27 children.

Clinical remission was defined as PUCAI <10 and PCDAI<10. At 2 years follow up, 55% (15/27) remained in remission on treatment. 1/27 is currently still on ustekinumab and has mild CD and 1/27 had their vedolizumab stopped due to compliance and monitoring issues. Of the 10/27 who failed, 50% were primary non-responders and 50% had secondary loss of response. 9/10 required subtotal colectomy and ileostomy, while the research patient, who was anti-TNF naïve, switched to infliximab after failing vedolizumab. Endoscopic remission was confirmed in 3 patients.

Conclusion

In children with refractory IBD failing anti-TNF treatment, vedolizumab and ustekinumab are effective and safe alternatives for inducing and maintaining remission, avoiding major invasive surgery.

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