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ObjectiveTo describe psoriatic arthritis (PsA) flares and their effect on patient-reported outcomes (PROs).MethodsCross-sectional surveys of rheumatologists/dermatologists and their patients with PsA were conducted in France, Germany, Italy, Spain, the United Kingdom, and the United States, capturing data on physician-reported patient flare status, demographics, PsA severity, and clinical outcomes. Patient-completed surveys captured data on PROs: 5-level EuroQol 5-dimension, Work Productivity and Activity Impairment questionnaire, Health Assessment Questionnaire–Disability Index, and 12-item Psoriatic Arthritis Impact of Disease questionnaire. Patients were compared by flare status using parametric and nonparametric tests. Multivariate regression was used to identify flare associations. Multivariate logistic regression adjusted for patient demographics and physician specialty assessed the effect of flare status.ResultsAmong 2238 patients (586 from the US, 1652 from Europe) managed by 572 physicians, physician-reported flare was present for 168 patients (7.5%), and self-reported flare was present for 95 patients (10% of available data). Mean (SD) flare count over 12 months was 2.2 (4.9), lasting on average 16.4 (16.2) days. Flare status was linked to worse PROs. Patients who had not flared in the last 12 months or had never flared had a higher quality of life, lower overall work impairment, and a lower degree of disability compared with patients who were currently experiencing a flare (all;P< 0.01).ConclusionActively experiencing a flare adversely affected QOL, disability, and work productivity. PsA flares should be routinely assessed and managed in clinical care.

Objective To assess the interchangeability of the Health Assessment Questionnaire-Disability Index (HAQ-DI) with the Patient-Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF) in the calculation of minimal disease activity (MDA) in psoriatic arthritis (PsA). Methods Comprehensive PsA disease activity was collected concomitantly with HAQ-DI and PROMIS-PF measures in a PsA cohort. PROMIS-based MDA definitions were built using the existing cross-walk between the scores: HAQ-DI≤0.5 equivalent to a PROMIS-PF Tscore≥41.3. We assessed agreement between MDA (MDA HAQ-DI) and PROMIS-PF MDA definitions (MDA PROMIS-PF4a, MDA PROMIS-PF Bank) at each visit and longitudinally (MDA state changes between consecutive visits) through the kappa statistic. The predictive value of MDA PROMIS-PF for MDA HAQ-DI was assessed using ROC curve analysis. Results One hundred participants contributed 352 observations with up to five visits. Mean (SD) age was 52 (12) years, 60% were female, and 43% were in MDA at baseline. Kappa statistic for PROMIS-PF based MDA reflected excellent agreement with HAQ-DI MDA: kappa=0.94 (95% CI 0.90-0.97) for MDA PROMIS-PF Bank, and kappa=0.90 (95% CI 0.80-0.95) for MDAPROMIS-PF4a. Higher longitudinal agreement was seen between MDA HAQ-DI and MDA PROMIS-PF Bank versus MDA PROMIS-PF4a between consecutive visits: kappa ranged between 0.81-0.94 versus 0.72-0.84, respectively. Area under ROC curve for predicting MDA HAQ-DI was 0.97 for MDA PROMIS-PF Bank and 0.95 for MDA PROMIS-PF4a. Conclusion Excellent agreement was seen between HAQ-DI and PROMIS-based MDA definitions statically and longitudinally. The PROMIS-PF Bank and PROMIS-PF4a are accurate replacements for the HAQ-DI in calculating MDA state in PsA.

Background Psoriatic arthritis (PsA) is a chronic, heterogeneous, immune-mediated disease manifesting as a spectrum of possible inflammatory signs and symptoms. Clinicians need therapeutic choices that work across all active PsA disease domains, as well as practical information about efficacy of available treatments for individual domains in specific groups of patients. The objective of this study was to evaluate the effect of prior tumor necrosis factor inhibitor (TNFi) exposure on the efficacy of secukinumab across PsA core domains. Methods Data were pooled from 2049 participants with PsA in four phase 3 studies (FUTURE 2–5). Efficacy at week 16 was evaluated for each GRAPPA-OMERACT PsA core domain using nonresponder imputation for musculoskeletal disease activity and Psoriasis Area and Severity Index scores or as-observed data for other outcomes. For each measure, comparisons with placebo were made separately in the TNFi-naive and TNFi-inadequate responder/intolerant (TNF-IR) cohorts. Results Treatment with secukinumab improved PsA disease activity across all disease domains regardless of previous TNFi use, although TNFi-naive patients experienced numerically greater benefits in most outcomes. Among patients treated with secukinumab 300 mg, 41.5% and 24.4% of TNFi-naive patients (P, Plain Language Summary Psoriatic arthritis (PsA) is a long-term disease that can affect a patient’s joints, skin, lower back, physical function, mental health, productivity, and other areas. Drugs called tumor necrosis factor inhibitors (TNFis) can be used to treat PsA, although not all patients benefit from TNFis and many seek other treatment options. These patients, known as TNFi-inadequate responders (TNF-IR), have PsA that is difficult to treat. Another treatment option is secukinumab, a drug that blocks a molecule called interleukin-17 that is involved in PsA. Doctors need to know how different drugs work for treating PsA signs and symptoms in different groups of patients, including TNF-IR patients and those who have never received TNFis (TNFi-naive patients). This study used data from 2049 patients in four different PsA clinical trials (FUTURE 2–5) to see how well secukinumab worked at treating different signs and symptoms of PsA in TNFi-naive and TNF-IR patients. After 16 weeks of treatment, patients who took secukinumab saw greater improvements across all measured PsA signs and symptoms than those who took placebo. This was true for both TNFi-naive and TNF-IR patients. TNFi-naive patients seemed to benefit slightly more than TNF-IR patients—especially in their joint symptoms—although this study was not designed to judge the significance of these differences. These results suggest that secukinumab would be an effective first treatment option for patients with PsA. Since secukinumab improves the skin, joints, and other affected areas, it can be useful in treating the whole patient who has psoriatic disease. Supplementary Information The online version contains supplementary material available at 10.1007/s40744-021-00337-5.

International audience; Objective: We evaluated the psychometric properties of 3 patient-reported outcome measures to assess the physical function in psoriatic arthritis (PsA).Methods: Data were available for the Health Assessment Questionnaire disability index (HAQ DI), the 12-item Short Form instrument physical component summary (SF-12 PCS), and the Psoriatic Arthritis Impact of Disease instrument functional capacity score (PsAID-FC). Data came from a longitudinal study in 14 countries of consecutive adults with definite PsA with ≥2 years of duration. The score distribution, construct validity, responsiveness, and thresholds of meaning of the patient-reported outcome measures were evaluated.Results: At baseline, 414 subjects (52% male) were analyzed. The mean ± SD age was 52.4 ± 12.5 years and duration of illness was 10.9 ± 8.1 years. Ceiling effects were noted in 31% and 21% of patients for HAQ DI and PsAID-FC, respectively; floor effects were minimal. All 3 patient-reported outcome measures met a priori hypotheses for construct validity. After a median follow-up of 4.1 (interquartile range 2.7) months in 350 patients, 27%, 54%, and 18% of patients reported themselves improved, not changed, and worsened, respectively. Change scores were statistically different for groups for worsening versus no-change for all patient-reported outcome measures. PsAID-FC was more sensitive to change than the other 2 patient-reported outcome measures. Comparing groups with worsening condition to no-change, the standardized response mean square ratios were HAQ DI 29.9, SF-12 PCS 16.7, and PsAID-FC 40.1.Conclusion: HAQ DI, SF-12 PCS, and PsAID-FC are valid measures of physical function for PsA. PsAID-FC, a single question, performed similarly to the other patient-reported outcome measures and may be an additional option to measure PsA-specific physical function.

Objectives To explore patient-defined flares in psoriatic arthritis (PsA), compared to an increase in disease activity in psoriatic arthritis (DAPSA) and to analyze the validity of a patient-reported flare question. Methods ReFlap (NCT03119805) was a longitudinal study in 14 countries of consecutive patients with definite PsA. Patients were seen twice in the context of usual care, 4.5 ± 2.2 months apart. Flares were reported by patients and physicians at the second visit using a single question. DAPSA worsening was defined as a change to a higher DAPSA category. Agreement between the definitions of worsening was calculated by prevalence adjusted bias adjusted kappa (PABAK). Validity of patient-reported flare was assessed by comparing patients with versus without flare and transition to flares. Results In 222 patients, mean disease duration 10.8 ± 8.3 years, 127 (58.8%) males: disease activity was low (mean DAPSA 11.5 ± 14.0); 63.3% received a bDMARD. Patient-reported flares between the 2 visits were seen in 27% patients (for these patients, mean 2.2 ± 3.7 flares per patient, mean duration 12.6 ± 21.0 days per flare). Physician- reported flares were seen in 17.6% and worsening in DAPSA in 40.1% of patients. Agreement between definitions was moderate (PABAK = 0.32-0.59). Patients in flare had significantly more active disease than patients not in flare for all outcomes (all P < 0.001). At the patient-level, transition to flare state was associated to a worsening in disease activity and impact outcomes. Conclusions Patient flares were frequent and were associated with active and symptomatic disease. These findings provide preliminary validation for patient-reported flares in PsA.

Introduction Patient-reported outcome measures (PROMs) are used to capture patient perspectives in disease assessment. The objective of this study was to capture feedback about commonly used PROMs for spondyloarthritis (SpA) through semi-structured group discussions with individuals diagnosed with psoriatic arthritis (PsA) or ankylosing spondylitis (AS). The goal was to identify PROM content that most resonated with patient experiences and is therefore suitable for implementation in SpA clinical practice. Methods Semi-structured tasks and probes were designed to elicit qualitative patient feedback on several general health and disease-specific PROMs. During a series of in-person and telephone meetings, participants with PsA or AS were asked to identify content that resonated with them and to identify items that may not have captured their personal experiences living with their disease. Both individualized and small group review and concept elicitation were captured after participant review of PROMs. Results Both PsA and AS participants identified concepts that reflected their experiences living with a chronic disease, including fatigue, isolation, depression, inter-personal relationships, and sexual intimacy. Constructs incorporated into existing PROMs, such as pain, physical function, ability to perform activities of daily living, and stiffness, were also identified as important to participants. There were a few qualitative differences in participant perceptions about what they would like to see addressed by PROMs. For example, AS participants said that they would like to see PROMs elicit feedback about their experiences with pelvic and chest pain (e.g., as a result of chest inflammation/tenderness and chest expansion). PsA participants felt that PROMs should include measures about the embarrassment and shame that they experience as well as the impact of PsA on their daily lives. Conclusion Results of these qualitative assessments suggest that PROMs should be incorporated more frequently in outpatient settings to help improve the quality of decision-making conversations between patients and their healthcare providers. Participants indicated that constructs such as isolation, depression, fatigue, and relationships with others were critical to inform healthcare professionals about the patient experience of living with their disease.

Objectives Using patient-reported outcomes to inform clinical decision-making depends on knowing how to interpret scores. Patient-Reported Outcome Measurement Information System® (PROMIS®) instruments are increasingly used in rheumatology research and care, but there is little information available to guide interpretation of scores. We sought to identify thresholds and meaningful change for PROMIS Pain Interference and Fatigue scores from the perspective of RA patients and clinicians. Methods We developed patient vignettes using the PROMIS item banks representing a continuum of Pain Interference and Fatigue levels. During a series of face-to-face ‘bookmarking’ sessions, patients and clinicians identified thresholds for mild, moderate and severe levels of symptoms and identified change deemed meaningful for making treatment decisions. Results In general, patients selected higher cut points to demarcate thresholds than clinicians. Patients and clinicians generally identified changes of 5–10 points as representing meaningful change. The thresholds and meaningful change scores of patients were grounded in their lived experiences having RA, approach to self-management, and the impacts on function, roles and social participation. Conclusion Results offer new information about how both patients and clinicians view RA symptoms and functional impacts. Results suggest that patients and providers may use different strategies to define and interpret RA symptoms, and select different thresholds when describing symptoms as mild, moderate or severe. The magnitude of symptom change selected by patients and clinicians as being clinically meaningful in interpreting treatment efficacy and loss of response may be greater than levels determined by external anchor and statistical methods.

ObjectiveTo evaluate secukinumab (SEC) 300 mg and 150 mg vs placebo in a United States–only population of biologic-naïve patients with psoriatic arthritis (PsA).MethodsCHOICE was a double-blind, randomized controlled trial conducted in the US. Biologic-naïve patients with PsA and psoriasis (PsO) were randomized 2:2:1 to SEC 300 mg (n = 103), SEC 150 mg (n = 103), or placebo (n = 52). The primary objective was to show superiority of SEC 300 mg vs placebo in American College of Rheumatology 20% (ACR20) response at week 16. Additional objectives included the effect of SEC on dactylitis, enthesitis, PsO, and safety.ResultsACR20 response rates at week 16 were higher with SEC 300 mg than with placebo (51.5% vs 23.1%; odds ratio 3.51 [95% CI 1.65-7.45]; P = 0.001). SEC 300 mg also led to greater ACR50/70 responses and improvements in other variables vs placebo. Responses were generally sustained over time. Patients with inadequate response to SEC 150 mg at weeks 16, 28, or 40 who received dose escalation to 300 mg experienced improved clinical response after uptitration. The most common adverse events were upper respiratory tract infections and diarrhea. No inflammatory bowel disease was reported or new safety signals observed.ConclusionSEC 300 mg led to rapid and significant improvements over placebo in symptoms of PsA in this heavier population of US-only, biologic-naïve patients. Findings were consistent with previous studies and suggest that SEC 300 mg is a safe and efficacious first-line biologic treatment for patients with PsA. [ClinicalTrials.gov: NCT02798211]

Introduction Enthesitis is a core outcome domain assessed in psoriatic arthritis (PsA) clinical trials. Limited evidence describes the impact of enthesitis on patient-reported outcomes (PROs) and physician satisfaction with current treatment options. The objective of this analysis is to characterize the impact of enthesitis on PROs and physician satisfaction with currently available treatment in clinical practice settings. Methods Cross-sectional survey of rheumatologists, dermatologists, and their consulting patients with PsA in Australia, Canada, European Union (EU5), and the USA conducted in 2018. Physicians assessed current presence and severity of enthesitis, overall disease severity, other symptoms experienced, and their satisfaction with the current treatment. PsA participant self-reported data included current pain level, EQ5D, Psoriatic Arthritis Impact of Disease (PsAID12), Health Assessment Questionnaire Disability Index (HAQ-DI), and Work Productivity and Activity Impairment Index (WPAI-SHP). Bivariate descriptive analyses were conducted to describe features and outcomes in participants with and without enthesitis. Results Rheumatologists (454) and dermatologists (238) provided information for 3157 participants with PsA. Mean participant age was 49.2 years, and 45.9% were female. Enthesitis was present currently in 6.5% (205) of participants with PsA. Those with enthesitis had worse overall disease severity compared to those without enthesitis (12.2% vs 2.2% severe) and had more extraarticular manifestations, including nail psoriasis, dactylitis, and sacroiliitis. Enthesitis was associated with more pain, worse quality of life (QoL), increased disability, and a negative impact on work. Participants with enthesitis had higher NSAIDs and opioid pain medication use but similar biologic use. Physicians were significantly less satisfied with current PsA treatment in participants with enthesitis versus without enthesitis. Conclusions Participants with psoriatic arthritis with enthesitis experienced significantly higher disease burden than those without enthesitis but were not more likely to receive advanced therapies. Physicians were significantly more dissatisfied with treatment in patients with enthesitis than in those without it. Electronic Supplementary Material The online version of this article (10.1007/s40744-020-00242-3) contains supplementary material, which is available to authorized users.

OBJECTIVE Sleep quality is diminished in patients with psoriatic arthritis (PsA) and close to 40% of PsA patients consider sleep difficulties a priority domain. This work analyzes determinants of impaired sleep in patients with PsA. METHODS This was a cross-sectional analysis of an observational study (ReFlap, NCT NCT03119805), which included adult patients with definite PsA with≥2 years disease duration from 14 countries. Sleep was assessed using the patient self-reported evaluation of sleep on a 0-10 numerical scale, included in the Psoriatic Arthritis Impact of Disease questionnaire (PSAID-12). A score≥4 was considered as sleep impairment. Demographic and clinical variables associated to sleep impairment were assessed through univariate analysis and Poisson regression modeling leading to prevalence ratio (PR) [95% confidence interval]. RESULTS A total of 396 patients were analyzed: mean age 51.9±12.6 years, 51% were females, 59.7% were receiving biologic therapy, 53.3% had 1-5% of body surface area affected by psoriasis; 23.7% were in remission and 36.9% in low disease activity according to the Disease Activity in Psoriatic Arthritis (DAPSA) score. Median (25th-75th) patient's self-evaluation of sleep difficulties was 2 (0-6), 157 (39.6%) had sleep impairment. In the Poisson regression model, self-reported levels of anxiety (PR: 1.05 [1.02-1.08], P=0.003) and pain (PR: 1.06 [1.04-1.09], P

Background: There is evidence that patients and physicians are frequently misaligned in their perspectives on psoriatic arthritis (PsA) treatment priorities, which may be associated with increased disease activity, greater disability, and poorer health-related quality of life of PsA patients. Objective: To identify factors associated with patient–physician misalignment in satisfaction with PsA disease control. Methods: In a cross-sectional survey of physicians and their patients with PsA from the United States and Europe, satisfaction with disease control was examined and classified as satisfied, neutral, or dissatisfied. Bivariate and multivariate regression analyses explored alignment in satisfaction between physicians and patients. Results: There were 656 PsA patient–physician pairs included in the analysis. Misalignment occurred in 20.6% of cases. Greater disease impact, worse physician-reported disease severity, and lower patient-reported involvement in treatment decisions were associated with misalignment. Conclusion: Greater patient–physician engagement may improve satisfaction, alignment, and outcomes in PsA disease control.

Objective. Improving the assessment of psoriatic arthritis (PsA) is a key purpose of the Group for Research and Assessment of Psoriasis and PsA (GRAPPA). Herein, we report the proceedings of the GRAPPA composites workshop at the 2019 GRAPPA annual meeting and the membership’s recommended next steps. Methods. A review of continuous composite measures was conducted in an introductory workshop, followed by 10 breakout group sessions and a final plenary session for feedback and voting. Results. Participants included 154 members: 87 rheumatologists, 18 dermatologists, 2 rheumatologist/dermatologists, 12 patient research partners, 14 academics, 1 methodologist, and 20 industry members. Of voting members, 88.8% agreed a need exists for a continuous composite measure for routine practice, but only 62% were currently using a composite measure. Of these, 27% were using the 28-joint count Disease Activity Score (DAS), which is not a PsA-specific measure; 20% were using a PsA-specific measure such as PsA DAS (PASDAS), Composite Psoriatic Disease Activity Index (CPDAI), or Disease Activity Index for PsA (DAPSA). Members agreed that the existing measures were not feasible in their current forms (CPDAI 83%, PASDAS 82%, and DAPSA 47%) and that modification should be tested. The majority (76%) agreed that disease effect should be measured separately from disease activity. Conclusion. The GRAPPA membership supports the need for a continuous composite measure of disease activity for use in routine clinical care, the separate measurement of disease effect and activity, and the testing of modifications to candidate instruments rather than the development of new measures.

The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)–Outcome Measures in Rheumatology (OMERACT) Psoriatic Arthritis (PsA) Core Set working group is focused on the development of a core set of instruments used to assess the domains described in the 2016 PsA Core Domain Set. At the 2021 annual meeting, the group presented an update on the domain of structural damage. In this report, we discuss the steps taken to assess the domain match and feasibility of plain radiographic instruments in the assessment of structural damage in PsA.

Objectives Physical function is one of the core domains to be measured in all trials in psoriatic arthritis (PsA). We aimed to evaluate two instruments for physical function in PsA: The Health Assessment Questionnaire-disability index (HAQ-DI) and the physical functioning subscale of the Medical Outcome Survey Short-Form 36 items (SF-36 PF). Methods We followed guidelines set out by the OMERACT Filter 2.1. A working group was formed to evaluate each instrument for domain match and feasibility to reach consensus. Two systematic literature reviews (SLRs) were conducted to identify the relevant articles supporting measurement properties of both instruments. Five additional measurement properties were appraised: construct validity, test-retest reliability, longitudinal construct validity, clinical trial discrimination, and threshold of meaning. New evidence was synthesized to fill the gap. Data were presented to the OMERACT technical advisory group (TAG) and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) community for endorsement. Results The results for seven measurement properties for HAQ-DI and SF-36 PF were presented in Summary of Measurement Property (SOMP) tables. The working group proposed “Provisional Endorsement” for both instruments. The body of evidence was approved by the OMERACT TAG. In two Delphi exercises among GRAPPA members, HAQ-DI received 93.9% and 97.5% endorsement votes, while that for SF-36 PF were 86.7% and 77.3%. Conclusion Both HAQ-DI and SF-36 PF were provisionally endorsed for the measurement of physical function in PsA trials, using the OMERACT Filter 2.1.

Objective.Due to no existing data, we aimed to derive evidence to support test-retest reliability for the Health Assessment Questionnaire–Disability Index (HAQ-DI) and 36-item Short Form Health Survey physical functioning domain (SF-36 PF) in psoriatic arthritis (PsA).Methods.We identified datasets that collected relevant data for test-retest reliability for HAQ-DI and SF-36 PF, and evaluated them using Outcome Measures in Rheumatology (OMERACT) Filter 2.1 methodology. We calculated intraclass correlation coefficients (ICC) as a measure of test-retest reliability. We then conducted a quality assessment and evaluated the adequacy of test-retest reliability performance.Results.Two datasets were identified for HAQ-DI and 1 for SF-36 PF in PsA. The quality of the datasets was good. The ICCs for HAQ-DI were good and excellent in study 1 (0.90, 95% CI 0.79–0.95) and study 2 (0.94, 95% CI 0.89–0.97). The ICC for SF-36 PF was excellent (0.96, 95% CI 0.92–0.98). The performance of test-retest reliability for both instruments was judged to be adequate.Conclusion.The new data derived support good and reasonable test-retest reliability for HAQ-DI and SF-36 PF in PsA.

Objective Ixekizumab is a monoclonal antibody targeting IL-17A and licensed for psoriasis, psoriatic arthritis (PsA) and axial spondyloarthritis. Review objectives were to summarize: 1) ixekizumab safety in people with PsA, 2) ixekizumab efficacy from Phase III randomized controlled trials, and 3) ixekizumab study participant PsA phenotypes. Methods We conducted a search in PubMed limited to phase III randomized controlled trials (RCT) and corresponding long-term extension studies where the intervention was treatment with ixekizumab in a population with PsA. Results We identified 17 publications and 13 met inclusion criteria. Injection site reactions (ISR) and allergic reactions occurred in up to 25.3% and 6.2% with ixekizumab and 4.5% and 1.85, respectively, with placebo. ISR occurred in 9.5–10.6% at 24 and 52 weeks with ixekizumab versus 3.2–3.5% with adalimumab (p < 0.01) in biologic-naïve PsA. Serious adverse events at 24 weeks occurred in 8.5% with adalimumab versus 3.5% with ixekizumab (p = 0.02), and at 52 weeks in 12.45 with adalimumab and 4.25 with ixekizumab (p < 0.01). Ixekizumab had similar efficacy to adalimumab across all PsA musculoskeletal, symptom and patient-reported outcome domains and surpassed adalimumab in psoriasis outcomes as well as all combined musculoskeletal and psoriasis outcomes. The study subject population was overwhelmingly white, balanced men-women, BMI at the obese threshold, had on average 7-year PsA duration and 15-year psoriasis duration. Disease activity was high with 7/66 swollen joints, 13/68 tender joints, 55% enthesitis, variable dactylitis (12–51%), and active psoriasis in >92%. Conclusion Ixekizumab treatment in PsA was associated with a statistically significant higher risk of injection site reactions versus placebo or adalimumab. Ixekizumab had statistically significantly fewer serious adverse events than adalimumab. Ixekizumab demonstrated efficacy for all PsA disease activity domains as well as for slowing radiographic disease progression. The main shortcoming of the ixekizumab PsA program is lack of representation of African American study participants.

Psoriatic arthritis (PsA) has many disease manifestations leading to diverse patient phenotypes. Treatment responses in the same individual may diverge for concomitantly active PsA components. For this reason, evaluation of disease activity and treatment effectiveness for PsA should ideally include assessment of the complete spectrum of manifestations: psoriasis of skin and nails, arthritis, enthesitis, dactylitis, axial spondyloarthritis (SpA), systemic inflammation, and effect on life. Signs of active disease could then be systematically addressed for each individual. Comprehensive PsA assessment is often challenging in clinical practice because of limitations on time and resources for rheumatology clinic visits. However, clinicians are uniformly confronted with effectiveness questions when treating PsA: Is the treatment working? Is it time to switch therapies? Which treatment should be next? Canete, et al , as described in this issue of The Journal 1, conducted a consensus exercise to define the effectiveness of biological disease-modifying antirheumatic drugs (bDMARD) and to support PsA treatment continuation decisions in clinical care. The study addresses a few scenarios relevant to clinicians such as disease severity or prior damage, peripheral and axial disease, and prior biologic experience. Criteria for bDMARD continuation are met in both peripheral and axial PsA if low disease activity (LDA) state and meaningful improvement [score improvement ≥ 3 in Psoriatic Arthritis Impact of Disease (PsAID)]2 have concomitantly been achieved (Table 1). The alternative continuation criteria, however, allow high or moderate disease activity in patients with severe PsA/damage/multiple biologic failures, as long as a major response to therapy and a patient acceptable symptom state in the PsAID (score ≤ 4) have concomitantly been achieved (Table 1). Because these effectiveness criteria define the lowest threshold for continuation of the treatment in the course in clinical care, they may shape PsA treatment and progression in the future. Comparing treatment strategies becomes … Address correspondence to Dr. A.M. Orbai, Johns Hopkins University School of Medicine, Division of Rheumatology, 5200 Eastern Ave., MFL Center Tower, Suite 4100, Baltimore, MD 21224, USA. Email: aorbai1{at}jhmi.edu.

Objective To evaluate the impact of integrating patient-reported outcomes (PROs) into routine clinics, from the perspective of patients with RA, clinicians and other staff. Methods We conducted a prospective cohort study using a mixed methods sequential explanatory design at an academic arthritis clinic. RA patients completed selected Patient-Reported Outcomes Measurement Information System measures on tablets in the waiting room. Results were immediately available to discuss during the visit. Post-visit surveys with patients and physicians evaluated topics discussed and their impact on decision making; patients rated confidence in treatment. Focus groups or interviews with patients, treating rheumatologists and clinic staff were conducted to understand perspectives and experiences. Results Some 196 patients and 20 rheumatologists completed post-visit surveys at 816 and 806 visits, respectively. Focus groups were conducted with 24 patients, 10 rheumatologists and 4 research/clinic staff. PROs influenced medical decision-making and RA treatment changes (38 and 18% of visits, respectively). Patients reported very high satisfaction and treatment confidence. Impact on clinical workflow was minimal after a period of initial adjustment. PROs were valued by patients and physicians, and provided new insight into how patients felt and functioned over time. Reviewing results together improved communication, and facilitated patient-centred care, shared decision making, and the identification of new symptoms and contributing psychosocial/behavioural factors. Conclusion PRO use at RA visits was feasible, increased understanding of how disease affects how patients feel and function, facilitated shared decision-making, and was associated with high patient satisfaction and treatment confidence.

Objective.To compare the efficacy of secukinumab with that of placebo across the updated Group for Research and Assessment of Psoriasis and Psoriatic Arthritis and Outcome Measures in Rheumatology (GRAPPA-OMERACT) individual psoriatic arthritis (PsA) core domains using pooled data from 4 phase III PsA studies and 1 phase III ankylosing spondylitis (AS) study.Methods.Data were pooled from 2049 patients with PsA participating in 4 on-label phase III PsA studies (FUTURE 2–5), and the efficacy of each GRAPPA-OMERACT PsA core domain (musculoskeletal disease activity, skin disease activity, pain, patient’s global assessment, physical function, health-related quality of life, fatigue, and systemic inflammation) was assessed using multiple measures and definitions specific to each domain. The MEASURE 2 study, a phase III clinical trial in patients with AS, was used to assess improvement in spine symptoms at Week 16.Results.Treatment with secukinumab demonstrated robust and consistent efficacy across all GRAPPA-OMERACT PsA core domains, with secukinumab 300 mg showing the greatest response rates across most PsA core domains compared with placebo at Week 16. Notably, among patients treated with secukinumab 300 mg, 34.3% and 19.5% achieved complete resolution of swollen and tender joint counts, respectively; 53.2% and 61.5% achieved complete resolution of enthesitis and dactylitis, respectively; and 33.2% achieved 100% improvement in Psoriasis Area and Severity Index (all p < 0.05 vs placebo); similar improvements were shown for all other core domains.Conclusion.This analysis suggests that secukinumab can benefit people with PsA across the clinical phenotypic spectrum commonly encountered in this disease.

Elderly patients are a group with a high frequency of psoriasis. Their disease burden has negative impacts on their quality of life. While there is a clear need to treat these patients, there are challenges in doing so. This work seeks to define the challenges that exist in treating elderly Medicare patients, as well as to provide treatment suggestions for providers to follow if they encounter one or more of these challenges. Providers face the following challenges when creating treatment plants for elderly patients with psoriasis: difficulty in obtaining drug coverage through Medicare, increased medical comorbidities, and polypharmacy. Providers aim for regimens that are affordable, safe, and efficacious, but it is not always clear how to achieve this combination, especially in elderly Medicare patients. This work is relevant in that it aims to explain the logistical roadblocks posed by Medicare coverage and provide solutions for commonly encountered issues in the treatment of a disabling and common disease in a high-risk population. Specifically, alternative treatment options to biologics and small-molecule inhibitors are discussed and include topical therapies, phototherapy, methotrexate, acitretin, and cyclosporine and for psoriatic arthritis include corticosteroids and leflunomide. The specific risks and benefits of these therapies in the elderly population are provided, allowing providers to make patient-specific decisions about optimal regimens.

Objective.The Psoriatic Arthritis (PsA) Core Domain Set for randomized controlled trials and longitudinal observational studies has recently been updated. The joint counts are central to the measurement of the peripheral arthritis component of the musculoskeletal (MSK) disease activity domain. We report the Outcome Measures in Rheumatology (OMERACT) 2018 meeting’s approaches to seek endorsement of the 66/68 swollen and tender joint count (SJC66/TJC68) for inclusion in the PsA Core Outcome Measurement Set (COS).Methods.Using the OMERACT Filter 2.1 Instrument Selection Process, the SJC66/TJC68 was assessed for (1) domain match, (2) feasibility, (3) numerical sense (construct validity), and (4) discrimination (test retest reliability, longitudinal construct validity, sensitivity in clinical trials, and thresholds of meaning). A protocol was designed to assess the measurement properties of the SJC66/TJC68 joint count. The results were summarized in a Summary of Measurement Properties table developed by OMERACT. OMERACT members discussed and voted on whether the strength of the evidence supported that the SJC66/TJC68 had passed the OMERACT Filter as an outcome measurement instrument for the PsA COS.Results.OMERACT delegates endorsed the use of the SJC66/TJC68 for the measurement of the peripheral arthritis component of the MSK disease activity domain. Among patient research partners, 100% voted for a “green” endorsement, whereas among the group of other stakeholders, 88% voted for a “green” endorsement.Conclusion.The SJC66/TJC68 is the first fully endorsed outcome measurement instrument using the OMERACT Filter 2.1 and the first instrument fully endorsed within the PsA COS.

Tofacitinib is an oral Janus kinase inhibitor approved for the treatment of psoriatic arthritis (PsA). It provides an alternative option for patients who have had an inadequate response and tolerance to other disease modifying antirheumatic drugs (DMARDs). It has demonstrated comparable efficacy to biologics, is effective in the management of treatment resistant disease, and is reported to improve enthesitis, dactylitis, and radiographic progression. Tofacitinib is also associated with an increased risk of serious infections, malignancy, and laboratory abnormalities. There is currently a large armamentarium of therapies for psoriatic arthritis, and choosing among treatments can be challenging. Due to this wide selection, a thorough assessment of psoriatic disease phenotype, patient preference, disease presentation, and comorbidities is critical. This review addresses key considerations in patient selection for the treatment of PsA with tofacitinib.

Introduction Sleep is essential for overall health and well-being, yet more than one-third of adults report inadequate sleep. The prevalence is higher among people with psoriasis, with up to 85.4% of the psoriatic population reporting sleep disruption. Poor sleep among psoriasis patients is particularly concerning because psoriasis is independently associated with many of the same comorbidities as sleep dysfunction, including cardiovascular disease, obesity, and depression. Given the high prevalence and serious consequences of disordered sleep in psoriasis, it is vital to understand the nature of sleep disturbance in this population. This study was designed to help meet this need by using survey data from Citizen Pscientist, an online patient portal developed by the National Psoriasis Foundation. Methods Our analysis included 3118 participants who identified as having a diagnosis by a physician of psoriasis alone or psoriasis with psoriatic arthritis. Demographic information, psoriasis severity and duration, sleep apnea status, smoking and alcohol consumption, itch timing, and sleep characteristics were included. Two separate multivariate logistic regression models in STATA were used to determine whether the presence of psoriatic arthritis, age, gender, body mass index, comorbid sleep apnea, psoriasis severity, timing of worst itch, smoking status, or high-risk alcohol consumption were associated with sleep difficulty or low sleep quantity, defined by the American Academy of Sleep Medicine as less than 7 h of sleep per night on average. Results Results from the multivariate logistic regressions found that sleep difficulty was associated with psoriatic arthritis (OR 2.15, 95% CI [1.79–2.58]), female gender (2.03 [1.67–2.46]), obese body mass index (BMI ≥ 30) (1.25 [1.00–1.56]), sleep apnea (1.41 [1.07–1.86]), psoriasis severity of moderate (1.59 [1.30–1.94]) or severe (2.40 [1.87–3.08]), and smoking (1.60 [1.26–2.02]). Low sleep quantity was associated with obese BMI (1.62 [1.29–2.03]), sleep apnea (1.30 [1.01–1.68]), psoriasis severity of moderate (1.41 [1.16–1.72]) or severe (1.40 [1.11–1.76]), and smoking (1.62 [1.31–2.00]). Sleep difficulty and low sleep quantity were not associated with age, alcohol consumption, or timing of worst itch. Conclusion These results are potentially meaningful in several aspects. We identify an important distinction between sleep difficulty and sleep quantity in psoriatic disease, whereby having psoriatic arthritis and being female are each associated with sleep difficulty despite no association with low sleep quantity. Furthermore, there is conflicting evidence from prior studies as to whether psoriasis severity is associated with sleep difficulty, but this well-powered, large study revealed a strong, graded relationship between psoriasis severity and both sleep difficulty and low sleep quantity. Overall, our results show that both sleep difficulty and low sleep quantity were associated with multiple factors in this analysis of a large psoriatic cohort. These findings suggest that dermatologists may gather clinically useful information by screening psoriatic patients for trouble sleeping and low sleep quantity to identify potential comorbidities and to more effectively guide disease management.

Objective.It is not known how the experience of stiffness varies between diagnoses or how best to measure stiffness. The aims of our study were to (1) compare stiffness in psoriatic arthritis (PsA) and rheumatoid arthritis (RA) using patient-reported outcomes, (2) investigate how dimensions of stiffness are associated with each other and reflect the patient experience, and (3) analyze how different dimensions of stiffness are associated with physical function.Methods.An online survey was sent to Australian Rheumatology Association Database participants (158 PsA, and 158 age- and sex-matched RA), assessing stiffness severity, duration, impact, importance, coping, and physical function [modified Health Assessment Questionnaire (mHAQ)]. Scores were compared between diagnoses and correlations among stiffness dimensions calculated. Multivariate regression was performed for stiffness severity, impact, and duration on mHAQ, adjusting for age, sex, disease duration, obesity, and pain. Cognitive debriefing was conducted through semistructured telephone interviews.Results.Overall, 240/316 (75.9%) responded [124/158 RA (78.5%) and 116/158 PsA (73.4%)], with no significant difference in stiffness ratings between diagnoses. Scores for all stiffness dimensions were strongly correlated (r = 0.52–0.89), and severity and impact were associated with mHAQ in both diagnoses. Stiffness duration was not associated with mHAQ in RA. In cognitive debriefing, participants described stiffness severity and impact by their effect on daily activities (10/16 and 14/16 participants, respectively).Conclusion.Stiffness ratings were similar between PsA and RA. Different dimensions of stiffness were strongly correlated. Stiffness severity and impact both independently predicted mHAQ. Stiffness was important to participants; however, measuring multiple dimensions of stiffness may have minimal additive value.

BackgroundThe objective was to compare different definitions of remission and low disease activity (LDA) in patients with psoriatic arthritis (PsA), based on both patients’ and physicians’ perspectives.MethodsIn ReFlap (Remission/Flare in PsA; NCT03119805), adults with physician-confirmed PsA and >2 years of disease duration in 14 countries were included. Remission was defined as very low disease activity (VLDA), Disease Activity index for PSoriatic Arthritis (DAPSA) ≤4, and physician-perceived and patient-perceived remission (specific question yes/no), and LDA as minimal disease activity (MDA), DAPSA ResultsOf 410 patients, the mean age (SD) was 53.9 (12.5) years, 50.7% were male, disease duration was 11.2 (8.2) years, 56.8% were on biologics, and remission/LDA was frequently attained: respectively, for remission from 12.4% (VLDA) to 36.1% (physician-perceived remission), and for LDA from 25.4% (MDA) to 43.9% (patient-perceived LDA). Thus, patient-perceived remission/LDA was frequent (65.4%). Agreement between patient-perceived remission/LDA and composite scores was moderate to good (kappa range, 0.12–0.65). When patient-perceived remission or LDA status is used as reference, DAPSA-defined remission/LDA and VLDA/MDA had a sensitivity of 73.1% and 51.5%, respectively, and a specificity of 76.8% and 88.0%, respectively. Physician-perceived remission/LDA using a single question was frequent (67.6%) but performed poorly against other definitions.ConclusionIn this unselected population, remission/LDA was frequently attained. VLDA/MDA was a more stringent definition than DAPSA-based remission/LDA. DAPSA-based remission/LDA performed better than VLDA/MDA to detect patient-defined remission or remission/LDA. Further studies of long-term outcomes are needed.

Background Ixekizumab improves signs/symptoms of psoriatic arthritis (PsA). We present an integrated analysis of baseline disease burden and post-baseline outcomes in ixekizumab-treated patients with enthesitis or dactylitis. Methods Data from SPIRIT-P1 and SPIRIT-P2 were integrated. Patients with PsA were randomized to 80-mg ixekizumab every 4 weeks (IXEQ4W) or 2 weeks (IXEQ2W), after a 160-mg starting dose, or to placebo. Inadequate responders at week 16 received rescue therapy. Among patients with baseline enthesitis (Leeds Enthesitis Index [LEI] > 0) or dactylitis (Leeds Dactylitis Index-Basic [LDI-B] > 0), baseline characteristics and disease burden were reported. At week 24, LEI and LDI-B (percentage of patients with resolution [LEI = 0, LDI-B = 0]) were assessed. In pooled treatment groups, the impact of enthesitis or dactylitis resolution on health-related quality of life (HRQoL) (EuroQol-5 Dimensions Visual Analogue Scale [EQ-5D VAS]), physical function (Health Assessment Questionnaire-Disability Index [HAQ-DI]), and pain was assessed. Results The integrated analysis set comprised 679 patients; of these, 60% (n = 403 of 675) had baseline enthesitis (LEI > 0) and 23% (n = 155 of 676) had baseline dactylitis (LDI > 0). At week 24, ixekizumab-treated patients experienced significantly more resolution than placebo of enthesitis (39% IXEQ4W, 35% IXEQ2W, 21% placebo) and dactylitis (78% IXEQ4W, 65% IXEQ2W, 24% placebo). Furthermore, at entheseal points measured by the LEI, ixekizumab-treated patients had significantly higher resolution of enthesitis compared to placebo. At week 24, among all placebo- and ixekizumab-treated patients, resolution of enthesitis was associated with improvements in function and HRQoL whereas dactylitis resolution was associated with more limited improvements. The least squares mean HAQ-DI improvements from baseline were − 0.44 and − 0.25 for patients who did/did not resolve enthesitis, and − 0.41 and − 0.31 for patients who did/did not resolve dactylitis. EQ-5D VAS improvements were 12.3 and 5.8 for patients who did/did not resolve enthesitis, and 10.8 and 9.8 for patients who did/did not resolve dactylitis. Conclusions Among patients with pre-existing enthesitis or dactylitis, IXEQ2W- and IXEQ4W-treatment resulted in significant improvements in enthesitis and dactylitis. Enthesitis resolution was associated with improvements in patients’ function, pain, and HRQoL. Trial registration ClinicalTrials.gov, NCT01695239, registered on September 25, 2012, and NCT02349295, registered on October 10, 2014. Electronic supplementary material The online version of this article (10.1186/s13075-019-1831-0) contains supplementary material, which is available to authorized users.

Objectif: La qualité du sommeil est diminuée chez les patients atteints de rhumatisme psoriasique (RPso) et près de 40 % des patients souffrant de RPso considèrent les troubles du sommeil comme un problème prioritaire. Ce travail analyse les déterminants des troubles du sommeil chez les patients souffrant de RPso. Méthodes: Il s'agissait d'une analyse transversale d'une étude observationnelle (ReFlap, NCT03119805) menée dans 14 pays sur des patients adultes ayant un RPso diagnostiqué depuis ≥ 2 ans. Le sommeil a fait l'objet d'une auto-évaluation au moyen de l’échelle numérique (0–10) « sommeil » du questionnaire Psoriatic Arthritis Impact of Disease (PSAID-12). Les troubles du sommeil ont été définis par une EN ≥ 4. Les variables démographiques et cliniques associées aux troubles du sommeil ont été évaluées par analyse univariée et par régression de Poisson afin d'estimer le rapport de prévalence (RP) [intervalle de confiance à 95 %]. Résultats: Au total, 396 patients ont été analysés: âge moyen 51,9 ± 12,6 ans, 51 % de femmes, 59,7 % sous biothérapie, 53,3 % ayant un psoriasis couvrant 1–5 % de la surface corporelle; 23,7 % en rémission et 36,9 % avec un faible niveau d'activité selon le score Disease Activity in Psoriatic Arthritis (DAPSA). Le score médian (25 e/75 e centiles) de la qualité du sommeil auto-rapportée était de 2 (0–6), 157 patients (39,6 %) présentaient des troubles du sommeil. Dans le modèle de régression de Poisson, l'anxiété (RP: 1,05 [1,02–1,08], p < 0,01) et la douleur (RP: 1,06 [1,04–1,09], p < 0,001) rapportées par le patient ont été associées de manière indépendante aux troubles du sommeil. Conclusions: Dans cette étude multicentrique, les troubles du sommeil étaient présents chez 40 % des patients atteints de RPso; contrairement à l'inflammation, la douleur et l'anxiété ont été associées aux difficultés de sommeil. L'impact sur le sommeil semble multifactoriel dans le RPso.