Outcome Measures In Psoriatic Arthritis Research Articles

Responsiveness and Minimum Clinically Important Difference in Patient-Reported Outcome Measures Among Patients With Psoriatic Arthritis: A Prospective Cohort Study.

To determine the responsiveness to therapy and minimum clinically important improvement (MCII) for patient-reported outcome measures in psoriatic arthritis (PsA) and to examine the impact of baseline disease activity on the ability to demonstrate change. A longitudinal cohort study was performed within the PsA Research Consortium. Patients completed several patient-reported outcomes, including the Routine Assessment of Patient Index Data, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the Psoriatic Arthritis Impact of Disease 12-item (PsAID12) questionnaire, and others. The mean change in the scores between visits and standardized response means (SRMs) were calculated. The MCII was calculated as the mean change in score among patients who reported minimal improvement. SRMs and MCIIs were compared among subgroups with moderate to highly active PsA and those with lower disease activity. Among 171 patients, 266 therapy courses were included. The mean ± SD age was 51 ± 13.8 years, 53% were female, and the mean swollen and tender joint counts were 3 and 6, respectively, at baseline. SRMs and MCII for all measures were small to moderate, although greater among those with higher baseline disease activity. BASDAI had the best SRM overall and for less active PsA, and the clinical Disease Activity of PsA (cDAPSA) and PsAID12 were best for those with higher disease activity. SRMs and MCII were relatively small in this real-world population, particularly among those with lower disease activity at baseline. BASDAI, cDAPSA, and PsAID12 had good sensitivity to change, but selection for use in trials should consider the baseline disease activity of patients to be enrolled.

Apremilast and its role in psoriatic arthritis

Psoriatic arthritis (PsA) is a seronegative inflammatory arthritis often observed in patients with skin psoriasis. Treatment of PsA, especially peripheral PsA, has typically relied on disease-modifying anti-rheumatic agents (DMARDs); however, these agents have limited efficacy and considerable associated toxicity. More recently, monoclonal antibodies (biologic agents) have revolutionized management of immune-mediated diseases; however, these therapies carry a high cost and require parenteral administration. Apremilast, a novel oral DMARD, was approved by the European Union for psoriatic arthritis in 2015. Apremilast inhibits the function of phosphodiesterase-4, a regulator of cyclic adenosine monophosphate, leading to a broad inhibition of proinflammatory mediators and subsequent reduction in tumour necrosis factor-alpha (TNF-α) response. The PALACE and ACTIVE trials, phase III randomized controlled trials for apremilast, showed that apremilast is effective at improving various clinical and patient-reported outcome measures for psoriatic arthritis in both DMARD-naïve and DMARD-experienced PsA patients. Efficacy was limited in patients with previous biologic DMARD failure and the overall efficacy of apremilast appears to be less than biologics agents, though no head-to-head trials exist comparing apremilast to biologic DMARDs. Apremilast is generally well tolerated, with short-lived gastrointestinal side effects being the most commonly reported adverse events. Guidelines suggest a trial of apremilast in patients who have failed traditional oral DMARDs and for whom, biologics are contraindicated. More studies directly comparing apremilast to conventional DMARDs and biologic DMARDs are needed and will be crucial in informing clinical and economic decisions about apremilast role in management of PsA.

Classification and Outcome Measures for Psoriatic Arthritis.

Psoriatic arthritis (PsA) is an inflammatory arthritis with multiple manifestations: peripheral/axial arthritis, enthesitis, dactylitis, psoriasis, and nail involvement. From having an agreed upon classification criteria in 2006, the assessment of PsA has advanced from uncertainties to development and validation of numerous specific outcome measures. The Group for Research and Assessment of Psoriasis and Psoriatic arthritis (GRAPPA) has spearheaded the development of a core domain set and is now working on a core outcome measurement set to standardize outcome measures for PsA, that will provide guidance for use of instruments in randomized controlled trials (RCTs) and longitudinal observational studies (LOS). This article summarizes and updates these work processes to improve assessment of this multisystem complex rheumatologic disease.

A systematic review of measurement properties of patient reported outcome measures in psoriatic arthritis: A GRAPPA-OMERACT initiative.

An updated psoriatic arthritis (PsA) core outcome set (COS) for randomized controlled trials (RCTs) was endorsed at the Outcome Measures in Rheumatology (OMERACT) meeting in 2016. To synthesize the evidence on measurement properties of patient reported outcome measures (PROMs) for PsA and thereby contribute to development of a PsA core outcome measurement set (COMS) as described by the OMERACT Filter 2.0. A systematic literature search was performed in EMBASE, MEDLINE and PsycINFO on Jan 1, 2017 to identify full-text articles with an aim of assessing the measurement properties of PROMs in PsA. Two independent reviewers rated the quality of studies using the COnsensus based standards for the Selection of health Measurement INstruments (COSMIN) checklist, and performed a qualitative evidence synthesis. Fifty-five studies were included in the systematic review. Forty-four instruments and a total of 89 scales were analyzed. PROMs measuring COS domains with at least fair quality evidence for good validity and reliability (and no evidence for poor properties) included the Stockerau Activity Score for PsA (German), Psoriasis Symptom Inventory, visual analogue scale for Patient Global, 36 Item Short Form Health Survey Physical Function subscale, Health Assessment Questionnaire Disability Index, Bath Ankylosing Spondylitis Functional Index, PsA Impact of Disease questionnaire, PsA Quality of Life questionnaire, VITACORA-19, Functional Assessment of Chronic Illness Therapy Fatigue scale and Social Role Participation Questionnaire. At least one PROM with some evidence for aspects of validity and reliability was available for six of the eight mandatory domains of the PsA COS.

A Multicenter Nominal Group Study to Rank Outcomes Important to Patients, and Their Representation in Existing Composite Outcome Measures for Psoriatic Arthritis.

To rank outcomes identified as important to patients with psoriatic arthritis (PsA) and examine their representation in existing composite measures. Seven nominal group technique (NGT) meetings took place at 4 hospital sites. Two sorting rounds were conducted to generate a shortlist of outcomes followed by a group discussion and final ranking. In the final ranking round, patients were given 15 points each and asked to rank their top 5 outcomes from the shortlist. The totals were summed across the 7 NGT groups and were presented as a percentage of the maximum possible priority score. Thirty-one patients took part: 16 men and 15 women; the mean age was 54 years (range 24-77; SD 12.2), the mean disease duration was 10.3 years (range 1-40; SD 9.2), and mean Health Assessment Questionnaire was 1.15 (range 0-2.63; SD 0.7). The highest-ranked outcomes that patients wished to see from treatment were pain with 93 points (20.0%), fatigue 62 (13.3%), physical fitness 33 (7.1%), halting/slowing damage 32 (6.9%), and quality of life/well-being 29 (6.2%). Reviewing existing composite measures for PsA demonstrated that no single measure adequately identifies all these outcomes. Pain and fatigue were ranked as the outcomes most important to patients receiving treatment for PsA and are not well represented within existing composite measures. Future work will focus on validating composite measures modified to identify outcomes important to patients.

Outcome Measures in Psoriatic Arthritis.

In the last decade, there have been significant advances in outcome measure research in psoriatic arthritis (PsA). In this article, the outcome measures for disease activity in individual key domains of PsA are reviewed, followed by the key patient-reported outcome measures of function, quality of life, fatigue, and a new measure for disease impact, the psoriatic arthritis impact of disease. New research into composite measures of psoriatic disease is summarized, including response measures and proposed cutoff points for disease activity. Finally, the key future issues in outcome measurement in PsA are addressed.

Patient Involvement in Outcome Measures for Psoriatic Arthritis

Psoriatic arthritis (PsA) is a heterogeneous inflammatory arthritis with a varied clinical phenotype. There has been considerable international collaboration over recent years to develop and prioritise appropriate disease domains and outcome measures to capture all aspects of this complex disease. It has been recognised that patient-reported measures and physician assessments are complementary and, when used together, allow an improved reflection of disease burden. Taking this concept one step further, the experience in rheumatoid arthritis has demonstrated benefits of incorporating the patient perspective in the development of outcome measures. We report a systematic review demonstrating (1) that there has been little incorporation of the patient perspective in the development of outcome measures and domains in PsA, (2) the proceedings from the preliminary patient involvement in outcome measures for PsA (PIOMPSA) meetings, and (3) a proposed roadmap for improving patient involvement.

Effect of adalimumab on joint disease: features of patients with psoriatic arthritis detected by magnetic resonance imaging

Background:Bone marrow oedema (BMO), synovitis, effusion and joint erosion on magnetic resonance imaging (MRI) may be used as outcome measures in psoriatic arthritis (PsA).Objective:To assess the impact of adalimumab on...

PsA Best Practices in 2006

Psoriatic arthritis (PsA) is a serious and progressive disease associated with significant morbidity and mortality. Defining outcome measures in PsA has been challenging because of the wide spectrum of clinical presentation, perceived low prevalence, and relapsing/remitting cycle. None of the current methods for defining outcome have been validated in PsA patients.

Outcome measures in psoriatic arthritis clinical trials

Outcome measures in psoriatic arthritis (PsA) have been primarily borrowed from the assessment of rheumatoid arthritis and ankylosing spondylitis, although several specific measures for PsA have been established. The advent of new therapeutic agents for the treatment of PsA has made the need for specific outcome measures for PsA more critical to evaluate the heterogeneous manifestations of this disease and features that are unique to its assessment. Several outcome measures have been validated for use in PsA clinical trials while others are being evaluated by groups such as The Group for Assessment of Psoriasis and Psoriatic Arthritis for future use in clinical trials.

Outcome measures in psoriatic arthritis.

Psoriatic arthritis (PsA) is an important condition that significantly impacts affected patients. The introduction of novel therapeutic agents for PsA has generated great interest in clinical trials as well as in clinical care. Therefore, there is a great need for standardized outcome measures that can accurately assess the activity of disease and response to therapy. Because it is a heterogeneous and multifaceted condition, defining outcome measures has been a challenge. To date, such measures have largely been adapted from other similar diseases. With further research, the most appropriate outcome measures specific for PsA will be delineated.

OMERACT 7 psoriatic arthritis workshop: synopsis

Outcome Measures in Rheumatology (OMERACT) conferences have developed a process by which outcome measures to be included in clinical trials are identified by consensus. During OMERACT 7, held in Asilomar,...

Preliminary identification of core domains for outcome studies in psoriatic arthritis using Delphi methods

Objective: To develop a consensus based set of core domains for outcome studies in psoriatic arthritis. Methods: A list of 26 potential domains was prepared through literature review and email...

Need for both clinical and outcome measures for psoriatic arthritis

Need for both clinical and outcome measures for psoriatic arthritis