Value of the Routine Assessment of Patient Index Data 3 in Patients With Psoriatic Arthritis: Results From a Tight‐Control Clinical Trial and an Observational Cohort

Coates, Laura C.; Tillett, William; Shaddick, Gavin; Pincus, Theodore; Kavanaugh, Arthur; Helliwell, Philip S.

doi:10.1002/acr.23460

Cited by 31 publications

(31 citation statements)

References 36 publications

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“…Achievement of VLDA, however, resulted in the least amount of residual disease activity across all aspects of disease evaluated other than CRP level. While the small number of patients achieving VLDA in this study should be noted, consistent results were recently reported in a retrospective analysis of 347 patients with PsA who received standard or biologic DMARDs in either a tight-control clinical trial or an observational cohort study (15). Herein, all patients achieving PASDAS VLDA and 20 of 22 (91%) achieving DAPSA remission also achieved MDA, while 15 of 23 patients (65%) who met the MDA criteria did not achieve PASDAS VLDA, and 13 of 23 (57%) did not meet the DAPSA remission criteria, suggesting that PASDAS VLDA and DAPSA remission criteria are more stringent and difficult to achieve than MDA.…”

Section: Discussionsupporting

confidence: 87%

Composite Measures of Disease Activity in Psoriatic Arthritis: Comparative Instrument Performance Based on the Efficacy of Guselkumab in an Interventional Phase II Trial

Helliwell

Deodhar

Gottlieb

et al. 2020

Arthritis Care & Research

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Objective. To assess performance of psoriatic arthritis (PsA) composite indices and evaluate guselkumab's effect on achieving low disease activity or remission. Methods. In this phase II trial, patients with active PsA (≥3 tender and ≥3 swollen joints, C-reactive protein level ≥0.3 mg/dl, ≥3% body surface-area with psoriasis involvement) were randomized 2:1 to subcutaneous guselkumab 100 mg (n = 100) or placebo (n = 49) at week 0, week 4, and every 8 weeks through week 44. At week 16, patients with <5% improvement in swollen and tender joints could early escape to open-label ustekinumab. Patients continuing placebo crossed over to receive guselkumab 100 mg at weeks 24, 28, 36, and 44 (placebo to guselkumab). PsA composite indices (Psoriatic Arthritis Disease Activity Score [PASDAS], Group for Research and Assessment of Psoriasis and Psoriatic Arthritis composite score [GRACE], modified Composite Psoriatic Disease Activity Index [mCPDAI], and Disease Activity in Psoriatic Arthritis [DAPSA]) were analyzed as secondary outcomes (last observation carried forward for missing/postearly escape data through week 24; observed data post-week 24). Instrument performance was assessed. Results. Baseline PASDAS, GRACE, mCPDAI, and DAPSA scores indicated moderate-to-high disease activity. At week 24, mean changes in each of these composite indices showed significant improvement with guselkumab (-2.50,-2.73,-3.8, and-23.08, respectively) versus placebo (-0.49, 0.35,-0.8, and-4.98, respectively; P < 0.001 for all). Significantly more guselkumab-treated patients achieved low/very low/remitted disease activity states according to PASDAS (very low + low 35% versus 4%; P < 0.001), GRACE (30% versus 2%; P < 0.001), mCPDAI (46% versus 10%; P < 0.001), and DAPSA (remission + low 40% versus 12%; P < 0.001). A total of 12% of guselkumab-treated versus no placebo-treated patients achieved DAPSA remission (P < 0.01). The PASDAS and GRACE instruments were more sensitive than the mCPDAI and DAPSA tools in detecting treatment effect. Residual skin disease and enthesitis were marginally more prominent in patients achieving DAPSA low disease activity versus other indices. Conclusion. Guselkumab demonstrated efficacy in achieving low disease activity/remission based on all PsA composite indices assessed. Composite index use in PsA trials and the clinic requires careful consideration to optimize feasibility and instrument performance. ClinicalTrials.gov identifier: NCT02319759.

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Section: Discussionsupporting

confidence: 87%

Composite Measures of Disease Activity in Psoriatic Arthritis: Comparative Instrument Performance Based on the Efficacy of Guselkumab in an Interventional Phase II Trial

Helliwell

Deodhar

Gottlieb

et al. 2020

Arthritis Care & Research

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“…Using our web-based survey, respondents provided sociodemographic characteristics (age, sex, race, education, employment, marital status, yearly income, and type of health insurance), clinical information (Routine Assessment of Patient Index Data 3 [RAPID3] cumulative score , [20][21][22], RAPID3 categorical disease activity/severity [near remission = 1-3, low = 4-6, medium = 7-12, high = 13-30], extent of psoriasis captured using the Patient Report of Extent of Psoriasis Involvement [23], current symptoms, and other comorbidities), and diagnosis history (time since onset of symptoms, first PsA symptom experienced that prompted the respondent to seek medical help, time between symptom onset and seeking treatment, the types of healthcare providers consulted, time between seeking medical treatment and receipt of formal diagnosis, time since official PsA diagnosis received, and misdiagnoses obtained). Stratification of data was performed based on time between seeking medical attention and receipt of a formal diagnosis of PsA; time cutoffs of < 6 months, 6 months to 4 years, and ≥ 5 years were chosen post hoc to yield an even distribution of the number of respondents across groups.…”

Section: Study Variablesmentioning

confidence: 99%

Patient perspectives on the pathway to psoriatic arthritis diagnosis: results from a web-based survey of patients in the United States

et al. 2020

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Background: There are limited real-world data on the diagnostic experiences of patients with psoriatic arthritis (PsA), including medical care sought and potential barriers to diagnosis. We aim to describe patient experiences related to receiving a PsA diagnosis. Methods: Ours was a mixed-method, 2-phase study. Phase 1 comprised concept elicitation and cognitive interviews with clinical experts and adults diagnosed with PsA to develop a cross sectional, web-based survey. US adults with a self-reported PsA diagnosis were recruited through a patient support community (CreakyJoints), an online patient research registry (ArthritisPower), and social media outreach. In Phase 2, the online survey collected data on sociodemographics, clinical symptoms, disease burden, and diagnosis history of survey respondents with PsA. Results: Of the 203 respondents included, 172 (84.7%) were female, and the mean (SD) age was 51.6 (10.8) years. The time between seeking medical attention and receiving a diagnosis was < 6 months for 69 respondents, 6 months to 4 years for 68 respondents, and ≥ 5 years for 66 respondents. Most respondents sought care from general practitioners (79.8%) and rheumatologists (66.5%). Common initial symptoms that led respondents to seek medical attention were joint pain (70.0%) and stiffness (53.7%). Among the initial symptoms that led respondents to seek care, joint pain, swollen joints, and sausage-like fingers or toes (indicating dactylitis) were more common among respondents with shorter time to diagnosis, whereas stiffness, fatigue, enthesitis (indicated by foot problems, tendon and ligament pain), and back pain were more common among respondents with longer time to diagnosis. Common misdiagnoses were psychosomatic issues (26.6%) and osteoarthritis (21.7%). Respondents with shorter times to diagnosis had lower frequencies of misdiagnosis. Conclusions: Respondents with PsA reported delays in diagnosis and misdiagnoses on their journey to a PsA diagnosis. Symptom differences, such as enthesitis and stiffness, were noted among respondents with shorter vs longer time to diagnosis. Increased understanding of diagnostic barriers may lead to earlier diagnosis and appropriate management to improve outcomes.

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“…Clinically important improvements in these PROs have been reported in PsA clinical trials of adalimumab, etanercept, infliximab, golimumab (subcutaneous and intravenous), certolizumab pegol, ustekinumab, guselkumab, secukinumab, ixekizumab, apremilast, tofacitinib, and abatacept (100)(101)(102)(103)(131)(132)(133)(134)(135)(136)(137)(138)(139). Additionally, the PsAID12, which is available on the GRAPPA mobile-phone app, and the RAPID3 questionnaires are useful for dermatologists to use in clinical practice to evaluate the impact of PsA symptoms on patients (140,141).…”

Section: Pro Measuresmentioning

confidence: 96%

Psoriatic arthritis for dermatologists

Gottlieb

Merola

2019

Journal of Dermatological Treatment

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Psoriatic arthritis (PsA) affects up to one-third of patients with psoriasis. It is the major comorbidity of psoriasis because of the likelihood that loss of function and permanent disability will develop if initiation of treatment is delayed. Dermatologists are uniquely positioned to recognize early signs of PsA and be the first-line healthcare practitioners to detect PsA in patients with psoriasis. PsA can affect six clinical domains: peripheral arthritis, dactylitis, enthesitis, psoriasis, psoriatic nail disease, and axial disease. However, not every patient will have involvement of all domains and the domains affected can change over time. Complicating the diagnosis is the condition's similarity with other arthritic diseases and potential heterogeneity. In this article, we provide practical guidance for dermatologists for detecting PsA in patients with psoriasis. We also review the available treatment options by each clinical domain of PsA and give advice on how to interpret the results of PsA clinical trials. Through early recognition of PsA in patients with psoriasis and initiation of proper treatment, dermatologists can help to prevent PsA disease progression, irreversible joint damage, and resultant permanent disability, and improve quality of life.

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Value of the Routine Assessment of Patient Index Data 3 in Patients With Psoriatic Arthritis: Results From a Tight‐Control Clinical Trial and an Observational Cohort

Abstract: RAPID3 appears comparably informative to PASDAS and DAPSA in PsA, with greater feasibility for routine clinical care.

Cited by 31 publications

References 36 publications

Composite Measures of Disease Activity in Psoriatic Arthritis: Comparative Instrument Performance Based on the Efficacy of Guselkumab in an Interventional Phase II Trial

Composite Measures of Disease Activity in Psoriatic Arthritis: Comparative Instrument Performance Based on the Efficacy of Guselkumab in an Interventional Phase II Trial

Patient perspectives on the pathway to psoriatic arthritis diagnosis: results from a web-based survey of patients in the United States

Psoriatic arthritis for dermatologists

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