Mapping Quality of Life (EQ-5D) from DAPsA, Clinical DAPsA and HAQ in Psoriatic Arthritis
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Clinical trials and observational studies lacking measures of health-related quality of life (QoL) are often inapplicable when conducting cost-effectiveness analyses using quality-adjusted life-years (QALYs). The only solution is to map QoL ex post from additionally collected clinical outcomes and generic QoL instruments. Nonetheless, mapping studies are absent in psoriatic arthritis (PsA).
In this 2-year, prospective, multicentre, non-interventional study of PsA patients, EQ-5D and key clinical parameters such as Disease Activity in PsA (DAPsA), clinical DAPsA (cDAPsA; DAPsA without C-reactive protein [CRP]), and Health Assessment Questionnaire disability index (HAQ) were collected. We employed a linear mixed-effect regression model (ME) of the longitudinal dataset to explore the best predictors of QoL.
A total of 228 patients were followed over 873 appointments/observations. DAPsA, cDAPsA and HAQ were stable and highly significant predictors of EQ-5D utilities in both cross-sectional and longitudinal analyses. The best prediction was provided using a linear ME with HAQ and cDAPsA or DAPsA. A HAQ increase of 1 point represented a decrease in EQ-5D by −0.204 or −0.203 (p < 0.0001); a one-point increase in cDAPsA or DAPsA dropped EQ-5D equally by −0.005 (p < 0.0001). The ME revealed steeper and more accurate association compared with cross-sectional regressions or non-linear models/transformations.
This is the first mapping study conducted in PsA and we hope that our study will encourage further mapping studies in PsA. The results showed that in cases where CRP is absent, cDAPsA provides similar results to DAPsA in predicting QoL.
L. Sedova, J. Stolfa, M. Urbanova and K. Pavelka were supported by a general grant from the Czech Ministry of Health IGA MZ CZ: No. 000 000 23, 728. K. Pavelka received honoraria for lectures and consultations from AbbVie, BMS, UCB, MSD, Amgen, Egis, Pfizer, and Roche. The authors acknowledge careful proofreading and insightful suggestions from Klara Lamblova MSc. (iHETA) and excellent English proofreading by Thomas O. Secrest.
Tomas Dolezal is owner of iHETA and also consultancy company Value Outcomes. Tomas Mlcoch, Jan Tuzil, Jitka Jircikova and Tereza Hrnciarova work for both iHETA and Value Outcomes. TD and TM work mainly as health economists. Their goal is to improve the healthcare system in the Czech Republic. JJ and TH design clinical trials and work as statisticians and data analysts. JT specialises in medical data interpretation in clinical trials. Liliana Sedova, Jiri Stolfa, David Suchy and Andrea Smrzova work as rheumatologists in respective specialised rheumatology clinics in which highly specialised medical technologies are prescribed (such as new biological treatment). Karel Pavelka is a director of the Institute of Rheumatology. None of these activities influenced the content or processing of this manuscript.
TD, LS, JS and KP designed the research. LS, JS, MU, DS, AS and KP collected the data in clinical practice. TM, JT and TD wrote the manuscript and TM had primary responsibility for final content. TM, JT, JJ and TH prepared and analysed the data. JT performed statistical analysis. LS, JS and TH conducted repeated and throughout revisions of the manuscript.
- 1.Gossec L, Smolen JS, Ramiro S, Wit M de, Cutolo M, Dougados M, et al. European league against rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Annals of the Rheumatic Diseases. 2015 Dec 7 (Annrheumdis-2015-208337).Google Scholar
- 8.Mlcoch T, Sedova L, Stolfa J, Urbanova M, Suchy D, Smrzova A, et al. Mapping the relationship between clinical and quality-of-life outcomes in patients with ankylosing spondylitis. Expert Rev Pharmacoecon Outcomes Res. 2016;24:1–9.Google Scholar
- 17.Searle SR, Casella G, McCulloch CE. Variance components. Hoboken: Wiley; 2006. p. 501 (Wiley series in probability and statistics).Google Scholar
- 27.Aletaha D, Funovits J, Schoels M, Kavanaugh A, Baker D, Smolen J. A simple additive disease activity index for psoriatic arthritis: first evaluations of clinical validity. In: Vol 58. Wiley-Blackwell commerce place, 350 main st, Malden 02148, MA USA; 2008:S201–S202.Google Scholar
- 29.Štolfa J, Šedová L. A contribution to the development of a composite disease activity index for patients with psoriatic arthritis (DAPA). Ann Rheum Dis. 2010;69(Suppl3):700.Google Scholar
- 34.EQ-5D value sets: inventory, comparative review and user guide | Agota Szende | Springer, Berlin. http://www.springer.com/gp/book/9781402055102. [Internet]. [cited 2017 Apr 13].
- 35.ČFES. Doporučené postupy České farmakoekonomické společnosti (ČFES) pro zdravotně-ekonomická hodnocení v ČR, Czech Pharmacoeconomic Society. 2016.Google Scholar
- 36.SUKL. Postup pro posuzování analýzy nákladové efektivity, State Institute for Drug Control. 2017.Google Scholar
- 40.McCulloch CE, Neuhaus JM. Generalized linear mixed models. In: Armitage P, Colton T, editors. Encyclopedia of biostatistics. New York: Wiley; 2005.Google Scholar
- 43.Ustekinumab for treating active psoriatic arthritis. |Guidance and guidelines| NICE. https://www.nice.org.uk/guidance/ta340. Accessed 15 May 2017.
- 44.Apremilast for treating active psoriatic arthritis |Guidance and guidelines| NICE. https://www.nice.org.uk/guidance/ta433. Accessed 15 May 2017.
- 45.Psoriatic arthritis—certolizumab pegol and secukinumab (after DMARDs) [ID579] | Guidance and guidelines | NICE. https://www.nice.org.uk/guidance/indevelopment/gid-tag521. Accessed 15 May 2017.
- 48.Malottki K, Barton P, Tsourapas A, Uthman AO, Liu Z, Routh K, et al. Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a tumour necrosis factor inhibitor: a systematic review and economic evaluation. Health Technol Assess. 2011;15(14):1–278.CrossRefPubMedPubMedCentralGoogle Scholar
- 49.Ducournau P, Kielhorn A, Wintfeld N. Comparison of linear and non-linear utility mapping between HAQ and EQ-5D using pooled data from the tocilizumab trials OPTION and LITHE. Annu Meet Br Soc Rheumatol. 2009;2009:258.Google Scholar