Gut | 2019
PTH-085\u2005Ustekinumab for refractory Crohn’s disease (CD) in adolescents: experience from two UK IBD centres
Abstract
Introduction The incidence of CD in adolescents and young persons (AYP) is increasing. Whilst antiTNF use in AYP is well established, little is known about the efficacy and safety of ustekinumab. We report our multicentre experience. Methods Data was retrospectively collected on 14–23yr olds starting ustekinumab at University College London Hospital (UCLH) and The Royal London Hospital (RLH) from September 2017–18. Endpoints were: clinical (i) response (reduction in Harvey Bradshaw Index (HBI) of ≥3 or sustained HBI ≤4 points) and (ii) remission (HBI ≤4 points) and biological (i) response (50% reduction in CRP) and (ii) remission (CRP <5 mg/L where baseline CRP >5 mg/L) after 1st, 2nd and 3rd doses. Results Table 1 summarises the baseline characteristics of 33 AYP commenced on ustekinumab. All patients received i.v. drug at baseline, s.c. second dose at week 8, and 8–12 weekly s.c. doses thereafter. Treatment was stopped in 5 patients prior to week 16 (one for drug reaction; three for primary non-response, two of whom required intestinal resection). Three patients experienced other adverse events (two related to perianal disease, one due to pain and vomiting) but did not discontinue treatment. After the 1st, 2nd, and 3rd doses, clinical rates of (i) response and (ii) remission were (i) 40, 38 and 43% and (ii) 50, 36 and 29% respectively. After the 1st, 2nd and 3rd doses, biological rates of (i) response and (ii) remission were (i) 24, 27, 33% and (ii) 10, 19, 11% respectively. Conclusions We report on the use of ustekinumab in AYP at 2 tertiary IBD centres. Baseline characteristics reflect early onset CD in antiTNF experienced patients with a high proportion of upper GI involvement and previous instestinal resection. Ustekinumab is efficacious in this cohort, with early clinical endpoints comparable to trial and real-world literature seen in older populations.Abstract PTH-085 Table 1 Characteristic Total N= 33 Gender(%) M 16 (48.5) F 17 (51.5) Tertiary Centre(%) RLH 12 (36.4) UCLH 21 (63.6) Median age(IQR), yr 20.7 (18.4–22.8) Median disease duration(IQR), yr 8.3 (5.6–10.5) Smoking Status(%) Current 3 (9.1) Never/Former 30 (90.9) Montreal Class.(%) Age at diagnosis A1 27 (81.8) A2 6 (18.2) Location L1 6 (18.2) L2 10 (30.3) L3 17 (51.5) + L4 3 (9.1) Behaviour B1 14 (42.4) B2 9 (27.3) B3 10 (30.3) Perianal disease 13 (39.4) Prior biologic(%) Anti-TNF 33 (100) Two anti-TNF experienced 24 (72.7) Vedolizumab experienced 11 (33.3) Prior surgery 10 (43.5) (n=23) Concomitant DHx(%) Aza/6 MP/MTX 17 (51.5) Steroids 7 (21.9) (n=32) Data at baseline, Mean(sd) HBI 6.8 (5.0) (n=26) CRP 25.1 (24.1) (n=31) FCP 746 (536) (n=6) BMI 21.23 (4.1) (n=19)