When is natalizumab therapy indicated for patients with Crohn disease?

Updated: Jul 26, 2019
  • Author: Leyla J Ghazi, MD; Chief Editor: Praveen K Roy, MD, AGAF  more...
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Answer

Natalizumab therapy is currently reserved for individuals with moderate to severe Crohn disease who are intolerant of or have lost response to other biologic or immunosuppressant therapies. The ENACT (Evaluation of Natalizumab As Continuous Therapy) [110] and ENCORE (Efficacy of Natalizumab in Crohn’s Disease Response and Remission) [111] trials evaluated the efficacy of natalizumab in the induction of response (ENACT 1 and ENCORE) and maintenance of response (ENACT 2) in patients with active Crohn disease.

In ENACT 1, natalizumab induced clinical response at week 10 in patients with an elevated C-RP level. [110] ENCORE found a 48% clinical response rate and 26% clinical remission rate at week 8. [111] In ENACT 2, of patients from ENACT 1 who had had a clinical response to natalizumab and who were rerandomized to maintenance therapy with natalizumab 300 mg or placebo every 4 weeks for 1 year, 61% of patients in the natalizumab group maintained response, and 44% achieved remission through weeks 36 and 60. [110]


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