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

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 Impact of duration and treatment of arterial hypertension on health-related quality of life

Medicina ◽  
2009 ◽  
Vol 45 (5) ◽  
pp. 405 ◽  
Author(s):  
Vilma Raškelienė ◽  
Marija Babarskienė ◽  
Jūratė Macijauskienė ◽  
Arvydas Šeškevičius
Keyword(s):  
Quality Of Life ◽  
Arterial Hypertension ◽  
Physical Health ◽  
Physical Functioning ◽  
Health Related Quality ◽  
General Evaluation ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related

Arterial hypertension (AH) is one of the most important risk factors for development of ischemic heart disease; thus, control of AH and effective treatment are of great importance. Since arterial hypertension is commonly referred as asymptomatic condition, the question whether hypertensive condition is associated with the change of well-being and health-related quality of life is still debatable. The aim of the study. To evaluate the impact of duration and treatment of AH on health-related quality of life. Material and methods. The contingent of the study consisted of patients who arrived for a cardiologist’s consultation at the Clinic of Cardiology, Hospital of Kaunas University of Medicine. The patients were randomly selected for the study. The inclusion criteria were as follows: diagnosed arterial hypertension, diabetes mellitus, and the metabolic syndrome. Diagnosed ischemic heart disease (chronic and acute coronary syndromes and their complications) and severe concomitant diseases were exclusion criteria. A total of 101 patients (19 males and 82 females) met the inclusion criteria and consented to participate in the study. Their mean age was 58.03±5.63 years. The patients’ quality of life was evaluated using the Medical Outcomes Study short form 36-item questionnaire (SF-36 questionnaire), which comprises 36 questions grouped into eight domains. The questionnaire was filled in by the subjects independently. Other methods applied to the study were inquiry (for the evaluation of risk factors, lifestyle, and medical history), analysis of medical documents (cholesterol levels and glycemia in blood), and objective examination (height, weight, waist circumference, and arterial blood pressure). Results. The subjects with AH showed lower values compared to normotensive patients in the following domains: physical functioning (P=0.014), role limitations due to physical health (P=0.012), energy/vitality (P=0.016), and general health evaluation (P=0.023). We have not determined the differences in quality of life of the patients whose AH was regulated if compared to those patients without AH. The patients whose treatment of AH was not effective reported lower quality of life in the following SF-36 domains: physical functioning (P=0.003), role limitations due to physical health (P=0.003), general evaluation of health (P=0.017), energy/vitality (P=0.008), and emotional status (P=0.015), if compared to the patients without AH. Conclusions. Patients with AH reported lower quality of life in the following domains: physical functioning, role limitations due to physical health, energy/vitality, and general evaluation of health. Compared to patients without AH, the quality of life of the patients who had the effective treatment did not differ, whereas patients with ineffective treatment had the lower quality of life. Functioning is more statistically significantly limited due to physical health in patients with AH.

scholarly journals Health-related Quality of Life Outcomes of Adalimumab for Patients with Early Rheumatoid Arthritis: Results from a Randomized Multicenter Study

2011 ◽  
Vol 39 (1) ◽  
pp. 63-72 ◽  
Author(s):  
VIBEKE STRAND ◽  
ANNE M. RENTZ ◽  
MARY A. CIFALDI ◽  
NAIJUN CHEN ◽  
SANJOY ROY ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rheumatoid Arthritis ◽  
Short Form ◽  
Health Related Quality ◽  
Link Type ◽  
Early Ra ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related

Objective.Rheumatoid arthritis (RA) is associated with significant impairments in health-related quality of life (HRQOL). We evaluated patient-reported outcomes including HRQOL outcomes following adalimumab plus methotrexate (MTX) therapy in patients with early RA.Methods.PREMIER was a phase III, multicenter, randomized, double-blind, active-comparator clinical trial in early RA. Patients aged ≥ 18 years were randomly assigned to receive adalimumab 40 mg every other week (eow) plus weekly MTX, weekly MTX, or adalimumab 40 mg eow for 104 weeks. American College of Rheumatology (ACR) criteria were used to evaluate clinical efficacy and response. Outcomes were assessed using the Health Assessment Questionnaire Disability Index (HAQ-DI), Short-Form 36 Health Survey (SF-36), Short-Form 6 Dimension (SF-6D), visual analog scale (VAS) assessments of global disease activity (patient’s global assessment; PtGA) and pain, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and Health Utility Index Mark 3 (HUI-3).Results.Of 799 patients enrolled, 268 received adalimumab plus MTX, 257 received MTX monotherapy, and 274 received adalimumab monotherapy. Patients treated with adalimumab plus MTX demonstrated significant baseline to Week 104 improvements in HAQ-DI (p < 0.0001), SF-36 Physical Component Summary (p < 0.0001), 4 SF-36 domains [physical function (p < 0.0001), bodily pain (p <0.0001), vitality (p = 0.0139), role limitations-physical (p = 0.0005)], SF-6D (p = 0.0152), VAS-PtGA (p < 0.0001), VAS-pain (p < 0.0001), FACIT-F (p < 0.0001), and HUI-3 (p = 0.0034) scores versus patients treated with MTX monotherapy. Both SF-6D and HUI-3 were found to be sensitive preference-based measures for assessing the effects of treatment on multidimensional function. No clinically meaningful differences between adalimumab and MTX monotherapy groups were observed for most measures. For each measure, there was significant association between HRQOL improvement and ACR clinical response.Conclusion.Adalimumab plus MTX significantly improved physical functioning and HRQOL in patients with early RA over 2 years of treatment. (ClinicalTrials.gov identifier NCT00195663).

scholarly journals Performance of the Dutch SF-36 version 2 as a measure of health-related quality of life in patients with rheumatoid arthritis

2013 ◽  
Vol 11 (1) ◽  
pp. 77 ◽  
Author(s):  
Peter M ten Klooster ◽  
Harald E Vonkeman ◽  
Erik Taal ◽  
Liseth Siemons ◽  
Lidy Hendriks ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rheumatoid Arthritis ◽  
Health Related Quality ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related

scholarly journals Health related quality of life in COVID-19 survivors discharged from acute hospitals: results of a short-form 36-item survey

F1000Research ◽  
2021 ◽  
Vol 10 ◽  
pp. 282
Author(s):  
Alessia Saverino ◽  
Eva Zsirai ◽  
Raphael Sonabend ◽  
Lorenza Gaggero ◽  
Isabella Cevasco ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Functioning ◽  
Short Form ◽  
Health Related Quality ◽  
Short Form 36 ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related ◽  
The Impact

Background: Health-related quality of life (HRQL) is important for evaluating the impact of a disease in the longer term across the physical and psychological domains of human functioning. The aim of this study is to evaluate HRQL in COVID-19 survivors in Italy using the short form 36-items questionnaire (SF-36). Methods: This is an observational study involving adults discharged home following a coronavirus disease 2019 (COVID-19)-related hospital admission. Baseline demographic and clinical data including the Cumulative Illness Rating Scale (CIRS) and the Hospital Anxiety and Depression Scale (HADS) were collected. The validated Italian version of SF-36 was administered cross-sectionally. The SF-36 contains eight scales measuring limitations in physical and social functioning, the impact on roles and activities, fatigue, emotional well-being, pain and general health perception. Results: A total of 35 patients, with a mean age of 60 years, completed the SF-36. The results showed difficulties across the physical and psychological domains, particularly affecting the return to previous roles and activities. A higher burden of co-morbidities as well as a more severe muscle weakness was associated to a lower physical functioning. Younger age, rather than older, correlated to a perceived greater limitation in physical functioning and vitality. Conclusions: COVID-19 survivors particularly the ones of working age may need support for resuming their premorbid level of functioning and returning to work.

scholarly journals Recent Injury and Health-Related Quality of Life in Adolescent Athletes

2009 ◽  
Vol 44 (6) ◽  
pp. 603-610 ◽  
Author(s):  
Tamara C. Valovich McLeod ◽  
R. Curtis Bay ◽  
John T. Parsons ◽  
Eric L. Sauers ◽  
Alison R. Snyder
Keyword(s):  
Quality Of Life ◽  
Social Functioning ◽  
Physical Functioning ◽  
Global Score ◽  
Health Related Quality ◽  
Adolescent Athletes ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related

Abstract Context: Health-related quality of life (HRQOL) is a global concept that takes into account the physical, psychological, and social domains of health. Determining the extent to which injury affects HRQOL is an important aspect of rehabilitation practice, enabling comparisons of clinical outcomes across different conditions in diverse patient groups. Objective: To examine the extent to which a self-reported recent injury affected HRQOL in adolescent athletes using 2 generic patient self-report scales. Design: Cross-sectional study. Setting: High school classrooms and athletic training facilities. Patients or Other Participants: A convenience sample of uninjured (n  =  160) and injured (n  =  45) adolescent athletes. Intervention(s): The independent variable was injury status: uninjured versus injured. All participants completed a self-administered brief health status questionnaire and the Short Form–36 Health Survey Questionnaire (SF-36) and Pediatric Outcomes Data Collection Instrument (PODCI) in a counterbalanced manner. Main Outcome Measure(s): Dependent variables included 8 subscale and 2 composite scores of the SF-36 and 5 subscale scores and 1 global score of the PODCI. Group differences were assessed with the Mann-Whitney U test (P ≤ .05) and reported as median and interquartile range. Results: On the SF-36, the injured group demonstrated lower scores (P &lt; .008) for physical functioning, limitations due to physical health problems, bodily pain, social functioning, and the physical composite. On the PODCI, the injured group reported lower scores (P &lt; .01) on the pain and comfort subscale and the global score. Conclusions: Adolescent athletes with self-reported injuries demonstrated lower HRQOL than their uninjured peers. As expected, recent injury affected physical functioning and pain. Social functioning (on the SF-36) and global HRQOL (on the PODCI) also decreased, suggesting that injuries affected areas beyond the expected physical component of health. Clinicians need to recognize the full spectrum of negative influences that injuries may have on HRQOL in adolescent athletes.

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.

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