Ustekinuma b for Crohn’s Disease: Two-Year Results of the Initiative on Crohn and Colitis (ICC) Registry, a Nationwide Prospective Observational Cohort Study

Autor:	P W Jeroen Maljaars, Marijn C. Visschedijk, Tessa Straatmijer, Cyriel Y. Ponsioen, Marjolijn Duijvestein, Bas Oldenburg, Annemarie C. de Vries, Jeoffrey J L Haans, Frank Hoentjen, Nanne K. H. de Boer, C. Janneke van der Woude, Alexander Bodelier, Gerard Dijkstra, Vince B. C. Biemans, Willemijn A van Dop, Marieke Pierik, Jeroen M. Jansen, Sander van der Marel, Andrea E. van der Meulen-de Jong, Rachel L. West
Přispěvatelé:	Gastroenterology and hepatology, Amsterdam Gastroenterology Endocrinology Metabolism, MUMC+: MA Maag Darm Lever (9), Interne Geneeskunde, RS: NUTRIM - R2 - Liver and digestive health, Gastroenterology & Hepatology, Gastroenterology and Hepatology, Graduate School, Groningen Institute for Organ Transplantation (GIOT), Translational Immunology Groningen (TRIGR), Groningen Institute for Gastro Intestinal Genetics and Immunology (3GI)
Rok vydání:	2021
Předmět:	Male real-world MULTICENTER Disease Gastroenterology Cohort Studies 0302 clinical medicine Crohn Disease Prospective Studies Registries 030212 general & internal medicine Prospective cohort study OUTCOMES Crohn's disease Antibodies Monoclonal General Medicine Middle Aged Treatment Outcome SAFETY Female Ustekinumab 030211 gastroenterology & hepatology Inflammatory diseases Radboud Institute for Molecular Life Sciences [Radboudumc 5] REAL-WORLD EXPERIENCE Cohort study medicine.drug Adult MAINTENANCE THERAPY medicine.medical_specialty Other Research Radboud Institute for Molecular Life Sciences [Radboudumc 0] Statistics Nonparametric 03 medical and health sciences All institutes and research themes of the Radboud University Medical Center VEDOLIZUMAB Internal medicine medicine Humans In patient Colitis business.industry medicine.disease Faecal calprotectin ICC Registry Multivariate Analysis business SUBCUTANEOUS USTEKINUMAB INFLAMMATORY-BOWEL-DISEASE
Zdroj:	Journal of Crohn's and Colitis, 15(11), 1920-1930. Elsevier Journal of Crohn's and Colitis, 15(11), 1920-1930. OXFORD UNIV PRESS Journal of Crohn's & Colitis, 15(11), 1920-1930. Oxford University Press Journal of Crohn's and Colitis, 15, 1920-1930 Journal of Crohn's and Colitis, 15(11), 1920-1930. Oxford University Press Straatmijer, T, Biemans, V B C, Hoentjen, F, de Boer, N K H, Bodelier, A G L, Dijkstra, G, van Dop, W A, Haans, J J L, Jansen, J M, Maljaars, P W J, van der Marel, S, Oldenburg, B, Ponsioen, C Y, Visschedijk, M C, de Vries, A C, West, R L, van der Woude, C J, Pierik, M, Duijvestein, M & van der Meulen-de Jong, A E 2021, ' Ustekinuma b for Crohn's Disease : Two-Year Results of the Initiative on Crohn and Colitis (ICC) Registry, a Nationwide Prospective Observational Cohort Study ', Journal of Crohn's and Colitis, vol. 15, no. 11, pp. 1920-1930 . https://doi.org/10.1093/ecco-jcc/jjab081 Journal of Crohn's and Colitis, 15, 11, pp. 1920-1930
ISSN:	1876-4479 1873-9946
Popis:	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 μg/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.
Databáze:	OpenAIRE
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