Systematic literature review of domains assessed in psoriatic arthritis to inform the update of the psoriatic arthritis core domain set

Abstract

The objectives of this systematic literature review (SLR) were to identify domains and outcome measures used in psoriatic arthritis (PsA) studies in the past 5 years, and to compare the measurement of the Outcome Measures in Rheumatology (OMERACT) 2006 PsA Core Domain Set in studies published in 2010–2015 vs those published in 2006–2010. We performed a systematic literature search in two databases, PubMed and Embase, to identify randomised controlled trials (RCTs) in PsA. We also identified PsA longitudinal observational studies (LOS). Three patient research partners provided input into study conception, and data collection and interpretation. We identified 41 studies representing 22 unique RCTs, 27 LOS and 12 registries. Across all studies, we identified 24 domains and 169 outcome measures. In addition to the PsA Core Domain Set (6 domains), the following domains were also assessed in more than 30% of RCTs: acute phase reactants, dactylitis, enthesitis, fatigue and work productivity. We identified a range of 1–15 outcome measures per domain with a mean (SD) of 7 (4.7) per domain. The complete PsA Core Domain Set was assessed in 59% of RCTs in 2010–2015 compared to 23.5% RCTs in 2006–2010. There has been increased measurement of the PsA Core Domain Set in RCTs and LOS in the past 5 years. Numerous additional outcomes were also measured. The PsA Core Domain Set needs an update to standardise PsA outcome assessments. This SLR will inform the development of an updated PsA Core Domain Set with patient research partner input.

International patient and physician consensus on a psoriatic arthritis core outcome set for clinical trials

“…10 A previous SLR reviewed the PsA outcomes used in the previous 5-year interval. 13 International focus groups Focus groups were conducted to identify domains important to patients with PsA.…”

“…8 9 Recent PsA RCTs assessed therapeutic efficacy not only by traditional outcomes centred on peripheral arthritis, but also additional measures of PsA manifestations (eg, systemic inflammation, enthesitis, dactylitis, structural damage, nail disease and the spine) and life impact (eg, fatigue, productivity). 10 These were considered important in the 2006 PsA core domain set but not essential to measure in all RCTs either due to insufficient data to support measurement or due to the absence of validated outcome measures. 5 11 The objective of the GRAPPA-OMERACT PsA working group was to develop consensus, at an international level, among patients and physicians on a core set of domains to be measured in PsA RCTs and LOS.…”

The Changing Face of Clinical Trials in Psoriatic Arthritis

“…First, recognition of the importance of individual disease manifestations of PsA (e.g., psoriasis, nail disease, enthesitis, dactylitis) and life impact (physical function, fatigue, participation, emotional wellbeing) has led to additional outcome measures included to measure these features in PsA RCTs. [33, 34] The newest trials are incorporating a proportion of patients who have previously used or failed a TNF inhibitor by either stratifying randomization for optimal stratified analysis, or in the case of tofacitinib, devoting a full trial to these patients. [14] These patient have blunted responses compared to biologic naïve patients and thus are a “risk” in some sense for trials.…”

GRAPPA-OMERACT initiative to standardise outcomes in psoriatic arthritis clinical trials and longitudinal observational studies

“…This PsA core domain set represented the minimum set of outcomes to be measured in randomised controlled trials (RCTs) and longitudinal observational studies (LOS). A systematic literature review demonstrated increased measurement of the complete PsA core domain set from 23.5% of RCTs in 2006–2010 to 59% of RCTs in 2010–2015 3. The PsA core domain set was updated, with enhanced patient representation, in 2016 following an extensive programme of work 4.…”