FDA Approves New Option for Crohn Disease

The US Food and Drug Administration has approved ustekinumab (Stelara) for the treatment of adults with moderate to severe active Crohn disease who have failed or were intolerant to treatment with immunomodulators or corticosteroids or have failed treatment with a tumor necrosis factor blocker.

The biologic works by targeting interleukin-12 and interleukin-23 cytokines, which affect inflammation and immune responses.
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In 3 clinical studies involving more than 1300 patients, between 34% and 56% of patients experienced relief from Crohn symptoms in 6 weeks following one-time intravenous infusion of ustekinumab, with the majority in remission by 44 weeks after continued maintenance doses every 8 weeks.

Common adverse events include upper respiratory infections, headache, joint pain, nausea, itching, vomiting, and urinary tract infections.

—Michael Potts

Reference:

Janssen. FDA approves Stelara® (ustekinumab) for treatment of adults with moderately to severely active Crohn’s disease [press release]. Horsham, PA: Janssen Immunology; September 26, 2016. http://www.multivu.com/players/English/7883551-janssen-stelara-crohn-s-fda-approval/. Accessed September 26, 2016.