Major Observational Study Compares Long-term Safety of Ustekinumab vs Other Biologics in IBD — 1,000+ Patient Cohort
247 Health News Editorial
·15 Apr 2026
·3 min read
·clinical-trialsMajor observational study tracking 1,000+ IBD patients compares long-term safety of ustekinumab versus other biologics, focusing on malignancy and infection risks. Results expected 2029 will inform clinical practice guidelines.
Originally reported by ClinicalTrials.gov
References
- 1.Janssen Scientific Affairs, LLC. (2020). An Observational Study to Assess the Long-term Safety of Ustekinumab Versus Other Biologic Therapies Among Patients With Crohn's Disease and Ulcerative Colitis [Clinical trial registration NCT04372108]. ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT04372108
- 2.Feagan, B. G., Sandborn, W. J., Gasink, C., Jacobstein, D., Lang, Y., Friedman, J. R., Blank, M. A., Johanns, J., Gao, L. L., Miao, Y., Adedokun, O. J., Sands, B. E., Hanauer, S. B., Vermeire, S., Targan, S., Ghosh, S., de Villiers, W. J., Colombel, J. F., Tulassay, Z., ... UNITI–IM-UNITI Study Group. (2016). Ustekinumab as Induction and Maintenance Therapy for Crohn's Disease. New England Journal of Medicine, 375(20), 1946-1960. https://doi.org/10.1056/NEJMoa1602773
- 3.Ray, W. A. (2003). Evaluating medication effects outside of clinical trials: new-user designs. American Journal of Epidemiology, 158(9), 915-920. https://doi.org/10.1093/aje/kwg091
- 4.Schneeweiss, S., & Avorn, J. (2005). A review of uses of health care utilization databases for epidemiologic research on therapeutics. Journal of Clinical Epidemiology, 58(4), 323-337. https://doi.org/10.1016/j.jclinepi.2004.10.012
- 5.Lichtenstein, G. R., Feagan, B. G., Cohen, R. D., Salzberg, B. A., Diamond, R. H., Chen, D. M., Pritchard, M. L., & Sandborn, W. J. (2012). Serious infection and mortality in patients with Crohn's disease: more than 5 years of follow-up in the TREAT registry. American Journal of Gastroenterology, 107(9), 1409-1422. https://doi.org/10.1038/ajg.2012.18
- 6.Sands, B. E., Sandborn, W. J., Van Assche, G., Lukas, M., Xu, J., James, A., Abhyankar, B., & Lasch, K. (2019). Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis. New England Journal of Medicine, 381(13), 1201-1214. https://doi.org/10.1056/NEJMoa1900750
- 7.Torres, J., Bonovas, S., Doherty, G., Kucharzik, T., Gisbert, J. P., Raine, T., Adamina, M., Armuzzi, A., Bachmann, O., Bager, P., Biancone, L., Bokemeyer, B., Bossuyt, P., Burisch, J., Collins, P., El-Hussuna, A., Ellul, P., Frei-Lanter, C., Furfaro, F., ... European Crohn's and Colitis Organisation. (2020). ECCO Guidelines on Therapeutics in Crohn's Disease: Medical Treatment. Journal of Crohn's and Colitis, 14(1), 4-22. https://doi.org/10.1093/ecco-jcc/jjz180
- 8.Lamb, C. A., Kennedy, N. A., Raine, T., Hendy, P. A., Smith, P. J., Limdi, J. K., Hayee, B., Lomer, M. C., Parkes, G. C., Selinger, C., Barrett, K. J., Davies, R. J., Bennett, C., Gittens, S., Dunlop, M. G., Faiz, O., Fraser, A., Garrick, V., Johnston, P. D., ... IBD Guidelines eDelphi Consensus Group. (2019). British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults. Gut, 68(Suppl 3), s1-s106. https://doi.org/10.1136/gutjnl-2019-318484
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247 Health News Editorial
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