scholarly journals PMS66 EARLY AND SUSTAINED REMISSION ASSOCIATED WITH NORMALIZED PHYSICAL FUNCTION AND HEALTH-RELATED QUALITY OF LIFE AND SIGNIFICANTLY IMPROVED PRODUCTIVITY IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS TREATED WITH GOLIMUMAB: TWO YEAR DATA FROM THE PHASE III GO-REVEAL CLINICAL TRIAL

2011 ◽  
Vol 14 (3) ◽  
pp. A135
Author(s):  
A. Kavanaugh ◽  
I. McInnes ◽  
G.G. Krueger ◽  
D. Gladman ◽  
A. Beutler ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Psoriatic Arthritis ◽  
Physical Function ◽  
Phase Iii ◽  
Sustained Remission ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related

Association Between Enthesitis and Health-related Quality of Life in Psoriatic Arthritis in Biologic-naive Patients from 2 Phase III Ustekinumab Trials

2019 ◽  
Vol 46 (11) ◽  
pp. 1458-1461 ◽  
Author(s):  
Iain B. McInnes ◽  
Lluís Puig ◽  
Alice B. Gottlieb ◽  
Christopher T. Ritchlin ◽  
Michael Song ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Psoriatic Arthritis ◽  
Physical Function ◽  
Phase Iii ◽  
Health Related Quality ◽  
Acr20 Response ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related

Objective.Evaluate enthesitis, physical function, and health-related quality of life (HRQOL) among patients with psoriatic arthritis (PsA) who are naive to anti–tumor necrosis factor agents.Methods.In PSUMMIT 1 and 2, patients with PsA were randomized to placebo or ustekinumab 45 mg or 90 mg. Enthesitis was assessed at weeks 0 and 24 (Maastricht Ankylosing Spondylitis Enthesitis Score). Assessments included Health Assessment Questionnaire–Disability Index (HAQ-DI), Medical Outcomes Study Short Form-36 (SF-36) physical component summary/mental component summary (PCS/MCS), and American College of Rheumatology 20 (ACR20).Results.At Week 24, 21 had worsened enthesitis, 158 had improved enthesitis, and 412 had unchanged enthesitis. Improved enthesitis was associated with improvements in HAQ-DI and SF-36 MCS. Results were similar for ACR20 responders and nonresponders.Conclusion.Improvement in enthesitis at Week 24 was associated with improvements in physical function/HRQOL regardless of ACR20 response.

The Effect of Intravenous Golimumab on Health-related Quality of Life in Rheumatoid Arthritis: 24-week Results of the Phase III GO-FURTHER Trial

2014 ◽  
Vol 41 (6) ◽  
pp. 1067-1076 ◽  
Author(s):  
Clifton O. Bingham ◽  
Michael Weinblatt ◽  
Chenglong Han ◽  
Timothy A. Gathany ◽  
Lilianne Kim ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rheumatoid Arthritis ◽  
Physical Function ◽  
Phase Iii ◽  
Health Related Quality ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related ◽  
Disease Effect

Objective.To evaluate the effects of intravenous (IV) golimumab 2 mg/kg + methotrexate (MTX) on patient-reported measures of health-related quality of life (HRQOL) in patients with active rheumatoid arthritis (RA) despite prior MTX therapy.Methods.In this randomized, multicenter, double-blind, placebo-controlled, phase III trial, adults with RA were randomly assigned to receive IV placebo (n = 197) or golimumab 2 mg/kg (n = 395) infusions at Week 0, Week 4, and every 8 weeks thereafter. All patients continued stable oral MTX (15–25 mg/wk). HRQOL assessments included Health Assessment Questionnaire-Disability Index (HAQ-DI; physical function), Medical Outcomes Study Short Form-36 questionnaire physical/mental component summary (SF-36 PCS/MCS) scores, EQ-5D assessment of current health state, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire, and disease effect on productivity [10-cm visual analog scale (VAS)].Results.Mean HAQ-DI improvements from baseline were significantly greater with golimumab + MTX than placebo + MTX at Week 14 and Week 24 (p < 0.001). Significantly greater improvements in all 8 individual SF-36 subscores and both the SF-36 PCS and MCS scores (p < 0.001) also accompanied golimumab + MTX therapy. Improved EQ-5D and EQ-5D VAS (p < 0.001) and FACIT-Fatigue (p < 0.001) scores were also observed for golimumab + MTX-treated patients at Week 12, Week 16, and Week 24, and greater proportions of golimumab + MTX-treated patients had clinically meaningful improvements in these measures. Greater reductions in disease effect on productivity were observed with golimumab + MTX versus placebo + MTX at Week 24 (p < 0.001). Improvements in physical function, HRQOL, fatigue, and productivity significantly correlated with disease activity improvement.Conclusion.In active RA, IV golimumab + MTX significantly improved physical function, HRQOL, fatigue, and productivity using multiple measurement tools; all correlated with improvements in disease activity (NCT00973479, EudraCT 2008-006064-11).

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

2016 ◽  
Vol 68 (12) ◽  
pp. 1812-1822 ◽  
Author(s):  
Proton Rahman ◽  
Lluis Puig ◽  
Alice B. Gottlieb ◽  
Arthur Kavanaugh ◽  
Iain B. McInnes ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Psoriatic Arthritis ◽  
Physical Function ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related

International Perspective on Health-Related Quality-of-Life Research in Cancer Clinical Trials: The European Organisation for Research and Treatment of Cancer Experience

2007 ◽  
Vol 25 (32) ◽  
pp. 5082-5086 ◽  
Author(s):  
Andrew Bottomley ◽  
Neil K. Aaronson
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Phase Iii ◽  
Cancer Clinical Trials ◽  
Health Related Quality ◽  
European Organisation ◽  
Related Quality ◽  
Health Related

Over recent decades, health-related quality of life (HRQOL) research has been increasingly integrated into cancer clinical trials. The purpose of this review is to examine the overall approach taken towards clinical trial–based HRQOL investigations within the European Organisation for Research and Treatment of Cancer (EORTC). This article reports a literature review of clinical trial–based HRQOL investigations and provides selective examples of HRQOL studies in phase III clinical trials in various disease sites. The findings of this review highlight that, historically, assessing HRQOL was a challenge. However, as EORTC has become more experienced in the assessment of HRQOL and has developed a portfolio of appropriate tools, HRQOL has become a more accepted end point in large-scale trials. The trials reviewed in this article show that, in general, HRQOL data do provide information that can both inform clinicians about the effectiveness of the treatments and also serve as an invaluable source of information for patients to make informed decisions regarding the treatment choice.

scholarly journals Itch as Major Mediator of Effect of Tofacitinib on Health-Related Quality of Life in Psoriatic Arthritis: A Mediation Analysis

2021 ◽  
Vol 10 (18) ◽  
pp. 4081
Author(s):  
Peter C. Taylor ◽  
Andrew G. Bushmakin ◽  
Joseph C. Cappelleri ◽  
Pamela Young ◽  
Rebecca Germino ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Psoriatic Arthritis ◽  
Treatment Effect ◽  
Indirect Effects ◽  
Janus Kinase ◽  
Phase Iii ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related

Patients with psoriatic arthritis (PsA) experience impaired health-related quality of life (HRQoL). Tofacitinib is an oral Janus kinase inhibitor for the treatment of PsA, which has been associated with improvements in dermatologic endpoints in patients with PsA. To assess the extent to which tofacitinib affects patient HRQoL via improvements in dermatologic symptoms, including itch, data were pooled from patients with PsA who received tofacitinib in phase III studies (NCT01866668 and NCT01882439). Mediation modeling assessed the indirect effects (via Itch Severity Item [ISI] and Physician’s Global Assessment of Psoriasis [PGA-PsO]) and direct effects (via all other factors) of tofacitinib treatment on dermatology-specific HRQoL (measured by Dermatology Life Quality Index [DLQI]). In the initial model, the treatment effect on DLQI was largely mediated by itch (ISI; p < 0.0001) and PGA-PsO (p < 0.01). The model was re-specified to assess the indirect effects only of itch and PGA-PsO on DLQI. Here, 17.7% of the treatment effect on DLQI was attributable to PGA-PsO (p = 0.0006), and 82.3% to itch (p < 0.0001). Tofacitinib-dependent improvements in DLQI were primarily mediated by itch relief, in addition to improvements in PGA-PsO.

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