Exploring recombinant human erythropoietin in chronic progressive multiple sclerosis
Identifieur interne : 000F03 ( Main/Exploration ); précédent : 000F02; suivant : 000F04Exploring recombinant human erythropoietin in chronic progressive multiple sclerosis
Auteurs : Hannelore Ehrenreich [Allemagne] ; Benjamin Fischer [Allemagne] ; Christine Norra [Allemagne] ; Felix Schellenberger [Allemagne] ; Nike Stender [Allemagne] ; Michael Stiefel [Allemagne] ; Anna-Leena Sirén [Allemagne] ; Walter Paulus [Allemagne] ; Klaus-Armin Nave [Allemagne] ; Ralf Gold [Allemagne] ; Claudia Bartels [Allemagne]Source :
- Brain [ 0006-8950 ] ; 2007-10.
Abstract
The neurodegenerative aspects of chronic progressive multiple sclerosis (MS) have received increasing attention in recent years, since anti-inflammatory and immunosuppressive treatment strategies have largely failed. However, successful neuroprotection and/or neuroregeneration in MS have not been demonstrated yet. Encouraged by the multifaceted neuroprotective effects of recombinant human erythropoietin (rhEPO) in experimental models, we performed an investigator-driven, exploratory open label study (phase I/IIa) in patients with chronic progressive MS. Main study objectives were (i) evaluating safety of long-term high-dose intravenous rhEPO treatment in MS, and (ii) collecting first evidence of potential efficacy on clinical outcome parameters. Eight MS patients, five randomly assigned to high-dose (48 000 IU), three to low-dose (8000 IU) rhEPO treatment, and, as disease controls, two drug-naïve Parkinson patients (receiving 48 000 IU) were followed over up to 48 weeks: A 6-week lead-in phase, a 12-week treatment phase with weekly EPO, another 12-week treatment phase with bi-weekly EPO, and a 24-week post-treatment phase. Clinical and electrophysiological improvement of motor function, reflected by a reduction in expanded disability status scale (EDSS), and of cognitive performance was found upon high-dose EPO treatment in MS patients, persisting for three to six months after cessation of EPO application. In contrast, low-dose EPO MS patients and drug-naïve Parkinson patients did not improve in any of the parameters tested. There were no adverse events, no safety concerns and a surprisingly low need of blood-lettings. This first pilot study demonstrates the necessity and feasibility of controlled trials using high-dose rhEPO in chronic progressive MS.
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DOI: 10.1093/brain/awm203
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unit="volume">130</biblScope><biblScope unit="issue">10</biblScope><biblScope unit="page" from="2577">2577</biblScope><biblScope unit="page" to="2588">2588</biblScope></imprint><idno type="ISSN">0006-8950</idno></series><idno type="istex">F79B31844D88403E7A46A5261B1CD5D3C51D8A32</idno><idno type="DOI">10.1093/brain/awm203</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0006-8950</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">The neurodegenerative aspects of chronic progressive multiple sclerosis (MS) have received increasing attention in recent years, since anti-inflammatory and immunosuppressive treatment strategies have largely failed. However, successful neuroprotection and/or neuroregeneration in MS have not been demonstrated yet. Encouraged by the multifaceted neuroprotective effects of recombinant human erythropoietin (rhEPO) in experimental models, we performed an investigator-driven, exploratory open label study (phase I/IIa) in patients with chronic progressive MS. Main study objectives were (i) evaluating safety of long-term high-dose intravenous rhEPO treatment in MS, and (ii) collecting first evidence of potential efficacy on clinical outcome parameters. Eight MS patients, five randomly assigned to high-dose (48 000 IU), three to low-dose (8000 IU) rhEPO treatment, and, as disease controls, two drug-naïve Parkinson patients (receiving 48 000 IU) were followed over up to 48 weeks: A 6-week lead-in phase, a 12-week treatment phase with weekly EPO, another 12-week treatment phase with bi-weekly EPO, and a 24-week post-treatment phase. Clinical and electrophysiological improvement of motor function, reflected by a reduction in expanded disability status scale (EDSS), and of cognitive performance was found upon high-dose EPO treatment in MS patients, persisting for three to six months after cessation of EPO application. In contrast, low-dose EPO MS patients and drug-naïve Parkinson patients did not improve in any of the parameters tested. There were no adverse events, no safety concerns and a surprisingly low need of blood-lettings. This first pilot study demonstrates the necessity and feasibility of controlled trials using high-dose rhEPO in chronic progressive MS.</div></front></TEI><affiliations><list><country><li>Allemagne</li></country></list><tree><country name="Allemagne"><noRegion><name sortKey="Ehrenreich, Hannelore" sort="Ehrenreich, Hannelore" uniqKey="Ehrenreich H" first="Hannelore" last="Ehrenreich">Hannelore Ehrenreich</name></noRegion><name sortKey="Bartels, Claudia" sort="Bartels, Claudia" uniqKey="Bartels C" first="Claudia" last="Bartels">Claudia Bartels</name><name sortKey="Ehrenreich, Hannelore" sort="Ehrenreich, Hannelore" uniqKey="Ehrenreich H" first="Hannelore" last="Ehrenreich">Hannelore Ehrenreich</name><name sortKey="Fischer, Benjamin" sort="Fischer, Benjamin" uniqKey="Fischer B" first="Benjamin" last="Fischer">Benjamin Fischer</name><name sortKey="Gold, Ralf" sort="Gold, Ralf" uniqKey="Gold R" first="Ralf" last="Gold">Ralf Gold</name><name sortKey="Nave, Klaus Armin" sort="Nave, Klaus Armin" uniqKey="Nave K" first="Klaus-Armin" last="Nave">Klaus-Armin Nave</name><name sortKey="Norra, Christine" sort="Norra, Christine" uniqKey="Norra C" first="Christine" last="Norra">Christine Norra</name><name sortKey="Paulus, Walter" sort="Paulus, Walter" uniqKey="Paulus W" first="Walter" last="Paulus">Walter Paulus</name><name sortKey="Schellenberger, Felix" sort="Schellenberger, Felix" uniqKey="Schellenberger F" first="Felix" last="Schellenberger">Felix Schellenberger</name><name sortKey="Siren, Anna Leena" sort="Siren, Anna Leena" uniqKey="Siren A" first="Anna-Leena" last="Sirén">Anna-Leena Sirén</name><name sortKey="Stender, Nike" sort="Stender, Nike" uniqKey="Stender N" first="Nike" last="Stender">Nike Stender</name><name sortKey="Stiefel, Michael" sort="Stiefel, Michael" uniqKey="Stiefel M" first="Michael" last="Stiefel">Michael Stiefel</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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