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      Relationship of pain and fatigue with health-related quality of life and work in patients with psoriatic arthritis on TNFi: results of a multi-national real-world study

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          Abstract

          Background/Objective

          The incidence of pain and/or fatigue in people with psoriatic arthritis (PsA) is associated with reduced health-related quality of life (HRQoL) and the ability to work, despite modern advanced therapeutic approaches. This real-world, international study examined these relationships in patients with PsA treated with tumour necrosis factor inhibitors (TNFi).

          Methods

          Data from 13 countries were analysed. Patients with PsA and their physicians completed questionnaires capturing demographics, current therapy, current disease status, HRQoL and work status via Medical Outcomes Study 36-Item Short-Form version 2 (SF-36v2), 3-level 5-dimension EuroQoL questionnaire, Health Assessment Questionnaire Disability Index, and Work Productivity and Activity Impairment (WPAI) questionnaire.

          Results

          640 patients with PsA were included who had been receiving TNFi for ≥3 months and had completed SF-36v2 bodily pain and vitality domains. Of these, 33.1%, 29.2% and 37.7% of patients reported no, moderate and severe pain, respectively, and 31.9%, 22.5% and 45.6% of patients reported low, moderate and severe fatigue, respectively. Scores across HRQoL variables and WPAI were significantly different across pain and fatigue cohorts (all p<0.0001), with HRQoL and WPAI measures considerably worse in patients with moderate to severe pain or fatigue than those with low pain or fatigue.

          Conclusions

          Despite treatment with biologic agents such as TNFi, data from this global study demonstrated that substantial pain and/or fatigue persist in patients with PsA and that these are significantly associated with reduced HRQoL, physical function and work productivity. These findings suggest that there is an unmet need for additional PsA therapies.

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          Most cited references30

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          Real-world physician and patient behaviour across countries: Disease-Specific Programmes - a means to understand.

          Treatment guidelines and strategies are often based on data from randomized controlled trials and observational clinical studies. These sources drive treatment decisions, yet the data they provide may have limited relevance to the wider population in real-world clinical practice due to the narrow selection criteria applied to patients in trials. Information used to inform clinical practice and improve patient outcomes can, therefore, be unreflective of real-world clinical situations. The purpose of this article is to assess the value of Adelphi Disease Specific Programmes (DSPs) as sources of real world data. DSPs are large, multinational, observational studies of clinical practice for a range of common chronic diseases. Treatment practice data are collected by physicians (n = 700) who are asked to provide information for the next 10 patients consulting for a specific condition. These patients (n = 7000) are also invited to fill out a self-completion form providing their own assessment of symptoms, expectations and quality of life. This article provides examples of the statistical techniques that have been employed to analyse the data in terms of cost/burden of illness, quality of life, disease severity and progression, compliance and adherence to therapy, impact of treatment guidelines and analyses of unmet need. DSPs can support clinical understanding of how diseases are managed including rationale for doctor decision-making and patient attitudes to their condition. Comparisons with other data sources and limitations of the programmes are discussed (including the fact that, unlike claims databases and registries, the DSPs are cross-sectional and not longitudinal).
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            Quality of Life and Work Productivity Impairment among Psoriasis Patients: Findings from the National Psoriasis Foundation Survey Data 2003–2011

            Objective To ascertain impairment in quality of life and work productivity among patients with psoriasis and psoriatic arthritis. Design From 2003 through 2011, the National Psoriasis Foundation collected survey data from patients with psoriasis and psoriatic arthritis via email and telephone correspondences. Setting Survey data were collected from psoriasis and psoriatic arthritis patients in the general community in the U.S. Main Outcome Measures Quality of life focusing on emotional impact (anger, frustration, helplessness, etc.) and physical impact (pain, pruritus, physical irritation, etc.); employment status. Patients The surveys were performed through random sampling of participants from a database of over 75,000 patients. Results From 2003 to 2011, 5,604 patients completed the surveys. Psoriasis and psoriatic arthritis affected overall emotional wellbeing in 88% of patients, and they interfered with enjoyment of life in 82%. Most patients reported experiencing anger (89%), frustration (89%), helplessness (87%), embarrassment (87%), and self-consciousness (89%). Many patients also actively concealed physical manifestations of their diseases (83%), and experienced pain (83%) and pruritus (93%) regularly. Of note, 12% of patients were unemployed, and 11% worked part-time. Among unemployed patients, 92% cited psoriasis and/or psoriatic arthritis as the sole reasons for not working. Among working patients, 49% missed work days regularly due to psoriasis. Compared to patients with mild psoriasis, patients with severe psoriasis have 1.8 times greater odds to be unemployed after adjusting for age and gender (Adjusted OR = 1.7, 95% CI 1.4–2.3). Conclusion Patients with psoriasis and psoriatic arthritis continue to experience significant impairment of quality of life and work productivity.
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              The prevalence of severe fatigue in rheumatic diseases: an international study

              Fatigue is a common, disabling, and difficult-to-manage problem in rheumatic diseases. Prevalence estimates of fatigue within rheumatic diseases vary considerably. Data on the prevalence of severe fatigue across multiple rheumatic diseases using a similar instrument is missing. Our aim was to provide an overview of the prevalence of severe fatigue across a broad range of rheumatic diseases and to examine its association with clinical and demographic variables. Online questionnaires were filled out by an international sample of 6120 patients (88 % female, mean age 47) encompassing 30 different rheumatic diseases. Fatigue was measured with the RAND(SF)-36 Vitality scale. A score of ≤35 was taken as representing severe fatigue (90 % sensitivity and 81 % specificity for chronic fatigue syndrome). Severe fatigue was present in 41 to 57 % of patients with a single inflammatory rheumatic disease such as rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, Sjögren’s syndrome, psoriatic arthritis, and scleroderma. Severe fatigue was least prevalent in patients with osteoarthritis (35 %) and most prevalent in patients with fibromyalgia (82 %). In logistic regression analysis, severe fatigue was associated with having fibromyalgia, having multiple rheumatic diseases without fibromyalgia, younger age, lower education, and language (French: highest prevalence; Dutch: lowest prevalence). In conclusion, one out of every two patients with a rheumatic disease is severely fatigued. As severe fatigue is detrimental to the patient, the near environment, and society at large, unraveling the underlying mechanisms of fatigue and developing optimal treatment should be top priorities in rheumatologic research and practice.
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                Author and article information

                Journal
                RMD Open
                RMD Open
                rmdopen
                rmdopen
                RMD Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2056-5933
                2020
                30 June 2020
                : 6
                : 2
                : e001240
                Affiliations
                [1 ] departmentLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds , Leeds, UK
                [2 ] departmentInternal Medicine II, Rheumatology, SCHLOSSPARK-KLINIK, University Medicine Berlin , Berlin, Germany
                [3 ] Oregon Health & Science University , Portland, Oregon, USA
                [4 ] Adelphi Values , Bollington, UK
                [5 ] Adelphi Real World , Bollington, UK
                [6 ] Novartis Pharmaceuticals Corporation , East Hanover, New Jersey, USA
                [7 ] Novartis AG , Basel, Switzerland
                [8 ] departmentImmunology/Rheumatology, Stanford University , Stanford, California, USA
                [9 ] departmentBiopharmaceutical Consultant , Portola Valley, California, USA
                Author notes
                Correspondence to Emma Sullivan; emma.sullivan@ 123456adelphivalues.com
                Author information
                http://orcid.org/0000-0002-3395-4412
                http://orcid.org/0000-0001-7780-1939
                Article
                rmdopen-2020-001240
                10.1136/rmdopen-2020-001240
                7425192
                32611650
                a9c3d846-3c48-4678-881b-29f58a3963ee
                © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 12 March 2020
                : 22 May 2020
                : 05 June 2020
                Categories
                Psoriatic Arthritis
                Original research

                osteoarthritis,early rheumatoid arthritis,knee osteoarthritis,outcomes research,treatment,patient perspective,rheumatoid arthritis,corticosteroids,ankylosing spondylitis,psoriatic arthritis,anti-tnf,das28,dmards (biologic)

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