Efficacy and safety of natalizumab in multiple sclerosis: interim observational programme results
Identifieur interne : 000253 ( Main/Exploration ); précédent : 000252; suivant : 000254Efficacy and safety of natalizumab in multiple sclerosis: interim observational programme results
Auteurs : Helmut Butzkueven [Australie] ; Ludwig Kappos [Suisse] ; Fabio Pellegrini [Italie] ; Maria Trojano [Italie] ; Heinz Wiendl [Allemagne] ; Radhika N. Patel [États-Unis] ; Annie Zhang [États-Unis] ; Christophe Hotermans [États-Unis] ; Shibeshih Belachew [États-Unis]Source :
- Journal of Neurology, Neurosurgery, and Psychiatry [ 0022-3050 ] ; 2014.
Abstract
Clinical trials established the efficacy and safety of natalizumab. Data are needed over longer periods of time and in the clinical practice setting.
To evaluate long-term safety of natalizumab and its impact on annualised relapse rate and Expanded Disability Status Scale (EDSS) progression in patients with relapsing-remitting multiple sclerosis (RRMS).
The Tysabri (natalizumab) Observational Program (TOP) is an open-label, multinational, 10-year prospective study in clinical practice settings.
In this 5-year interim analysis, 4821 patients were enrolled. Follow-up for at least 4 years from natalizumab commencement in 468 patients and at least 2 years in 2496 patients revealed no new safety signals. There were 18 cases of progressive multifocal leucoencephalopathy reported, following 11–44 natalizumab infusions. Mean annualised relapse rate decreased from 1.99 in the 12 months prior to baseline to 0.31 on natalizumab therapy (p<0.0001), remaining low at 5 years. Lower annualised relapse rates were observed in patients who used natalizumab as first MS therapy, in patients with lower baseline EDSS scores, and in patients with lower prenatalizumab relapse rates. Mean EDSS scores remained unchanged up to 5 years.
Interim TOP data confirm natalizumab's overall safety profile and the low relapse rate and stabilised disability levels in natalizumab-treated patients with RRMS in clinical practice.
NCT00493298.
Url:
DOI: 10.1136/jnnp-2013-306936
PubMed: 24532785
PubMed Central: 4215289
Affiliations:
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Medicine</addr-line>,<institution>Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne</institution>,<addr-line>Melbourne, Victoria</addr-line>,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="af2"><addr-line>Department of Neurology</addr-line>,<institution>Box Hill Hospital, Monash University</institution>,<addr-line>Victoria, Victoria</addr-line>,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kappos, Ludwig" sort="Kappos, Ludwig" uniqKey="Kappos L" first="Ludwig" last="Kappos">Ludwig Kappos</name><affiliation wicri:level="1"><nlm:aff id="af3"><addr-line>Departments of Neurology and Biomedicine</addr-line>,<institution>University Hospital Basel</institution>,<addr-line>Basel</addr-line>,<country>Switzerland</country></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Pellegrini, Fabio" sort="Pellegrini, Fabio" uniqKey="Pellegrini F" first="Fabio" last="Pellegrini">Fabio Pellegrini</name><affiliation wicri:level="1"><nlm:aff id="af4"><addr-line>Department of Clinical Pharmacology and Epidemiology</addr-line>,<institution>Consorzio Mario Negri Sud</institution>,<addr-line>Chieti</addr-line>,<country>Italy</country></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Trojano, Maria" sort="Trojano, Maria" uniqKey="Trojano M" first="Maria" last="Trojano">Maria Trojano</name><affiliation wicri:level="1"><nlm:aff id="af5"><addr-line>Department of Neuroscience and Sense Organs</addr-line>,<institution>University of Bari</institution>,<addr-line>Bari</addr-line>,<country>Italy</country></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Wiendl, Heinz" sort="Wiendl, Heinz" uniqKey="Wiendl H" first="Heinz" last="Wiendl">Heinz Wiendl</name><affiliation wicri:level="1"><nlm:aff id="af6"><addr-line>Department of Neurology–Inflammatory Disorders of the Nervous System and Neurooncology</addr-line>,<institution>University of Münster</institution>,<addr-line>Münster</addr-line>,<country>Germany</country></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Patel, Radhika N" sort="Patel, Radhika N" uniqKey="Patel R" first="Radhika N" last="Patel">Radhika N. Patel</name><affiliation wicri:level="1"><nlm:aff id="af7"><institution>Biogen Idec Inc</institution>,<addr-line>Cambridge, Massachusetts</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Zhang, Annie" sort="Zhang, Annie" uniqKey="Zhang A" first="Annie" last="Zhang">Annie Zhang</name><affiliation wicri:level="1"><nlm:aff id="af7"><institution>Biogen Idec Inc</institution>,<addr-line>Cambridge, Massachusetts</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Hotermans, Christophe" sort="Hotermans, Christophe" uniqKey="Hotermans C" first="Christophe" last="Hotermans">Christophe Hotermans</name><affiliation wicri:level="1"><nlm:aff id="af7"><institution>Biogen Idec Inc</institution>,<addr-line>Cambridge, Massachusetts</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Belachew, Shibeshih" sort="Belachew, Shibeshih" uniqKey="Belachew S" first="Shibeshih" last="Belachew">Shibeshih Belachew</name><affiliation wicri:level="1"><nlm:aff id="af7"><institution>Biogen Idec Inc</institution>,<addr-line>Cambridge, Massachusetts</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></analytic><series><title level="j">Journal of Neurology, Neurosurgery, and Psychiatry</title><idno type="ISSN">0022-3050</idno><idno type="eISSN">1468-330X</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>Clinical trials established the efficacy and safety of natalizumab. Data are needed over longer periods of time and in the clinical practice setting.</p></sec><sec><title>Objective</title><p>To evaluate long-term safety of natalizumab and its impact on annualised relapse rate and Expanded Disability Status Scale (EDSS) progression in patients with relapsing-remitting multiple sclerosis (RRMS).</p></sec><sec><title>Methods</title><p>The Tysabri (natalizumab) Observational Program (TOP) is an open-label, multinational, 10-year prospective study in clinical practice settings.</p></sec><sec><title>Results</title><p>In this 5-year interim analysis, 4821 patients were enrolled. Follow-up for at least 4 years from natalizumab commencement in 468 patients and at least 2 years in 2496 patients revealed no new safety signals. There were 18 cases of progressive multifocal leucoencephalopathy reported, following 11–44 natalizumab infusions. Mean annualised relapse rate decreased from 1.99 in the 12 months prior to baseline to 0.31 on natalizumab therapy (p<0.0001), remaining low at 5 years. Lower annualised relapse rates were observed in patients who used natalizumab as first MS therapy, in patients with lower baseline EDSS scores, and in patients with lower prenatalizumab relapse rates. Mean EDSS scores remained unchanged up to 5 years.</p></sec><sec><title>Conclusions</title><p>Interim TOP data confirm natalizumab's overall safety profile and the low relapse rate and stabilised disability levels in natalizumab-treated patients with RRMS in clinical practice.</p></sec><sec><title>Trial registration number</title><p>NCT00493298.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Rudick, Ra" uniqKey="Rudick R">RA Rudick</name></author><author><name sortKey="Sandrock, A" uniqKey="Sandrock A">A Sandrock</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Polman, Ch" uniqKey="Polman C">CH Polman</name></author><author><name sortKey="O Connor, Pw" uniqKey="O Connor P">PW O'Connor</name></author><author><name sortKey="Havrdova, E" uniqKey="Havrdova E">E Havrdova</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Hutchinson, M" uniqKey="Hutchinson M">M Hutchinson</name></author><author><name sortKey="Kappos, L" uniqKey="Kappos L">L Kappos</name></author><author><name sortKey="Calabresi, Pa" uniqKey="Calabresi P">PA Calabresi</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Roxburgh, Rh" uniqKey="Roxburgh R">RH Roxburgh</name></author><author><name sortKey="Seaman, Sr" uniqKey="Seaman S">SR Seaman</name></author><author><name sortKey="Masterman, T" uniqKey="Masterman T">T Masterman</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Rudick, Ra" uniqKey="Rudick R">RA Rudick</name></author><author><name sortKey="Stuart, Wh" uniqKey="Stuart W">WH Stuart</name></author><author><name sortKey="Calabresi, Pa" uniqKey="Calabresi P">PA Calabresi</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Phillips, Jt" uniqKey="Phillips J">JT Phillips</name></author><author><name sortKey="Giovannoni, G" uniqKey="Giovannoni G">G Giovannoni</name></author><author><name sortKey="Lublin, Fd" uniqKey="Lublin F">FD Lublin</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Kappos, L" uniqKey="Kappos L">L Kappos</name></author><author><name sortKey="Wu, S" uniqKey="Wu S">S Wu</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="O Connor, Pw" uniqKey="O Connor P">PW O'Connor</name></author><author><name sortKey="Goodman, Ad" uniqKey="Goodman A">AD Goodman</name></author><author><name sortKey="Kappos, L" uniqKey="Kappos L">L Kappos</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Bozic, C" uniqKey="Bozic C">C Bozic</name></author><author><name sortKey="Cristiano, Lm" uniqKey="Cristiano L">LM Cristiano</name></author><author><name sortKey="Hyde, R" uniqKey="Hyde R">R Hyde</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Kappos, L" uniqKey="Kappos L">L Kappos</name></author><author><name sortKey="Bates, D" uniqKey="Bates D">D Bates</name></author><author><name sortKey="Edan, G" uniqKey="Edan G">G Edan</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Bloomgren, G" uniqKey="Bloomgren G">G Bloomgren</name></author><author><name sortKey="Richman, S" uniqKey="Richman S">S Richman</name></author><author><name sortKey="Hotermans, C" uniqKey="Hotermans C">C Hotermans</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Ferlay, J" uniqKey="Ferlay J">J Ferlay</name></author><author><name sortKey="Steliarova Foucher, E" uniqKey="Steliarova Foucher E">E Steliarova-Foucher</name></author><author><name sortKey="Lortet Tieulent, J" uniqKey="Lortet Tieulent J">J Lortet-Tieulent</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Putzki, N" uniqKey="Putzki N">N Putzki</name></author><author><name sortKey="Yaldizli, O" uniqKey="Yaldizli O">O Yaldizli</name></author><author><name sortKey="Buhler, R" uniqKey="Buhler R">R Bühler</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Sangalli, F" uniqKey="Sangalli F">F Sangalli</name></author><author><name sortKey="Moiola, L" uniqKey="Moiola L">L Moiola</name></author><author><name sortKey="Bucello, S" uniqKey="Bucello S">S Bucello</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Kallweit, U" uniqKey="Kallweit U">U Kallweit</name></author><author><name sortKey="Jelcic, I" uniqKey="Jelcic I">I Jelcic</name></author><author><name sortKey="Braun, N" uniqKey="Braun N">N Braun</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Italie</li><li>Suisse</li><li>États-Unis</li></country></list><tree><country name="Australie"><noRegion><name sortKey="Butzkueven, Helmut" sort="Butzkueven, Helmut" uniqKey="Butzkueven H" first="Helmut" last="Butzkueven">Helmut Butzkueven</name></noRegion><name sortKey="Butzkueven, Helmut" sort="Butzkueven, Helmut" uniqKey="Butzkueven H" first="Helmut" last="Butzkueven">Helmut Butzkueven</name></country><country name="Suisse"><noRegion><name sortKey="Kappos, Ludwig" sort="Kappos, Ludwig" uniqKey="Kappos L" first="Ludwig" last="Kappos">Ludwig Kappos</name></noRegion></country><country name="Italie"><noRegion><name sortKey="Pellegrini, Fabio" sort="Pellegrini, Fabio" uniqKey="Pellegrini F" first="Fabio" last="Pellegrini">Fabio Pellegrini</name></noRegion><name sortKey="Trojano, Maria" sort="Trojano, Maria" uniqKey="Trojano M" first="Maria" last="Trojano">Maria Trojano</name></country><country name="Allemagne"><noRegion><name sortKey="Wiendl, Heinz" sort="Wiendl, Heinz" uniqKey="Wiendl H" first="Heinz" last="Wiendl">Heinz Wiendl</name></noRegion></country><country name="États-Unis"><noRegion><name sortKey="Patel, Radhika N" sort="Patel, Radhika N" uniqKey="Patel R" first="Radhika N" last="Patel">Radhika N. Patel</name></noRegion><name sortKey="Belachew, Shibeshih" sort="Belachew, Shibeshih" uniqKey="Belachew S" first="Shibeshih" last="Belachew">Shibeshih Belachew</name><name sortKey="Hotermans, Christophe" sort="Hotermans, Christophe" uniqKey="Hotermans C" first="Christophe" last="Hotermans">Christophe Hotermans</name><name sortKey="Zhang, Annie" sort="Zhang, Annie" uniqKey="Zhang A" first="Annie" last="Zhang">Annie Zhang</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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