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The Patient - Patient-Centered Outcomes Research
Published in: The Patient - Patient-Centered Outcomes Research 3/2018

01-06-2018 | Original Research Article

Mapping Quality of Life (EQ-5D) from DAPsA, Clinical DAPsA and HAQ in Psoriatic Arthritis

Authors: Tomas Mlcoch, Jan Tuzil, Liliana Sedova, Jiri Stolfa, Monika Urbanova, David Suchy, Andrea Smrzova, Jitka Jircikova, Tereza Hrnciarova, Karel Pavelka, Tomas Dolezal

Published in: The Patient - Patient-Centered Outcomes Research | Issue 3/2018

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Abstract

Background

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).

Methods

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.

Results

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.

Conclusions

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.
Appendix
Available only for authorised users
Footnotes
1
For example, patients enrolled into the study in July 2015 could not have completed the following visit as the planned 6-monthly visit falls after the data-lock point.
 
2
In our study, DAPsA was calculated using the definition valid at the time of the patient enrolment (2012–2015). These were further refined in 2015 by Schoels et al. [28], who proposed changing the global health assessment by physician (GHA) via visual analogue scale (VAS) to patient’s assessment of pain on VAS. Nonetheless, there is some evidence showing that physician’s GHA-VAS might be more precise than pain assessment due to lower variability and higher objectivity of the physician’s point of view [29].
 
3
Working productivity, and thus WPAI, was proportionally decreased according to the stage of disability since disability in the Czech Republic is defined in stages: 1st stage is defined by law as a decrease in working productivity by 35–49%, 2nd stage by 50–69%, and 3rd stage by 70–100%.
 
4
A majority of patients present low values of BSA. At baseline, 62% of patients had BSA ≤ 1 and 76% had BSA ≤ 3. Extrapolation beyond these values cannot be considered reliable due to very low number of observations. Being the second reason for omitting BSA from the ultimate regressions, high skewness is an inherent character of this parameter in any PsA population.
 
5
Interestingly, the most recent cost-effectiveness analyses (CEA) of new PsA treatments (e.g. see ampremilast or ustekinumab NICE guidance [43, 44]) use the mapping algorithm by Rodgers et al. despite its drawbacks. Another solution is to present specific utility mapping using data from in-house RCTs; however, the results are usually not further available for other researchers (sometimes are even of commercial confidence) and/or the methods employed are not thoroughly discussed (e.g. see certolizumab pegol and secukinumab NICE guidance [45]).
 
Literature
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).
2.
3.
4.
Bergman M, Lundholm A. Mitigation of disease- and treatment-related risks in patients with psoriatic arthritis. Arthritis Res Therapy. 2017;19:63.CrossRef
5.
Cortesi PA, Scalone L, D’Angiolella L, Belisari A, Fusco F, Olivieri I, et al. Systematic literature review on economic implications and pharmacoeconomic issues of psoriatic arthritis. Clin Exp Rheumatol. 2012;30(4 Suppl 73):S126–31.PubMed
6.
McDonough E, Ayearst R, Eder L, Chandran V, Rosen CF, Thavaneswaran A, et al. Depression and anxiety in psoriatic disease: prevalence and associated factors. J Rheumatol. 2014;41(5):887–96.CrossRefPubMed
7.
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.
9.
Kruntorádová K, Klimeš J, Šedová L, Štolfa J, Doležal T, Petříková A. Work productivity and costs related to patients with ankylosing spondylitis, rheumatoid arthritis, and psoriasis. Value in Health Reg Issues. 2014;4:100–6.CrossRef
10.
Gudu T, Kiltz U, de Wit M, Kvien TK, Gossec L. Mapping the effect of psoriatic arthritis using the international classification of functioning, disability Health. J Rheumatol. 2017;44(2):193–200.CrossRefPubMed
11.
Dures E, Hewlett S, Lord J, Bowen C, McHugh N, Group F the PS, et al. Important treatment outcomes for patients with psoriatic arthritis: a multisite qualitative study. Patient. 2017;10(4):455–62.CrossRefPubMedPubMedCentral
12.
Klimeš J, Vocelka M, Šedová L, Doležal T, Mlčoch T, Petříková A, et al. Medical and Productivity costs of rheumatoid arthritis in The Czech Republic: cost-of-illness study based on disease severity. Value in Health Reg Issues. 2014;4:75–81.CrossRef
13.
Kearns B, Ara R, Wailoo A, Manca A, Alava MH, Abrams K, et al. Good practice guidelines for the use of statistical regression models in economic evaluations. Pharmacoeconomics. 2013;31(8):643–52.CrossRefPubMed
14.
Brazier JE, Yang Y, Tsuchiya A, Rowen DL. A review of studies mapping (or cross walking) non-preference based measures of health to generic preference-based measures. Eur J Health Econ. 2010;11(2):215–25.CrossRefPubMed
15.
Heintz E, Gerber-Grote A, Ghabri S, et al. Is there a European view on health economic evaluations? Results from a synopsis of methodological guidelines used in the EUnetHTA partner countries. PharmacoEconomics. 2016;34(1):59–76.CrossRefPubMed
16.
Mlčoch T, Klimeš J, Fila L, Vávrová V, Skalická V, Turnovec M, et al. Cost-of-illness analysis and regression modeling in cystic fibrosis: a retrospective prevalence-based study. Eur J Health Econ. 2017;18(1):73–82.CrossRefPubMed
17.
Searle SR, Casella G, McCulloch CE. Variance components. Hoboken: Wiley; 2006. p. 501 (Wiley series in probability and statistics).
18.
Cnaan A, Laird NM, Slasor P. Using the general linear mixed model to analyse unbalanced repeated measures and longitudinal data. Stat Med. 1997;16(20):2349–80.CrossRefPubMed
19.
Burton P, Gurrin L, Sly P. Extending the simple linear regression model to account for correlated responses: an introduction to generalized estimating equations and multi-level mixed modelling. Stat Med. 1998;17(11):1261–91.CrossRefPubMed
20.
Coates LC, FitzGerald O, Mease PJ, Gladman DD, Strand V, Goel N, et al. Development of a disease activity and responder index for psoriatic arthritis–report of the Psoriatic Arthritis Module at OMERACT 11. J Rheumatol. 2014;41(4):782–91.CrossRefPubMed
21.
Péntek M, Poór G, Wiland P, Olejárová M, Brzosko M, Codreanu C, et al. Biological therapy in inflammatory rheumatic diseases: issues in Central and Eastern European countries. Eur J Health Econ. 2014;15(Suppl 1):S35–43.CrossRefPubMed
22.
Wailoo AJ, Hernandez-Alava M, Manca A, Mejia A, Ray J, Crawford B, et al. Mapping to estimate health-state utility from non-preference-based outcome measures: An ISPOR good practices for outcomes research task force report. Value Health. 2017;20(1):18–27.CrossRefPubMed
23.
Petrou S, Rivero-Arias O, Dakin H, Longworth L, Oppe M, Froud R, et al. The MAPS reporting statement for studies mapping onto generic preference-based outcome measures: explanation and elaboration. PharmacoEconomics. 2015;33(10):993–1011.CrossRefPubMed
24.
Wolowacz SE, Briggs A, Belozeroff V, Clarke P, Doward L, Goeree R, et al. Estimating health-state utility for economic models in clinical studies: an ISPOR good research practices task force report. Value Health. 2016;19(6):704–19.CrossRefPubMed
25.
Taylor W, Gladman D, Helliwell P, Marchesoni A, Mease P, Mielants H, et al. Classification criteria for psoriatic arthritis: development of new criteria from a large international study. Arthritis Rheum. 2006;54(8):2665–73.CrossRefPubMed
26.
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.
28.
Smolen JS, Schoels M, Aletaha D. Disease activity and response assessment in psoriatic arthritis using the disease activity index for PSoriatic arthritis (DAPSA). A brief review. Clin Exp Rheumatol. 2015;33(5 Suppl 93):S48–50.PubMed
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.
30.
Schoels MM, Aletaha D, Alasti F, Smolen JS. Disease activity in psoriatic arthritis (PsA): defining remission and treatment success using the DAPSA score. Ann Rheum Dis. 2016;75(5):811–8.CrossRefPubMed
31.
Langley RGB, Feldman SR, Nyirady J, van de Kerkhof P, Papavassilis C. The 5-point investigator’s global assessment (IGA) scale: a modified tool for evaluating plaque psoriasis severity in clinical trials. J Dermatol Treat. 2015;26(1):23–31.CrossRef
32.
Bruce B, Fries JF. The health assessment questionnaire (HAQ). Clin Exp Rheumatol. 2005;23(5 Suppl 39):S14–8.PubMed
33.
34.
35.
ČFES. Doporučené postupy České farmakoekonomické společnosti (ČFES) pro zdravotně-ekonomická hodnocení v ČR, Czech Pharmacoeconomic Society. 2016.
36.
SUKL. Postup pro posuzování analýzy nákladové efektivity, State Institute for Drug Control. 2017.
37.
Burström K, Sun S, Gerdtham U-G, Henriksson M, Johannesson M, Levin L-Å, et al. Swedish experience-based value sets for EQ-5D health states. Qual Life Res. 2014;23(2):431–42.CrossRefPubMed
38.
Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993;4(5):353–65.CrossRefPubMed
39.
Basu A, Manca A. Regression estimators for generic health-related quality of life and quality-adjusted life years. Med Decis Making. 2012;32(1):56–69.CrossRefPubMed
40.
McCulloch CE, Neuhaus JM. Generalized linear mixed models. In: Armitage P, Colton T, editors. Encyclopedia of biostatistics. New York: Wiley; 2005.
41.
D’Angelo S, Tramontano G, Gilio M, Leccese P, Olivieri I. Review of the treatment of psoriatic arthritis with biological agents: choice of drug for initial therapy and switch therapy for non-responders. Open Access Rheumatol. 2017;9:21–8.CrossRefPubMedPubMedCentral
42.
Nakagawa S, Schielzeth H. A general and simple method for obtaining R2 from generalized linear mixed-effects models. Methods Ecol Evol. 2013;4(2):133–42.CrossRef
43.
44.
45.
46.
Marra CA, Marion SA, Guh DP, Najafzadeh M, Wolfe F, Esdaile JM, et al. Not all “quality-adjusted life years” are equal. J Clin Epidemiol. 2007;60(6):616–24.CrossRefPubMed
47.
Corbacho MI, Dapueto JJ. Assessing the functional status and quality of life of patients with rheumatoid arthritis. Rev Bras Reumatol. 2010;50(1):31–43.CrossRefPubMed
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.CrossRefPubMedPubMedCentral
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.
Metadata
Title
Mapping Quality of Life (EQ-5D) from DAPsA, Clinical DAPsA and HAQ in Psoriatic Arthritis
Authors
Tomas Mlcoch
Jan Tuzil
Liliana Sedova
Jiri Stolfa
Monika Urbanova
David Suchy
Andrea Smrzova
Jitka Jircikova
Tereza Hrnciarova
Karel Pavelka
Tomas Dolezal
Publication date
01-06-2018
Publisher
Springer International Publishing
Published in
The Patient - Patient-Centered Outcomes Research / Issue 3/2018
Print ISSN: 1178-1653
Electronic ISSN: 1178-1661
DOI
https://doi.org/10.1007/s40271-017-0285-1

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