PTH-084 Ustekinumab: Early experience and medium-term outcomes from a UK multi-centre real-world cohort. (June 2019)

• Record Type: Journal Article
• Authors: Gadhok, R; Rao, R; Honap, S; Samaan, M; Harpham-Lockyer, L; Kwok, H; Whitley, L; Ibarra, A; Burgess, N; Seward, E; Parkes, G; Mehta, S; Vega, R; McCartney, S; Bloom, S; Irving, P; Lindsay, JO; Kok, K; Rahman, F
• Is Part Of: Gut. Volume 68(2019)Supplement 2
• Page Start: A74
• Page End: A75
• Publication Date: 2019-06
• Subjects: Gastroenterology -- Periodicals; 616.33
• DOI: 10.1136/gutjnl-2019-BSGAbstracts.143
• Languages: English
• ISSNs: 0017-5749

Abstract

Abstract : Background: Ustekinumab is effective in inducing and maintaining remission of Crohn's disease (CD) in clinical trials. We present the first UK realworld, multicentre study of effectiveness. Methods: Data was 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 . 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 nonresponse (14 (9.4%)), drug reactions (2 (1.3%)), side effects (2 (1.3%)), and other causes (6 (4.0%)). Followup to week 32 was available for 125 (83.8%) patients. Adverse events occurred in 16 (10.7%) patients. Dosing schedule did not impact clinical and biological outcome at week 32. Where paired data was 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 wk 32 (12.9 mg/L(17.4), n=93, p=0.158). At weeks 8 and 32, clinical rates of (i) response, (ii) remission, and (iii) steroid-free remission were (i) 68 and 63%, (ii) 53 and 38%, (iii) 45 and 36% respectively. At weeks 8 and 32, biological rates of (i) response and (ii) remission were (i) 45 and 34%, (ii) 24 and 20% respectively. 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 1.238.13), and biological remission (n=56, p=0.027, RR1.95, 95% CI 1.213.13). 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). Conclusions: Ustekinumab is effective in a realworld cohort with response sustained at 6 months. Clinical and biological remission at week 8 predicted both clinical and biological outcomes at week 32.