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 Health related quality of life of survivors of trauma six months after discharge

2013 ◽  
Vol 69 (1) ◽  
Author(s):  
J. Schneiderman ◽  
H. Van Aswegen ◽  
P. Becker
Keyword(s):  
Quality Of Life ◽  
Physical Function ◽  
General Health ◽  
Mental Component Summary Score ◽  
Trauma Survivors ◽  
Health Related Quality ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related

To investigate the health-related quality of life (HRQOL) of survivors of major trauma at six months following discharge, using two popular HRQOL tools. A cross-sectional study was done on adult trauma survivors in Johannesburg. Subjects completed the EQ-5D and SF-36 HRQOL questionnaires. Additional demographic and clinical data were collected. The majority of subjects reported some problems in usual activities and pain/discomfort as measured with the EQ-5D at six months. The mean EQ-5D VAS was 68 (±26.1). lowest scores were reported in the role physical (44.6 ± 41.6) and role emotional (44.1 ± 45.4) domains of the SF-36. mean SF-36 physical component summary (PCS) score (62.1 ± 27.8) was higher than mental component summary score (58.7 ±20.1). EQ-5D VAS was found to be moderately correlated with age (r=-0.4; p=0.05). A negative correlation was found between SF-36 physical function score and ICU length of stay (LOS), hospital LOS and age (r=-0.4 (p=0.03), -0.4 (p=0.03) and -0.6 (p=0.00) respectively). Statistical significance was observed in the correlation between age and SF-36 general health domain (r=-0.4; p=0.02) as well as age and PCS score (r=-0.5; p=0.01). Trauma survivors in Johannesburg experience limitations in specific emotional and physical domains of HRQOL at six months after discharge. Age was associated with the level of self-rated health as well as limitations in general health and physical function. ICU and hospital LOS were associated with limitations in physical function. There is a need for physical and psychological rehabilitation after discharge from trauma intensive care.

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

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.

Patient-reported Health-related Quality of Life with Apremilast for Psoriatic Arthritis: A Phase II, Randomized, Controlled Study

2013 ◽  
Vol 40 (7) ◽  
pp. 1158-1165 ◽  
Author(s):  
Vibeke Strand ◽  
Georg Schett ◽  
ChiaChi Hu ◽  
Randall M. Stevens
Keyword(s):  
Quality Of Life ◽  
Psoriatic Arthritis ◽  
Health Related Quality ◽  
Randomized Controlled ◽  
Sf 36 ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related ◽  
Vas Scores

Objective.Apremilast, a specific inhibitor of phosphodiesterase 4, modulates proinflammatory and antiinflammatory cytokine production. A phase IIb randomized, controlled trial (RCT) evaluated the effect of apremilast on patient-reported outcomes (PRO) in psoriatic arthritis (PsA).Methods.In this 12-week RCT, patients with active disease (duration > 6 mo, ≥ 3 swollen and ≥ 3 tender joints) received apremilast (20 mg BID or 40 mg QD) or placebo. PRO included pain and global assessment of disease activity [visual analog scale (VAS)], Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and Medical Outcomes Study Short-Form 36 Health Survey (SF-36) assessing health-related quality of life (HRQOL). Percentages of patients reporting improvements ≥ minimum clinically important differences (MCID) and correlations between SF-36 domains and pain VAS, HAQ-DI, and FACIT-F were determined.Results.Among the 204 randomized patients (52.5% men; mean age 50.6 yrs), baseline SF-36 scores reflected large impairments in HRQOL. Apremilast 20 mg BID resulted in statistically significant and clinically meaningful improvements in physical and mental component summary scores and 7 and 6 SF-36 domains, respectively, compared with no change/deterioration in placebo group. Patients receiving apremilast 20 mg BID and 40 mg QD reported significant improvements ≥ MCID in global VAS scores and FACIT-F versus placebo, and significant improvements in pain VAS scores. Moderate-high, significant correlations were evident between SF-36 domains and other PRO.Conclusion.Apremilast resulted in statistically significant and clinically meaningful improvements in HRQOL, pain and global VAS, and FACIT-F scores.

scholarly journals High levels of interleukin-6 in patients with rheumatoid arthritis are associated with greater improvements in health-related quality of life for sarilumab compared with adalimumab

2020 ◽  
Vol 22 (1) ◽  
Author(s):  
Vibeke Strand ◽  
Susan H. Boklage ◽  
Toshio Kimura ◽  
Florence Joly ◽  
Anita Boyapati ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rheumatoid Arthritis ◽  
Physical Functioning ◽  
Interleukin 6 ◽  
Phase Iii ◽  
Health Related Quality ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related

Abstract Background Increased levels of cytokines, including interleukin-6 (IL-6), reflect inflammation and have been shown to be predictive of therapeutic responses, fatigue, pain, and depression in patients with rheumatoid arthritis (RA), but limited data exist on associations between IL-6 levels and health-related quality of life (HRQoL). This post hoc analysis of MONARCH phase III randomized controlled trial data evaluated the potential of baseline IL-6 levels to differentially predict HRQoL improvements with sarilumab, a fully human monoclonal antibody directed against both soluble and membrane-bound IL-6 receptor α (anti-IL-6Rα) versus adalimumab, a tumor necrosis factor α inhibitor, both approved for treatment of active RA. Methods Baseline serum IL-6 levels in 300/369 randomized patients were categorized into low (1.6–7.1 pg/mL), medium (7.2–39.5 pg/mL), and high (39.6–692.3 pg/mL) tertiles. HRQoL was measured at baseline and week (W)24 and W52 by Short Form 36 (SF-36) physical/mental component summary (PCS/MCS) and domain scores, Functional Assessment of Chronic Illness Therapy -fatigue, and duration of morning stiffness visual analog scale (AM-stiffness VAS). Linear regression of changes from baseline in HRQoL (IL-6 tertile, treatment, region as a stratification factor, and IL-6 tertile-by-treatment interaction as fixed effects) assessed predictivity of baseline IL-6 levels, with low tertile as reference. Pairwise comparisons of improvements between treatment groups were performed by tertile; least squares mean differences and 95% CIs were calculated. Similar analyses evaluated W24 patient-level response on minimum clinically important differences (MCID). Results At baseline, patients with high versus medium or low IL-6 levels (n = 100, respectively) reported worse (nominal p < 0.05) SF-36 MCS and role-physical, bodily pain, social functioning, role-emotional domain, and AM-stiffness VAS scores. There was a greater treatment effect with sarilumab versus adalimumab in high tertile versus low tertile groups in SF-36 PCS, physical functioning domain, and AM-stiffness VAS (nominal interaction p < 0.05). PCS improvements ≥MCID were higher in high (odds ratio [OR] 6.31 [2.37, 16.81]) versus low (OR 0.97 [0.43, 2.16]) tertiles with sarilumab versus adalimumab (nominal interaction p < 0.05). Adverse events between IL-6 tertiles were similar. Conclusions Patients with high baseline IL-6 levels reported better improvements in PCS, physical functioning domain, and AM-stiffness scores with sarilumab versus adalimumab and safety consistent with IL-6R blockade. Trial registration NCT02332590. Registered on 5 January 2015

scholarly journals Improved Health-related Quality of Life and Physical Function in Patients with Refractory Chronic Gout Following Treatment with Pegloticase: Evidence from Phase III Randomized Controlled Trials

2012 ◽  
Vol 39 (7) ◽  
pp. 1450-1457 ◽  
Author(s):  
VIBEKE STRAND ◽  
DINESH KHANNA ◽  
JASVINDER A. SINGH ◽  
ANNA FORSYTHE ◽  
N. LAWRENCE EDWARDS
Keyword(s):  
Physical Function ◽  
Phase Iii ◽  
Health Related Quality ◽  
Chronic Gout ◽  
Randomized Controlled ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related ◽  
Refractory Chronic Gout

Objective.To assess the efficacy of pegloticase on pain, physical function, and health-related quality of life (HRQOL) in patients with refractory chronic gout.Methods.Subjects in 2 replicate, 6-month, randomized controlled phase III trials received intravenous infusions of pegloticase 8 mg twice monthly (biweekly group), pegloticase alternating with placebo (8-mg monthly group), or placebo. Medical Outcomes Study Short Form-36 (SF-36), Health Assessment Questionnaire-Disability Index (HAQ-DI), patient global assessment of disease activity (PtGA), and pain by visual analog scale were completed at weeks 1 (baseline), 13, 19, and 25. Prespecified pooled analyses of patient-reported outcomes were performed by combining values for each treatment group (biweekly treatment, monthly treatment, and placebo) at Week 25.Results.Of 212 patients enrolled, 157 (74.1%) completed treatment. At entry, mean age was 55.4 years (range 23–89 yrs) and mean plasma uric acid was 9.7 mg/dl; most were male (81.6%) and white (67.5%). Subjects reported an average of 9.8 flares in the previous 18 months. Baseline SF-36 physical component summary (PCS) scores were > 1.5 SD below US normative values. At Week 25, mean changes from baseline in PtGA, pain, HAQ-DI, and PCS scores were statistically significant and exceeded minimum clinically important differences (MCID) in the biweekly treatment group, compared with little to no improvement in placebo group. Statistically significant improvements greater than or equal to MCID were reported in 6 of 8 SF-36 domains. Monthly pegloticase resulted in significantly improved PtGA, HAQ-DI, PCS, and 3 SF-36 domains.Conclusion.Pegloticase therapy resulted in statistically significant and clinically meaningful improvements in PtGA, pain, physical function, and HRQOL.

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