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Ustekinumab Treatment and Improvement of Physical Function and Health-Related Quality of Life in Patients With Psoriatic Arthritis.

ABSTRACT: To examine the effects of ustekinumab on patient-reported outcomes (PROs) in PSUMMIT 1 and PSUMMIT 2 patients with active psoriatic arthritis (PsA) who were methotrexate (MTX) naive, MTX experienced, or anti-tumor necrosis factor (TNF) experienced.Patients in the phase 3, PSUMMIT 1 (n?=?615) and PSUMMIT 2 (n?=?312) studies randomly (1:1:1) received placebo, ustekinumab 45-mg, or ustekinumab 90-mg subcutaneous injections at weeks 0, 4, 16, 28, 40, and 52. The PROs (Health Assessment Questionnaire [HAQ] disability index [DI], Dermatology Life Quality Index [DLQI], 36-Item Short Form [SF-36] health survey physical (PCS) and mental component summary scores, patient assessments of pain and disease activity, and impact of disease on productivity) were assessed at weeks 0, 24, and 52. In these post hoc analyses, outcomes were compared between the ustekinumab and placebo groups for 3 mutually exclusive antecedent-exposure populations from the combined studies: MTX/anti-TNF naive (placebo, n?=?56; 45 mg, n?=?58; and 90 mg, n?=?66), MTX experienced, biologic agent naive (placebo, n?=?192; 45 mg, n?=?190; and 90 mg, n?=?185), and anti-TNF experienced with or without MTX (placebo, n?=?62; 45 mg, n?=?60; and 90 mg, n?=?58).At week 24, mean improvements from baseline in HAQ DI, DLQI, and SF-36 PCS scores were significantly greater in both ustekinumab groups versus placebo across antecedent-exposure groups. Greater proportions of ustekinumab-treated than placebo-treated patients (all P?

SUBMITTER: Rahman P

PROVIDER: S-EPMC5132036 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature

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Ustekinumab Treatment and Improvement of Physical Function and Health-Related Quality of Life in Patients With Psoriatic Arthritis.

Rahman Proton P Puig Lluis L Gottlieb Alice B AB Kavanaugh Arthur A McInnes Iain B IB Ritchlin Christopher C Li Shu S Wang Yuhua Y Song Michael M Mendelsohn Alan A Han Chenglong C

Arthritis care & research 20161021 12

<h4>Objective</h4>To examine the effects of ustekinumab on patient-reported outcomes (PROs) in PSUMMIT 1 and PSUMMIT 2 patients with active psoriatic arthritis (PsA) who were methotrexate (MTX) naive, MTX experienced, or anti-tumor necrosis factor (TNF) experienced.<h4>Methods</h4>Patients in the phase 3, PSUMMIT 1 (n = 615) and PSUMMIT 2 (n = 312) studies randomly (1:1:1) received placebo, ustekinumab 45-mg, or ustekinumab 90-mg subcutaneous injections at weeks 0, 4, 16, 28, 40, and 52. The PRO ...[more]

PMID: 27483458

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Project description:IntroductionPsoriatic arthritis (PsA) is considered a multifaceted disease, with patients reporting low health-related quality of life (HRQoL). Data on disease burden are substantial and there exists a need for properly designed studies to learn more about the evolution of HRQoL in this condition. This study aims to identify factors associated to HRQoL evolution in PsA patients followed-up in a real-world setting in Spain.MethodsWe conducted a retrospective longitudinal observational study including incident patients from the rheumatology outpatient clinic of Hospital Clínico San Carlos (Madrid, Spain), diagnosed for the first time of PsA, defined as having received any ICD9/ICD10 diagnosis code of PsA, from 2007 to 2016, and followed-up until loss of follow-up, death, or November 2017. The influence of demographic and clinical variables in baseline HRQoL [assessed with the Rosser Classification Index (RCI)] was analyzed using bivariable and multivariable generalized linear models. The influence of those variables and of treatment-related factors in repeated measures of HRQoL was analyzed using bivariable and multivariable generalized estimating equations (GEE) models nested by patient.ResultsTwo hundred and thirty patients were included in the analysis, with 3384 registered visits. At baseline, older age, a previous diagnosis of obesity, and the presence of enthesitis were significantly associated with worse HRQoL. During follow-up, using an exchangeable working correlation structure, the presence of enthesitis was also associated with worse HRQoL, coefficient (95% CI) - 0.006 (- 0.01 to - 0.002), p = 1.00E-03; conversely, treatment with methotrexate or antimalarials was associated with better HRQoL with 0.007 (0.001-0.014), p = 0.020 and 0.003 (0.001-0.005), p = 3.00E-03, respectively.ConclusionsMusculoskeletal manifestations and comorbidities exert a deleterious effect in HRQoL of PsA patients. Therefore, the optimal management of this condition needs to also address these manifestations in order to try to restore the QoL of these patients.

Dataset Information

Ustekinumab Treatment and Improvement of Physical Function and Health-Related Quality of Life in Patients With Psoriatic Arthritis.

Publications

Ustekinumab Treatment and Improvement of Physical Function and Health-Related Quality of Life in Patients With Psoriatic Arthritis.

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