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The Patient - Patient-Centered Outcomes Research
Erschienen 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

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

Erschienen in: The Patient - Patient-Centered Outcomes Research | Ausgabe 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.
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Fußnoten
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]).
 
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Metadaten
Titel
Mapping Quality of Life (EQ-5D) from DAPsA, Clinical DAPsA and HAQ in Psoriatic Arthritis
verfasst von
Tomas Mlcoch
Jan Tuzil
Liliana Sedova
Jiri Stolfa
Monika Urbanova
David Suchy
Andrea Smrzova
Jitka Jircikova
Tereza Hrnciarova
Karel Pavelka
Tomas Dolezal
Publikationsdatum
01.06.2018
Verlag
Springer International Publishing
Erschienen in
The Patient - Patient-Centered Outcomes Research / Ausgabe 3/2018
Print ISSN: 1178-1653
Elektronische ISSN: 1178-1661
DOI
https://doi.org/10.1007/s40271-017-0285-1

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