Clinical Similarity of the Biosimilar ABP 501 Compared With Adalimumab After Single Transition: Long-Term Results From a Randomised, Double-Blind, 52-Week, Phase 3 Study in Moderate-to-Severe Plaque Psoriasis Patients.
Identifieur interne : 000936 ( PubMed/Curation ); précédent : 000935; suivant : 000937Clinical Similarity of the Biosimilar ABP 501 Compared With Adalimumab After Single Transition: Long-Term Results From a Randomised, Double-Blind, 52-Week, Phase 3 Study in Moderate-to-Severe Plaque Psoriasis Patients.
Auteurs : K. Papp [Canada] ; H. Bachelez [France] ; A. Costanzo [Italie] ; P. Foley [Australie] ; M. Gooderham [Canada] ; P. Kaur [États-Unis] ; S. Philipp [Allemagne] ; L. Spelman [Australie] ; N. Zhang [États-Unis] ; B. Strober [États-Unis]Source :
- The British journal of dermatology [ 1365-2133 ] ; 2017.
Abstract
ABP 501, an FDA- and EMA-approved biosimilar, is highly similar to adalimumab in structure, function, and pharmacokinetics.
DOI: 10.1111/bjd.15857
PubMed: 28755394
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Clinical Similarity of the Biosimilar ABP 501 Compared With Adalimumab After Single Transition: Long-Term Results From a Randomised, Double-Blind, 52-Week, Phase 3 Study in Moderate-to-Severe Plaque Psoriasis Patients.</title><author><name sortKey="Papp, K" sort="Papp, K" uniqKey="Papp K" first="K" last="Papp">K. Papp</name><affiliation wicri:level="1"><nlm:affiliation>Clinical Research and Probity Medical Research, Waterloo, ON, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Clinical Research and Probity Medical Research, Waterloo, ON</wicri:regionArea></affiliation></author><author><name sortKey="Bachelez, H" sort="Bachelez, H" uniqKey="Bachelez H" first="H" last="Bachelez">H. Bachelez</name><affiliation wicri:level="1"><nlm:affiliation>Sorbonne Paris Cité Université Paris Diderot, Department of Dermatology, AP-HP HP Hôpital Saint-Louis, INSERM U1163, Institut Imagine, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Sorbonne Paris Cité Université Paris Diderot, Department of Dermatology, AP-HP HP Hôpital Saint-Louis, INSERM U1163, Institut Imagine, Paris</wicri:regionArea></affiliation></author><author><name sortKey="Costanzo, A" sort="Costanzo, A" uniqKey="Costanzo A" first="A" last="Costanzo">A. Costanzo</name><affiliation wicri:level="1"><nlm:affiliation>Dermatology Unit, Department of Biomedical Sciences, Humanitas University, Rozzano - Milan, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Dermatology Unit, Department of Biomedical Sciences, Humanitas University, Rozzano - Milan</wicri:regionArea></affiliation></author><author><name sortKey="Foley, P" sort="Foley, P" uniqKey="Foley P" first="P" last="Foley">P. Foley</name><affiliation wicri:level="1"><nlm:affiliation>Department of Medicine (Dermatology), The University of Melbourne, St Vincent's Hospital Melbourne, Skin& Cancer Foundation Inc, and Probity Medical Research, Carlton, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Medicine (Dermatology), The University of Melbourne, St Vincent's Hospital Melbourne, Skin& Cancer Foundation Inc, and Probity Medical Research, Carlton</wicri:regionArea></affiliation></author><author><name sortKey="Gooderham, M" sort="Gooderham, M" uniqKey="Gooderham M" first="M" last="Gooderham">M. Gooderham</name><affiliation wicri:level="1"><nlm:affiliation>SKiN Centre for Dermatology and Probity Medical Research, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>SKiN Centre for Dermatology and Probity Medical Research, Ontario</wicri:regionArea></affiliation></author><author><name sortKey="Kaur, P" sort="Kaur, P" uniqKey="Kaur P" first="P" last="Kaur">P. Kaur</name><affiliation wicri:level="1"><nlm:affiliation>Amgen Inc, Thousand Oaks, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Amgen Inc, Thousand Oaks, CA</wicri:regionArea></affiliation></author><author><name sortKey="Philipp, S" sort="Philipp, S" uniqKey="Philipp S" first="S" last="Philipp">S. Philipp</name><affiliation wicri:level="1"><nlm:affiliation>Psoriasis Research and Treatment Center, University Hospital Charité, Berlin, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Psoriasis Research and Treatment Center, University Hospital Charité, Berlin</wicri:regionArea></affiliation></author><author><name sortKey="Spelman, L" sort="Spelman, L" uniqKey="Spelman L" first="L" last="Spelman">L. Spelman</name><affiliation wicri:level="1"><nlm:affiliation>Veracity Clinical Research and Probity Medical Research, Woolloongabba, Queensland, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Veracity Clinical Research and Probity Medical Research, Woolloongabba, Queensland</wicri:regionArea></affiliation></author><author><name sortKey="Zhang, N" sort="Zhang, N" uniqKey="Zhang N" first="N" last="Zhang">N. Zhang</name><affiliation wicri:level="1"><nlm:affiliation>Amgen Inc, Thousand Oaks, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Amgen Inc, Thousand Oaks, CA</wicri:regionArea></affiliation></author><author><name sortKey="Strober, B" sort="Strober, B" uniqKey="Strober B" first="B" last="Strober">B. Strober</name><affiliation wicri:level="1"><nlm:affiliation>University of Connecticut Health Center and Probity Medical Research, Farmington, CT, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Connecticut Health Center and Probity Medical Research, Farmington, CT</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:28755394</idno><idno type="pmid">28755394</idno><idno type="doi">10.1111/bjd.15857</idno><idno type="wicri:Area/PubMed/Corpus">000939</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000939</idno><idno type="wicri:Area/PubMed/Curation">000936</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">000936</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Clinical Similarity of the Biosimilar ABP 501 Compared With Adalimumab After Single Transition: Long-Term Results From a Randomised, Double-Blind, 52-Week, Phase 3 Study in Moderate-to-Severe Plaque Psoriasis Patients.</title><author><name sortKey="Papp, K" sort="Papp, K" uniqKey="Papp K" first="K" last="Papp">K. Papp</name><affiliation wicri:level="1"><nlm:affiliation>Clinical Research and Probity Medical Research, Waterloo, ON, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Clinical Research and Probity Medical Research, Waterloo, ON</wicri:regionArea></affiliation></author><author><name sortKey="Bachelez, H" sort="Bachelez, H" uniqKey="Bachelez H" first="H" last="Bachelez">H. Bachelez</name><affiliation wicri:level="1"><nlm:affiliation>Sorbonne Paris Cité Université Paris Diderot, Department of Dermatology, AP-HP HP Hôpital Saint-Louis, INSERM U1163, Institut Imagine, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Sorbonne Paris Cité Université Paris Diderot, Department of Dermatology, AP-HP HP Hôpital Saint-Louis, INSERM U1163, Institut Imagine, Paris</wicri:regionArea></affiliation></author><author><name sortKey="Costanzo, A" sort="Costanzo, A" uniqKey="Costanzo A" first="A" last="Costanzo">A. Costanzo</name><affiliation wicri:level="1"><nlm:affiliation>Dermatology Unit, Department of Biomedical Sciences, Humanitas University, Rozzano - Milan, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Dermatology Unit, Department of Biomedical Sciences, Humanitas University, Rozzano - Milan</wicri:regionArea></affiliation></author><author><name sortKey="Foley, P" sort="Foley, P" uniqKey="Foley P" first="P" last="Foley">P. Foley</name><affiliation wicri:level="1"><nlm:affiliation>Department of Medicine (Dermatology), The University of Melbourne, St Vincent's Hospital Melbourne, Skin& Cancer Foundation Inc, and Probity Medical Research, Carlton, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Medicine (Dermatology), The University of Melbourne, St Vincent's Hospital Melbourne, Skin& Cancer Foundation Inc, and Probity Medical Research, Carlton</wicri:regionArea></affiliation></author><author><name sortKey="Gooderham, M" sort="Gooderham, M" uniqKey="Gooderham M" first="M" last="Gooderham">M. Gooderham</name><affiliation wicri:level="1"><nlm:affiliation>SKiN Centre for Dermatology and Probity Medical Research, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>SKiN Centre for Dermatology and Probity Medical Research, Ontario</wicri:regionArea></affiliation></author><author><name sortKey="Kaur, P" sort="Kaur, P" uniqKey="Kaur P" first="P" last="Kaur">P. Kaur</name><affiliation wicri:level="1"><nlm:affiliation>Amgen Inc, Thousand Oaks, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Amgen Inc, Thousand Oaks, CA</wicri:regionArea></affiliation></author><author><name sortKey="Philipp, S" sort="Philipp, S" uniqKey="Philipp S" first="S" last="Philipp">S. Philipp</name><affiliation wicri:level="1"><nlm:affiliation>Psoriasis Research and Treatment Center, University Hospital Charité, Berlin, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Psoriasis Research and Treatment Center, University Hospital Charité, Berlin</wicri:regionArea></affiliation></author><author><name sortKey="Spelman, L" sort="Spelman, L" uniqKey="Spelman L" first="L" last="Spelman">L. Spelman</name><affiliation wicri:level="1"><nlm:affiliation>Veracity Clinical Research and Probity Medical Research, Woolloongabba, Queensland, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Veracity Clinical Research and Probity Medical Research, Woolloongabba, Queensland</wicri:regionArea></affiliation></author><author><name sortKey="Zhang, N" sort="Zhang, N" uniqKey="Zhang N" first="N" last="Zhang">N. Zhang</name><affiliation wicri:level="1"><nlm:affiliation>Amgen Inc, Thousand Oaks, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Amgen Inc, Thousand Oaks, CA</wicri:regionArea></affiliation></author><author><name sortKey="Strober, B" sort="Strober, B" uniqKey="Strober B" first="B" last="Strober">B. Strober</name><affiliation wicri:level="1"><nlm:affiliation>University of Connecticut Health Center and Probity Medical Research, Farmington, CT, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Connecticut Health Center and Probity Medical Research, Farmington, CT</wicri:regionArea></affiliation></author></analytic><series><title level="j">The British journal of dermatology</title><idno type="eISSN">1365-2133</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">ABP 501, an FDA- and EMA-approved biosimilar, is highly similar to adalimumab in structure, function, and pharmacokinetics.</div></front></TEI><pubmed><MedlineCitation Status="Publisher" Owner="NLM"><PMID Version="1">28755394</PMID><DateCreated><Year>2017</Year><Month>07</Month><Day>29</Day></DateCreated><DateRevised><Year>2017</Year><Month>07</Month><Day>29</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1365-2133</ISSN><JournalIssue CitedMedium="Internet"><PubDate><Year>2017</Year><Month>Jul</Month><Day>28</Day></PubDate></JournalIssue><Title>The British journal of dermatology</Title><ISOAbbreviation>Br. J. Dermatol.</ISOAbbreviation></Journal><ArticleTitle>Clinical Similarity of the Biosimilar ABP 501 Compared With Adalimumab After Single Transition: Long-Term Results From a Randomised, Double-Blind, 52-Week, Phase 3 Study in Moderate-to-Severe Plaque Psoriasis Patients.</ArticleTitle><ELocationID EIdType="doi" ValidYN="Y">10.1111/bjd.15857</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">ABP 501, an FDA- and EMA-approved biosimilar, is highly similar to adalimumab in structure, function, and pharmacokinetics.</AbstractText><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">Demonstrate similarity in efficacy, safety, and immunogenicity of ABP 501 versus adalimumab for moderate-to-severe plaque psoriasis.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">Patients were randomised (1:1) to receive ABP 501 or adalimumab 40 mg every 2 weeks for 16 weeks. At Week 16, patients with ≥50% improvement from baseline in psoriasis area-and-severity index score (PASI) were eligible to continue to Week 52. Patients receiving ABP 501 continued; adalimumab patients were re-randomised (1:1) to continue adalimumab or undergo a single transition to ABP 501. Key efficacy assessments included % PASI improvement from baseline, PASI responders, and mean change in affected body surface area (BSA) from baseline to Weeks 16, 32, and 50. Safety was monitored via adverse events (AEs) and antidrug antibodies (ADAs) were assessed.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">308 patients were re-randomised at Week 16 (ABP 501/ABP 501, n=152; adalimumab/adalimumab, n=79; adalimumab/ABP 501, n=77). PASI percent improvements from baseline were similar across groups for Weeks 16, 32, and 50 (range: 85.8%-88.2%), with no significant differences detected across groups in percentages of PASI 50, 75, 90, and 100 responders. Changes from baseline in %BSA affected were similar across groups and timepoints. No new safety signals were detected. AEs were balanced between groups. Percentages of patients with binding and neutralizing ADAs were similar across treatments.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">ABP 501 and adalimumab have similar clinical efficacy, safety, and immunogenicity profiles over 52 weeks, including after single transition, in this patient population. This article is protected by copyright. All rights reserved.</AbstractText><CopyrightInformation>This article is protected by copyright. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Papp</LastName><ForeName>K</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Clinical Research and Probity Medical Research, Waterloo, ON, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bachelez</LastName><ForeName>H</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Sorbonne Paris Cité Université Paris Diderot, Department of Dermatology, AP-HP HP Hôpital Saint-Louis, INSERM U1163, Institut Imagine, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Costanzo</LastName><ForeName>A</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Dermatology Unit, Department of Biomedical Sciences, Humanitas University, Rozzano - Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Foley</LastName><ForeName>P</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Department of Medicine (Dermatology), The University of Melbourne, St Vincent's Hospital Melbourne, Skin& Cancer Foundation Inc, and Probity Medical Research, Carlton, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gooderham</LastName><ForeName>M</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>SKiN Centre for Dermatology and Probity Medical Research, Ontario, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kaur</LastName><ForeName>P</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Amgen Inc, Thousand Oaks, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Philipp</LastName><ForeName>S</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Psoriasis Research and Treatment Center, University Hospital Charité, Berlin, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Spelman</LastName><ForeName>L</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Veracity Clinical Research and Probity Medical Research, Woolloongabba, Queensland, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zhang</LastName><ForeName>N</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Amgen Inc, Thousand Oaks, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Strober</LastName><ForeName>B</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>University of Connecticut Health Center and Probity Medical Research, Farmington, CT, USA.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2017</Year><Month>07</Month><Day>28</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Br J Dermatol</MedlineTA><NlmUniqueID>0004041</NlmUniqueID><ISSNLinking>0007-0963</ISSNLinking></MedlineJournalInfo><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">ABP 501</Keyword><Keyword MajorTopicYN="N">adalimumab</Keyword><Keyword MajorTopicYN="N">biosimilar</Keyword><Keyword MajorTopicYN="N">psoriasis</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>7</Month><Day>30</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2017</Year><Month>7</Month><Day>30</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>7</Month><Day>30</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>aheadofprint</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">28755394</ArticleId><ArticleId IdType="doi">10.1111/bjd.15857</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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