Abstract
Objectives
The aim of the study is to evaluate the performance of extreme patient-reported outcomes (PRO) against definitions of fibromyalgia (FM) in patients with axial spondyloarthritis (axSpA).
Methods
Ancillary analysis of the Predict-SpA trial, an observational study of axSpA patients receiving TNF-α inhibitor, was performed. ‘Extreme PRO’ was defined as a score ≥ 8 on three out of the first five Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions (scored 0–10). FM was defined by the American College of Rheumatology (ACR) 1990 criteria and the Fibromyalgia Rapid Screening Test (FiRST). Performances of ‘extreme PRO’ for FM were evaluated by the sensitivity, specificity and positive likelihood ratio using the 1990 ACR criteria as gold standard. As secondary analysis, the FiRST was used as the external standard.
Results
The prevalence of ‘extreme PRO’ in this population was 28.8% at baseline and decreased to 9.9% at 12 weeks. ‘Extreme PRO’ had low sensitivity 12 weeks after TNF initiation (0.18, 95% confidence interval [CI] 0.10–0.27 vs 0.60, 95% CI 0.50–0.71, at baseline), but high specificity (0.92, 95% CI 0.89–0.94 vs 0.78, 95% 0.74–0.82, at baseline), using ACR 1990 criteria as gold standard. Performances when tested against FiRST at 12 weeks showed higher sensitivity (0.27, 95% CI 0.20–0.35) and specificity (0.96, 95% CI 0.94–0.98).
Conclusion
The proposed extreme PRO definition showed great specificity for FM recognition in patients with axSpA, suggesting it could be used in observational studies when specific items for FM classification are not available.
References
Wolfe F, Ross K, Anderson J, Russell IJ, Hebert L (1995) The prevalence and characteristics of fibromyalgia in the general-population. Arthritis Rheum 38(1):19–28
Branco JC, Bannwarth B, Failde I, Abello Carbonell J, Blotman F, Spaeth M et al (2010) Prevalence of fibromyalgia: a survey in five European countries. Semin Arthritis Rheum 39(6):448–453
Haliloglu S, Carlioglu A, Akdeniz D, Karaaslan Y, Kosar A (2014) Fibromyalgia in patients with other rheumatic diseases: prevalence and relationship with disease activity. Rheumatol Int 34(9):1275–1280
Perrot S, Peixoto M, Dieude P, Hachulla E, Avouac J, Ottaviani S et al (2017) Patient phenotypes in fibromyalgia comorbid with systemic sclerosis or rheumatoid arthritis: influence of diagnostic and screening tests. Screening with the FiRST questionnaire, diagnosis with the ACR 1990 and revised ACR 2010 criteria. Clin Exp Rheumatol 35(3):35–42
Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL et al (1990) The American College of Rheumatology 1990 criteria for the classification of fibromyalgia. Report of the multicenter criteria committee. Arthritis Rheum 33(2):160–172
Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Häuser W, Katz RS et al (2011) Fibromyalgia criteria and severity scales for clinical and epidemiological studies: a modification of the ACR preliminary diagnostic criteria for fibromyalgia. J Rheumatol 38(6):1113–1122
Perrot S, Bouhassira D, Fermanian J (2010) Development and validation of the fibromyalgia rapid screening tool (FiRST). Pain 150(2):250–256
Sieper J, Rudwaleit M, Baraliakos X, Brandt J, Braun J, Burgos-Vargas R et al (2009) The Assessment of Spondylo Arthritis international Society (ASAS) handbook: a guide to assess spondyloarthritis. Ann Rheum Dis 68(Suppl 2):ii1–ii44
Almodovar R, Carmona L, Zarco P, Collantes E, González C, Mulero J et al. Fibromyalgia in patients with ankylosing spondylitis: Prevalence and utility of the measures of activity, function and radiological damage. Clin Exp Rheumatol. 2010;28:63.
Baraliakos X, Regel A, Kiltz U, Menne H-J, Dybowski F, Igelmann M et al (2018) Patients with fibromyalgia rarely fulfil classification criteria for axial spondyloarthritis. Rheumatology 57(9):1541–1547
Azevedo VF, Paiva Edos S, Felippe LR, Moreira RA (2010) Occurrence of fibromyalgia in patients with ankylosing spondylitis. Rev Bras Reum 50(6):646–650
Bello N, Etcheto A, Beal C, Dougados M, Molto A (2016) Evaluation of the impact of fibromyalgia in disease activity and treatment effect in spondyloarthritis. Arthritis Res Ther 18:42
Fan A, Pereira B, Tournadre A, Tatar Z, Malochet-Guinamand S, Mathieu S et al (2017) Frequency of concomitant fibromyalgia in rheumatic diseases: Monocentric study of 691 patients. Semin Arthritis Rheum 47(1):129–132
Salaffi F, De Angelis R, Carotti M, Gutierrez M, Sarzi-Puttini P, Atzeni F (2014) Fibromyalgia in patients with axial spondyloarthritis: Epidemiological profile and effect on measures of disease activity. Rheumatol Int 34(8):1103–1110
Wach J, Letroublon M-C, Coury F, Tebib JG (2016) Fibromyalgia in spondyloarthritis: effect on disease activity assessment in clinical practice. J Rheumatol 43(11):2056–2063
Moltó A, Etcheto A, Gossec L, Boudersa N, Claudepierre P, Roux N et al (2018) Evaluation of the impact of concomitant fibromyalgia on TNF alpha blockers’ effectiveness in axial spondyloarthritis: results of a prospective, multicentre study. Ann Rheum Dis 77(4):533
van Tuyl LHD, Boers M (2015) Patient-reported outcomes in core domain sets for rheumatic diseases. Nat Rev Rheumatol 11(12):705–712
Zochling J (2011) Measures of symptoms and disease status in ankylosing spondylitis: Ankylosing Spondylitis Disease Activity Score (ASDAS), Ankylosing Spondylitis Quality of Life Scale (ASQoL), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Sp. Arthritis Care Res 63:11
Dougados M, Logeart I, Szumski A, Coindreau J, Jones H (2017) Evaluation of whether extremely high enthesitis or Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores suggest fibromyalgia and confound the anti-TNF response in early non-radiographic axial spondyloarthritis. Clin Exp Rheumatol 35:50–53
Meghnathi B, Etcheto A, Claudepierre P, Dougados M, Moltό A (2017) SAT0386 Extreme patient reported outcome (PRO) in early spondyloarthritis: a surrogate for fibromyalgia? its impact on TNF-ALPHA blockers treatment effect? Ann Rheum Dis 76(Suppl 2):917–918
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This study was conducted thanks to an unrestricted grant from MSD.
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None of the authors has any conflicts of interest to declare for the present study.
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CPP Île de France 3 - date 24/10/2014. The manuscript has been read and approved by all the authors and we confirm that each individual named as an author meets the journal’s criteria for authorship.
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Santos-Faria, D., Dougados, M., Gossec, L. et al. Evaluation of the performance of extreme patient-reported outcomes as surrogate markers for fibromyalgia in axial spondyloarthritis. Rheumatol Int 39, 141–146 (2019). https://doi.org/10.1007/s00296-018-4200-4
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DOI: https://doi.org/10.1007/s00296-018-4200-4