OBJECTIVE: Ustekinumab is a monoclonal antibody that selectively targets p40, a shared subunit of the cytokines interleukin (IL)-12 and IL-23. It is registered for the treatment of inflammatory bowel diseases. We assessed the two-year effectiveness and safety of ustekinumab in a real world, prospective cohort of patients with Crohn's disease (CD).
METHODS: Patients who started ustekinumab were prospectively enrolled in the nationwide Initiative on Crohn and Colitis (ICC) Registry. At week 0, 12, 24, 52 and 104, clinical remission (HBI ≤ 4 points), biochemical remission (fecal calprotectin (FC) ≤200 μg/g and/or CRP ≤5 mg/L), peri-anal fistula remission, extra-intestinal manifestations, ustekinumab dosage and safety outcomes were determined. The primary outcome was corticosteroid-free clinical remission at week 104.
RESULTS: In total, 252 CD patient with at least two years of follow up were included. Of all included patients, the proportion of patients in corticosteroid-free clinical remission was 32.3% (81/251), 41.4% (104/251), 39% (97/249) and 34.0% (84/247), at week 12, 24, 52 and 104, respectively. In patients with combined clinical and biochemical disease activity at baseline (n=122), the corticosteroid-free clinical remission rates were 23.8% (29/122), 35.2% (43/122), 40.0% (48/120) and 32.8% (39/119) at week 12, 24, 52 and 104, respectively. The probability of remaining on ustekinumab treatment after 52 and 104 weeks in all patients was 64.3% and 54.8%, respectively. The main reason for discontinuing treatment after 52 weeks was loss of response (66.7%). No new safety issues were observed.
CONCLUSION: After 104 weeks of ustekinumab treatment, one third of CD patients were in corticosteroid-free clinical remission.