Novel methods of measuring clinical outcomes from psoriasis and psoriatic arthritis clinical trials

Abstract

Numerous instruments exist that measure the clinical and health related quality of life impact of psoriasis and psoriatic arthritis (PsA) in clinical trials. However, many of these instruments are not typically used in economic evaluations to inform decision problems facing health care decision makers. This study reviews the current state of psoriasis and PsA health outcome measures and evaluates their limitations in cost–effectiveness analyses (CEAs). We highlight the health related quality of life and clinical outcome measures that are typically used in CEAs, with special focus on studies with quality adjusted life years as a primary outcome measure. Despite the high prevalence of psoriasis and PsA health outcome measures in clinical trials, only a few are used in CEAs. The methods by which utilities are estimated from these measures vary across cost–effectiveness studies. These differences should be considered when conducting cost–effectiveness research in psoriasis and PsA.

Keywords::

• clinical trials
• cost–effectiveness
• psoriasis
• psoriatic arthritis
• quality of life

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending or royalties.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Numerous instruments are available for measuring the clinical and health-related quality-of-life (HRQOL) progression of psoriasis and psoriatic arthritis (PsA) in clinical trials.

• The development and evaluation of clinical and HRQOL instruments is a priority research area in the psoriasis and PsA research community.

• The various stakeholders of psoriasis and PsA therapies (i.e., patients, physicians, payers and regulatory agencies) should be considered when evaluating and developing clinical and HRQOL instruments.

• Novel methods in comparative effectiveness research and further research in cost–effectiveness studies, where the quality-adjusted life-year is an outcome measure, are opportunities for future work in the psoriasis and PsA research community.

• Cost–effectiveness analyses of psoriasis and PsA therapies, where the quality-adjusted life-year is a primary outcome, typically apply indirect utility models in estimating utilities. In comparison, few apply utilities from direct preference elicitation and direct utility models.

• Limitations related to the various utility estimates (such as indirect utility models and direct preference utilities) available for cost–effectiveness studies should be considered when evaluating psoriasis and PsA therapies.