When is ustekinumab indicated for the treatment of Crohn disease?

Updated: Jul 26, 2019
  • Author: Leyla J Ghazi, MD; Chief Editor: Praveen K Roy, MD, AGAF  more...
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Ustekinumab inhibits interleukin (IL)-12 and IL-23 cytokines, which play a key role in inflammatory and immune responses. In September 2016, the FDA approved ustekinumab for adults with moderately to severely active Crohn disease who have [113, 114] :

  • Failed or were intolerant to immunomodulators or corticosteroids, but never failed treatment with a TNF blocker, OR
  • Failed or were intolerant to treatment with 1 or more TNF blockers

FDA approval was based on three phase 3 studies (UNITI-1, UNITI-2, IM UNITI) in more than 1300 patients. [113, 114] Of patients who were either new to, experienced with, or failed biologic therapy (TNF blockers), between 34% (UNITI-1 study) and 56% (UNITI-2 study) of patients experienced relief of symptoms within 6 weeks after receiving ustekinumab as a one-time IV infusion. Noticeable improvement was observed as early as 3 weeks. A majority of those who responded to induction dosing and continued treatment with subcutaneous (SC) maintenance doses every 8 weeks were in remission at the end of 44 weeks (52 weeks from the initiation of the induction dose). [115, 116, 117]

Results from the ENEIDA registry study that evaluated the the real-world, short-term effectiveness of ustekinumab in 305 patients with highly refractory Crohn disease found clinical remission rates of 47% at week 8 and 58% at week 14 of treatment, normalization of fecal calprotectin levels in 46% at week 8 and 54% at week 14, and normalization of C-reactive protein levels in 35% at week 8 and 41% at week 14. [118]

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