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Early and sustained efficacy with apremilast monotherapy in biological-naïve patients with psoriatic arthritis: a phase IIIB, randomised controlled trial (ACTIVE)
dc.contributor.author | Nash, Peter | |
dc.contributor.author | Ohson, Kamal | |
dc.contributor.author | Walsh, Jessica | |
dc.contributor.author | Delev, Nikolay | |
dc.contributor.author | Nguyen, Dianne | |
dc.contributor.author | Teng, Lichen | |
dc.contributor.author | Gómez-Reino, Juan J. | |
dc.contributor.author | Aelion, Jacob | |
dc.date.accessioned | 2020-03-18T09:13:58Z | |
dc.date.available | 2020-03-18T09:13:58Z | |
dc.date.issued | 2018-01-17 | |
dc.identifier.citation | Nash P, Ohson K, Walsj J, Delev N, Nguyen D, Teng L, et al. Early and sustained efficacy with apremilast monotherapy in biological-naïve patients with psoriatic arthritis: a phase IIIB, randomised controlled trial (ACTIVE). Ann Rheum Dis. 2018;77(5): 690-698 | es_ES |
dc.identifier.issn | 0003-4967 | |
dc.identifier.uri | http://hdl.handle.net/2183/25186 | |
dc.description | Trial registration number NCT01925768 | es_ES |
dc.description.abstract | [Abstract] Objective Evaluate apremilast efficacy across various psoriatic arthritis (PsA) manifestations beginning at week 2 in biological-naïve patients with PsA. Methods Patients were randomised (1:1) to apremilast 30 mg twice daily or placebo. At week 16, patients whose swollen and tender joint counts had not improved by ≥10% were eligible for early escape. At week 24, all patients received apremilast through week 52. Results Among 219 randomised patients (apremilast: n=110; placebo: n=109), a significantly greater American College of Rheumatology 20 response at week 16 (primary outcome) was observed with apremilast versus placebo (38.2% (42/110) vs 20.2% (22/109); P=0.004); response rates at week 2 (first assessment) were 16.4% (18/110) versus 6.4% (7/109) (P=0.025). Improvements in other efficacy outcomes, including 28-joint count Disease Activity Score (DAS-28) using C reactive protein (CRP), swollen joint count, Health Assessment Questionnaire-Disability Index (HAQ-DI), enthesitis and morning stiffness severity, were observed with apremilast at week 2. At week 16, apremilast significantly reduced PsA disease activity versus placebo, with changes in DAS-28 (CRP) (P<0.0001), HAQ-DI (P=0.023) and Gladman Enthesitis Index (P=0.001). Improvements were maintained with continued treatment through week 52. Over 52 weeks, apremilast’s safety profile was consistent with prior phase 3 studies in psoriasis and PsA. During weeks 0–24, the incidence of protocol-defined diarrhoea was 11.0% (apremilast) and 8.3% (placebo); serious adverse event rates were 2.8% (apremilast) and 4.6% (placebo). Conclusions In biological-naïve patients with PsA, onset of effect with apremilast was observed at week 2 and continued through week 52. The safety profile was consistent with previous reports. | es_ES |
dc.language.iso | eng | es_ES |
dc.publisher | BMJ | es_ES |
dc.relation.uri | http://dx.doi.org/10.1136/annrheumdis-2017-211568 | es_ES |
dc.rights | Atribución-NoComercial 3.0 España | es_ES |
dc.rights.uri | http://creativecommons.org/licenses/by-nc/3.0/es/ | * |
dc.subject | Anti-Inflammatory Agents-Non-Steroidal | es_ES |
dc.subject | Arthritis | es_ES |
dc.subject | C-Reactive Protein | es_ES |
dc.subject | Thalidomide | es_ES |
dc.subject | Psoriatic | |
dc.title | Early and sustained efficacy with apremilast monotherapy in biological-naïve patients with psoriatic arthritis: a phase IIIB, randomised controlled trial (ACTIVE) | es_ES |
dc.type | info:eu-repo/semantics/article | es_ES |
dc.rights.access | info:eu-repo/semantics/openAccess | es_ES |
UDC.journalTitle | Annals of the Rheumatic Diseases | es_ES |
UDC.volume | 77 | es_ES |
UDC.issue | 5 | es_ES |
UDC.startPage | 690 | es_ES |
UDC.endPage | 698 | es_ES |
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