Residual Disease Activity in Canadian Patients With Psoriatic Arthritis Treated With Advanced Therapies: Results From a Multiregistry Analysis (UNISON-PsA).

OBJECTIVE: Although patient outcomes in psoriatic arthritis (PsA) have improved with the advent of advanced therapies, there remains a high unmet need to treat residual disease activity. The objective of the current study was to quantify residual disease activity and burden of disease in Canadian patients with PsA. METHODS: This was a multiregion, observational, retrospective analysis of patient data extracted from the Rhumadata and the International Psoriasis and Arthritis Research Team (IPART) registries, analyzing deidentified data from patients who had initiated advanced therapy for the treatment of PsA between January 2010 and December 2019. The primary endpoint was the proportion of patients failing to achieve minimal disease activity (MDA) within 6 months; secondary endpoints included clinical and patient-reported burden of disease. Descriptive statistics included summaries by region, treatment class, and number of prior advanced therapies. RESULTS: One thousand five hundred ninety-six patients were included. The proportions of patients who failed to achieve MDA within 6 months of an advanced therapy were 64.8% in Ontario, 68.3% in Western Canada, 74.8% in Quebec, and 75% in the Atlantic/East region. Failure to achieve MDA was higher among patients receiving an IL-17i compared with a TNFi in all regions except the Atlantic/East. Between 73.2% and 78.6% of patients reported pain at 6 months, and continuing functional impairment varied from 24% in the West to 83.3% in the Atlantic/East. CONCLUSION: There is substantial burden and unmet need for improved therapies for Canadians with PsA. There is a wide regional variation in outcomes that requires further assessment.

Assessment of the Toronto Psoriatic Arthritis Screen 2 as a Screening Tool for Psoriasis.

BACKGROUND: Psoriasis is a chronic inflammatory disease affecting multiple organ systems and resulting in reduced quality of life for many patients. A screening tool would be useful, particularly in underserviced or research settings with limited access to dermatologists. The Toronto Psoriatic Arthritis Screen, version 2 (ToPAS 2) is a validated screening tool for psoriatic arthritis containing questions specific for psoriasis. OBJECTIVES: To evaluate the performance of skin-specific questions from ToPAS 2 for the diagnosis of psoriasis. METHODS: Participants aged >18 were recruited from Dermatology and Family Medicine clinics and completed the ToPAS 2 questionnaire prior to being examined by a dermatologist for psoriasis. Two scoring indexes were derived from the ToPAS 2 skin-related questions using backward selection regression models. Statistical analysis was performed using receiver operating characteristic (ROC) curves to measure their performances. RESULTS: Two hundred and fifty eight participants were recruited. 32 (12%) were diagnosed with psoriasis by dermatologist assessment. Index 1 includes all 5 skin-related questions from ToPAS 2, while Index 2 includes three of the five questions. Both indexes demonstrate high specificity (82% to 92%), sensitivity (69% to 84%), and excellent negative predictive value (NPV) (>95%) for a diagnosis of psoriasis. The overall discriminatory power of these models is 0.823 (Index 1) and 0.875 (Index 2). CONCLUSIONS: Skin-related questions from ToPAS 2 have discriminatory value in detecting psoriasis, specifically questions relating to a family history, a prior physician diagnosis of psoriasis or a rash consistent with images of plaque psoriasis. This study is a valuable step in developing a screening tool for psoriasis.

Axial Involvement in Psoriatic Arthritis cohort (AXIS): the protocol of a joint project of the Assessment of SpondyloArthritis international Society (ASAS) and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

BACKGROUND: Involvement of the axial skeleton (sacroiliac joints and spine) is a relatively frequent manifestation associated with psoriatic skin disease, mostly along with involvement of peripheral musculoskeletal structures (peripheral arthritis, enthesitis, dactylitis), which are referred to as psoriatic arthritis (PsA). Data suggest that up to 30% of patients with psoriasis have PsA. Depending on the definition used, the prevalence of axial involvement varies from 25% to 70% of patients with PsA. However, there are currently no widely accepted criteria for axial involvement in PsA.Objective: The overarching aim of the Axial Involvement in Psoriatic Arthritis (AXIS) study is to systematically evaluate clinical and imaging manifestations indicative of axial involvement in patients with PsA and to develop classification criteria and a unified nomenclature for axial involvement in PsA that would allow defining a homogeneous subgroup of patients for research. DESIGN: Prospective, multicenter, multinational, cross-sectional study. METHODS AND ANALYSES: In this multicenter, multinational, cross-sectional study, eligible patients [adult patients diagnosed with PsA and fulfilling Classification Criteria for Psoriatic Arthritis (CASPAR) with musculoskeletal symptom duration of ⩽10 years not treated with biological or targeted synthetic disease-modifying anti-rheumatic drugs] will be recruited prospectively. They will undergo study-related clinical and imaging examinations. Imaging will include radiography and magnetic resonance imaging examinations of sacroiliac joints and spine. Local investigators will evaluate for the presence of axial involvement based on clinical and imaging information which will represent the primary outcome of the study. In addition, imaging will undergo evaluation by central review. Finally, the central clinical committee will determine the presence of axial involvement based on all available information. ETHICS: The study will be performed according to the ethical principles of the Declaration of Helsinki and International Council for Harmonisation Good Clinical Practice guidelines. The study protocol will be approved by the individual Independent Ethics Committee / Institutional Review Board of participating centers. Written informed consent will be obtained from all included patients.Registration: ClinicalTrials.gov ID: NCT04434885.

The relationship between patient acceptable symptom state and disease activity in patients with psoriatic arthritis.

OBJECTIVES: The Psoriatic Arthritis Disease Activity Score (PASDAS) and Disease Activity Index for Psoriatic Arthritis (DAPSA) are composite PsA disease activity measures. We sought to identify the PASDAS and DAPSA cut-off points consistent with patient acceptable symptom state (PASS), the threshold of symptoms beyond which patients consider themselves well, and examine PASS across published PASDAS and DAPSA thresholds for low, moderate and high disease activity. METHODS: We used a standard protocol including physician assessment and patient-reported outcomes to prospectively record measures required to calculate PASDAS and DAPSA. We identified PASS thresholds for the PASDAS and DAPSA using receiver operating characteristics curve analyses. We assessed the frequency of reporting acceptable symptom state across disease activity thresholds for PASDAS and DAPSA scores. RESULTS: A total of 229 patients (58.5% male, mean age 55.5 years, mean disease duration 17.1 years) were recruited. The PASS threshold for the PASDAS was 3.79 [area under the curve (AUC) 0.86, sensitivity 0.75, specificity 0.82] and for the DAPSA was 11.10 (AUC 0.91, sensitivity 0.89, specificity 0.82). With the PASDAS, 90% of patients defined as having low disease activity considered their symptom state acceptable, compared with 55% and 17% among those with moderate and high disease activity, respectively. With the DAPSA, 98% of patients in disease remission considered their symptom state acceptable compared with 85, 22 and 18% among those with low, moderate and high disease activity, respectively. CONCLUSION: We have defined PASS thresholds for PASDAS and DAPSA. The PASDAS target for low disease activity and DAPSA targets of low disease activity or remission align well with PASS.

A novel role for the psoriatic arthritis impact of disease (PsAID) questionnaire.

BACKGROUND: The Minimal Disease Activity (MDA) uses the Health Assessment Questionnaire (HAQ) as one criterion. HAQ does not correlate well with disease activity with increased PsA disease duration, and its use in the MDA has been questioned. The Psoriatic Arthritis Impact of Disease (PsAID) was specifically developed for PsA Patients. We aimed to validate the PsAID within our patient cohort and determine if the PsAID can replace the HAQ in the MDA. METHODS: Patients were recruited from the PsA clinic and assessed according to a standard protocol including demographics, clinical features and laboratory tests. Descriptive statistics were calculated. PsAID cut-offs for use in the MDA were generated based on the Clinical Disease Activity for Psoriatic Arthritis (cDAPSA). RESULTS: 115 patients completed the PsAID. There were 70 males, 45 females, with a mean PsA duration of 18.7 (±11.6) years. Mean scores of PsAID-9 and PsAID-12 were 3.4 (±2.4) and 3.2 (±2.3), respectively. The PsAID correlated moderately well with 9 of the PROMs administered in the clinic (ρ = 0.51-0.78). Four PsAID cutoffs based on cDAPSA were generated for use in the MDA: remission (REM) PsAID-9, REM PsAID-12, low disease activity (LDA) PsAID-9, and LDA PsAID-12. All four versions of the PsAID MDAs had sensitivity greater than 85% with the HAQ-MDA, and three versions of the PsAID-MDA had specificity greater than 85% with the HAQ-MDA. CONCLUSIONS: The high sensitivity and specificity of the PsAID-MDA with the HAQ-MDA suggest that the PsAID is an effective replacement for the HAQ in the MDA.

Genetic signature to provide robust risk assessment of psoriatic arthritis development in psoriasis patients.

Psoriatic arthritis (PsA) is a complex chronic musculoskeletal condition that occurs in ~30% of psoriasis patients. Currently, no systematic strategy is available that utilizes the differences in genetic architecture between PsA and cutaneous-only psoriasis (PsC) to assess PsA risk before symptoms appear. Here, we introduce a computational pipeline for predicting PsA among psoriasis patients using data from six cohorts with >7000 genotyped PsA and PsC patients. We identify 9 new loci for psoriasis or its subtypes and achieve 0.82 area under the receiver operator curve in distinguishing PsA vs. PsC when using 200 genetic markers. Among the top 5% of our PsA prediction we achieve >90% precision with 100% specificity and 16% recall for predicting PsA among psoriatic patients, using conditional inference forest or shrinkage discriminant analysis. Combining statistical and machine-learning techniques, we show that the underlying genetic differences between psoriasis subtypes can be used for individualized subtype risk assessment.

Factors explaining the discrepancy between physician and patient global assessment of joint and skin disease activity in psoriatic arthritis patients.

OBJECTIVE: To assess the extent and determinants of discordance in scoring between patient global assessment (PtGA) and physician global assessment (PhGA) in patients with psoriatic arthritis (PsA). METHODS: A cross-sectional and longitudinal analysis of data was conducted in patients attending a large PsA clinic. The difference between PtGA and PhGA (each measured on a scale of 0-10, with 0 indicating best status and 10 indicating worst status) reflected the discrepancy between the PtGA and PhGA of joint and skin activity and could take values from -10 (higher rating of disease activity by the patient) to 10 (higher rating of disease activity by the physician). Multivariate regression identified variables that contributed significantly to each of the outcomes. The proportion of variability of each outcome explained by each predictor was expressed by the partial R(2) . RESULTS: A total of 565 patients were included in the analysis. Patients tended to score their disease worse than their physicians, with greater discordance for the joints than for the skin (mean ± SD 1.68 ± 2.41 PtGA-PhGA difference for joints, and 0.77 ± 2.66 for skin). Fatigue accounted for 21% of the variation in the difference between PtGA and PhGA for joints. Pain (Rpartial2 = 9%) and disability by Short Form 36 health survey (Rpartial2 = 1.2%) were also important factors, each of which led to higher patient rating; whereas increased tender joint count (Rpartial2 = 16%) and swollen joint count (Rpartial2 = 1.4%) resulted in a higher physician rating of arthritis. CONCLUSION: Fatigue, pain, disability, and tender and swollen joint counts were the most important factors contributing to discrepancy between patient and physician assessment of joint activity.

Plasma adipokine levels and their association with overall burden of painful joints among individuals with hip and knee osteoarthritis.

OBJECTIVE: To investigate the association between plasma adipokine levels and the burden of painful joints among individuals with hip and knee osteoarthritis (OA). METHODS: Adipokines (leptin, adiponectin, adipsin, resistin) were determined by ELISA (n = 78). Individuals reported painful joints on a homunculus. Associations were examined by sex-stratified Poisson analyses. RESULTS: Adjusted for age, body mass index, and hip/knee OA, higher leptin and adiponectin and lower adipsin levels were associated with greater painful joint burden (i.e., counts) among women (p < 0.01). Among men, higher resistin levels were associated with lower counts (p = 0.03). CONCLUSION: Findings support the likelihood of a systemic-dependent sex-specific pain burden among individuals with OA.

Psoriatic arthritis in Canadian clinical practice: the PsA assessment in rheumatology.

OBJECTIVE: We aimed to determine disease severity and treatment of patients with psoriatic arthritis (PsA) in rheumatology practices in Canada through the PsA Assessment in Rheumatology (PAIR) study. METHODS: Rheumatologists who were members of the Canadian Rheumatology Association were asked to complete a form for each patient addressing demographic questions, history, clinical examination, and patient-reported outcomes. Results were compared with a cohort seen in a PsA clinic during the same period. RESULTS: From across Canada, 22 rheumatologists from 5 provinces submitted information about 233 consecutive patients with PsA [145 men (62.2%), 88 women (37.8%), mean age 53.2 yrs (±12.7), 88.4% disease duration>2 yrs]. A majority (80.7%) fulfilled ClASsification for Psoriatic ARthritis (CASPAR) criteria, and 30% had taken no disease-modifying antirheumatic drugs. Clinical joint damage was documented in 60% of the patients, active skin disease in 70%, and nail lesions in 32%. Only 22% were rated as having moderate to high disease activity, while 52% were rated as low disease activity and 26% were deemed in remission. The decision was based on joint counts, patient global assessment, physician global assessment, and acute-phase reactants. Twenty-seven percent of the patients were to have their medications changed based on the current visit, the majority for inadequate response to medications. Patients in the PAIR cohort had more inflamed joints but similar damage to those in the PsA clinic. CONCLUSION: Patients with PsA seen in regular rheumatology practice fulfill CASPAR criteria, have active disease, and more than half have joint damage. The majority have low activity or are in remission.

International multicenter psoriasis and psoriatic arthritis reliability trial for the assessment of skin, joints, nails, and dactylitis.

OBJECTIVE: Clinical trials in psoriasis and psoriatic arthritis (PsA) involve assessment of the skin and joints. This study aimed to determine whether assessment of the skin and joints in patients with PsA by rheumatologists and dermatologists is reproducible. METHODS: Ten rheumatologists and 9 dermatologists from 7 countries met for a combined physical examination exercise to assess 20 PsA patients (11 men, mean age 51 years, mean PsA duration 11 years). Each physician assessed 10 patients according to a modified Latin square design that enabled the assessment of patient, assessor, and order effect. Tender joint count (TJC), swollen joint count (SJC), dactylitis, physician's global assessment (PGA) of PsA disease activity (PGA-PsA), psoriasis body surface area (BSA), Psoriasis Area and Severity Index (PASI), Lattice System Physician's Global Assessment of psoriasis (LS-PGA), National Psoriasis Foundation Psoriasis Score (NPF-PS), modified Nail Psoriasis Severity Index (mNAPSI), number of fingernails with nail changes (NN), and PGA of psoriasis activity (PGA-Ps) were assessed. Variance components analyses were carried out to estimate the intraclass correlation coefficient (ICC), adjusted for the order of measurements. RESULTS: There is excellent agreement (ICC >/=0.80) on the mNAPSI, substantial agreement (0.6 >/= ICC < 0.80) on the TJC, PASI, and NN, moderate agreement (0.4 >/= ICC < 0.60) on the PGA-Ps, LS-PGA, NPF-PS, and BSA, and fair agreement (0.2 >/= ICC < 0.40) on the SJC, dactylitis, and PGA-PsA. The only measure that showed a significant difference between dermatologists and rheumatologists was dactylitis (P = 0.0005). CONCLUSION: There is substantial to excellent agreement on the TJC, PASI, NN, and mNAPSI among rheumatologists and dermatologists.

International spondyloarthritis interobserver reliability exercise--the INSPIRE study: II. Assessment of peripheral joints, enthesitis, and dactylitis.

OBJECTIVE: To determine whether the assessments of peripheral joints and enthesitis were reproducible for both AS and PsA with axial disease, and whether dactylitis assessment is reproducible in patients with PsA. METHODS: A group of 20 rheumatologists from 11 countries with expertise in spondyloarthritis (SpA) met for a combined physical examination exercise to assess 10 patients with PsA with axial involvement (9 men, 1 woman, mean age 52 yrs, disease duration 17 yrs) and 9 patients with AS (7 men, 2 women, mean age 38 yrs, disease duration 16 yrs). A modified Latin-square design that enabled assessment of patient, assessor, and order effect was used. Measures included were number of tender and swollen joints, presence of enthesitis using 6 different indices, and dactylitis score. Data were analyzed using intraclass correlation (ICC) adjusted for order of measurements. RESULTS: The majority of the variance was contributed by the patients. There was no order effect. The assessment of tender joints (ICC 0.69) was more reliable than the assessment of swollen joints (ICC 0.54). Moreover, there was better agreement in patients with PsA (ICC 0.78) than in patients with AS (ICC 0.62). There was excellent agreement on the number of active enthesitis sites (ICC 0.86). All the enthesitis indices provided substantial to excellent agreement among observers. Agreement for the dactylitis score was substantial (ICC 0.70). CONCLUSION: The assessment of peripheral joints is more reliable in patients with PsA. Enthesitis instruments can be used reliably in patients with AS and patients with PsA with spinal involvement. The Leeds dactylitis instrument functions well in PsA.

International spondyloarthritis interobserver reliability exercise--the INSPIRE study: I. Assessment of spinal measures.

OBJECTIVE: To determine whether the axial measures used in primary ankylosing spondylitis (AS) were reproducible for both AS and psoriatic arthritis (PsA) with axial disease. METHODS: A group of 20 rheumatologists from 11 countries with expertise in spondyloarthritis (SpA) met for a combined physical examination exercise to assess 10 patients with PsA with axial involvement (9 men, 1 woman, mean age 52 yrs, mean disease duration 17 yrs) and 9 AS patients (7 men, 2 women, mean age 38 yrs, mean disease duration 16 yrs). A modified Latin-square design was used. Measures included were occiput to wall, tragus to wall, cervical rotation, chest expansion, lateral spinal bending, modified Schober, and hip mobility. Data were analyzed using intraclass correlation coefficients (ICC) adjusted for order of measurements. RESULTS: The majority of the variance was contributed by the patients. There was no order effect. Observer effect was noted especially for chest expansion for both AS and PsA patients, and for the modified Schober in PsA. The ICC demonstrated very good to excellent agreement for most measures for both AS and PsA. Chest expansion provided only moderate agreement for AS and PsA. CONCLUSION: Overall, measures of spinal mobility used in primary AS perform well with respect to interobserver reliability, and are equally reproducible when applied to PsA patients with axial involvement. Thus, these measures should now be evaluated in therapeutic trials of patients with PsA to determine sensitivity to change and concordance with other measures of structural damage.

Functional assessment of chronic illness therapy-fatigue scale is valid in patients with psoriatic arthritis.

BACKGROUND: Fatigue is an important symptom in psoriatic arthritis (PsA). AIM: To determine the reliability and validity of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT fatigue) Scale in PsA. METHODS: Consecutive patients attending the PsA clinic were assessed with the FACIT fatigue Scale twice, 1 week apart. Patients were assessed clinically according to a standardised PsA clinic protocol. Internal consistency of the 13 items on the FACIT fatigue questionnaire was measured using Cronbach's alpha; test-retest reliability by the intraclass correlation coefficient (ICC), and validity by the correlation of the FACIT fatigue results with other fatigue measures and disease characteristics. RESULTS: 135 patients (80 men and 55 women, mean (SD) age 52 (13) years, mean (SD) disease duration 17 (10) years) participated. The mean FACIT fatigue score was 35.8 (12.4). Cronbach's alpha was 0.96. Repeat questionnaires were returned by 54% of patients. No difference in disease characteristics was observed between those who did and did not return the questionnaires. The ICC for first and repeat FACIT fatigue scores was 0.95. The correlation between the FACIT fatigue and modified Fatigue Severity Score was -0.79 (95% CI -0.85 to -0.72). FACIT fatigue scores were lower in patients with overwhelming fatigue and fibromyalgia than in those without (p<0.001). The FACIT fatigue was correlated with the actively inflamed joint count (-0.43, 95% CI -0.56 to -0.28, p<0.001), but not with the clinically damaged joint count (-0.06, 95% CI -0.23 to 0.11, p = 0.51). CONCLUSION: The FACIT fatigue results were reproducible, and correlated with other fatigue measures as well as with disease activity in patients with PsA. Therefore, the FACIT fatigue is a reliable and valid instrument to measure fatigue in PsA.