{"id":"https://openalex.org/W2952089805","doi":"https://doi.org/10.1111/bjd.18220","title":"AURIEL \u2010PsO: a randomized, double\u2010blind phase III equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB 11022 to reference adalimumab in patients with moderate\u2010to\u2010severe chronic plaque\u2010type psoriasis","display_name":"AURIEL \u2010PsO: a randomized, double\u2010blind phase III equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB 11022 to reference adalimumab in patients with moderate\u2010to\u2010severe chronic plaque\u2010type psoriasis","publication_year":2019,"publication_date":"2019-06-17","ids":{"openalex":"https://openalex.org/W2952089805","doi":"https://doi.org/10.1111/bjd.18220","mag":"2952089805","pmid":"https://pubmed.ncbi.nlm.nih.gov/31206593","pmcid":"https://www.ncbi.nlm.nih.gov/pmc/articles/7027805"},"language":"en","primary_location":{"id":"doi:10.1111/bjd.18220","doi":"https://doi.org/10.1111/bjd.18220","is_oa":true,"landing_page_url":"https://doi.org/10.1111/bjd.18220","pdf_url":"https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/bjd.18220","source":{"id":"https://openalex.org/S45720283","display_name":"British Journal of Dermatology","issn_l":"0007-0963","issn":["0007-0963","1365-2133"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-b","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310311648","host_organization_name":"Oxford University Press","host_organization_lineage":["https://openalex.org/P4310311648","https://openalex.org/P4310311647"],"host_organization_lineage_names":["Oxford University Press","University of Oxford"],"type":"journal"},"license":"cc-by-nc","license_id":"https://openalex.org/licenses/cc-by-nc","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"British Journal of Dermatology","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref","pubmed"],"open_access":{"is_oa":true,"oa_status":"hybrid","oa_url":"https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/bjd.18220","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5022295471","display_name":"Jana Tresnak Hercogova","orcid":"https://orcid.org/0000-0003-1702-5995","observed_orcids":["https://orcid.org/0000-0003-1702-5995"]},"institutions":[{"id":"https://openalex.org/I21250087","display_name":"Charles University","ror":"https://ror.org/024d6js02","country_code":"CZ","type":"education","lineage":["https://openalex.org/I21250087"]},{"id":"https://openalex.org/I2803076161","display_name":"Fakultn\u00ed nemocnice Bulovka","ror":"https://ror.org/009e9xr64","country_code":"CZ","type":"healthcare","lineage":["https://openalex.org/I2803076161"]}],"countries":["CZ"],"is_corresponding":true,"raw_author_name":"J. Hercogov\u00e1","raw_affiliation_strings":["Dermatology Department, 2nd Medical Faculty, Charles University and Na Bulovce Hospital, Prague, Czech Republic"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Dermatology Department, 2nd Medical Faculty, Charles University and Na Bulovce Hospital, Prague, Czech Republic","institution_ids":["https://openalex.org/I21250087","https://openalex.org/I2803076161"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5008286260","display_name":"Kim Alexander Papp","orcid":"https://orcid.org/0000-0001-9557-3642","observed_orcids":["https://orcid.org/0000-0001-9557-3642"]},"institutions":[{"id":"https://openalex.org/I4210122653","display_name":"Probity Medical Research","ror":"https://ror.org/0222df516","country_code":"CA","type":"facility","lineage":["https://openalex.org/I4210122653"]}],"countries":["CA"],"is_corresponding":false,"raw_author_name":"K.A. Papp","raw_affiliation_strings":["K Papp Clinical Research and Probity Medical Research Inc., Waterloo, ON, Canada"],"raw_orcid":"https://orcid.org/0000-0001-9557-3642","affiliations":[{"raw_affiliation_string":"K Papp Clinical Research and Probity Medical Research Inc., Waterloo, ON, Canada","institution_ids":["https://openalex.org/I4210122653"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5003952903","display_name":"V. Chyrok","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"V. Chyrok","raw_affiliation_strings":["Fresenius Kabi, Eysin, Switzerland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Fresenius Kabi, Eysin, Switzerland","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5063867674","display_name":"Martin Ullmann","orcid":"https://orcid.org/0000-0002-3088-3209","observed_orcids":["https://orcid.org/0000-0002-3088-3209"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"M. Ullmann","raw_affiliation_strings":["Fresenius Kabi, Eysin, Switzerland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Fresenius Kabi, Eysin, Switzerland","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5010108804","display_name":"Pantelis K. Vlachos","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"P. Vlachos","raw_affiliation_strings":["Cytel, Geneva, Switzerland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Cytel, Geneva, Switzerland","institution_ids":[]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5080267247","display_name":"Christopher John Edwards","orcid":"https://orcid.org/0000-0002-8233-6602","observed_orcids":["https://orcid.org/0000-0002-8233-6602"]},"institutions":[{"id":"https://openalex.org/I43439940","display_name":"University of Southampton","ror":"https://ror.org/01ryk1543","country_code":"GB","type":"education","lineage":["https://openalex.org/I43439940"]}],"countries":["GB"],"is_corresponding":false,"raw_author_name":"C.J. Edwards","raw_affiliation_strings":["NIHR Clinical Research Facility, University of Southampton, Southampton, U.K"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"NIHR Clinical Research Facility, University of Southampton, Southampton, U.K","institution_ids":["https://openalex.org/I43439940"]}]}],"institutions":[],"countries_distinct_count":3,"institutions_distinct_count":4,"corresponding_author_ids":["https://openalex.org/A5022295471"],"corresponding_institution_ids":["https://openalex.org/I21250087","https://openalex.org/I2803076161"],"apc_list":{"value":2700,"currency":"GBP","value_usd":3800},"apc_paid":{"value":2700,"currency":"GBP","value_usd":3800},"fwci":3.3925,"has_fulltext":true,"cited_by_count":67,"citation_normalized_percentile":{"value":0.93352843,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":95,"max":99},"biblio":{"volume":"182","issue":"2","first_page":"316","last_page":"326"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10469","display_name":"Psoriasis: Treatment and Pathogenesis","score":0.763700008392334,"subfield":{"id":"https://openalex.org/subfields/2403","display_name":"Immunology"},"field":{"id":"https://openalex.org/fields/24","display_name":"Immunology and Microbiology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},"topics":[{"id":"https://openalex.org/T10469","display_name":"Psoriasis: Treatment and Pathogenesis","score":0.763700008392334,"subfield":{"id":"https://openalex.org/subfields/2403","display_name":"Immunology"},"field":{"id":"https://openalex.org/fields/24","display_name":"Immunology and Microbiology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T12255","display_name":"Biosimilars and Bioanalytical Methods","score":0.22460000216960907,"subfield":{"id":"https://openalex.org/subfields/2403","display_name":"Immunology"},"field":{"id":"https://openalex.org/fields/24","display_name":"Immunology and Microbiology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T11092","display_name":"Spondyloarthritis Studies and Treatments","score":0.001500000013038516,"subfield":{"id":"https://openalex.org/subfields/2745","display_name":"Rheumatology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/adalimumab-biosimilar","display_name":"adalimumab biosimilar","score":0.8769999742507935},{"id":"https://openalex.org/keywords/plaque-psoriasis","display_name":"plaque psoriasis","score":0.8479999899864197},{"id":"https://openalex.org/keywords/therapeutic-equivalence","display_name":"therapeutic equivalence","score":0.8360000252723694},{"id":"https://openalex.org/keywords/tnf-alpha-inhibitors","display_name":"TNF-alpha inhibitors","score":0.6230000257492065},{"id":"https://openalex.org/keywords/pasi-75","display_name":"PASI 75","score":0.8550000190734863},{"id":"https://openalex.org/keywords/immunogenicity","display_name":"immunogenicity","score":0.847000002861023},{"id":"https://openalex.org/keywords/treatment-emergent-adverse-events","display_name":"treatment-emergent adverse events","score":0.7820000052452087},{"id":"https://openalex.org/keywords/pharmacokinetics","display_name":"pharmacokinetics","score":0.7879999876022339},{"id":"https://openalex.org/keywords/treatment-switching","display_name":"treatment switching","score":0.5180000066757202},{"id":"https://openalex.org/keywords/biological-therapy","display_name":"biologic therapy","score":0.36899998784065247},{"id":"https://openalex.org/keywords/efficacy-and-safety-comparison","display_name":"comparative efficacy and safety","score":0.5789999961853027}],"concepts":[{"id":"https://openalex.org/C59491497","wikidata":"https://www.wikidata.org/wiki/Q864715","display_name":"Biosimilar","level":2,"score":0.901639461517334},{"id":"https://openalex.org/C2780069185","wikidata":"https://www.wikidata.org/wiki/Q7977945","display_name":"Equivalence (formal languages)","level":2,"score":0.679643988609314},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.5282237529754639},{"id":"https://openalex.org/C2991744798","wikidata":"https://www.wikidata.org/wiki/Q608510","display_name":"Double blind","level":4,"score":0.5265082716941833},{"id":"https://openalex.org/C103278499","wikidata":"https://www.wikidata.org/wiki/Q254465","display_name":"Similarity (geometry)","level":3,"score":0.4931411147117615},{"id":"https://openalex.org/C2780132546","wikidata":"https://www.wikidata.org/wiki/Q348260","display_name":"Adalimumab","level":3,"score":0.4891543686389923},{"id":"https://openalex.org/C33923547","wikidata":"https://www.wikidata.org/wiki/Q395","display_name":"Mathematics","level":0,"score":0.3826702833175659},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.34000760316848755},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.24004888534545898},{"id":"https://openalex.org/C154945302","wikidata":"https://www.wikidata.org/wiki/Q11660","display_name":"Artificial intelligence","level":1,"score":0.23525744676589966},{"id":"https://openalex.org/C118615104","wikidata":"https://www.wikidata.org/wiki/Q121416","display_name":"Discrete mathematics","level":1,"score":0.16415157914161682},{"id":"https://openalex.org/C2779134260","wikidata":"https://www.wikidata.org/wiki/Q12136","display_name":"Disease","level":2,"score":0.08672618865966797},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.07614937424659729},{"id":"https://openalex.org/C204787440","wikidata":"https://www.wikidata.org/wiki/Q188504","display_name":"Alternative medicine","level":2,"score":0.0},{"id":"https://openalex.org/C115961682","wikidata":"https://www.wikidata.org/wiki/Q860623","display_name":"Image (mathematics)","level":2,"score":0.0},{"id":"https://openalex.org/C27081682","wikidata":"https://www.wikidata.org/wiki/Q269829","display_name":"Placebo","level":3,"score":0.0}],"mesh":[{"descriptor_ui":"D000068879","descriptor_name":"Adalimumab","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":true},{"descriptor_ui":"D000328","descriptor_name":"Adult","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D004311","descriptor_name":"Double-Blind Method","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005260","descriptor_name":"Female","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D008297","descriptor_name":"Male","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D008875","descriptor_name":"Middle Aged","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D011565","descriptor_name":"Psoriasis","qualifier_ui":"Q000188","qualifier_name":"drug therapy","is_major_topic":true},{"descriptor_ui":"D012720","descriptor_name":"Severity of Illness Index","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D013810","descriptor_name":"Therapeutic Equivalency","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D016896","descriptor_name":"Treatment Outcome","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D059451","descriptor_name":"Biosimilar Pharmaceuticals","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":true}],"locations_count":3,"locations":[{"id":"doi:10.1111/bjd.18220","doi":"https://doi.org/10.1111/bjd.18220","is_oa":true,"landing_page_url":"https://doi.org/10.1111/bjd.18220","pdf_url":"https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/bjd.18220","source":{"id":"https://openalex.org/S45720283","display_name":"British Journal of Dermatology","issn_l":"0007-0963","issn":["0007-0963","1365-2133"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-b","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310311648","host_organization_name":"Oxford University Press","host_organization_lineage":["https://openalex.org/P4310311648","https://openalex.org/P4310311647"],"host_organization_lineage_names":["Oxford University Press","University of Oxford"],"type":"journal"},"license":"cc-by-nc","license_id":"https://openalex.org/licenses/cc-by-nc","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"British Journal of Dermatology","raw_type":"journal-article"},{"id":"pmid:31206593","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/31206593","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"The British journal of dermatology","raw_type":"Clinical Trial, Phase III"},{"id":"pmh:oai:pubmedcentral.nih.gov:7027805","doi":null,"is_oa":true,"landing_page_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC7027805/","pdf_url":null,"source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by-nc","license_id":"https://openalex.org/licenses/cc-by-nc","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Br J Dermatol","raw_type":"Text"}],"best_oa_location":{"id":"doi:10.1111/bjd.18220","doi":"https://doi.org/10.1111/bjd.18220","is_oa":true,"landing_page_url":"https://doi.org/10.1111/bjd.18220","pdf_url":"https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/bjd.18220","source":{"id":"https://openalex.org/S45720283","display_name":"British Journal of Dermatology","issn_l":"0007-0963","issn":["0007-0963","1365-2133"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-b","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310311648","host_organization_name":"Oxford University Press","host_organization_lineage":["https://openalex.org/P4310311648","https://openalex.org/P4310311647"],"host_organization_lineage_names":["Oxford University Press","University of Oxford"],"type":"journal"},"license":"cc-by-nc","license_id":"https://openalex.org/licenses/cc-by-nc","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"British Journal of Dermatology","raw_type":"journal-article"},"sustainable_development_goals":[{"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3","score":1.0}],"study_designs":[{"display_name":"Randomized Controlled Trial","id":"https://openalex.org/study-designs/randomized-controlled-trial"},{"display_name":"Clinical Trial","id":"https://openalex.org/study-designs/clinical-trial"}],"awards":[],"funders":[{"id":"https://openalex.org/F4320307776","display_name":"Merck","ror":"https://ror.org/02891sr49"},{"id":"https://openalex.org/F4320311647","display_name":"Merck KGaA","ror":"https://ror.org/04b2dty93"},{"id":"https://openalex.org/F4320317447","display_name":"Fresenius Kabi","ror":"https://ror.org/043f79m81"}],"has_content":{"grobid_xml":true,"pdf":true},"content_urls":{"pdf":"https://content.openalex.org/works/W2952089805.pdf","grobid_xml":"https://content.openalex.org/works/W2952089805.grobid-xml"},"referenced_works_count":45,"referenced_works":["https://openalex.org/W41296863","https://openalex.org/W823422456","https://openalex.org/W1147565511","https://openalex.org/W1576788104","https://openalex.org/W1741207664","https://openalex.org/W1878131139","https://openalex.org/W1893309200","https://openalex.org/W1960922507","https://openalex.org/W2003717175","https://openalex.org/W2005176759","https://openalex.org/W2008716526","https://openalex.org/W2009735641","https://openalex.org/W2017932566","https://openalex.org/W2028656318","https://openalex.org/W2042872568","https://openalex.org/W2051118349","https://openalex.org/W2063627867","https://openalex.org/W2067327580","https://openalex.org/W2075382650","https://openalex.org/W2075890705","https://openalex.org/W2095756367","https://openalex.org/W2096991001","https://openalex.org/W2120080891","https://openalex.org/W2132164477","https://openalex.org/W2152740900","https://openalex.org/W2156899784","https://openalex.org/W2161137669","https://openalex.org/W2163232748","https://openalex.org/W2342464058","https://openalex.org/W2417110244","https://openalex.org/W2462341035","https://openalex.org/W2512942811","https://openalex.org/W2519779602","https://openalex.org/W2551295995","https://openalex.org/W2613299853","https://openalex.org/W2615103550","https://openalex.org/W2684473450","https://openalex.org/W2725280076","https://openalex.org/W2741340135","https://openalex.org/W2790246629","https://openalex.org/W2791731545","https://openalex.org/W2791960968","https://openalex.org/W2793866077","https://openalex.org/W2809293243","https://openalex.org/W2996422894"],"related_works":["https://openalex.org/W2893246991","https://openalex.org/W4246534099","https://openalex.org/W2944388672","https://openalex.org/W2995092451","https://openalex.org/W2953433507","https://openalex.org/W2950452500","https://openalex.org/W2967573860","https://openalex.org/W2809293243","https://openalex.org/W2417110244","https://openalex.org/W2741340135"],"abstract_inverted_index":{"BACKGROUND:":[0],"MSB11022":[1,16,43,94,240,299,322,353,377,404],"is":[2,270,300],"a":[3,23,67,76,88,271,301,333],"proposed":[4,302],"adalimumab":[5,101,111,243,303,356,380,402],"biosimilar.":[6],"OBJECTIVES:":[7],"To":[8],"compare":[9],"the":[10,161,167,176,184,197,200,230,233,251,281,313,384],"efficacy,":[11,259,372,411],"safety":[12,205,220,260,328,373,412],"and":[13,58,97,121,124,137,140,166,202,241,261,296,309,326,329,354,374,378,392],"immunogenicity":[14,123,222,330,375],"of":[15,71,186,199,232,253,283,376],"with":[17,32,66,75,256],"reference":[18,45,100,110,242,314,355,379,401],"adalimumab.":[19,46],"METHODS:":[20],"AURIEL-PsO":[21,246],"was":[22,51,164,174,190,244],"double-blind":[24,89],"randomized":[25,38],"controlled":[26],"equivalence":[27,69,178,238],"trial,":[28,201],"in":[29,55,79,152,183,219,316,332,337,357,363],"which":[30],"patients":[31,92,98,147,358],"moderate-to-severe":[33,364],"chronic":[34,365],"plaque-type":[35,366],"psoriasis":[36,367],"were":[37,84,102,127,148,207,223,381],"1":[39,41,104,106],":":[40,105],"to":[42,86,108,113,115,133,172,196,229,249,258,312,403],"or":[44,112,221,413],"The":[47,150,371],"primary":[48],"end":[49,119,198,231],"point":[50],"\u2265":[52],"75%":[53],"improvement":[54,78],"Psoriasis":[56],"Area":[57],"Severity":[59],"Index":[60],"(PASI":[61],"75)":[62],"at":[63,81,129,157,212,368,405],"week":[64,82,158,213,369,394,406],"16,":[65,214],"prespecified":[68,177],"interval":[70,170],"\u00b1":[72],"18%.":[73],"Patients":[74],"\u226550%":[77],"PASI":[80,153],"16":[83,159,407],"eligible":[85],"enter":[87],"extension":[90],"period:":[91],"receiving":[93,99],"continued":[95],"treatment,":[96],"rerandomized":[103],"either":[107],"continue":[109],"switch":[114,211,399],"MSB11022.":[116],"Other":[117],"efficacy":[118,351,391],"points":[120],"safety,":[122],"pharmacokinetic":[125],"parameters":[126],"evaluated":[128],"scheduled":[130],"visits":[131],"up":[132,195],"weeks":[134],"52":[135,389],"(efficacy":[136],"immunogenicity),":[138],"54":[139],"66":[141,395],"(safety).":[142],"RESULTS:":[143],"In":[144],"total,":[145],"443":[146],"randomized.":[149],"difference":[151,182],"75":[154],"response":[155],"rates":[156],"between":[160,192,225,239],"treatment":[162,193,210,226,282],"arms":[163,194,227],"-1\u00b79%,":[165],"95%":[168],"confidence":[169],"(-7\u00b78%":[171],"4\u00b71%)":[173],"within":[175],"interval.":[179],"No":[180],"notable":[181],"incidence":[185],"treatment-emergent":[187],"adverse":[188],"events":[189],"observed":[191],"no":[203,215],"new":[204],"signals":[206],"observed.":[208],"Following":[209],"clinically":[216],"meaningful":[217],"differences":[218],"seen":[224],"through":[228],"observation":[234,386],"period.":[235],"CONCLUSIONS:":[236],"Therapeutic":[237],"demonstrated.":[245],"provides":[247],"evidence":[248],"support":[250],"similarity":[252,311],"both":[254],"products":[255],"regard":[257],"immunogenicity.":[262,414],"What's":[263],"already":[264],"known":[265],"about":[266],"this":[267,342],"topic?":[268],"Adalimumab":[269],"fully":[272],"human":[273],"antitumour":[274],"necrosis":[275],"factor-\u03b1":[276],"monoclonal":[277],"antibody,":[278],"indicated":[279],"for":[280,352,390,396],"multiple":[284],"inflammatory":[285,293],"disorders,":[286],"including":[287],"psoriasis,":[288],"psoriatic":[289],"arthritis,":[290,292],"rheumatoid":[291],"bowel":[294],"diseases":[295],"ankylosing":[297],"spondylitis.":[298],"biosimilar":[304],"that":[305],"has":[306,323],"shown":[307],"structural":[308],"functional":[310],"product":[315],"an":[317],"extensive":[318],"analytical":[319],"comparability":[320],"exercise.":[321],"demonstrated":[324],"bioequivalence":[325],"comparable":[327],"profiles":[331],"phase":[334,346],"I":[335],"study":[336,343,348],"healthy":[338],"volunteers.":[339],"What":[340],"does":[341],"add?":[344],"This":[345],"III":[347],"confirmed":[349],"equivalent":[350],"without":[359],"any":[360],"immunomodulation":[361],"comedication":[362],"16.":[370],"similar":[382],"over":[383],"respective":[385],"periods":[387],"(week":[388],"immunogenicity,":[393],"safety).":[397],"A":[398],"from":[400],"did":[408],"not":[409],"impact":[410]},"counts_by_year":[{"year":2026,"cited_by_count":3},{"year":2025,"cited_by_count":8},{"year":2024,"cited_by_count":11},{"year":2023,"cited_by_count":10},{"year":2022,"cited_by_count":14},{"year":2021,"cited_by_count":11},{"year":2020,"cited_by_count":7},{"year":2019,"cited_by_count":3}],"updated_date":"2026-11-10T11:39:43.021295","created_date":"2019-06-27T00:00:00"}
