Abstract
Natalizumab, a highly specific α4-integrin antagonist, is approved for treatment of patients with active relapsing-remitting multiple sclerosis (RRMS). It is generally recommended for individuals who have not responded to a currently available first-line disease-modifying therapy or who have very active disease. The expected benefits of natalizumab treatment have to be weighed against risks, especially the rare but serious adverse event of progressive multifocal leukoencephalopathy. In this Review, we revisit and update previous recommendations on natalizumab for treatment of patients with RRMS, based on additional long-term follow-up of clinical studies and post-marketing observations, including appropriate patient selection and management recommendations.
| Original language | English |
|---|---|
| Pages (from-to) | 745-758 |
| Number of pages | 14 |
| Journal | The Lancet Neurology |
| Volume | 10 |
| Issue number | 8 |
| DOIs | |
| State | Published - Aug 2011 |
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In: The Lancet Neurology, Vol. 10, No. 8, 08.2011, p. 745-758.
Research output: Contribution to journal › Review article › peer-review
TY - JOUR
T1 - Natalizumab treatment for multiple sclerosis
T2 - Updated recommendations for patient selection and monitoring
AU - Kappos, Ludwig
AU - Bates, David
AU - Edan, Gilles
AU - Eraksoy, Mefkûre
AU - Garcia-Merino, Antonio
AU - Grigoriadis, Nikolaos
AU - Hartung, Hans Peter
AU - Havrdová, Eva
AU - Hillert, Jan
AU - Hohlfeld, Reinhard
AU - Kremenchutzky, Marcelo
AU - Lyon-Caen, Olivier
AU - Miller, Ariel
AU - Pozzilli, Carlo
AU - Ravnborg, Mads
AU - Saida, Takahiko
AU - Sindic, Christian
AU - Vass, Karl
AU - Clifford, David B.
AU - Hauser, Stephen
AU - Major, Eugene O.
AU - O'Connor, Paul W.
AU - Weiner, Howard L.
AU - Clanet, Michel
AU - Gold, Ralf
AU - Hirsch, Hans H.
AU - Radü, Ernst Wilhelm
AU - Sørensen, Per Soelberg
AU - King, John
N1 - Funding Information: LK discloses that the University Hospital, Basel, has received research support from Actelion, Advancell, Allozyne, BaroFold, Bayer Health Care Pharmaceuticals, Bayer Schering Pharma, Bayhill, Biogen Idec, BioMarin, CLC Behring, Elan, Genmab, Genmark, GeNeuro SA, GlaxoSmithKline, Lilly, Merck Serono, MediciNova, Novartis, Novonordisk, Peptimmune, Sanofi-Aventis, Santhera, Roche, Teva, UCB, and Wyeth. LK has been principal investigator, member, or chair of steering committees or advisory boards on multiple sclerosis clinical trials sponsored by these companies, and has received lecture fees from one or more of these companies. Payments and consultancy fees have been used exclusively for support of research activities. DB has received honoraria and research support from Biogen Idec, Serono, Schering, and Teva Pharmaceuticals. GE has received honoraria for advisory board participation from Bayer, Biogen Idec, and LFB, and his institution has received grant support from Bayer, Merck Serono, and Teva. AG-M has received honoraria for consultancy and research support from Biogen Idec, Schering, Serono, and Teva Pharmaceuticals. NG has received honoraria and travel support from Biogen Idec, consultancy fees from Biogen Idec and Novartis, lecture fees from Biogen Idec and Merck Serono, and grants from Biogen Idec, Merck Serono, Sanofi-Aventis, and Genesis Pharma. H-PH has received honoraria and consultancy fees from Bayer Healthcare, Biogen Idec, Merck Serono, Novartis, and Genzyme and travel costs from Biogen Idec, Novartis, Merck Serono, and Bayer Schering with the approval of the Rector of the University of Düsseldorf. EH has received research funding from Biogen Idec, Novartis Pharmaceuticals, Octapharma, Schering, Serono, and Teva Pharmaceuticals and honoraria for lecturing from Biogen Idec, Pfizer, Schering, and Teva Pharmaceuticals. JH has received honoraria for consultancy from Biogen Idec and for lecturing from Bayer, Merck, and Teva, and grant support to his institution from Bayer, Biogen Idec, Merck, and Sanofi-Aventis. RH has received consultancy honoraria from Biogen Idec, Schering, Novartis, Teva, Sanofi-Aventis, and Merck Serono. MK has received payment for consultancy from Biogen Idec, Bayer, EMD Serono, Teva, and Novartis and clinical trial support from Biogen Idec, Sanofi-Aventis, Genzyme, CellGene, Teva, Bayer, EMD Serono, and Novartis. OL-C has received payments as advisory board member and for development of educational programmes by Biogen Idec. CP has received honoraria for consultancy, board membership, and lectures, including service of speakers' bureaus, from Bayer Schering, Merck Serono, Novartis, and Sanofi-Aventis, and research grants from Bayer Schering, Merck Serono, and Sanofi-Aventis. MR has received honoraria for consultancy from Novartis and Sanofi-Aventis, for lecturing from Novartis, and for grant support and travel expenses from Biogen Idec. CS has received payments to his institution for consultancy from Bayer Schering, GSK Biologicals Vaccines, Merck Serono, Novartis, and Sanofi-Aventis and for lecturing from Bayer Schering, Merck Serono, and Sanofi-Aventis, and has received research grants from Merck Serono and Novartis. KV has received honoraria for lectures and board memberships from Biogen Idec, Bayer Schering, Merck Serono, Sanofi-Aventis, and Novartis. DBC has received honoraria and consultancy fees from Biogen Idec, Bristol-Myers Squibb, Genentech, Genzyme, Millennium, and Pfizer, fees for expert testimony from Biogen Idec, lecture fees from GlaxoSmithKline, Millenium, and Biogen Idec, and travel costs from Biogen Idec. SH has received travel support from Roche, and his institution has received consulting and advisory board membership fees from Wyeth-Pfizer, Novartis, Receptos, and BioMarin. SH and his institution own stock in Receptos. PWO'C has received consulting fees, research support for MS trials, or both from Actelion, Bayer, Biogen Idec, BioMS, Cognosci, Daiichi Sankyo, EMD Serono, Genentech, and Genmab. HLW has received consultancy fees from Autoimmune, Biogen Idec, Pepgen, Pfizer, Serono, Teva Pharmaceuticals, and Vascular Biogenics. MC has received consultancy honoraria from Biogen and Novartis and grant support from Biogen, Novartis, Teva, Sanofi-Aventis, and Merck Serono. RG has received payments for consultancy from Biogen and Teva. E-WR has received payments to his institution for membership of advisory boards of Biogen Idec and Novartis, honoraria for consultancy from Biogen Idec, Bayer Schering, Merck, and Novartis, and for lecturing from Bayer Schering, Biogen Idec, and Novartis. PSS has received grant support, honoraria, and support for travel from Biogen Idec, consultancy fees from Merck Serono, Teva, Elan, Genmab, Novartis, and Sanofi-Aventis, and payments for lectures from Merck Serono, Novartis, Bayer Schering, Teva, and Sanofi-Aventis. JK has received honoraria and consultancy fees from Biogen Idec, Sanofi-Aventis, Schering, and Serono. ME, AM, TS, EOM, and HHH declare that they have no conflicts of interest.
PY - 2011/8
Y1 - 2011/8
N2 - Natalizumab, a highly specific α4-integrin antagonist, is approved for treatment of patients with active relapsing-remitting multiple sclerosis (RRMS). It is generally recommended for individuals who have not responded to a currently available first-line disease-modifying therapy or who have very active disease. The expected benefits of natalizumab treatment have to be weighed against risks, especially the rare but serious adverse event of progressive multifocal leukoencephalopathy. In this Review, we revisit and update previous recommendations on natalizumab for treatment of patients with RRMS, based on additional long-term follow-up of clinical studies and post-marketing observations, including appropriate patient selection and management recommendations.
AB - Natalizumab, a highly specific α4-integrin antagonist, is approved for treatment of patients with active relapsing-remitting multiple sclerosis (RRMS). It is generally recommended for individuals who have not responded to a currently available first-line disease-modifying therapy or who have very active disease. The expected benefits of natalizumab treatment have to be weighed against risks, especially the rare but serious adverse event of progressive multifocal leukoencephalopathy. In this Review, we revisit and update previous recommendations on natalizumab for treatment of patients with RRMS, based on additional long-term follow-up of clinical studies and post-marketing observations, including appropriate patient selection and management recommendations.
UR - http://www.scopus.com/inward/record.url?scp=79960344014&partnerID=8YFLogxK
U2 - 10.1016/S1474-4422(11)70149-1
DO - 10.1016/S1474-4422(11)70149-1
M3 - Review article
C2 - 21777829
AN - SCOPUS:79960344014
SN - 1474-4422
VL - 10
SP - 745
EP - 758
JO - The Lancet Neurology
JF - The Lancet Neurology
IS - 8
ER -