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Background Real-life data on the efficacy of ustekinumab as first-line therapy for the treatment of moderate to severe Crohn’s disease (CD) is lacking. The objective of this study was to compare the clinical remission rate at 3 months of patients treated by ustekinumab or anti-TNF agents as first-line biological therapy. Methods We conducted a two-center retrospective study including biologic-naïve patients starting either ustekinumab or an anti-TNF agent for CD between January 2016 and December 2019. The primary endpoint was clinical remission at 3 months after therapy initiation, defined as a Harvey Bradshaw Index (HBI) &amp;lt; 4 without steroids, need for CD-related surgery or treatment discontinuation due to treatment failure or intolerance. Secondary endpoints were remission at 12 months and time to drug withdrawal. Patients treated with ustekinumab were matched 1:3 to patients receiving anti-TNF agents using a propensity score including age, CD duration, smoking status, CD location according to the Montréal classification and history of perianal disease. Results 208 patients [104 (50%) female, median age (InterQuartileRange) 30 years (23–47)] were included, 156 (75%) patients starting anti-TNF (95 (45%) adalimumab and 61 (29%) infliximab) and 52 (25%) ustekinumab and followed for a median (IQR) duration of 39 (22–52) months. Median (IQR) CD duration was 21 (6–104) months and 45 (22%) patients had previously undergone a CD-related surgery. At inclusion, the median (IQR) HBI was 5 (2–8) and 83 (39%) patients were receiving oral corticosteroids. After matching, remission rates at 3 months were 25/45 (56%) patients in the ustekinumab group versus 102/135 (76%) in the antiTNF group [p=0.01, odds ratio (OR) 0.40 (Confidence Interval (CI) 95% 0.20, 0.82)]. At 12 months, remission rates were 26/41 (63%) patients in the ustekinumab group versus 99/123 (81%) in the antiTNF group (p=0.03). No difference was observed in terms of time to drug withdrawal (p=0.25). Rates of drug persistence at 12 months were 89% in patients treated with ustekinumab and 87% in those treated with antiTNF, respectively. Similar rates of adverse events were observed in the two groups (13% versus 13%, p&amp;gt;0.9). In the antiTNF group, 3/156 (2%) adverse events leading to hospitalization were observed compared to 0/52 (0%) in the ustekinumab group (p=0.6). Conclusion In this retrospective cohort, we found that anti-TNF agents as a first-line biological therapy led to higher rates of remission at 3 and 12 months in biologic-naïve patients with Crohn’s disease than ustekinumab.

P524 Compared efficacy of ustekinumab and anti-TNF agents as first-line biological therapy in luminal Crohn’s disease