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Non-interventional, multicenter, 52-week prospective cohort study, enrolling biologic-na\u00efve patients with early active peripheral PsA who started apremilast after intolerance or inadequate response (within the first 12\u00a0months of treatment) to an initial conventional synthetic (cs)DMARD treatment. Non-responder imputation was applied for missing data.In total, 167 consecutive patients (mean age: 52.5\u00a0years; median PsA duration: 0.9\u00a0years) were analyzed. At baseline, the median (interquartile range) clinical Disease Activity in Psoriatic Arthritis (cDAPSA) score was 22.0 (16.0\u201329.0), with 86.8% of patients having at least moderate (29.3% high) disease activity; 87.4% had skin psoriasis, 37.7% nail psoriasis, 30.7% enthesitis, and 12.4% dactylitis. At 16, 24, and 52\u00a0weeks, 28.7, 42.5, and 48.5% of patients, achieved\u2009\u2265\u200950% improvement in their baseline cDAPSA score, respectively. At week 52, 55.6, 50, and 26.8% of evaluable patients achieved complete resolution of enthesitis, dactylitis and nail psoriasis, respectively. Improvements were also observed in patient\u2019s health state assessed by the Psoriatic Arthritis Impact of Disease 12-item questionnaire, and health-related quality of life. The 52-week drug survival rate was 75%, while 13.8% of patients experienced at least one adverse drug reaction.Biologic-na\u00efve patients with early PsA, treated with apremilast experienced significant improvements in disease activity, extra-articular manifestations and patient-centered outcomes, accompanied by a favorable tolerability profile.<\/jats:p>","DOI":"10.1007\/s00296-022-05269-z","type":"journal-article","created":{"date-parts":[[2023,3,1]],"date-time":"2023-03-01T06:04:01Z","timestamp":1677650641000},"page":"889-902","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Apremilast for biologic-na\u00efve, peripheral psoriatic arthritis, including patients with early disease: results from the APROACH observational prospective study"],"prefix":"10.1007","volume":"43","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5484-2930","authenticated-orcid":false,"given":"Petros P.","family":"Sfikakis","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dimitrios","family":"Vassilopoulos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gkikas","family":"Katsifis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Georgios","family":"Vosvotekas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Theodoros","family":"Dimitroulas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Prodromos","family":"Sidiropoulos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Periklis","family":"Vounotrypidis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dimitrios P.","family":"Bogdanos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Athanasios \u0399.","family":"Georgountzos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas G.","family":"Bounas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Panagiotis","family":"Georgiou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Souzana","family":"Gazi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evangelia","family":"Kataxaki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stamatis-Nick","family":"Liossis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evangelos","family":"Theodorou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charalampos","family":"Papagoras","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evangelos","family":"Theotikos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Panayiotis","family":"Vlachoyiannopoulos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paraskevi V.","family":"Voulgari","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angeliki","family":"Kekki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nikolaos","family":"Antonakopoulos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dimitrios T.","family":"Boumpas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,3,1]]},"reference":[{"key":"5269_CR1","doi-asserted-by":"publisher","first-page":"115","DOI":"10.1186\/s13075-015-0640-3","volume":"17","author":"O FitzGerald","year":"2015","unstructured":"FitzGerald O, Haroon M, Giles JT, Winchester R (2015) Concepts of pathogenesis in psoriatic arthritis: genotype determines clinical phenotype. 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DV was a sub-PI of the study sponsored by Genesis. GK has received honoraria for educational activities and consultancy payments from Abbvie, Aenorasis, Amgen, Celgene, Genesis Pharma, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, Sobi, and Vianex. GV has received investigator and consultant fees from Genesis Pharma. TD has served as a speaker and consultant and has received investigator honoraria and travel fees from Genesis Pharma and Abbvie, has served as a speaker and consultant and has received investigator honoraria from Lilly, has served as a speaker, consultant, and has received investigator honoraria and travel fees from Novartis, has served as a speaker, consultant, and has received travel fees from Pfizer, has served as a speaker, consultant, and has received investigator honoraria and travel fees from Janssen and UCB, has served as a consultant and has received investigator honoraria and travel fees from Elpen, has served as a speaker and consultant for Boehringer Ingelheim, has served as a speaker and consultant, and has received travel fees from Mylan, has served as a consultant for Amgen, has received investigator honoraria from Demo, has received travel fees from MSD, has served as a speaker and consultant, and has received travel fees from Aenorasis, and travel fees from Faran. PS has received research grants, consultation fees and speaker honoraria through the \u201cUnivesity of Crete Special Account for Research\u201d. PV has received investigator fees from Abbvie, Novartis and Genesis Pharma, and travel fees from Viatris, Abbvie and Boehringer Ingelheim. DPB has received lecture honoraria from Menarini Hellas, Boehringer Ingelheim, Genesis Pharma, and Fresenius Kabi, lecture honoraria, hospital line travel fees and accommodation support from Novartis, travel fees and accommodation support from Pfizer, Elpen, Aenorasis Hellas, Novartis, and IFT Hellas, and grant support for research and educational activities from Elpen, Boehringer Ingelheim, Demo, and Menarini Hellas. AIG has received investigator and consultant fees from AbbVie, investigator fees from Genesis\u00a0Pharma and Janssen Pharmaceuticals, speaker fees from Mylan, consultant fees from UCB, and speaker fees from Boehringer Ingelheim and Roche Hellas. AGB has served as speaker\/consultant for Abbvie, Aenorasis, Amgen, Bausch Health, FARAN, Genesis Pharma, GSK, Janssen, MSD, Novartis, Pfizer, UCB, and has received grant\/research support from Abbvie, Amgen, Genesis, MSD, Novartis, Pfizer. PG has received investigator honoraria and consultant fees from UCB, Genesis Pharma, Abbvie, Mylan, Aenorasis Jannsen Cilag. SG has received speaker and travel fees from Eli Lilly, investigator, speaker and travel fees from Abbvie, travel fees in congress from Jannsen, consultant and speaker honoraria from Boehringer Ingelheim, investigator fees from Genesis Pharma, investigator honoraria from Mylan, Elpen, Aenorasis, and registration in congress from Novartis. EK has received investigator fees from Genesis Pharma and Mylan. SNL has no conflicts of interest. ET has received speaker and consultant fees from Amgen, investigator,\u00a0speaker and consultant fees from Abbvie, consultant fees from Aenorasis, consultant and\u00a0travel fees from Faran, speaker fees from Lilly, speaker and investigator fees from Pfizer, and consultant fees and investigator fees (PhD grant) from GSK. CP has served as speaker for Abbvie, Genesis, Lilly, Pfizer, UCB, and Boehringer-Ingelheim, consultant for Lilly, Genesis, Pfizer, and Janssen, and has received grant\/research support from Lilly, Faran, Elpen, and Demo. ET has no conflict of interest. PV has no conflict of interest. PVV has received consultant fees from UCB, Gilead Sciences Hellas, Novartis, Abbvie, Pfizer, Janssen Gilag, Glaxo Smith Kline, and Amgen. AK is an employee of Genesis Pharma. NA is an employee of Genesis Pharma. DTB has received an educational grant to the University research Account.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The study was reviewed and approved by the competent Institutional Review Boards of all participating hospital sites (study code: \u039dIS-GEN-APR-002). All patients provided written informed consent.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval and consent to participate"}},{"value":"Not applicable.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}}]}}