Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: A randomized, double-blind, multicenter, phase III study.
Identifieur interne : 000F82 ( PubMed/Checkpoint ); précédent : 000F81; suivant : 000F83Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: A randomized, double-blind, multicenter, phase III study.
Auteurs : Kim Papp [Canada] ; Herve Bachelez [France] ; Antonio Costanzo [Italie] ; Peter Foley [Australie] ; Melinda Gooderham [Canada] ; Primal Kaur [États-Unis] ; Joanna Narbutt [Pologne] ; Sandra Philipp [Allemagne] ; Lynda Spelman [Australie] ; Jolanta Weglowska [Pologne] ; Nan Zhang [États-Unis] ; Bruce Strober [États-Unis]Source :
- Journal of the American Academy of Dermatology [ 1097-6787 ] ; 2017.
Descripteurs français
- KwdFr :
- MESH :
- traitement médicamenteux : Psoriasis.
- usage thérapeutique : Adalimumab, Produits pharmaceutiques biosimilaires.
- Adulte, Adulte d'âge moyen, Femelle, Humains, Indice de gravité médicale, Mâle, Méthode en double aveugle.
English descriptors
- KwdEn :
- MESH :
- chemical , therapeutic use : Adalimumab, Biosimilar Pharmaceuticals.
- drug therapy : Psoriasis.
- Adult, Double-Blind Method, Female, Humans, Male, Middle Aged, Severity of Illness Index.
Abstract
ABP 501 is a biosimilar of adalimumab.
DOI: 10.1016/j.jaad.2016.12.014
PubMed: 28291552
Affiliations:
- Allemagne, Australie, Canada, France, Italie, Pologne, États-Unis
- Berlin, Californie, Connecticut, Latium, Victoria (État), Île-de-France
- Berlin, Melbourne, Paris, Rome
- Université de Melbourne
Links toward previous steps (curation, corpus...)
Links to Exploration step
pubmed:28291552Le document en format XML
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Electronic address: kapapp@probitymedical.com.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>K Papp Clinical Research, Waterloo, Ontario, Canada; Probity Medical Research, Waterloo, Ontario</wicri:regionArea><wicri:noRegion>Ontario</wicri:noRegion></affiliation></author><author><name sortKey="Bachelez, Herve" sort="Bachelez, Herve" uniqKey="Bachelez H" first="Herve" last="Bachelez">Herve Bachelez</name><affiliation wicri:level="3"><nlm:affiliation>Sorbonne Paris Cité Université Paris Diderot, Department of Dermatology, Assistance Publique-Hopitaux de Paris Saint-Louis Hospital, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Sorbonne Paris Cité Université Paris Diderot, Department of Dermatology, Assistance Publique-Hopitaux de Paris Saint-Louis Hospital, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Costanzo, Antonio" sort="Costanzo, Antonio" uniqKey="Costanzo A" first="Antonio" last="Costanzo">Antonio Costanzo</name><affiliation wicri:level="3"><nlm:affiliation>Dermatology Unit, Department of Neuroscience, Mental Health and Sensory Systems (NeSMOS) Department, Sapienza University of Rome, Rome, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Dermatology Unit, Department of Neuroscience, Mental Health and Sensory Systems (NeSMOS) Department, Sapienza University of Rome, Rome</wicri:regionArea><placeName><settlement type="city">Rome</settlement><region nuts="2">Latium</region></placeName></affiliation></author><author><name sortKey="Foley, Peter" sort="Foley, Peter" uniqKey="Foley P" first="Peter" last="Foley">Peter Foley</name><affiliation wicri:level="4"><nlm:affiliation>Probity Medical Research, Carlton, Australia; Department of Medicine (Dermatology), University of Melbourne, St Vincent's Hospital Melbourne, Skin and Cancer Foundation Inc, Melbourne, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Probity Medical Research, Carlton, Australia; Department of Medicine (Dermatology), University of Melbourne, St Vincent's Hospital Melbourne, Skin and Cancer Foundation Inc, Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region><settlement type="city">Melbourne</settlement></placeName><orgName type="university">Université de Melbourne</orgName></affiliation></author><author><name sortKey="Gooderham, Melinda" sort="Gooderham, Melinda" uniqKey="Gooderham M" first="Melinda" last="Gooderham">Melinda Gooderham</name><affiliation wicri:level="1"><nlm:affiliation>Probity Medical Research, Waterloo, Ontario, Canada; SKiN Centre for Dermatology, Peterborough, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Probity Medical Research, Waterloo, Ontario, Canada; 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Veracity Clinical Research, Woolloongabba, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Probity Medical Research, Woolloongabba, Australia; Veracity Clinical Research, Woolloongabba</wicri:regionArea><wicri:noRegion>Woolloongabba</wicri:noRegion></affiliation></author><author><name sortKey="Weglowska, Jolanta" sort="Weglowska, Jolanta" uniqKey="Weglowska J" first="Jolanta" last="Weglowska">Jolanta Weglowska</name><affiliation wicri:level="1"><nlm:affiliation>Regional Hospital, Department of Dermatology, Wroclaw, Poland.</nlm:affiliation><country xml:lang="fr">Pologne</country><wicri:regionArea>Regional Hospital, Department of Dermatology, Wroclaw</wicri:regionArea><wicri:noRegion>Wroclaw</wicri:noRegion></affiliation></author><author><name sortKey="Zhang, Nan" sort="Zhang, Nan" uniqKey="Zhang N" first="Nan" last="Zhang">Nan Zhang</name><affiliation wicri:level="2"><nlm:affiliation>Amgen Inc, Thousand Oaks, California.</nlm:affiliation><country>États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>Amgen Inc, Thousand Oaks</wicri:cityArea></affiliation></author><author><name sortKey="Strober, Bruce" sort="Strober, Bruce" uniqKey="Strober B" first="Bruce" last="Strober">Bruce Strober</name><affiliation wicri:level="2"><nlm:affiliation>Probity Medical Research, Farmington, Connecticut; University of Connecticut Health Center, Connecticut.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Connecticut</region></placeName><wicri:cityArea>Probity Medical Research, Farmington, Connecticut; University of Connecticut Health Center</wicri:cityArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:28291552</idno><idno type="pmid">28291552</idno><idno type="doi">10.1016/j.jaad.2016.12.014</idno><idno type="wicri:Area/PubMed/Corpus">000B53</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000B53</idno><idno type="wicri:Area/PubMed/Curation">000B50</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">000B50</idno><idno type="wicri:Area/PubMed/Checkpoint">000B50</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">000B50</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: A randomized, double-blind, multicenter, phase III study.</title><author><name sortKey="Papp, Kim" sort="Papp, Kim" uniqKey="Papp K" first="Kim" last="Papp">Kim Papp</name><affiliation wicri:level="1"><nlm:affiliation>K Papp Clinical Research, Waterloo, Ontario, Canada; Probity Medical Research, Waterloo, Ontario, Canada. Electronic address: kapapp@probitymedical.com.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>K Papp Clinical Research, Waterloo, Ontario, Canada; Probity Medical Research, Waterloo, Ontario</wicri:regionArea><wicri:noRegion>Ontario</wicri:noRegion></affiliation></author><author><name sortKey="Bachelez, Herve" sort="Bachelez, Herve" uniqKey="Bachelez H" first="Herve" last="Bachelez">Herve Bachelez</name><affiliation wicri:level="3"><nlm:affiliation>Sorbonne Paris Cité Université Paris Diderot, Department of Dermatology, Assistance Publique-Hopitaux de Paris Saint-Louis Hospital, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Sorbonne Paris Cité Université Paris Diderot, Department of Dermatology, Assistance Publique-Hopitaux de Paris Saint-Louis Hospital, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Costanzo, Antonio" sort="Costanzo, Antonio" uniqKey="Costanzo A" first="Antonio" last="Costanzo">Antonio Costanzo</name><affiliation wicri:level="3"><nlm:affiliation>Dermatology Unit, Department of Neuroscience, Mental Health and Sensory Systems (NeSMOS) Department, Sapienza University of Rome, Rome, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Dermatology Unit, Department of Neuroscience, Mental Health and Sensory Systems (NeSMOS) Department, Sapienza University of Rome, Rome</wicri:regionArea><placeName><settlement type="city">Rome</settlement><region nuts="2">Latium</region></placeName></affiliation></author><author><name sortKey="Foley, Peter" sort="Foley, Peter" uniqKey="Foley P" first="Peter" last="Foley">Peter Foley</name><affiliation wicri:level="4"><nlm:affiliation>Probity Medical Research, Carlton, Australia; Department of Medicine (Dermatology), University of Melbourne, St Vincent's Hospital Melbourne, Skin and Cancer Foundation Inc, Melbourne, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Probity Medical Research, Carlton, Australia; Department of Medicine (Dermatology), University of Melbourne, St Vincent's Hospital Melbourne, Skin and Cancer Foundation Inc, Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region><settlement type="city">Melbourne</settlement></placeName><orgName type="university">Université de Melbourne</orgName></affiliation></author><author><name sortKey="Gooderham, Melinda" sort="Gooderham, Melinda" uniqKey="Gooderham M" first="Melinda" last="Gooderham">Melinda Gooderham</name><affiliation wicri:level="1"><nlm:affiliation>Probity Medical Research, Waterloo, Ontario, Canada; SKiN Centre for Dermatology, Peterborough, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Probity Medical Research, Waterloo, Ontario, Canada; SKiN Centre for Dermatology, Peterborough, Ontario</wicri:regionArea><wicri:noRegion>Ontario</wicri:noRegion></affiliation></author><author><name sortKey="Kaur, Primal" sort="Kaur, Primal" uniqKey="Kaur P" first="Primal" last="Kaur">Primal Kaur</name><affiliation wicri:level="2"><nlm:affiliation>Amgen Inc, Thousand Oaks, California.</nlm:affiliation><country>États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>Amgen Inc, Thousand Oaks</wicri:cityArea></affiliation></author><author><name sortKey="Narbutt, Joanna" sort="Narbutt, Joanna" uniqKey="Narbutt J" first="Joanna" last="Narbutt">Joanna Narbutt</name><affiliation wicri:level="1"><nlm:affiliation>Dermoklinika Medical Centre, Lodz, Poland.</nlm:affiliation><country xml:lang="fr">Pologne</country><wicri:regionArea>Dermoklinika Medical Centre, Lodz</wicri:regionArea><wicri:noRegion>Lodz</wicri:noRegion></affiliation></author><author><name sortKey="Philipp, Sandra" sort="Philipp, Sandra" uniqKey="Philipp S" first="Sandra" last="Philipp">Sandra Philipp</name><affiliation wicri:level="3"><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><placeName><region type="land" nuts="3">Berlin</region><settlement type="city">Berlin</settlement></placeName></affiliation></author><author><name sortKey="Spelman, Lynda" sort="Spelman, Lynda" uniqKey="Spelman L" first="Lynda" last="Spelman">Lynda Spelman</name><affiliation wicri:level="1"><nlm:affiliation>Probity Medical Research, Woolloongabba, Australia; Veracity Clinical Research, Woolloongabba, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Probity Medical Research, Woolloongabba, Australia; Veracity Clinical Research, Woolloongabba</wicri:regionArea><wicri:noRegion>Woolloongabba</wicri:noRegion></affiliation></author><author><name sortKey="Weglowska, Jolanta" sort="Weglowska, Jolanta" uniqKey="Weglowska J" first="Jolanta" last="Weglowska">Jolanta Weglowska</name><affiliation wicri:level="1"><nlm:affiliation>Regional Hospital, Department of Dermatology, Wroclaw, Poland.</nlm:affiliation><country xml:lang="fr">Pologne</country><wicri:regionArea>Regional Hospital, Department of Dermatology, Wroclaw</wicri:regionArea><wicri:noRegion>Wroclaw</wicri:noRegion></affiliation></author><author><name sortKey="Zhang, Nan" sort="Zhang, Nan" uniqKey="Zhang N" first="Nan" last="Zhang">Nan Zhang</name><affiliation wicri:level="2"><nlm:affiliation>Amgen Inc, Thousand Oaks, California.</nlm:affiliation><country>États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>Amgen Inc, Thousand Oaks</wicri:cityArea></affiliation></author><author><name sortKey="Strober, Bruce" sort="Strober, Bruce" uniqKey="Strober B" first="Bruce" last="Strober">Bruce Strober</name><affiliation wicri:level="2"><nlm:affiliation>Probity Medical Research, Farmington, Connecticut; University of Connecticut Health Center, Connecticut.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Connecticut</region></placeName><wicri:cityArea>Probity Medical Research, Farmington, Connecticut; University of Connecticut Health Center</wicri:cityArea></affiliation></author></analytic><series><title level="j">Journal of the American Academy of Dermatology</title><idno type="eISSN">1097-6787</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adalimumab (therapeutic use)</term><term>Adult</term><term>Biosimilar Pharmaceuticals (therapeutic use)</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Psoriasis (drug therapy)</term><term>Severity of Illness Index</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adalimumab (usage thérapeutique)</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Femelle</term><term>Humains</term><term>Indice de gravité médicale</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Produits pharmaceutiques biosimilaires (usage thérapeutique)</term><term>Psoriasis (traitement médicamenteux)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Adalimumab</term><term>Biosimilar Pharmaceuticals</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Psoriasis</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Psoriasis</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Adalimumab</term><term>Produits pharmaceutiques biosimilaires</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Severity of Illness Index</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Femelle</term><term>Humains</term><term>Indice de gravité médicale</term><term>Mâle</term><term>Méthode en double aveugle</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">ABP 501 is a biosimilar of adalimumab.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">28291552</PMID><DateCreated><Year>2017</Year><Month>03</Month><Day>14</Day></DateCreated><DateCompleted><Year>2017</Year><Month>07</Month><Day>26</Day></DateCompleted><DateRevised><Year>2017</Year><Month>07</Month><Day>26</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1097-6787</ISSN><JournalIssue CitedMedium="Internet"><Volume>76</Volume><Issue>6</Issue><PubDate><Year>2017</Year><Month>Jun</Month></PubDate></JournalIssue><Title>Journal of the American Academy of Dermatology</Title><ISOAbbreviation>J. Am. Acad. Dermatol.</ISOAbbreviation></Journal><ArticleTitle>Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: A randomized, double-blind, multicenter, phase III study.</ArticleTitle><Pagination><MedlinePgn>1093-1102</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S0190-9622(16)31238-5</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.jaad.2016.12.014</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">ABP 501 is a biosimilar of adalimumab.</AbstractText><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">We sought to compare the efficacy and safety of ABP 501 with adalimumab.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">This 52-week, double-blind study randomized patients with moderate to severe psoriasis to ABP 501 or adalimumab. At week 16, those with 50% or more improvement in Psoriasis Area and Severity Index score from baseline on ABP 501 continued the same treatment, whereas adalimumab-treated patients were rerandomized to adalimumab or ABP 501. Clinical similarity in Psoriasis Area and Severity Index percent improvement from baseline to week 16 (primary end point) was established if the point estimate of treatment difference and its 2-sided 95% confidence interval between groups was within equivalence margin of ±15. Patients, including those undergoing a single transition at week 16, were evaluated for safety and immunogenicity.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Psoriasis Area and Severity Index percent improvement at week 16 was 80.9 for ABP 501 and 83.1 for adalimumab (least-square mean difference -2.18 [95% confidence interval -7.39 to 3.02]). Adverse events (67.2% [117/174] vs 63.6% [110/173]) and antidrug antibody incidence (55.2% [96/174] vs 63.6% [110/173]) for ABP 501 vs adalimumab were similar. Safety, including immunogenicity, was similar among groups after single transition (week 20).</AbstractText><AbstractText Label="LIMITATIONS" NlmCategory="CONCLUSIONS">The 52-week data are not reported here.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">ABP 501 was shown to be clinically similar to adalimumab. Safety and immunogenicity were not impacted immediately after single transition (adalimumab to ABP 501).</AbstractText><CopyrightInformation>Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Papp</LastName><ForeName>Kim</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>K Papp Clinical Research, Waterloo, Ontario, Canada; Probity Medical Research, Waterloo, Ontario, Canada. Electronic address: kapapp@probitymedical.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bachelez</LastName><ForeName>Herve</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Sorbonne Paris Cité Université Paris Diderot, Department of Dermatology, Assistance Publique-Hopitaux de Paris Saint-Louis Hospital, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Costanzo</LastName><ForeName>Antonio</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Dermatology Unit, Department of Neuroscience, Mental Health and Sensory Systems (NeSMOS) Department, Sapienza University of Rome, Rome, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Foley</LastName><ForeName>Peter</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Probity Medical Research, Carlton, Australia; Department of Medicine (Dermatology), University of Melbourne, St Vincent's Hospital Melbourne, Skin and Cancer Foundation Inc, Melbourne, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gooderham</LastName><ForeName>Melinda</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Probity Medical Research, Waterloo, Ontario, Canada; SKiN Centre for Dermatology, Peterborough, Ontario, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kaur</LastName><ForeName>Primal</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Amgen Inc, Thousand Oaks, California.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Narbutt</LastName><ForeName>Joanna</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Dermoklinika Medical Centre, Lodz, Poland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Philipp</LastName><ForeName>Sandra</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>Lynda</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Probity Medical Research, Woolloongabba, Australia; Veracity Clinical Research, Woolloongabba, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Weglowska</LastName><ForeName>Jolanta</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Regional Hospital, Department of Dermatology, Wroclaw, Poland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zhang</LastName><ForeName>Nan</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Amgen Inc, Thousand Oaks, California.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Strober</LastName><ForeName>Bruce</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Probity Medical Research, Farmington, Connecticut; University of Connecticut Health Center, Connecticut.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType><PublicationType UI="D003160">Comparative Study</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2017</Year><Month>03</Month><Day>11</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>J Am Acad Dermatol</MedlineTA><NlmUniqueID>7907132</NlmUniqueID><ISSNLinking>0190-9622</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D059451">Biosimilar Pharmaceuticals</NameOfSubstance></Chemical><Chemical><RegistryNumber>FYS6T7F842</RegistryNumber><NameOfSubstance UI="D000068879">Adalimumab</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000068879" MajorTopicYN="N">Adalimumab</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D059451" MajorTopicYN="N">Biosimilar Pharmaceuticals</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011565" MajorTopicYN="N">Psoriasis</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012720" MajorTopicYN="N">Severity of Illness Index</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">ABP 501</Keyword><Keyword MajorTopicYN="N">adalimumab</Keyword><Keyword MajorTopicYN="N">biosimilar</Keyword><Keyword MajorTopicYN="N">efficacy</Keyword><Keyword MajorTopicYN="N">equivalence</Keyword><Keyword MajorTopicYN="N">psoriasis</Keyword><Keyword MajorTopicYN="N">safety</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2016</Year><Month>08</Month><Day>24</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2016</Year><Month>12</Month><Day>06</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2016</Year><Month>12</Month><Day>08</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2017</Year><Month>3</Month><Day>16</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>7</Month><Day>27</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>3</Month><Day>15</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">28291552</ArticleId><ArticleId IdType="pii">S0190-9622(16)31238-5</ArticleId><ArticleId IdType="doi">10.1016/j.jaad.2016.12.014</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Canada</li><li>France</li><li>Italie</li><li>Pologne</li><li>États-Unis</li></country><region><li>Berlin</li><li>Californie</li><li>Connecticut</li><li>Latium</li><li>Victoria (État)</li><li>Île-de-France</li></region><settlement><li>Berlin</li><li>Melbourne</li><li>Paris</li><li>Rome</li></settlement><orgName><li>Université de Melbourne</li></orgName></list><tree><country name="Canada"><noRegion><name sortKey="Papp, Kim" sort="Papp, Kim" uniqKey="Papp K" first="Kim" last="Papp">Kim Papp</name></noRegion><name sortKey="Gooderham, Melinda" sort="Gooderham, Melinda" uniqKey="Gooderham M" first="Melinda" last="Gooderham">Melinda Gooderham</name></country><country name="France"><region name="Île-de-France"><name sortKey="Bachelez, Herve" sort="Bachelez, Herve" uniqKey="Bachelez H" first="Herve" last="Bachelez">Herve Bachelez</name></region></country><country name="Italie"><region name="Latium"><name sortKey="Costanzo, Antonio" sort="Costanzo, Antonio" uniqKey="Costanzo A" first="Antonio" last="Costanzo">Antonio Costanzo</name></region></country><country name="Australie"><region name="Victoria (État)"><name sortKey="Foley, Peter" sort="Foley, Peter" uniqKey="Foley P" first="Peter" last="Foley">Peter Foley</name></region><name sortKey="Spelman, Lynda" sort="Spelman, Lynda" uniqKey="Spelman L" first="Lynda" last="Spelman">Lynda Spelman</name></country><country name="États-Unis"><region name="Californie"><name sortKey="Kaur, Primal" sort="Kaur, Primal" uniqKey="Kaur P" first="Primal" last="Kaur">Primal Kaur</name></region><name sortKey="Strober, Bruce" sort="Strober, Bruce" uniqKey="Strober B" first="Bruce" last="Strober">Bruce Strober</name><name sortKey="Zhang, Nan" sort="Zhang, Nan" uniqKey="Zhang N" first="Nan" last="Zhang">Nan Zhang</name></country><country name="Pologne"><noRegion><name sortKey="Narbutt, Joanna" sort="Narbutt, Joanna" uniqKey="Narbutt J" first="Joanna" last="Narbutt">Joanna Narbutt</name></noRegion><name sortKey="Weglowska, Jolanta" sort="Weglowska, Jolanta" uniqKey="Weglowska J" first="Jolanta" last="Weglowska">Jolanta Weglowska</name></country><country name="Allemagne"><region name="Berlin"><name sortKey="Philipp, Sandra" sort="Philipp, Sandra" uniqKey="Philipp S" first="Sandra" last="Philipp">Sandra Philipp</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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