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P688 Ustekinumab in resistant Crohn’s disease: 1-year UK IBD tertiary referral centre ‘real-world’ experience

S. P. Borg-Bartolo*1, K. Kemp1, R. P. Willert1, A. J. Makin1, S. E. Levison1

1Manchester University NHS Foundation Trust, Department of Gastroenterology, Manchester, UK

Background

Ustekinumab (UST) binds to the p40 subunit of IL12 and IL23 to prevent IL12RB1 cell-surface receptor activation thus inhibiting downstream inflammatory signalling and cytokine production. In the UK, it is approved for moderately to severely active Crohn’s disease (CD). We assessed the efficacy and safety of UST in a ‘real-world’ cohort of refractory CD patients treated at a single UK centre over the course of 1 year.

Methods

We retrospectively collected data from the electronic records of CD patients treated with UST at a single UK IBD tertiary referral centre. Patient demographics and adverse events were recorded. Clinical response to UST was evaluated at baseline and follow-up using Harvey–Bradshaw Index (HBI) scores, C reactive protein (CRP), and faecal calprotectin (FC). Paired Student’s T-tests were used to determine statistical significance.

Results

46 patients with CD (mean age at UST commencement 36 years; range 18–73 years; M:F ratio 1:1.2) with mean CD duration at UST commencement of 9 years (range 1–20 years) were treated with UST. CD location was ileal in 10 patients (22%), colonic in 11 patients (24%) and ileo-colonic in 25 patients (54%). 1 patient (2%) also had upper gastrointestinal CD involvement. CD behaviour was penetrating in 8 patients (17%), stricturing in 18 patients (39%) and non-penetrating, non-stricturing in 20 patients (44%). All patients had failed at least one anti-TNF agent. 19 patients (41%) had failed two anti-TNF agents and 16 patients (35%) had failed two anti-TNF agents and vedolizumab. Fourteen patients (30%) received concomitant immunomodulator therapy and 14 patients (30%) received bridging steroids. Data were available for 38 patients at 3 months and 17 patients at 12 months of UST treatment. Mean HBI significantly improved by both month 3 (9 vs. 4; p < 0.001) and 1 year (8 vs. 3; p < 0.001). Mean FC also significantly improved by both month 3 (1532 vs. 583; p < 0.001) and 1 year (1252 vs. 324; p = 0.0016). There was no statistically significant change in mean CRP by month 3 (16 vs. 9; ns) or 1 year (11 vs. 8; ns). Three/38 (8%) patients discontinued due to primary non-response and 2/38 (5%) patients discontinued due to secondary loss of response. A transitional cell carcinoma recurrence was detected in 1 patient while on treatment. A further patient developed a facial palsy.

Conclusion

UST appears clinically effective and safe in this cohort of treatment-refractory CD patients after 1 year of therapy. Future work to combine ‘real-world’ data and to assess longer term outcomes will help us to better understand when and how to use UST in the management of CD.