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Tofacitinib in Patients With Psoriatic Arthritis and Metabolic Syndrome: A Post hoc Analysis of Phase 3 Studies
dc.contributor.author | Ritchlin, C. T. | |
dc.contributor.author | Giles, J. T. | |
dc.contributor.author | Ogdie, A. | |
dc.contributor.author | Gómez-Reino Carnota, Juan Jesús | |
dc.contributor.author | Helliwell, P. | |
dc.contributor.author | Young, P. | |
dc.contributor.author | Wang, C. | |
dc.contributor.author | Wu, J. | |
dc.contributor.author | Romero, A. B. | |
dc.contributor.author | Woolcott, J. | |
dc.contributor.author | Stockert, L. | |
dc.date.accessioned | 2022-04-26T07:44:31Z | |
dc.date.available | 2022-04-26T07:44:31Z | |
dc.date.issued | 2020 | |
dc.identifier.issn | 2578-5745 | |
dc.identifier.other | https://www.ncbi.nlm.nih.gov/pubmed/32910531 | es |
dc.identifier.uri | http://hdl.handle.net/20.500.11940/16551 | |
dc.description.abstract | OBJECTIVE: 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.rights | Atribución-NoComercial 4.0 Internacional | |
dc.rights.uri | http://creativecommons.org/licenses/by-nc/4.0/ | |
dc.title | Tofacitinib in Patients With Psoriatic Arthritis and Metabolic Syndrome: A Post hoc Analysis of Phase 3 Studies | en |
dc.type | Journal Article | es |
dc.authorsophos | Ritchlin, 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.doi | 10.1002/acr2.11166 | |
dc.identifier.pmid | 32910531 | |
dc.identifier.sophos | 39333 | |
dc.issue.number | 10 | es |
dc.journal.title | ACR OPEN RHEUMATOLOGY | es |
dc.organization | Servizo Galego de Saúde::Estrutura de Xestión Integrada (EOXI)::EOXI de Santiago de Compostela - Complexo Hospitalario Universitario de Santiago de Compostela::Reumatoloxía | es |
dc.page.initial | 543 | es |
dc.page.final | 554 | es |
dc.rights.accessRights | openAccess | |
dc.subject.keyword | CHUS | es |
dc.typefides | Artículo Original | es |
dc.typesophos | Artículo Original | es |
dc.volume.number | 2 | es |