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dc.contributor.authorRitchlin, C. T.
dc.contributor.authorGiles, J. T.
dc.contributor.authorOgdie, A.
dc.contributor.authorGómez-Reino Carnota, Juan Jesús 
dc.contributor.authorHelliwell, P.
dc.contributor.authorYoung, P.
dc.contributor.authorWang, C.
dc.contributor.authorWu, J.
dc.contributor.authorRomero, A. B.
dc.contributor.authorWoolcott, J.
dc.contributor.authorStockert, L.
dc.date.accessioned2022-04-26T07:44:31Z
dc.date.available2022-04-26T07:44:31Z
dc.date.issued2020
dc.identifier.issn2578-5745
dc.identifier.otherhttps://www.ncbi.nlm.nih.gov/pubmed/32910531es
dc.identifier.urihttp://hdl.handle.net/20.500.11940/16551
dc.description.abstractOBJECTIVE: Metabolic syndrome (MetS) is a cluster of concurrent risk factors for cardiovascular disease and type 2 diabetes. This post hoc analysis explored key efficacy and safety endpoints in patients with psoriatic arthritis (PsA) and MetS treated with tofacitinib. METHODS: Tofacitinib 5 and 10 mg twice daily and placebo data were pooled from two Phase 3 studies (OPAL Broaden [12 months; ClinicalTrials.gov identifier NCT01877668]; OPAL Beyond [6 months; ClinicalTrials.gov identifier NCT01882439]); patients received one background conventional synthetic disease-modifying antirheumatic drug. Patients were stratified by baseline presence/absence of MetS. Efficacy and safety were reported to month 3 (tofacitinib and placebo) and 6 (tofacitinib only). Efficacy outcomes included: American College of Rheumatology (ACR)20/50/70, Health Assessment Questionnaire-Disability Index (HAQ-DI) response, Psoriasis Area Severity Index (PASI)75 response, and enthesitis/dactylitis resolution rates; and changes from baseline (Delta) in C-reactive protein, HAQ-DI, Patient's/Physician's Global Assessment of Arthritis, and patient-reported outcomes. Safety outcomes included treatment-emergent all-causality adverse events (AEs), Delta in lipid/hepatic values, and liver parameter increases. RESULTS: Of 710 patients, 41.4% (n = 294) had baseline MetS. All efficacy outcomes improved with both tofacitinib doses versus placebo, to month 3; tofacitinib efficacy was consistent to month 6, regardless of MetS status. MetS did not appear to affect the incidence of AEs or Delta in lipid/hepatic values with tofacitinib up to month 3 or 6. Arterial thromboembolism and myocardial infarction (adjudicated major adverse cardiovascular events) were each reported once in tofacitinib-treated patients with MetS. CONCLUSION: Regardless of baseline MetS status, tofacitinib showed greater efficacy versus placebo in patients with active PsA. The tofacitinib safety profile appeared similar in patients with versus without MetS.en
dc.rightsAtribución-NoComercial 4.0 Internacional
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/
dc.titleTofacitinib in Patients With Psoriatic Arthritis and Metabolic Syndrome: A Post hoc Analysis of Phase 3 Studiesen
dc.typeJournal Articlees
dc.authorsophosRitchlin, C. T.;Giles, J. T.;Ogdie, A.;Gomez-Reino, J. J.;Helliwell, P.;Young, P.;Wang, C.;Wu, J.;Romero, A. B.;Woolcott, J.;Stockert, L.
dc.identifier.doi10.1002/acr2.11166
dc.identifier.pmid32910531
dc.identifier.sophos39333
dc.issue.number10es
dc.journal.titleACR OPEN RHEUMATOLOGYes
dc.organizationServizo Galego de Saúde::Estrutura de Xestión Integrada (EOXI)::EOXI de Santiago de Compostela - Complexo Hospitalario Universitario de Santiago de Compostela::Reumatoloxíaes
dc.page.initial543es
dc.page.final554es
dc.rights.accessRightsopenAccess
dc.subject.keywordCHUSes
dc.typefidesArtículo Originales
dc.typesophosArtículo Originales
dc.volume.number2es


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