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P318 Ustekinumab: early experience and medium-term outcomes from a UK multi-centre real-world cohort

R. Gadhok*1, R. Rao1, S. Honap2, M. Samaan3, L. Harpham-Lockyer3, H. Kwok3, L. Whitley3, A. Ibarra1, N. Burgess1, E. Seward3, G. Parkes1, S. Mehta3, R. Vega3, S. McCartney3, S. Bloom3, P. Irving2, J. O. Lindsay1, K. Kok1, F. Rahman3

1The Royal London Hospital, Barts Health NHS Trust, Department of Gastroenterology, London, UK, 2Guy's and St Thomas' NHS Foundation Trust, Department of Gastroenterology, London, UK, 3University College London Hospitals NHS Foundation Trust, Department of Gastroenterology, London, UK

Background

Ustekinumab is effective in inducing and maintaining remission of Crohn’s disease (CD) in clinical trials. We present the first UK real-world, multi-centre study of effectiveness.

Methods

Data were collected for patients started on ustekinumab for CD from September 2015 to May 2018 at 3 tertiary London centres. Clinical endpoints were (i) remission (Harvey–Bradshaw Index (HBI) ≤4 points) and (ii) response (reduction in HBI of ≥3 points or sustained HBI ≤ 4 points) at Week 8 and 32. Biological endpoints were (i) remission (CRP < 5 mg/l in patients with a baseline CRP >5 mg/l) and (ii) response (50% reduction in CRP) at Weeks 8 and 32.

Results

Baseline characteristics of the 149 patients analysed are shown in Table 1.

Table 1. Baseline characteristics of patients treated with ustekinumab between 2015 and 2018

The majority (146 (98%)) had failed anti TNF therapy. All patients received i.v. induction and 147 (99%) received a s.c. dose at Week 8. At Week 32, 91 (75.8%) patients were on 8 weekly dosing. Discontinuation occurred in 24 (16.1%) patients due to: primary non-response (14 (9.4%)), drug reactions (2 (1.3%)), side effects (2 (1.3%)), and other causes (6 (4.0%)). Follow-up to Week 32 was available for 125 (83.8%) patients. Clinical and biological outcomes at Week 8 and 32 are shown in Figure 1.

Figure 1. Clinical and biological outcomes at Weeks 8 and 32.

Clinical and biological outcomes at Weeks 8 and 32.

Adverse events occurred in 16 (10.7%) patients. Dosing schedule did not impact clinical and biological outcome at Week 32. Where paired data were available, mean (SD) HBI decreased significantly from baseline (6.2(4.9)) to Week 8 (4.6 (4.4), n = 99, p = 0.016) and was sustained at Week 32 (4.7 (4.1), n = 56, p < 0.001). Mean (SD) CRP decreased significantly from baseline (18.1 mg/l (21.9)) to Week 8 (11.9 mg/l (17.2), n = 122, p = 0.002), but did not sustain significant improvement at Week 32 (12.9 mg/l (17.4), n = 93, p = 0.158). Clinical remission at Week 8 was significantly associated with remission at Week 32: clinical remission (n = 34, p = 0.013, RR 3.16, 95% CI 1.23–8.13), and biological remission (n = 56, p = 0.027, RR 1.95, 95% CI 1.21–3.13). Biological remission at Week 8 was significantly associated with outcome at Week 32: biological response (n = 62, p = 0.003, RR 4.72, 95% CI 0.65–13.51), and biological remission (n = 62, p = 0.003, RR 4.41, 95% CI 1.78–10.87).

Conclusion

Ustekinumab is effective in a real-world cohort with response sustained at 6 months. Clinical and biological remission at Week 8 predicted both clinical and biological outcomes at Week 32.