P284 Drug survival and remission rates in ustekinumab treated ulcerative colitis: Results from the Swedish Inflammatory Bowel Disease register (SWIBREG)

Abstract

\n \n \n Randomised controlled trials may not correctly reflect clinical practice. We aimed to assess the clinical effectiveness of ustekinumab in a real-world cohort of patients with ulcerative colitis (UC).\n \n \n \n This observational, multi-centre cohort study explored ustekinumab treated patients with UC from the Swedish inflammatory bowel disease register (SWIBREG), a nationwide quality register. Prospectively collected clinical data were extracted December 2020. The primary outcome was the 16-week ustekinumab continuation rate. Secondary outcomes included A) drug continuation rate at the end of follow-up, B) corticosteroid-free biochemical remission, defined as f-Calprotectin<250µg/g, and C) corticosteroid-free clinical remission per patient-reported Mayo score, i.e. a rectal bleeding subscore <1 and a stool frequency subscore ≤1 and not greater than baseline. Continuous data are presented as median and (interquartile range). Differences between baseline and follow-up visits were assessed by the Wilcoxon signed-rank test.\n \n \n \n In total, 145 patients were included and followed for a median period of 32 (19-56) weeks. Baseline characteristics are presented in Table 1. The drug continuation rate was 87% (126/145) at 16 weeks and 69% (100/145) at end of follow-up (Figure 1-2). Corticosteroid-free clinical and biochemical remission rates at follow-up visits are shown in Figure 3. The 6-point Mayo score decreased from 5 (3-6) at baseline to 2 (2-4) at 16 weeks (p<0.01) and to 3 (2-4) at last follow-up (p<0.01). F-calprotectin levels decreased from 779 (252-1530) µg/g to 246 (56-844) µg/g at week 16 (p=0.02) and to 142 (36-935) µg/g at last follow-up (p<0.01).\n \n \n \n Ustekinumab was associated with clinical effectiveness in this nationwide real-world treatment refractory cohort.\n \n \n \n \n