TY - JOUR
T1 - Ustekinuma b for Crohn's Disease: Two-Year Results of the Initiative on Crohn and Colitis (ICC) Registry, a Nationwide Prospective Observational Cohort Study
AU - Straatmijer, T.
AU - Biemans, V.B.C.
AU - Hoentjen, F.
AU - de Boer, N.K.H.
AU - Bodelier, A.G.L.
AU - Dijkstra, G.
AU - van Dop, W.A.
AU - Haans, J.J.L.
AU - Jansen, J.M.
AU - Maljaars, P.W.J.
AU - van der Marel, S.
AU - Oldenburg, B.
AU - Ponsioen, C.Y.
AU - Visschedijk, M.C.
AU - de Vries, A.C.
AU - West, R.L.
AU - van der Woude, C.J.
AU - Pierik, M.
AU - Duijvestein, M.
AU - van der Meulen-de Jong, A.E.
PY - 2021/11/1
Y1 - 2021/11/1
N2 - Aims: 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 2-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 weeks 0, 12, 24, 52 and 104, clinical remission Harvey Bradshaw Index <= 4 points], biochemical remission (faecal calprotectin <= 200 mu g/g and/or C-reactive protein <= 5 mg/L], perianal 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 patients with at least 2 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 weeks 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 weeks 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.
AB - Aims: 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 2-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 weeks 0, 12, 24, 52 and 104, clinical remission Harvey Bradshaw Index <= 4 points], biochemical remission (faecal calprotectin <= 200 mu g/g and/or C-reactive protein <= 5 mg/L], perianal 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 patients with at least 2 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 weeks 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 weeks 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.
KW - Ustekinumab
KW - Crohn's disease
KW - real-world
KW - ICC Registry
KW - INFLAMMATORY-BOWEL-DISEASE
KW - REAL-WORLD EXPERIENCE
KW - SUBCUTANEOUS USTEKINUMAB
KW - MAINTENANCE THERAPY
KW - MULTICENTER
KW - VEDOLIZUMAB
KW - OUTCOMES
KW - SAFETY
U2 - 10.1093/ecco-jcc/jjab081
DO - 10.1093/ecco-jcc/jjab081
M3 - Article
C2 - 33909062
SN - 1873-9946
VL - 15
SP - 1920
EP - 1930
JO - Journal of Crohn's & Colitis
JF - Journal of Crohn's & Colitis
IS - 11
ER -