Ustekinumab is a new human monoclonal antibody, biologic immune response modifying agent indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Ustekinumab targets interleukin-12 and interleukin-23. In clinical studies, serious bacterial, fungal and viral infections have been observed in patients who received ustekinumab, according to the release.
Patients receiving ustekinumab who develop salmonella infections, particularly recurrent infections, may present to gastroenterologists for evaluation, and the FDA and Centocor Ortho Biotech are asking gastroenterologists report adverse events in patients treated with ustekinumab. Physicians can report these events using the following resources:
- Centocor Ortho Biotech Inc. at 800-457-6399.
- MedWatch (FDA safety information and adverse event reporting program) at 800-332-1088 or www.fda.gov/medwatch/report.
If you have a patient who develops a serious infection or RPLS while being treated with ustekinumab, or if you have a patient with cancer at any time after receiving ustekinumab therapy, it is important that you report the case even if you do not think there is a causal relationship. More information is available in the healthcare professional letter (pdf).
Read the AGA’s release about the STELARA safety alert for gastroenterologists.
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