Health Technology/clinical-trials

Major Observational Study Compares Long-term Safety of Ustekinumab vs Other Biologics in IBD — 1,000+ Patient Cohort

247 Health News Editorial

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15 Apr 2026

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3 min read

·clinical-trials

Major 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. 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. 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
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  5. 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. 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. 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. 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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