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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a case series, an 18-year-old woman and a 54-year-old man were described, who developed posterior reversible encephalopathy syndrome (PRES) and encephalopathy, respectively during treatment with ustekinumab for Crohn's disease and Crohn's ileocolitis.
Case 1: An 18-year-old woman had a 6-year history of ileocolonic involvement and stricturing and fistulising phenotype, and received mesalazine [mesalamine], mercaptopurine [6-mercaptopurine], methotrexate and infliximab, with periods of medication non-adherence. In the year leading up to the presentation, she had multiple hospitalisations due to active Crohn's disease. During that time, the infliximab dose was increased to 10 mg/kg every 4 weeks, and methotrexate was continued. She presented to the hospital with abdominal pain...
- Mishra A, et al. Posterior Reversible Encephalopathy Syndrome following Ustekinumab Induction for Crohn's Disease. Case Reports in Gastroenterology 12: 521-527, No. 2, May-Aug 2018. Available from: URL: http://doi.org/10.1159/000492462 - USA