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Drug safety

Lindå H, von Heijne A, Major EO et al. N Engl J Med 2009;361:1081–7.

Cases of progressive multifocal leukoencephalopathy (PML), caused by a rare, opportunistic, demyelinating viral infection, have previously been reported in Crohn’s disease and multiple sclerosis (MS) patients treated with the anti-α4 integrin antibody natalizumab. This brief report details the clinical course and treatment of an MS patient treated with natalizumab in whom PMLwas diagnosed.

 

The main treatment goal in Crohn’s disease is to manage acute attack and then to maintain remission. Conventional therapy for Crohn’s disease includes mesalamine or budesonide, with prednisone reserved for those patients with moderate-to-severe disease who fail to respond to these agents. Immunomodulating agents such as azathioprine, 6-mercaptopurine, or methotrexate can be safely added in nearly 40% of steroid-dependent or steroid-refractory patients while biological drugs (anti-tumor necrosis factor agents such as adalimumab, certolizumab pegol, and infliximab; or anti-α4 integrin antibodies such as natalizumab) are employed to induce and maintain clinical remission in those with moderate-to-severe Crohn’s disease and an inadequate response to conventional therapy. However, infectious and malignancy risks associated with biological drugs must be a serious consideration.

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