Pain and Fatigue in Patients With Ankylosing Spondylitis Treated With Tumor Necrosis Factor Inhibitors: Multinational Real-World Findings.
Journal
Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases
ISSN: 1536-7355
Titre abrégé: J Clin Rheumatol
Pays: United States
ID NLM: 9518034
Informations de publication
Date de publication:
01 Dec 2021
01 Dec 2021
Historique:
pubmed:
23
8
2020
medline:
26
11
2021
entrez:
23
8
2020
Statut:
ppublish
Résumé
Patients with ankylosing spondylitis (AS) experience symptoms and comorbidities that impact their health-related quality of life (HRQoL) and ability to work. This real-world, global survey was conducted among AS patients receiving tumor necrosis factor inhibitors (TNFis) to evaluate both the frequency and severity of persistent symptoms, and the impact of pain and fatigue on HRQoL, employment status, and work activity. Patients with AS and their treating physicians from 13 countries across 5 continents completed questionnaires capturing demographics, patient symptoms, current disease status, HRQoL, current therapy, employment status, and Work Productivity and Activity Impairment. Seven hundred five patients who had been receiving a TNFi for 3 months or more and completed both Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) pain and fatigue domains were included in the analysis; of these, 37.6% reported high BASDAI pain scores and 41.3% high BASDAI fatigue scores. Medical Outcomes Study-Short Form, 36-item version 2 domain, 5-dimensional EuroQoL Questionnaire, and 5-dimensional EuroQoL visual analog scale scores were significantly lower (p < 0.0001), and Work Productivity and Activity Impairment scores significantly higher (p < 0.0001), in patients with high levels of pain or fatigue than low levels. Globally, levels of pain and fatigue remained high in AS patients receiving TNFi treatment, which were significantly associated with reduced HRQoL and work productivity. Such persistent symptoms in usual care suggest a substantial unmet need in AS pharmacologic and nonpharmacologic therapeutic pathways.
Sections du résumé
BACKGROUND/OBJECTIVE
OBJECTIVE
Patients with ankylosing spondylitis (AS) experience symptoms and comorbidities that impact their health-related quality of life (HRQoL) and ability to work. This real-world, global survey was conducted among AS patients receiving tumor necrosis factor inhibitors (TNFis) to evaluate both the frequency and severity of persistent symptoms, and the impact of pain and fatigue on HRQoL, employment status, and work activity.
METHODS
METHODS
Patients with AS and their treating physicians from 13 countries across 5 continents completed questionnaires capturing demographics, patient symptoms, current disease status, HRQoL, current therapy, employment status, and Work Productivity and Activity Impairment.
RESULTS
RESULTS
Seven hundred five patients who had been receiving a TNFi for 3 months or more and completed both Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) pain and fatigue domains were included in the analysis; of these, 37.6% reported high BASDAI pain scores and 41.3% high BASDAI fatigue scores. Medical Outcomes Study-Short Form, 36-item version 2 domain, 5-dimensional EuroQoL Questionnaire, and 5-dimensional EuroQoL visual analog scale scores were significantly lower (p < 0.0001), and Work Productivity and Activity Impairment scores significantly higher (p < 0.0001), in patients with high levels of pain or fatigue than low levels.
CONCLUSIONS
CONCLUSIONS
Globally, levels of pain and fatigue remained high in AS patients receiving TNFi treatment, which were significantly associated with reduced HRQoL and work productivity. Such persistent symptoms in usual care suggest a substantial unmet need in AS pharmacologic and nonpharmacologic therapeutic pathways.
Identifiants
pubmed: 32826654
pii: 00124743-202112000-00032
doi: 10.1097/RHU.0000000000001544
pmc: PMC8612885
doi:
Substances chimiques
Tumor Necrosis Factor Inhibitors
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e446-e455Informations de copyright
Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc.
Références
Bohn R, Cooney M, Deodhar A, et al. Incidence and prevalence of axial spondyloarthritis: methodologic challenges and gaps in the literature. Clin Exp Rheumatol . 2017.
Braun J, Sieper J. Ankylosing spondylitis. Lancet . 2007;369:1379–1390.
Dean LE, Jones GT, MacDonald AG, et al. Global prevalence of ankylosing spondylitis. Rheumatology (Oxford) . 2014;53:650–657.
Salaffi F, Carotti M, Gasparini S, et al. The health-related quality of life in rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis: a comparison with a selected sample of healthy people. Health Qual Life Outcomes . 2009;7:25.
Boonen A, Boone C, Albert A, et al. Understanding limitations in at-work productivity in patients with active ankylosing spondylitis: the role of work-related contextual factors. J Rheumatol . 2015;42:93–100.
Dean LE, Macfarlane GJ, Jones GT. Five potentially modifiable factors predict poor quality of life in Ankylosing spondylitis: results from the Scotland registry for Ankylosing spondylitis. J Rheumatol . 2017.
Taurog JD, Chhabra A, Colbert RA. Ankylosing spondylitis and axial spondyloarthritis. N Engl J Med . 2016;374:2563–2574.
Nhan DT, Caplan L. Patient-reported outcomes in axial spondyloarthritis. Rheum Dis Clin North Am . 2016;42:285–299.
Mogard E, Bremander A, Lindqvist E, et al. Prevalence of chronic widespread pain in a population-based cohort of patients with spondyloarthritis—a cross-sectional study. BMC Rheumatol . 2018;2:11.
Overman CL, Kool MB, Da Silva JA, et al. The prevalence of severe fatigue in rheumatic diseases: an international study. Clin Rheumatol . 2016;35:409–415.
Walsh JA, McFadden ML, Morgan MD, et al. Work productivity loss and fatigue in psoriatic arthritis. J Rheumatol . 2014;41:1670–1674.
Brophy S, Davies H, Dennis MS, et al. Fatigue in ankylosing spondylitis: treatment should focus on pain management. Semin Arthritis Rheum . 2013;42:361–367.
Sveaas SH, Berg IJ, Provan SA, et al. Circulating levels of inflammatory cytokines and cytokine receptors in patients with ankylosing spondylitis: a cross-sectional comparative study. Scand J Rheumatol . 2015;44:118–124.
Kim CF, Moalem-Taylor G. Interleukin-17 contributes to neuroinflammation and neuropathic pain following peripheral nerve injury in mice. J Pain . 2011;12:370–383.
Zhang JM, An J. Cytokines, inflammation, and pain. Int Anesthesiol Clin . 2007;45:27–37.
Louati K, Berenbaum F. Fatigue in chronic inflammation—a link to pain pathways. Arthritis Res Ther . 2015;17:254.
Andersen T, Rasmussen TK, Hvid M, et al. Increased plasma levels of IL-21 and IL-23 in spondyloarthritis are not associated with clinical and MRI findings. Rheumatol Int . 2012;32:387–393.
Mei Y, Pan F, Gao J, et al. Increased serum IL-17 and IL-23 in the patient with ankylosing spondylitis. Clin Rheumatol . 2011;30:269–273.
Romero-Sanchez C, Jaimes DA, Londono J, et al. Association between Th-17 cytokine profile and clinical features in patients with spondyloarthritis. Clin Exp Rheumatol . 2011;29:828–834.
van der Heijde D, Ramiro S, Landewe R, et al. 2016 Update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis . 2017.
Anderson P, Benford M, Harris N, et al. Real-world physician and patient behaviour across countries: disease-specific programmes—a means to understand. Curr Med Res Opin . 2008;24:3063–3072.
EuroQol Group. EuroQol—a new facility for the measurement of health-related quality of life. Health Policy . 1990;16:199–208.
Garrett S, Jenkinson T, Kennedy LG, et al. A new approach to defining disease status in ankylosing spondylitis: the Bath Ankylosing Spondylitis Disease Activity Index. J Rheumatol . 1994;21:2286–2291.
Ware JE Jr., Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care . 1992;30:473–483.
Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a Work Productivity and Activity Impairment instrument. Pharmacoeconomics . 1993;4:353–365.
U.S. Department of Health and Human Services. Summary of the HIPAA Privacy Rule. Available at: http://www.hhs.gov/sites/default/files/privacysummary.pdf . Published 2003. Accessed May 11, 2017.
Health Information Technology Act. Available at: https://www.healthit.gov/sites/default/files/hitech_act_excerpt_from_arra_with_index.pdf . Accessed May 11, 2017.
Association EPMR. European Pharmaceutical Market Research Association (EphMRA) code of conduct. Available at: http://www.ephmra.org/Code-of-Conduct-Support . Published 2017. Updated January 2017. Accessed May 11, 2017.
van Tubergen A, Coenen J, Landewe R, et al. Assessment of fatigue in patients with ankylosing spondylitis: a psychometric analysis. Arthritis Rheum . 2002;47:8–16.
Dolan P. Modeling valuations for EuroQol health states. Med Care . 1997;35:1095–1108.
Ware JE, Kosinski M, Bjorner JB, et al. User's Manual for the SF-36v2® Health Survey (2nd ed.). Lincoln, RI: Quality Metric Incorporated; 2007.
Fischer BD, Adeyemo A, O'Leary ME, et al. Animal models of rheumatoid pain: experimental systems and insights. Arthritis Res Ther . 2017;19:146.
Garrido-Cumbrera M, Hillmann O, Mahapatra R, et al. Improving the management of psoriatic arthritis and axial spondyloarthritis: roundtable discussions with healthcare professionals and patients. Rheumatol Ther . 2017;4:219–231.
Pradeep DJ, Keat AC, Gaffney K, et al. Switching anti-TNF therapy in ankylosing spondylitis. Rheumatology (Oxford) . 2008;47:1726–1727.
Bidad K, Gracey E, Hemington KS, et al. Pain in ankylosing spondylitis: a neuro-immune collaboration. Nat Rev Rheumatol . 2017;13:410–420.
Morris G, Berk M, Walder K, et al. Central pathways causing fatigue in neuro-inflammatory and autoimmune illnesses. BMC Med . 2015;13:28.
Rizzo A, Guggino G, Ferrante A, et al. Role of subclinical gut inflammation in the pathogenesis of spondyloarthritis. Front Med (Lausanne) . 2018;5:63.
Valente RL, Valente JM, de Castro GR, et al. Subclinical atherosclerosis in ankylosing spondylitis: is there a role for inflammation? Rev Bras Reumatol . 2013;53:377–381.
Kirwan JR, Hewlett S. Patient perspective: reasons and methods for measuring fatigue in rheumatoid arthritis. J Rheumatol . 2007;34:1171–1173.
Dernis-Labous E, Messow M, Dougados M. Assessment of fatigue in the management of patients with ankylosing spondylitis. Rheumatology (Oxford) . 2003;42:1523–1528.
Wu Q, Inman RD, Davis KD. Tumor necrosis factor inhibitor therapy in ankylosing spondylitis: differential effects on pain and fatigue and brain correlates. Pain . 2015;156:297–304.
Lindstrom Egholm C, Krogh NS, Pincus T, et al. Discordance of global assessments by patient and physician is higher in female than in male patients regardless of the physician's sex: data on patients with rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis from the DANBIO registry. J Rheumatol . 2015;42:1781–1785.
Desthieux C, Molto A, Granger B, et al. Patient-physician discordance in global assessment in early spondyloarthritis and its change over time: the DESIR cohort. Ann Rheum Dis . 2016;75:1661–1666.
Wang CTM, Fong W, Kwan YH, et al. A cross-sectional study on factors associated with patient-physician discordance in global assessment of patients with axial spondyloarthritis: an Asian perspective. Int J Rheum Dis . 2018;21:1436–1442.
Khan NA, Spencer HJ, Abda E, et al. Determinants of discordance in patients' and physicians' rating of rheumatoid arthritis disease activity. Arthritis Care Res (Hoboken) . 2012;64:206–214.
Espahbodi S, Bassett P, Cavill C, et al. Fatigue contributes to work productivity impairment in patients with axial spondyloarthritis: a cross-sectional UK study. Clin Exp Rheumatol . 2017;35:571–578.
Mau W, Listing J, Huscher D, et al. Employment across chronic inflammatory rheumatic diseases and comparison with the general population. J Rheumatol . 2005;32:721–728.
Williams EM, Walker RJ, Faith T, et al. The impact of arthritis and joint pain on individual healthcare expenditures: findings from the Medical Expenditure Panel Survey (MEPS), 2011. Arthritis Res Ther . 2017;19:38.
Kvamme MK, Lie E, Kvien TK, et al. Two-year direct and indirect costs for patients with inflammatory rheumatic joint diseases: data from real-life follow-up of patients in the NOR-DMARD registry. Rheumatology (Oxford) . 2012;51:1618–1627.
Saunders C, Byrne CD, Guthrie B, et al. External validity of randomized controlled trials of glycaemic control and vascular disease: how representative are participants? Diabet Med . 2012;30:300–308.
Hubbard TE, Paradis R; NEHI. Real World Evidence: A New Era for Health Care Innovation. Available at: https://www.nehi.net/writable/publication_files/file/rwe_issue_brief_final.pdf . Published 2015. Accessed May 11, 2020.
Babineaux SM, Curtis B, Holbrook T, et al. Evidence for validity of a national physician and patient-reported, cross-sectional survey in China and UK: the disease specific programme. BMJ Open . 2016;6:e010352.