Reactions 1293 - 20 Mar 2010 PML risk increases after 2 years of Tysabri therapy The UK MHRA is warning that the risk of developing progressive multifocal leukoencephalopathy (PML) appears to increase after 2 years of therapy with natalizumab [Tysabri]. Therefore, the agency recommends that patients with multiple sclerosis should be informed of the risk of PML both before commencing therapy and again after 2 years, and that the risk: benefit balance be reconsidered at this time. Against a backdrop of approximately 66 000 patients exposed to natalizumab up to 20 January 2010, there have been 31 cases of PML reported worldwide; eight were fatal. Of the 31 confirmed cases, 23 occurred in MS patients treated with natalizumab for ≥ 2 years. This equates to a reporting rate of approximately 1–2 cases of PML per 1000 patients exposed to natalizumab for ≥ 2 years. The MHRA recommends that an MRI be performed within 3 months prior to commencing natalizumab therapy and on an annual basis thereafter. The drug should be promptly discontinued if PML is suspected and patients treated for PML should be monitored closely for the development of immune reconstitution inflammatory syndrome. Natalizumab (Tysabri): risk of progressive multifocal leukoencephalopathy increases after 2 years of therapy. Drug Safety Update 3: 2-3, No. 8, Mar 2010 801140380 1 Reactions 20 Mar 2010 No. 1293 0114-9954/10/1293-0001/$14.95 © 2010 Adis Data Information BV. All rights reserved

PML risk increases after 2 years of Tysabri therapy

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Reactions 1293 - 20 Mar 2010

PML risk increases after 2 yearsof Tysabri therapy

The UK MHRA is warning that the risk of developingprogressive multifocal leukoencephalopathy (PML)appears to increase after 2 years of therapy withnatalizumab [Tysabri]. Therefore, the agencyrecommends that patients with multiple sclerosisshould be informed of the risk of PML both beforecommencing therapy and again after 2 years, and thatthe risk: benefit balance be reconsidered at this time.

Against a backdrop of approximately 66 000 patientsexposed to natalizumab up to 20 January 2010, therehave been 31 cases of PML reported worldwide; eightwere fatal. Of the 31 confirmed cases, 23 occurred inMS patients treated with natalizumab for ≥ 2 years. Thisequates to a reporting rate of approximately 1–2 cases ofPML per 1000 patients exposed to natalizumab for≥ 2 years.

The MHRA recommends that an MRI be performedwithin 3 months prior to commencing natalizumabtherapy and on an annual basis thereafter. The drugshould be promptly discontinued if PML is suspectedand patients treated for PML should be monitoredclosely for the development of immune reconstitutioninflammatory syndrome.Natalizumab (Tysabri): risk of progressive multifocal leukoencephalopathyincreases after 2 years of therapy. Drug Safety Update 3: 2-3, No. 8, Mar2010 801140380