TY - JOUR
T1 - Ustekinumab for Crohn's Disease
T2 - Two-Year Results of the Initiative on Crohn and Colitis (ICC) Registry, a Nationwide Prospective Observational Cohort Study
AU - Straatmijer, Tessa
AU - Biemans, Vince B C
AU - Hoentjen, Frank
AU - de Boer, Nanne K H
AU - Bodelier, Alexander G L
AU - Dijkstra, Gerard
AU - van Dop, Willemijn A
AU - Haans, Jeoffrey J L
AU - Jansen, Jeroen M
AU - Maljaars, P W Jeroen
AU - van der Marel, Sander
AU - Oldenburg, Bas
AU - Ponsioen, Cyriel Y
AU - Visschedijk, Marijn C
AU - de Vries, Annemarie C
AU - West, Rachel L
AU - van der Woude, C Janneke
AU - Pierik, Marieke
AU - Duijvestein, Marjolijn
AU - van der Meulen-de Jong, Andrea E
N1 - © The Author(s) 2021. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.
PY - 2021/11
Y1 - 2021/11
N2 - 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.
AB - 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.
U2 - 10.1093/ecco-jcc/jjab081
DO - 10.1093/ecco-jcc/jjab081
M3 - Article
C2 - 33909062
VL - 15
SP - 1920
EP - 1930
JO - Journal of Crohn's and Colitis
JF - Journal of Crohn's and Colitis
SN - 1873-9946
IS - 11
ER -