Efficacy and safety of Privigen® in patients with chronic inflammatory demyelinating polyneuropathy: results of a prospective, single‐arm, open‐label Phase III study (the PRIMA study)
Identifieur interne : 001172 ( Istex/Corpus ); précédent : 001171; suivant : 001173Efficacy and safety of Privigen® in patients with chronic inflammatory demyelinating polyneuropathy: results of a prospective, single‐arm, open‐label Phase III study (the PRIMA study)
Auteurs : Jean-Marc Léger ; Jan L. De Bleecker ; Claudia Sommer ; Wim Robberecht ; Mika Saarela ; Jerzy Kamienowski ; Zbigniew Stelmasiak ; Orell Mielke ; Björn Tackenberg ; Amgad Shebl ; Artur Bauhofer ; Othmar Zenker ; Ingemar S. J. MerkiesSource :
- Journal of the Peripheral Nervous System [ 1085-9489 ] ; 2013-06.
Abstract
This prospective, multicenter, single‐arm, open‐label Phase III study aimed to evaluate the efficacy and safety of Privigen® (10% liquid human intravenous immunoglobulin [IVIG], stabilized with l‐proline) in patients with chronic inflammatory demyelinating polyneuropathy (CIDP). Patients received one induction dose of Privigen (2 g/kg body weight [bw]) and up to seven maintenance doses (1 g/kg bw) at 3‐week intervals. The primary efficacy endpoint was the responder rate at completion, defined as improvement of ≥1 point on the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale. The preset success criterion was the responder rate being ≥35%. Of the 31 screened patients, 28 patients were enrolled including 13 (46.4%) IVIG‐pretreated patients. The overall responder rate at completion was 60.7% (95% confidence interval [CI]: 42.41%–76.43%). IVIG‐pretreated patients demonstrated a higher responder rate than IVIG‐naïve patients (76.9% vs. 46.7%). The median (25%–75% quantile) INCAT score improved from 3.5 (3.0–4.5) points at baseline to 2.5 (1.0–3.0) points at completion, as did the mean (standard deviation [SD]) maximum grip strength (66.7 [37.24] kPa vs. 80.9 [31.06] kPa) and the median Medical Research Council sum score (67.0 [61.5–72.0] points vs. 75.5 [71.5–79.5] points). Of 108 adverse events (AEs; 0.417 AEs per infusion), 95 AEs (88.0%) were mild or moderate in intensity and resolved by the end of study. Two serious AEs of hemolysis were reported that resolved after discontinuation of treatment. Thus, Privigen provided efficacious and well‐tolerated induction and maintenance treatment in patients with CIDP.
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DOI: 10.1111/jns5.12017
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De Bleecker</name><affiliation><mods:affiliation>AZ St‐Lucas, Gent, Belgium</mods:affiliation></affiliation></author><author><name sortKey="Sommer, Claudia" sort="Sommer, Claudia" uniqKey="Sommer C" first="Claudia" last="Sommer">Claudia Sommer</name><affiliation><mods:affiliation>Department of Neurology, Universitätsklinikum Würzburg, Würzburg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Robberecht, Wim" sort="Robberecht, Wim" uniqKey="Robberecht W" first="Wim" last="Robberecht">Wim Robberecht</name><affiliation><mods:affiliation>UZ Leuven, Leuven, Belgium</mods:affiliation></affiliation></author><author><name sortKey="Saarela, Mika" sort="Saarela, Mika" uniqKey="Saarela M" first="Mika" last="Saarela">Mika Saarela</name><affiliation><mods:affiliation>Department of Neurology, Helsinki University Central Hospital, Helsinki, Finland</mods:affiliation></affiliation></author><author><name sortKey="Kamienowski, Jerzy" sort="Kamienowski, Jerzy" uniqKey="Kamienowski J" first="Jerzy" last="Kamienowski">Jerzy Kamienowski</name><affiliation><mods:affiliation>Dolnośląski Szpital Specjalistyczny, Wrocław, Poland</mods:affiliation></affiliation></author><author><name sortKey="Stelmasiak, Zbigniew" sort="Stelmasiak, Zbigniew" uniqKey="Stelmasiak Z" first="Zbigniew" last="Stelmasiak">Zbigniew Stelmasiak</name><affiliation><mods:affiliation>Samodzielny Publiczny Szpital Kliniczny, Lublin, Poland</mods:affiliation></affiliation></author><author><name sortKey="Mielke, Orell" sort="Mielke, Orell" uniqKey="Mielke O" first="Orell" last="Mielke">Orell Mielke</name><affiliation><mods:affiliation>CSL Behring GmbH, Marburg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Tackenberg, Bjorn" sort="Tackenberg, Bjorn" uniqKey="Tackenberg B" first="Björn" last="Tackenberg">Björn Tackenberg</name><affiliation><mods:affiliation>Department of Neurology, Philipps University, Marburg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Shebl, Amgad" sort="Shebl, Amgad" uniqKey="Shebl A" first="Amgad" last="Shebl">Amgad Shebl</name><affiliation><mods:affiliation>CSL Behring GmbH, Marburg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Bauhofer, Artur" sort="Bauhofer, Artur" uniqKey="Bauhofer A" first="Artur" last="Bauhofer">Artur Bauhofer</name><affiliation><mods:affiliation>CSL Behring GmbH, Marburg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Zenker, Othmar" sort="Zenker, Othmar" uniqKey="Zenker O" first="Othmar" last="Zenker">Othmar Zenker</name><affiliation><mods:affiliation>CSL Behring GmbH, Marburg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Merkies, Ingemar S J" sort="Merkies, Ingemar S J" uniqKey="Merkies I" first="Ingemar S. J." last="Merkies">Ingemar S. J. 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De Bleecker</name><affiliation><mods:affiliation>AZ St‐Lucas, Gent, Belgium</mods:affiliation></affiliation></author><author><name sortKey="Sommer, Claudia" sort="Sommer, Claudia" uniqKey="Sommer C" first="Claudia" last="Sommer">Claudia Sommer</name><affiliation><mods:affiliation>Department of Neurology, Universitätsklinikum Würzburg, Würzburg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Robberecht, Wim" sort="Robberecht, Wim" uniqKey="Robberecht W" first="Wim" last="Robberecht">Wim Robberecht</name><affiliation><mods:affiliation>UZ Leuven, Leuven, Belgium</mods:affiliation></affiliation></author><author><name sortKey="Saarela, Mika" sort="Saarela, Mika" uniqKey="Saarela M" first="Mika" last="Saarela">Mika Saarela</name><affiliation><mods:affiliation>Department of Neurology, Helsinki University Central Hospital, Helsinki, Finland</mods:affiliation></affiliation></author><author><name sortKey="Kamienowski, Jerzy" sort="Kamienowski, Jerzy" uniqKey="Kamienowski J" first="Jerzy" last="Kamienowski">Jerzy Kamienowski</name><affiliation><mods:affiliation>Dolnośląski Szpital Specjalistyczny, Wrocław, Poland</mods:affiliation></affiliation></author><author><name sortKey="Stelmasiak, Zbigniew" sort="Stelmasiak, Zbigniew" uniqKey="Stelmasiak Z" first="Zbigniew" last="Stelmasiak">Zbigniew Stelmasiak</name><affiliation><mods:affiliation>Samodzielny Publiczny Szpital Kliniczny, Lublin, Poland</mods:affiliation></affiliation></author><author><name sortKey="Mielke, Orell" sort="Mielke, Orell" uniqKey="Mielke O" first="Orell" last="Mielke">Orell Mielke</name><affiliation><mods:affiliation>CSL Behring GmbH, Marburg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Tackenberg, Bjorn" sort="Tackenberg, Bjorn" uniqKey="Tackenberg B" first="Björn" last="Tackenberg">Björn Tackenberg</name><affiliation><mods:affiliation>Department of Neurology, Philipps University, Marburg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Shebl, Amgad" sort="Shebl, Amgad" uniqKey="Shebl A" first="Amgad" last="Shebl">Amgad Shebl</name><affiliation><mods:affiliation>CSL Behring GmbH, Marburg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Bauhofer, Artur" sort="Bauhofer, Artur" uniqKey="Bauhofer A" first="Artur" last="Bauhofer">Artur Bauhofer</name><affiliation><mods:affiliation>CSL Behring GmbH, Marburg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Zenker, Othmar" sort="Zenker, Othmar" uniqKey="Zenker O" first="Othmar" last="Zenker">Othmar Zenker</name><affiliation><mods:affiliation>CSL Behring GmbH, Marburg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Merkies, Ingemar S J" sort="Merkies, Ingemar S J" uniqKey="Merkies I" first="Ingemar S. J." last="Merkies">Ingemar S. J. Merkies</name><affiliation><mods:affiliation>Spaarne Hospital, Hoofddorp and Maastricht University Medical Centre, Maastricht, The Netherlands</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Journal of the Peripheral Nervous System</title><title level="j" type="abbrev">J Peripher Nerv Syst</title><idno type="ISSN">1085-9489</idno><idno type="eISSN">1529-8027</idno><imprint><publisher>Wiley Periodicals, Inc.</publisher><pubPlace>Malden, USA</pubPlace><date type="published" when="2013-06">2013-06</date><biblScope unit="volume">18</biblScope><biblScope unit="issue">2</biblScope><biblScope unit="page" from="130">130</biblScope><biblScope unit="page" to="140">140</biblScope></imprint><idno type="ISSN">1085-9489</idno></series><idno type="istex">4499980138C56F9612808B836593D865DE2D44CA</idno><idno type="DOI">10.1111/jns5.12017</idno><idno type="ArticleID">JNS512017</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">1085-9489</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">This prospective, multicenter, single‐arm, open‐label Phase III study aimed to evaluate the efficacy and safety of Privigen® (10% liquid human intravenous immunoglobulin [IVIG], stabilized with l‐proline) in patients with chronic inflammatory demyelinating polyneuropathy (CIDP). Patients received one induction dose of Privigen (2 g/kg body weight [bw]) and up to seven maintenance doses (1 g/kg bw) at 3‐week intervals. The primary efficacy endpoint was the responder rate at completion, defined as improvement of ≥1 point on the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale. The preset success criterion was the responder rate being ≥35%. Of the 31 screened patients, 28 patients were enrolled including 13 (46.4%) IVIG‐pretreated patients. The overall responder rate at completion was 60.7% (95% confidence interval [CI]: 42.41%–76.43%). IVIG‐pretreated patients demonstrated a higher responder rate than IVIG‐naïve patients (76.9% vs. 46.7%). The median (25%–75% quantile) INCAT score improved from 3.5 (3.0–4.5) points at baseline to 2.5 (1.0–3.0) points at completion, as did the mean (standard deviation [SD]) maximum grip strength (66.7 [37.24] kPa vs. 80.9 [31.06] kPa) and the median Medical Research Council sum score (67.0 [61.5–72.0] points vs. 75.5 [71.5–79.5] points). Of 108 adverse events (AEs; 0.417 AEs per infusion), 95 AEs (88.0%) were mild or moderate in intensity and resolved by the end of study. Two serious AEs of hemolysis were reported that resolved after discontinuation of treatment. Thus, Privigen provided efficacious and well‐tolerated induction and maintenance treatment in patients with CIDP.</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Jean‐Marc Léger</name><affiliations><json:string>Reference Center for Rare Neuromuscular Diseases, Hôpital Pitié‐Salpêtrière and University Paris VI, Paris, France</json:string></affiliations></json:item><json:item><name>Jan L. De Bleecker</name><affiliations><json:string>AZ St‐Lucas, Gent, Belgium</json:string></affiliations></json:item><json:item><name>Claudia Sommer</name><affiliations><json:string>Department of Neurology, Universitätsklinikum Würzburg, Würzburg, Germany</json:string></affiliations></json:item><json:item><name>Wim Robberecht</name><affiliations><json:string>UZ Leuven, Leuven, Belgium</json:string></affiliations></json:item><json:item><name>Mika Saarela</name><affiliations><json:string>Department of Neurology, Helsinki University Central Hospital, Helsinki, Finland</json:string></affiliations></json:item><json:item><name>Jerzy Kamienowski</name><affiliations><json:string>Dolnośląski Szpital Specjalistyczny, Wrocław, Poland</json:string></affiliations></json:item><json:item><name>Zbigniew Stelmasiak</name><affiliations><json:string>Samodzielny Publiczny Szpital Kliniczny, Lublin, Poland</json:string></affiliations></json:item><json:item><name>Orell Mielke</name><affiliations><json:string>CSL Behring GmbH, Marburg, Germany</json:string></affiliations></json:item><json:item><name>Björn Tackenberg</name><affiliations><json:string>Department of Neurology, Philipps University, Marburg, Germany</json:string></affiliations></json:item><json:item><name>Amgad Shebl</name><affiliations><json:string>CSL Behring GmbH, Marburg, Germany</json:string></affiliations></json:item><json:item><name>Artur Bauhofer</name><affiliations><json:string>CSL Behring GmbH, Marburg, Germany</json:string></affiliations></json:item><json:item><name>Othmar Zenker</name><affiliations><json:string>CSL Behring GmbH, Marburg, Germany</json:string></affiliations></json:item><json:item><name>Ingemar S. J. Merkies</name><affiliations><json:string>Spaarne Hospital, Hoofddorp and Maastricht University Medical Centre, Maastricht, The Netherlands</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>chronic inflammatory demyelinating polyneuropathy</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>INCAT</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>IVIG</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>PRIMA</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Privigen®</value></json:item></subject><articleId><json:string>JNS512017</json:string></articleId><language><json:string>eng</json:string></language><originalGenre><json:string>article</json:string></originalGenre><abstract>This prospective, multicenter, single‐arm, open‐label Phase III study aimed to evaluate the efficacy and safety of Privigen® (10% liquid human intravenous immunoglobulin [IVIG], stabilized with l‐proline) in patients with chronic inflammatory demyelinating polyneuropathy (CIDP). Patients received one induction dose of Privigen (2 g/kg body weight [bw]) and up to seven maintenance doses (1 g/kg bw) at 3‐week intervals. The primary efficacy endpoint was the responder rate at completion, defined as improvement of ≥1 point on the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale. The preset success criterion was the responder rate being ≥35%. Of the 31 screened patients, 28 patients were enrolled including 13 (46.4%) IVIG‐pretreated patients. The overall responder rate at completion was 60.7% (95% confidence interval [CI]: 42.41%–76.43%). IVIG‐pretreated patients demonstrated a higher responder rate than IVIG‐naïve patients (76.9% vs. 46.7%). The median (25%–75% quantile) INCAT score improved from 3.5 (3.0–4.5) points at baseline to 2.5 (1.0–3.0) points at completion, as did the mean (standard deviation [SD]) maximum grip strength (66.7 [37.24] kPa vs. 80.9 [31.06] kPa) and the median Medical Research Council sum score (67.0 [61.5–72.0] points vs. 75.5 [71.5–79.5] points). Of 108 adverse events (AEs; 0.417 AEs per infusion), 95 AEs (88.0%) were mild or moderate in intensity and resolved by the end of study. Two serious AEs of hemolysis were reported that resolved after discontinuation of treatment. Thus, Privigen provided efficacious and well‐tolerated induction and maintenance treatment in patients with CIDP.</abstract><qualityIndicators><score>7.832</score><pdfVersion>1.3</pdfVersion><pdfPageSize>595.276 x 782.362 pts</pdfPageSize><refBibsNative>true</refBibsNative><keywordCount>5</keywordCount><abstractCharCount>1661</abstractCharCount><pdfWordCount>6029</pdfWordCount><pdfCharCount>39853</pdfCharCount><pdfPageCount>11</pdfPageCount><abstractWordCount>236</abstractWordCount></qualityIndicators><title>Efficacy and safety of Privigen® in patients with chronic inflammatory demyelinating polyneuropathy: results of a prospective, single‐arm, open‐label Phase III study (the PRIMA study)</title><corporate><json:item><name>on behalf of the PRIMA study investigators</name></json:item></corporate><genre><json:string>article</json:string></genre><host><volume>18</volume><publisherId><json:string>JNS</json:string></publisherId><pages><total>11</total><last>140</last><first>130</first></pages><issn><json:string>1085-9489</json:string></issn><issue>2</issue><subject><json:item><value>RESEARCH REPORT</value></json:item></subject><genre><json:string>journal</json:string></genre><language><json:string>unknown</json:string></language><eissn><json:string>1529-8027</json:string></eissn><title>Journal of the Peripheral Nervous System</title><doi><json:string>10.1111/(ISSN)1529-8027</json:string></doi></host><publicationDate>2013</publicationDate><copyrightDate>2013</copyrightDate><doi><json:string>10.1111/jns5.12017</json:string></doi><id>4499980138C56F9612808B836593D865DE2D44CA</id><score>0.233808</score><fulltext><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/4499980138C56F9612808B836593D865DE2D44CA/fulltext/pdf</uri></json:item><json:item><original>false</original><mimetype>application/zip</mimetype><extension>zip</extension><uri>https://api.istex.fr/document/4499980138C56F9612808B836593D865DE2D44CA/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/4499980138C56F9612808B836593D865DE2D44CA/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">Efficacy and safety of Privigen® in patients with chronic inflammatory demyelinating polyneuropathy: results of a prospective, single‐arm, open‐label Phase III study (the PRIMA study)</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Wiley Periodicals, Inc.</publisher><pubPlace>Malden, USA</pubPlace><availability status="free"><p>Open Access</p></availability><date>2013-05-20</date></publicationStmt><notesStmt><note>CSL Behring AG</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Efficacy and safety of Privigen® in patients with chronic inflammatory demyelinating polyneuropathy: results of a prospective, single‐arm, open‐label Phase III study (the PRIMA study)</title><author><orgName>on behalf of the PRIMA study investigators</orgName></author><author xml:id="author-1"><persName><forename type="first">Jean‐Marc</forename><surname>Léger</surname></persName><note type="correspondence"><p>Correspondence: : Prof. Dr. Jean‐Marc Léger, Groupe Hospitalier Pitié‐Salpêtrière, Unité de Pathologie Neuro‐Musculaire, 47–83 Boulevard de l'Hôpital, Paris, 75651, France. Tel: +33 1 42 16 37 73; Fax: +33 1 42 16 37 93, E‐mail:</p></note><affiliation>Reference Center for Rare Neuromuscular Diseases, Hôpital Pitié‐Salpêtrière and University Paris VI, Paris, France</affiliation></author><author xml:id="author-2"><persName><forename type="first">Jan L.</forename><surname>De Bleecker</surname></persName><affiliation>AZ St‐Lucas, Gent, Belgium</affiliation></author><author xml:id="author-3"><persName><forename type="first">Claudia</forename><surname>Sommer</surname></persName><affiliation>Department of Neurology, Universitätsklinikum Würzburg, Würzburg, Germany</affiliation></author><author xml:id="author-4"><persName><forename type="first">Wim</forename><surname>Robberecht</surname></persName><affiliation>UZ Leuven, Leuven, Belgium</affiliation></author><author xml:id="author-5"><persName><forename type="first">Mika</forename><surname>Saarela</surname></persName><affiliation>Department of Neurology, Helsinki University Central Hospital, Helsinki, Finland</affiliation></author><author xml:id="author-6"><persName><forename type="first">Jerzy</forename><surname>Kamienowski</surname></persName><affiliation>Dolnośląski Szpital Specjalistyczny, Wrocław, Poland</affiliation></author><author xml:id="author-7"><persName><forename type="first">Zbigniew</forename><surname>Stelmasiak</surname></persName><affiliation>Samodzielny Publiczny Szpital Kliniczny, Lublin, Poland</affiliation></author><author xml:id="author-8"><persName><forename type="first">Orell</forename><surname>Mielke</surname></persName><affiliation>CSL Behring GmbH, Marburg, Germany</affiliation></author><author xml:id="author-9"><persName><forename type="first">Björn</forename><surname>Tackenberg</surname></persName><affiliation>Department of Neurology, Philipps University, Marburg, Germany</affiliation></author><author xml:id="author-10"><persName><forename type="first">Amgad</forename><surname>Shebl</surname></persName><affiliation>CSL Behring GmbH, Marburg, Germany</affiliation></author><author xml:id="author-11"><persName><forename type="first">Artur</forename><surname>Bauhofer</surname></persName><affiliation>CSL Behring GmbH, Marburg, Germany</affiliation></author><author xml:id="author-12"><persName><forename type="first">Othmar</forename><surname>Zenker</surname></persName><affiliation>CSL Behring GmbH, Marburg, Germany</affiliation></author><author xml:id="author-13"><persName><forename type="first">Ingemar S. J.</forename><surname>Merkies</surname></persName><affiliation>Spaarne Hospital, Hoofddorp and Maastricht University Medical Centre, Maastricht, The Netherlands</affiliation></author></analytic><monogr><title level="j">Journal of the Peripheral Nervous System</title><title level="j" type="abbrev">J Peripher Nerv Syst</title><idno type="pISSN">1085-9489</idno><idno type="eISSN">1529-8027</idno><idno type="DOI">10.1111/(ISSN)1529-8027</idno><imprint><publisher>Wiley Periodicals, Inc.</publisher><pubPlace>Malden, USA</pubPlace><date type="published" when="2013-06"></date><biblScope unit="volume">18</biblScope><biblScope unit="issue">2</biblScope><biblScope unit="page" from="130">130</biblScope><biblScope unit="page" to="140">140</biblScope></imprint></monogr><idno type="istex">4499980138C56F9612808B836593D865DE2D44CA</idno><idno type="DOI">10.1111/jns5.12017</idno><idno type="ArticleID">JNS512017</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2013-05-20</date></creation><langUsage><language ident="en">en</language></langUsage><abstract><p>This prospective, multicenter, single‐arm, open‐label Phase III study aimed to evaluate the efficacy and safety of Privigen® (10% liquid human intravenous immunoglobulin [IVIG], stabilized with l‐proline) in patients with chronic inflammatory demyelinating polyneuropathy (CIDP). Patients received one induction dose of Privigen (2 g/kg body weight [bw]) and up to seven maintenance doses (1 g/kg bw) at 3‐week intervals. The primary efficacy endpoint was the responder rate at completion, defined as improvement of ≥1 point on the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale. The preset success criterion was the responder rate being ≥35%. Of the 31 screened patients, 28 patients were enrolled including 13 (46.4%) IVIG‐pretreated patients. The overall responder rate at completion was 60.7% (95% confidence interval [CI]: 42.41%–76.43%). IVIG‐pretreated patients demonstrated a higher responder rate than IVIG‐naïve patients (76.9% vs. 46.7%). The median (25%–75% quantile) INCAT score improved from 3.5 (3.0–4.5) points at baseline to 2.5 (1.0–3.0) points at completion, as did the mean (standard deviation [SD]) maximum grip strength (66.7 [37.24] kPa vs. 80.9 [31.06] kPa) and the median Medical Research Council sum score (67.0 [61.5–72.0] points vs. 75.5 [71.5–79.5] points). Of 108 adverse events (AEs; 0.417 AEs per infusion), 95 AEs (88.0%) were mild or moderate in intensity and resolved by the end of study. Two serious AEs of hemolysis were reported that resolved after discontinuation of treatment. Thus, Privigen provided efficacious and well‐tolerated induction and maintenance treatment in patients with CIDP.</p></abstract><textClass><keywords scheme="keyword"><list><head>keywords</head><item><term>chronic inflammatory demyelinating polyneuropathy</term></item><item><term>INCAT</term></item><item><term>IVIG</term></item><item><term>PRIMA</term></item><item><term>Privigen®</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>article-category</head><item><term>RESEARCH REPORT</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2012-11-09">Received</change><change when="2013-04-09">Registration</change><change when="2013-05-20">Created</change><change when="2013-06">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/4499980138C56F9612808B836593D865DE2D44CA/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Wiley, elements deleted: body"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="yes"</istex:xmlDeclaration><istex:document><component version="2.0" type="serialArticle" xml:lang="en" xml:id="jns512017"><header xml:id="jns512017-hdr-0001"><publicationMeta level="product"><publisherInfo><publisherName>Wiley Periodicals, Inc.</publisherName><publisherLoc>Malden, USA</publisherLoc></publisherInfo><doi>10.1111/(ISSN)1529-8027</doi><issn type="print">1085-9489</issn><issn type="electronic">1529-8027</issn><idGroup><id type="product" value="JNS"></id></idGroup><titleGroup><title type="main" xml:lang="en">Journal of the Peripheral Nervous System</title><title type="short">J Peripher Nerv Syst</title></titleGroup></publicationMeta><publicationMeta level="part" position="20"><doi origin="wiley">10.1111/jns5.2013.18.issue-2</doi><copyright ownership="publisher">© 2013 Peripheral Nerve Society</copyright><numberingGroup><numbering type="journalVolume" number="18">18</numbering><numbering type="journalIssue">2</numbering></numberingGroup><coverDate startDate="2013-06">June 2013</coverDate></publicationMeta><publicationMeta level="unit" position="30" type="article" accessType="open" status="forIssue"><doi>10.1111/jns5.12017</doi><idGroup><id type="unit" value="JNS512017"></id></idGroup><countGroup><count type="pageTotal" number="11"></count></countGroup><titleGroup><title type="articleCategory">RESEARCH REPORT</title><title type="tocHeading1">RESEARCH REPORTS</title></titleGroup><copyright ownership="publisher">© 2013 The Authors. Journal of the Peripheral Nervous System published by Wiley Periodicals, Inc. on behalf of Peripheral Nerve Society.</copyright><legalStatement type="creativeCommonsBy"><p>This is an open access article under the terms of the <url href="http://creativecommons.org/licenses/by/3.0/">Creative Commons Attribution</url> License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.</p></legalStatement><eventGroup><event type="manuscriptReceived" date="2012-11-09"></event><event type="manuscriptRevised" date="2013-04-02"></event><event type="manuscriptAccepted" date="2013-04-09"></event><event type="xmlCreated" agent="Laserwords Private Ltd." date="2013-05-20"></event><event type="publishedOnlineAccepted" date="2013-05-15"></event><event type="firstOnline" date="2013-06-19"></event><event type="publishedOnlineFinalForm" date="2013-06-19"></event><event type="xmlConverted" agent="Converter:WILEY_ML3G_TO_WILEY_ML3GV2 version:3.8.8" date="2014-01-31"></event><event type="xmlConverted" agent="Converter:WML3G_To_WML3G version:4.6.4 mode:FullText" date="2015-10-01"></event></eventGroup><numberingGroup><numbering type="pageFirst">130</numbering><numbering type="pageLast">140</numbering></numberingGroup><correspondenceTo><i>Address correspondence to</i>: Prof. Dr. Jean‐Marc Léger, Groupe Hospitalier Pitié‐Salpêtrière, Unité de Pathologie Neuro‐Musculaire, 47–83 Boulevard de l'Hôpital, Paris, 75651, France. Tel: +33 1 42 16 37 73; Fax: +33 1 42 16 37 93, E‐mail: <email>jean-marc.leger@psl.aphp.fr</email></correspondenceTo><objectNameGroup><objectName elementName="appendix">Appendix</objectName></objectNameGroup><linkGroup><link type="toTypesetVersion" href="file:JNS.JNS512017.pdf"></link></linkGroup></publicationMeta><contentMeta><titleGroup><title type="main">Efficacy and safety of Privigen<sup>®</sup> in patients with chronic inflammatory demyelinating polyneuropathy: results of a prospective, single‐arm, open‐label Phase <fc>III</fc> study (the <fc>PRIMA</fc> study)</title><title type="shortAuthors">Léger et al</title></titleGroup><creators><creator creatorRole="author" xml:id="jns512017-cr-0001" affiliationRef="#jns512017-aff-0001" corresponding="yes"><personName><givenNames>Jean‐Marc</givenNames> <familyName>Léger</familyName></personName></creator><creator creatorRole="author" xml:id="jns512017-cr-0002" affiliationRef="#jns512017-aff-0002"><personName><givenNames>Jan L.</givenNames> <familyName>De Bleecker</familyName></personName></creator><creator creatorRole="author" xml:id="jns512017-cr-0003" affiliationRef="#jns512017-aff-0003"><personName><givenNames>Claudia</givenNames> <familyName>Sommer</familyName></personName></creator><creator creatorRole="author" xml:id="jns512017-cr-0004" affiliationRef="#jns512017-aff-0004"><personName><givenNames>Wim</givenNames> <familyName>Robberecht</familyName></personName></creator><creator creatorRole="author" xml:id="jns512017-cr-0005" affiliationRef="#jns512017-aff-0005"><personName><givenNames>Mika</givenNames> <familyName>Saarela</familyName></personName></creator><creator creatorRole="author" xml:id="jns512017-cr-0006" affiliationRef="#jns512017-aff-0006"><personName><givenNames>Jerzy</givenNames> <familyName>Kamienowski</familyName></personName></creator><creator creatorRole="author" xml:id="jns512017-cr-0007" affiliationRef="#jns512017-aff-0007"><personName><givenNames>Zbigniew</givenNames> <familyName>Stelmasiak</familyName></personName></creator><creator creatorRole="author" xml:id="jns512017-cr-0008" affiliationRef="#jns512017-aff-0008"><personName><givenNames>Orell</givenNames> <familyName>Mielke</familyName></personName></creator><creator creatorRole="author" xml:id="jns512017-cr-0009" affiliationRef="#jns512017-aff-0009"><personName><givenNames>Björn</givenNames> <familyName>Tackenberg</familyName></personName></creator><creator creatorRole="author" xml:id="jns512017-cr-0010" affiliationRef="#jns512017-aff-0008"><personName><givenNames>Amgad</givenNames> <familyName>Shebl</familyName></personName></creator><creator creatorRole="author" xml:id="jns512017-cr-0011" affiliationRef="#jns512017-aff-0008"><personName><givenNames>Artur</givenNames> <familyName>Bauhofer</familyName></personName></creator><creator creatorRole="author" xml:id="jns512017-cr-0012" affiliationRef="#jns512017-aff-0008"><personName><givenNames>Othmar</givenNames> <familyName>Zenker</familyName></personName></creator><creator creatorRole="author" xml:id="jns512017-cr-0013" affiliationRef="#jns512017-aff-0010"><personName><givenNames>Ingemar S. J.</givenNames> <familyName>Merkies</familyName></personName></creator><creator creatorRole="author" xml:id="jns512017-cr-0014" noteRef="#jns512017-note-0001"><groupName xml:id="jns512017-gp-0003">on behalf of the PRIMA study investigators</groupName></creator></creators><affiliationGroup xml:id="jns512017-affgp-0001"><affiliation countryCode="FR" type="organization" xml:id="jns512017-aff-0001"><orgDiv>Reference Center for Rare Neuromuscular Diseases</orgDiv><orgName>Hôpital Pitié‐Salpêtrière and University Paris VI</orgName><address><city>Paris</city><country>France</country></address></affiliation><affiliation countryCode="BE" type="organization" xml:id="jns512017-aff-0002"><orgName>AZ St‐Lucas</orgName><address><city>Gent</city><country>Belgium</country></address></affiliation><affiliation countryCode="DE" type="organization" xml:id="jns512017-aff-0003"><orgDiv>Department of Neurology</orgDiv><orgName>Universitätsklinikum Würzburg</orgName><address><city>Würzburg</city><country>Germany</country></address></affiliation><affiliation countryCode="BE" type="organization" xml:id="jns512017-aff-0004"><orgName>UZ Leuven</orgName><address><city>Leuven</city><country>Belgium</country></address></affiliation><affiliation countryCode="FI" type="organization" xml:id="jns512017-aff-0005"><orgDiv>Department of Neurology</orgDiv><orgName>Helsinki University Central Hospital</orgName><address><city>Helsinki</city><country>Finland</country></address></affiliation><affiliation countryCode="PL" type="organization" xml:id="jns512017-aff-0006"><orgName>Dolnośląski Szpital Specjalistyczny</orgName><address><city>Wrocław</city><country>Poland</country></address></affiliation><affiliation countryCode="PL" type="organization" xml:id="jns512017-aff-0007"><orgName>Samodzielny Publiczny Szpital Kliniczny</orgName><address><city>Lublin</city><country>Poland</country></address></affiliation><affiliation countryCode="DE" type="organization" xml:id="jns512017-aff-0008"><orgName>CSL Behring GmbH</orgName><address><city>Marburg</city><country>Germany</country></address></affiliation><affiliation countryCode="DE" type="organization" xml:id="jns512017-aff-0009"><orgDiv>Department of Neurology</orgDiv><orgName>Philipps University</orgName><address><city>Marburg</city><country>Germany</country></address></affiliation><affiliation countryCode="NL" type="organization" xml:id="jns512017-aff-0010"><orgDiv>Spaarne Hospital</orgDiv><orgName>Hoofddorp and Maastricht University Medical Centre</orgName><address><city>Maastricht</city><country>The Netherlands</country></address></affiliation></affiliationGroup><keywordGroup type="author"><keyword xml:id="jns512017-kwd-0001">chronic inflammatory demyelinating polyneuropathy</keyword><keyword xml:id="jns512017-kwd-0002"><fc>INCAT</fc></keyword><keyword xml:id="jns512017-kwd-0003"><fc>IVIG</fc></keyword><keyword xml:id="jns512017-kwd-0004"><fc>PRIMA</fc></keyword><keyword xml:id="jns512017-kwd-0005">Privigen<sup>®</sup></keyword></keywordGroup><fundingInfo><fundingAgency>CSL Behring AG</fundingAgency></fundingInfo><abstractGroup><abstract type="main" xml:id="jns512017-abs-0001"><title type="main">Abstract</title><p xml:id="jns512017-para-0001">This prospective, multicenter, single‐arm, open‐label Phase <fc>III</fc> study aimed to evaluate the efficacy and safety of Privigen<sup>®</sup> (10% liquid human intravenous immunoglobulin [<fc>IVIG</fc>], stabilized with <sc>l</sc>‐proline) in patients with chronic inflammatory demyelinating polyneuropathy (<fc>CIDP</fc>). Patients received one induction dose of Privigen (2 g/kg body weight [bw]) and up to seven maintenance doses (1 g/kg bw) at 3‐week intervals. The primary efficacy endpoint was the responder rate at completion, defined as improvement of ≥1 point on the adjusted Inflammatory Neuropathy Cause and Treatment (<fc>INCAT</fc>) disability scale. The preset success criterion was the responder rate being ≥35%. Of the 31 screened patients, 28 patients were enrolled including 13 (46.4%) <fc>IVIG</fc>‐pretreated patients. The overall responder rate at completion was 60.7% (95% confidence interval [<fc>CI</fc>]: 42.41%–76.43%). <fc>IVIG</fc>‐pretreated patients demonstrated a higher responder rate than <fc>IVIG</fc>‐naïve patients (76.9% vs. 46.7%). The median (25%–75% quantile) <fc>INCAT</fc> score improved from 3.5 (3.0–4.5) points at baseline to 2.5 (1.0–3.0) points at completion, as did the mean (standard deviation [<fc>SD</fc>]) maximum grip strength (66.7 [37.24] <fc>kPa</fc> vs. 80.9 [31.06] <fc>kPa</fc>) and the median Medical Research Council sum score (67.0 [61.5–72.0] points vs. 75.5 [71.5–79.5] points). Of 108 adverse events (<fc>AEs</fc>; 0.417 <fc>AEs</fc> per infusion), 95 <fc>AEs</fc> (88.0%) were mild or moderate in intensity and resolved by the end of study. Two serious <fc>AEs</fc> of hemolysis were reported that resolved after discontinuation of treatment. Thus, Privigen provided efficacious and well‐tolerated induction and maintenance treatment in patients with <fc>CIDP</fc>.</p></abstract></abstractGroup></contentMeta><noteGroup xml:id="jns512017-ntgp-0001"><note xml:id="jns512017-note-0001"><p xml:id="jns512017-para-0002"><i>See Appendix for complete list of Study group members</i>.</p></note></noteGroup></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Efficacy and safety of Privigen® in patients with chronic inflammatory demyelinating polyneuropathy: results of a prospective, single‐arm, open‐label Phase III study (the PRIMA study)</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Efficacy and safety of Privigen® in patients with chronic inflammatory demyelinating polyneuropathy: results of a prospective, single‐arm, open‐label Phase III study (the PRIMA study)</title></titleInfo><name type="personal"><namePart type="given">Jean‐Marc</namePart><namePart type="family">Léger</namePart><affiliation>Reference Center for Rare Neuromuscular Diseases, Hôpital Pitié‐Salpêtrière and University Paris VI, Paris, France</affiliation><description>Correspondence: : Prof. Dr. Jean‐Marc Léger, Groupe Hospitalier Pitié‐Salpêtrière, Unité de Pathologie Neuro‐Musculaire, 47–83 Boulevard de l'Hôpital, Paris, 75651, France. Tel: +33 1 42 16 37 73; Fax: +33 1 42 16 37 93, E‐mail: </description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Jan L.</namePart><namePart type="family">De Bleecker</namePart><affiliation>AZ St‐Lucas, Gent, Belgium</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Claudia</namePart><namePart type="family">Sommer</namePart><affiliation>Department of Neurology, Universitätsklinikum Würzburg, Würzburg, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Wim</namePart><namePart type="family">Robberecht</namePart><affiliation>UZ Leuven, Leuven, Belgium</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Mika</namePart><namePart type="family">Saarela</namePart><affiliation>Department of Neurology, Helsinki University Central Hospital, Helsinki, Finland</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Jerzy</namePart><namePart type="family">Kamienowski</namePart><affiliation>Dolnośląski Szpital Specjalistyczny, Wrocław, Poland</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Zbigniew</namePart><namePart type="family">Stelmasiak</namePart><affiliation>Samodzielny Publiczny Szpital Kliniczny, Lublin, Poland</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Orell</namePart><namePart type="family">Mielke</namePart><affiliation>CSL Behring GmbH, Marburg, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Björn</namePart><namePart type="family">Tackenberg</namePart><affiliation>Department of Neurology, Philipps University, Marburg, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Amgad</namePart><namePart type="family">Shebl</namePart><affiliation>CSL Behring GmbH, Marburg, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Artur</namePart><namePart type="family">Bauhofer</namePart><affiliation>CSL Behring GmbH, Marburg, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Othmar</namePart><namePart type="family">Zenker</namePart><affiliation>CSL Behring GmbH, Marburg, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Ingemar S. J.</namePart><namePart type="family">Merkies</namePart><affiliation>Spaarne Hospital, Hoofddorp and Maastricht University Medical Centre, Maastricht, The Netherlands</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="corporate"><namePart>on behalf of the PRIMA study investigators</namePart></name><typeOfResource>text</typeOfResource><genre type="article" displayLabel="article"></genre><originInfo><publisher>Wiley Periodicals, Inc.</publisher><place><placeTerm type="text">Malden, USA</placeTerm></place><dateIssued encoding="w3cdtf">2013-06</dateIssued><dateCreated encoding="w3cdtf">2013-05-20</dateCreated><dateCaptured encoding="w3cdtf">2012-11-09</dateCaptured><dateValid encoding="w3cdtf">2013-04-09</dateValid><copyrightDate encoding="w3cdtf">2013</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType></physicalDescription><abstract>This prospective, multicenter, single‐arm, open‐label Phase III study aimed to evaluate the efficacy and safety of Privigen® (10% liquid human intravenous immunoglobulin [IVIG], stabilized with l‐proline) in patients with chronic inflammatory demyelinating polyneuropathy (CIDP). Patients received one induction dose of Privigen (2 g/kg body weight [bw]) and up to seven maintenance doses (1 g/kg bw) at 3‐week intervals. The primary efficacy endpoint was the responder rate at completion, defined as improvement of ≥1 point on the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale. The preset success criterion was the responder rate being ≥35%. Of the 31 screened patients, 28 patients were enrolled including 13 (46.4%) IVIG‐pretreated patients. The overall responder rate at completion was 60.7% (95% confidence interval [CI]: 42.41%–76.43%). IVIG‐pretreated patients demonstrated a higher responder rate than IVIG‐naïve patients (76.9% vs. 46.7%). The median (25%–75% quantile) INCAT score improved from 3.5 (3.0–4.5) points at baseline to 2.5 (1.0–3.0) points at completion, as did the mean (standard deviation [SD]) maximum grip strength (66.7 [37.24] kPa vs. 80.9 [31.06] kPa) and the median Medical Research Council sum score (67.0 [61.5–72.0] points vs. 75.5 [71.5–79.5] points). Of 108 adverse events (AEs; 0.417 AEs per infusion), 95 AEs (88.0%) were mild or moderate in intensity and resolved by the end of study. Two serious AEs of hemolysis were reported that resolved after discontinuation of treatment. Thus, Privigen provided efficacious and well‐tolerated induction and maintenance treatment in patients with CIDP.</abstract><note type="funding">CSL Behring AG</note><subject><genre>keywords</genre><topic>chronic inflammatory demyelinating polyneuropathy</topic><topic>INCAT</topic><topic>IVIG</topic><topic>PRIMA</topic><topic>Privigen®</topic></subject><relatedItem type="host"><titleInfo><title>Journal of the Peripheral Nervous System</title></titleInfo><titleInfo type="abbreviated"><title>J Peripher Nerv Syst</title></titleInfo><genre type="journal">journal</genre><subject><genre>article-category</genre><topic>RESEARCH REPORT</topic></subject><identifier type="ISSN">1085-9489</identifier><identifier type="eISSN">1529-8027</identifier><identifier type="DOI">10.1111/(ISSN)1529-8027</identifier><identifier type="PublisherID">JNS</identifier><part><date>2013</date><detail type="volume"><caption>vol.</caption><number>18</number></detail><detail type="issue"><caption>no.</caption><number>2</number></detail><extent unit="pages"><start>130</start><end>140</end><total>11</total></extent></part></relatedItem><identifier type="istex">4499980138C56F9612808B836593D865DE2D44CA</identifier><identifier type="DOI">10.1111/jns5.12017</identifier><identifier type="ArticleID">JNS512017</identifier><accessCondition type="use and reproduction" contentType="creativeCommonsBy">This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.</accessCondition><recordInfo><recordContentSource>WILEY</recordContentSource><recordOrigin>Wiley Periodicals, Inc.</recordOrigin></recordInfo></mods></metadata><enrichments><json:item><type>multicat</type><uri>https://api.istex.fr/document/4499980138C56F9612808B836593D865DE2D44CA/enrichments/multicat</uri></json:item></enrichments><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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