P684 The effect of tofacitinib on serum lipids and cardiovascular safety in patients with ulcerative colitis: updated results from the tofacitinib ulcerative colitis clinical programme

Abstract

S023 Table 1: Baseline characteristics. Baseline characteristics n = 18 Median age (IQR) at IBD diagnosis and conception (year) 23 (17-w27) / 31 (26-34) Crohn's disease/Ulcerative colitis 12/18(67%) / 6/18 (33%) Median CRP (IQR) before conception (mg/l) 5 (2-13) Median duration (IQR) of VDZ therapy at conception (months) 12 (6-14) IBD medication (<12 weeks of conception) Systemic 5-ASA 3/18 (17%) Immunomodulators 1/18 (6%) Usage during pregnancy Smoking 3/18 (17%) Folic acid supplementation 16/17 (94%) Caesarean section* 5/16 (31%) *All Crohn's patients with elective Caesarean section due to perianal disease or prior surgery Background: Tofacitinib is an oral, small-molecule Janus kinase inhibitor that is being investigated for ulcerative colitis (UC). We describe baseline (BL) cardiovascular (CV) risk, the effect of tofaci-tinib treatment on lipid concentrations, and incidence rates (IRs; patients with events per 100 patient-years) of major adverse CV events (MACE) in patients enrolled in the UC global development programme. Methods: Analyses were performed for patients in three placebo-controlled induction studies (Ind), a 52-week placebo-controlled maintenance study (Main) and an ongoing, open-label, long-term extension (LTE) study (N = 1157). Lipid concentrations were assessed at pre-induction BL and up to Week 61 for responders to tofacitinib 10 mg twice daily (BID) in Ind who were randomised to tofacitinib 5 or 10 mg BID or placebo in Main. IRs and confidence intervals (CI) for MACE were calculated (follow-up to December 2016), including patients with ≥1 event per 100 patient-years of exposure. The distribution of CV risk factors and Reynolds Risk Score (RRS) was determined for male patients ≤45 and >45 years and female patients ≤55 and >55 years. Results: Mean pt age was 41.3 years. At BL, RRS was ≥10% in 24.4% of males >45 years and 6.4% of females >55 years. Most patients did not require lipid-lowering medication (Table). Dose-dependent increases in total cholesterol (TC), high-density