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OBJECTIVE: To determine the annual incidence of psoriatic arthritis in a UK primary care population with preexisting psoriasis followed prospectively over two years after excluding baseline prevalence of existing disease. METHODS: TUDOR (Total bUrDen of psORiasis) was a multi-centre, prospective, two-arm parallel-group cluster randomised controlled trial of the early identification of PsA by annual rheumatological assessment (termed Enhanced Surveillance) versus standard care in people with psoriasis identified in primary care. Incidence of psoriatic arthritis is reported at 12- and 24-months using patients from the Enhanced Surveillance arm, which allows the exclusion of patients with prevalent PsA at baseline. RESULTS: Fourteen of 511 participants attending a 12-month screen developed PsA over that interval giving an incidence of 2.74 per 100 patient years (p-yrs) (95% CI: 1.32 to 4.16) and another 7 of 444 participants attending the 24-month visit developed PsA giving an incidence of 1.58 per 100 p-yrs (95% CI: 0.42 to 2.74). The combined incidence over 2 years was 2.20 per 100 p-yrs (95% CI: 1.27 to 3.13). CONCLUSION: The estimated annual incidence of PsA over a 2-year period was 2.20 per 100 p-yrs, that is in keeping with a higher incidence of PsA than that found when relying on health records alone. Extended follow-up of the TUDOR cohort with accrual of larger numbers of incident cases will allow risk factors for psoriatic arthritis to be explored in more depth.
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OBJECTIVE: Psoriatic arthritis (PsA) is a heterogenous condition with musculoskeletal and skin manifestations. The physician global visual analog scale (VAS) is an important component of many composite scores used in clinical trials and observational studies. Currently, no training material exists to standardize this assessment. METHODS: The Psoriatic Arthritis Validation of Physician Global VAS (PAVLOVAS) project describes the development of a novel training infographic with stakeholder involvement, which was then evaluated in a Latin square design in which 20 patients with PsA were assessed by 10 clinicians. For each group of 10 patients, 5 assessors conducted traditional assessment (consisting of 66/68-joint count, body surface area, Leeds Enthesitis Index, and dactylitis and nail counts) and 5 assessors conducted a standardized, thorough general examination informed by the infographic. Assessors switched assessment type between groups. The 3-item (3VAS) and 4VAS informed by traditional and infographic methods were compared, alongside other composite scores. RESULTS: There was strong agreement between traditional and infographic physician global VAS (intraclass correlation coefficient [ICC] 0.69, P = 0.01). This improved to very strong agreement when incorporated into the 3VAS (ICC 0.99, P < 0.001) and 4VAS (ICC 0.99, P < 0.001). The duration of assessment was significantly less for the infographic vs traditional groups (6.5 vs 7.8 mins, P < 0.001). There was moderately high agreement between the 3VAS and 4VAS categories of disease activity, with the same categories defined by Psoriatic Arthritis Disease Activity Score (PASDAS) and Disease Activity Index for Psoriatic Arthritis (DAPSA; Ⲭ2 17.0, P = 0.049). CONCLUSION: Our group developed and validated a novel training infographic that informs a briefer assessment of the physician global VAS than traditional assessments. This tool has potential applications in training and routine clinical practice.
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BACKGROUND: Our objective was to determine whether early detection of undiagnosed psoriatic arthritis (PsA) in a primary care psoriasis population improves outcome in physical function at 24 months post-registration. METHODS: A multicentre, prospective, parallel group cluster randomised controlled trial in patients with psoriasis was conducted. Participants with suspected inflammatory arthritis on screening were referred for an assessment of PsA (enhanced surveillance (ES) arm: at baseline, 12 and 24 months; standard care (SC) arm: at 24 months). The primary outcome measure was the Health Assessment Questionnaire Disability Index (HAQ-DI) at 24 months post registration in participants diagnosed with PsA. RESULTS: A total of 2225 participants across 135 GP practices registered: 1123 allocated to ES and 1102 to SC. The primary analysis population consisted of 87 participants with a positive diagnosis of PsA: 64 in ES, 23 in SC. The adjusted odds ratio (OR) for achieving a HAQ-DI score of 0 at 24 months post registration in ES compared with SC was 0.64 (95% CI (0.17, 2.38)), and the adjusted OR of achieving a higher (non-zero) HAQ-DI score at 24 months post registration in ES relative to SC arm was 1.12 (95% CI: 0.67, 1.86), indicating no evidence of a difference between the two treatment groups (p= 0.66). CONCLUSION: The trial was underpowered for demonstrating the prespecified treatment effect; in patients with psoriasis there was no evidence that early diagnosis of PsA by ES in primary care changes physical function at 24 months compared with SC. CLINICAL TRIAL REGISTRATION: The TUDOR trial is registered as ISRCTN38877516.
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INTRODUCTION: Some retrospective data sources, such as electronic health records in the USA, report composite outcome measures not fully validated in psoriatic arthritis (PsA). However, they often contain global assessments, such as a Physician Global Assessment (PhGA) and Patient Global Assessment (PatGA), along with patient-reported pain scores, which individually are considered validated in PsA. This research described the performance characteristics of a 3-item global assessment and pain (GAP) composite endpoint using data from the ixekizumab phase 3 PsA clinical trial program. METHODS: Discrimination of GAP was assessed by comparing placebo to active treatment arms. The magnitude of treatment effect and responsiveness were compared to Disease Activity Index for PsA (DAPSA), clinical DAPSA, DAPSA28, and Psoriatic Arthritis Disease Activity Score (PASDAS) using effect size (ES) and standardized response mean (SRM), respectively. Construct validity was evaluated through correlation among the composite endpoints, and with other physician- and patient-reported outcomes. Change in GAP was compared in patients who reached low disease activity (LDA) levels based on DAPSA, cDAPSA, and PASDAS vs those who did not. RESULTS: GAP discriminated between active treatment and placebo with statistically significant separation as early as week 1. The largest ES/SRM was seen with GAP (2.29/1.74) and PASDAS (2.47/1.68). GAP had the strongest correlation with PASDAS (0.81-0.92) and showed moderate correlations with patient-assessed physical function, low correlations with physician-assessed skin and nail psoriasis, and low to moderate correlation with physician-assessed enthesitis. A significantly greater improvement in GAP was seen in the groups achieving LDA states compared to those not (p < 0.001). CONCLUSION: The GAP composite, an abbreviated endpoint comprising measures common in electronic health records, has promising performance characteristics and could be used to address important clinical questions regarding outcomes and impact of PsA in existing datasets. CLINTRIALS. GOV IDENTIFIER: NCT01695239; NCT02349295.
When doctors are assessing patients with psoriatic arthritis in clinical trials, they use tools, which include questions that patients answer and questions that doctors answer, in addition to a physical exam, to help evaluate how patients are doing. In a routine clinical practice setting, all of these same tools may not be used because they take a longer time to document information during a patient office visit. The goals of this research were to (1) create a new tool, which uses questions that patients and doctors answer, to help doctors evaluate how patients with psoriatic arthritis are doing in routine clinical practice, and (2) to assess if this new tool works as well as older tools. The new tool has fewer questions for the doctor and patient to answer and may take less time to document information but may result in some symptoms that patients experience not being regularly assessed. Data from clinical trials were used to compare the new tool to older tools to evaluate if doctors are able to assess psoriatic arthritis the same way. The results of the study showed that doctors are able to assess patients with psoriatic arthritis similarly with the new tool compared to older tools. This information will increase awareness of the new tool and could make it easier for doctors to evaluate patients with psoriatic arthritis in routine clinical practice.
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Despite substantial evidence that methotrexate (MTX) has inferior efficacy, safety, and tolerability compared to newer systemic therapies, MTX remains one of the most commonly prescribed first-line systemic therapies for psoriatic arthritis worldwide and for psoriasis in some countries. At the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2023 annual meeting in Dublin, Ireland, Drs. William Tillett and Joseph Merola engaged in debate over whether MTX should be the first systemic therapy used in psoriatic disease (PsD). Each presented evidence-based arguments, incorporating multiple data sources, including clinical trials, in support for and against MTX's status as first-line systemic therapy for PsD. This article summarizes their debate for the broader PsD community.
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The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-Outcome Measures in Rheumatology (OMERACT) psoriatic arthritis (PsA) working group provided updates at the GRAPPA 2023 annual meeting on its work to evaluate composite outcome measures for PsA. An ongoing systematic literature review is in progress to evaluate psychometric measurement properties using the OMERACT filter 2.2 for a list of candidate composite outcome measures, which include minimal disease activity (MDA), Disease Activity for Psoriatic Arthritis (DAPSA), American College of Rheumatology (ACR) response criteria, Psoriatic Arthritis Disease Activity Score (PASDAS), Composite Psoriatic Disease Activity Index (CPDAI), 3 visual analog scale (3VAS), and 4VAS. The performance of the 3VAS and 4VAS in clinical practice and a synthesis of new data were presented, including estimates for minimal clinically important differences and thresholds of meaning, discrimination and construct validity, and longitudinal construct validity. Numeric rating scale (NRS) versions of the VAS have also been tested. Performance characteristics and psychometric properties are similar to the ASSESS study, a UK multicenter study, indicating that the VAS scales may be feasible tools for routine clinical care with a preference for the 4VAS because of superior face validity and clinical utility.
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BACKGROUND: Since the publication of the 2011 European Alliance of Associations for Rheumatology (EULAR) recommendations for patient research partner (PRP) involvement in rheumatology research, the role of PRPs has evolved considerably. Therefore, an update of the 2011 recommendations was deemed necessary. METHODS: In accordance with the EULAR Standardised Operational Procedures, a task force comprising 13 researchers, 2 health professionals and 10 PRPs was convened. The process included an online task force meeting, a systematic literature review and an in-person second task force meeting to formulate overarching principles (OAPs) and recommendations. The level of agreement of task force members was assessed anonymously (0-10 scale). RESULTS: The task force developed five new OAPs, updated seven existing recommendations and formulated three new recommendations. The OAPs address the definition of a PRP, the contribution of PRPs, the role of informal caregivers, the added value of PRPs and the importance of trust and communication in collaborative research efforts. The recommendations address the research type and phases of PRP involvement, the recommended number of PRPs per project, the support necessary for PRPs, training of PRPs and acknowledgement of PRP contributions. New recommendations concern the benefits of support and guidance for researchers, the need for regular evaluation of the patient-researcher collaboration and the role of a designated coordinator to facilitate collaboration. Agreements within the task force were high and ranged between 9.16 and 9.96. CONCLUSION: The updated EULAR recommendations for PRP involvement are more substantially based on evidence. Together with added OAPs, they should serve as a guide for researchers and PRPs and will ultimately strengthen the involvement of PRPs in rheumatology research.
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Objectives: The aim of the Severe Psoriatic arthritis - Early intervEntion to control Disease trial is to compare outcomes in psoriatic arthritis (PsA) patients with poor prognostic factors treated with standard step-up conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), combination csDMARDs or a course of early biologics. Design: This multicentre UK trial was embedded within the MONITOR-PsA cohort, which uses a trial within cohort design. Methods and analysis: Patients with newly diagnosed PsA and at least one poor prognostic factor (polyarthritis, C-reactive protein >5 mg/dL, health assessment questionnaire >1, radiographic erosions) were randomized equally and open-label to either standard care with 'step-up' csDMARD therapy, initial therapy with combination csDMARDs (methotrexate with either sulfasalazine or leflunomide) or to early biologics induction therapy (adalimumab plus methotrexate). The primary outcome is the PsA disease activity score at week 24. Ethics: Ethical approval for the study was granted by the South Central Research Ethics Committee (ref 18/SC/0107). Discussion: Treatment recommendations for PsA suggest more intensive therapy for those with poor prognostic factors but there are no studies that have previously used prognostic factors to guide therapy. Applying initial intensive therapy has shown improved outcomes in other inflammatory arthritides but has never been tried in PsA. Combination csDMARDs have shown some superiority over single therapies but there are limited data and concerns about side effects. Early use of biologics has also been shown to be superior to methotrexate but these drugs are costly and not usually funded first line. However, if a short course of biologics can rapidly suppress inflammation allowing treatment to be withdrawn and response maintained on methotrexate, this may be a cost-effective model for early use. Trial registration: ClinicalTrials.gov (NCT03739853) and EudraCT (2017-004542-24).
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To assess current evidence of effectiveness of sequential lines of biologic and targeted small molecule drugs for psoriasis beyond first line. A systematic search of the literature (Medline, Embase and bibliographic) was undertaken in October and December 2022 to find all studies assessing effectiveness of biologics and targeted small molecules when used beyond first-line in adults with psoriasis (PROSPERO CRD42022365298). Data extraction and a bias assessment (Risk Of Bias In Non-randomized Studies-of Interventions/Cochrane RoB2) were undertaken for all included studies. A random effects proportional meta-analysis was undertaken for PASI75/90/100 at 12-16 weeks for each line of treatment (1st to 4th). Of 2666 abstracts identified, a full text review was undertaken of 177 studies; 20 manuscripts met eligibility criteria. Twenty studies were included in the analysis: 19 observational studies and one sub analysis of a RCT; n = 6495 (average age 49.7 years, female 35.1%). Eleven studies assessed second line biologic, nine assessed third + line. A meta-analysis of PASI75 at 12-16 weeks found pooled effect percentage achieving PASI75 of 61%, 56%, 79% and 61% in 1st, 2nd, 3rd and 4th line biologics respectively. Meta-analyses of PASI90/100 also found no evidence of diminished effectiveness with sequential lines (PASI90 46.1%, 39.9%, 55.8% and 33.7% and PASI100 36.7%, 30.3%, 46.7% and 30.4% in 1st to 4th line respectively). Available evidence for effectiveness of biologics beyond first line in psoriasis is predominantly observational, at high risk of bias and of low quality. There is very limited data for effectiveness beyond second line. Evidence indicates that biologics can be effective to fourth-line.
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OBJECTIVE: Many clinically extremely vulnerable rheumatology patients have only recently ceased shielding from COVID-19, while some continue to minimise in-person contact. The objective of this study was to understand the impact of shielding and associated support needs in patients with rheumatic conditions and to understand how rheumatology teams can meet these needs both currently and in future pandemics. DESIGN, PARTICIPANTS AND SETTING: The study was conducted in the Southwest of England using a case-study design. The participants were 15 patients with rheumatic conditions who were advised to shield and/or chose to shield at any time during the COVID-19 pandemic. METHODS: Qualitative data collected via telephone and online semi-structured interviews and analysed using reflexive thematic analysis. RESULTS: Fifteen interviews were conducted. Three main themes represent the data:'Just shove them over there in the corner' captures changes in patients' self-perception. They felt different to most other people, vulnerable and left behind. The initial sense of shock was followed by a sense of loss as changes became long term.'A long and lonely road' captures patients' psychological isolation due to a perceived lack of understanding and support. This included having to prove their health status and justify their shielding behaviours, which impacted their relationships. At times, they felt abandoned by their healthcare providers.'You can't just flip a switch' captures the difficulty of getting back to pre-pandemic normal after shielding. Patients did not recognise themselves physically and mentally. They wanted to collaborate with health professionals and identified the need for specific guidance to support their recovery. CONCLUSION: Patients are dealing with lasting physical and mental effects from shielding and consequences of delayed healthcare. Health professionals need time and resources to ask about patients' well-being, identify their health needs and refer/signpost to appropriate sources of support.
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COVID-19 , Investigación Cualitativa , Enfermedades Reumáticas , SARS-CoV-2 , Humanos , COVID-19/prevención & control , COVID-19/psicología , COVID-19/epidemiología , Masculino , Femenino , Enfermedades Reumáticas/psicología , Persona de Mediana Edad , Inglaterra , Adulto , Anciano , Entrevistas como Asunto , Pandemias , ReumatologíaRESUMEN
OBJECTIVES: Existing guidelines for psoriatic arthritis (PsA) cover many aspects of management. Some gaps remain relating to routine practice application. An expert group aimed to enhance current guidance and develop recommendations for clinical practice that are complementary to existing guidelines. METHODS: A steering committee comprising experienced, research-active clinicians in rheumatology, dermatology and primary care agreed on themes and relevant questions. A targeted literature review of PubMed and Embase following a PICO framework was conducted. At a second meeting, recommendations were drafted and subsequently an extended faculty comprising rheumatologists, dermatologists, primary care clinicians, specialist nurses, allied health professionals, non-clinical academic participants and members of the Brit-PACT patient group, was recruited. Consensus was achieved via an online voting platform when 75% of respondents agreed in the range of 7-9 on a 9-point scale. RESULTS: The guidance comprised 34 statements covering four PsA themes. Diagnosis focused on strategies to identify PsA early and refer appropriately, assessment of diagnostic indicators, use of screening tools and use of imaging. Disease assessment centred on holistic consideration of disease activity, physical functioning and impact from a patient perspective, and on how to implement shared decision-making. For comorbidities, recommendations included specific guidance for high-impact conditions such as depression and obesity. Management statements (which excluded extant guidance on pharmacological therapies) covered multidisciplinary team working, implementation of lifestyle modifications and treat-to-target strategies. Minimising corticosteroid use was recommended where feasible. CONCLUSION: The consensus group have made evidence-based best practice recommendations for the management of PsA to enhance the existing guidelines.
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BACKGROUND: Capacity to work is impacted by psoriatic arthritis (PsA). Our objective was to describe the course of work productivity and leisure activity in patients with PsA treated with biologic (b) and targeted synthetic (ts) disease-modifying antirheumatic drugs (DMARDs). METHODS: A systematic literature review identified all trials and observational studies published January 1, 2010-October 22, 2021, reporting work productivity using the Work Productivity and Activity Impairment Questionnaire (WPAI) in patients with PsA treated with b/tsDMARDs. Outcomes for WPAI domains (absenteeism, presenteeism, total work productivity, and activity impairment) were collected at baseline and time point closest to 24 weeks of treatment. A random effects meta-analysis of single means was conducted to calculate an overall absolute mean change from baseline for each WPAI domain. RESULTS: Twelve studies (ten randomized controlled and two observational) assessing patients treated with adalimumab, bimekizumab, guselkumab, ixekizumab, risankizumab, secukinumab, or upadacitinib were analysed. Among 3741 employed patients, overall mean baseline scores were 11.4%, 38.7%, 42.7%, and 48.9% for absenteeism, presenteeism, total work productivity impairment, and activity impairment, respectively. Estimated absolute mean improvements (95% confidence interval) to week 24 were 2.4 percentage points (%p) (0.6, 4.1), 17.8%p (16.2,19.3), 17.6%p (15.9,19.4), and 19.3%p (17.6, 21.0) respectively, leading to a mean relative improvement of 41% for total work productivity. The change in work outcomes in the b/tsDMARDs appeared similar. CONCLUSIONS: This systematic literature review and meta-analysis confirmed that patients with active PsA have a substantially reduced capacity to work and participate in leisure activities. Substantial improvements across various WPAI domains were noted after 24 weeks of b/tsDMARD treatment, especially in presenteeism, total work productivity, and activity impairment. These findings may be useful for reimbursement purposes and in the context of shared decision-making. This systematic literature review (SLR) of randomized clinical trials and observational studies of biologic (b) and targeted synthetic (ts) disease-modifying antirheumatic drugs b/tsDMARDs in patients with PsA found that at treatment introduction, patients presented with a 42.7% mean productivity loss per week as assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire. Through a meta-analysis comparing before/after values without adjustment for placebo response, we found that after 24 weeks of treatment with b/tsDMARDs, there was a mean absolute improvement of 17.6 percentage points and a mean relative improvement of 41% in total work productivity, with similar magnitudes of improvement in time spent at work and regular activities outside of work. These results provide clinical-, regulatory- and reimbursement decision-makers with data on the potential societal and socio-economic benefits of b/tsDMARDs in PsA.
Psoriatic arthritis (PsA) has a major impact on patients' lives, including their ability to work by causing absence and reducing productivity. By pooling together published studies (12 studies, corresponding to 3741 patients) and comparing what patients reported before starting treatment to during treatment, we found that over the course of treatment with biologic (b) and targeted synthetic (ts) disease-modifying antirheumatic drugs (DMARDs), patients with PsA had an average of 18% higher total work productivity, translating to a 41% reduced impact of PsA at the group level (without looking at comparisons to a placebo response). It is important for health professionals and patients to know that work outcomes affected by PsA are improved when patients take b/tsDMARDS.
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Absentismo , Antirreumáticos , Artritis Psoriásica , Eficiencia , Humanos , Artritis Psoriásica/tratamiento farmacológico , Antirreumáticos/uso terapéutico , Productos Biológicos/uso terapéutico , Resultado del Tratamiento , Presentismo/estadística & datos numéricos , Drogas Sintéticas/uso terapéuticoRESUMEN
INTRODUCTION: To evaluate the effect of guselkumab on work productivity and nonwork daily activity impairment and general health status through 2 years in patients who were biologic-naïve with active psoriatic arthritis (PsA) in the phase 3 DISCOVER-2 clinical trial. METHODS: Adult patients with PsA were randomized to subcutaneous injections of guselkumab 100 mg every 4 weeks (Q4W); at weeks 0, 4, then every 8 weeks (Q8W); or placebo (through week 24 with crossover to guselkumab Q4W). Work productivity and nonwork daily activity impairment were assessed using the Work Productivity and Activity Impairment Questionnaire for PsA (WPAI-PsA) and patient-reported general health status using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index and EQ-Visual Analog Scale (EQ-VAS). Least-squares (LS) mean changes from baseline in WPAI-PsA domains and EQ-5D-5L/EQ-VAS were assessed through week 100. Changes in employment status were utilized to estimate potential indirect savings from improved work productivity. RESULTS: Of 739 randomized patients, 738 had available baseline data for the analyses (Q4W 245; Q8W 248; placebo 245). At week 24, greater improvements in work productivity, nonwork daily activity, and EQ-5D-5L/EQ-VAS were observed in the Q4W and Q8W groups versus the placebo group. At week 100, LS mean reductions in work productivity impairment (- 23.8% to - 28.0%) and nonwork daily activity impairment (- 26.6% to - 29.2%) and improvements in EQ-5D-5L/EQ-VAS (0.14 to 0.15/21.2 to 25.0) were maintained in patients receiving guselkumab. Among patients employed at baseline, 12.1-16.4% were not employed at week 100, and 20.0-25.3% shifted from not employed at baseline to employed at week 100. Potential yearly indirect cost savings (USD) from improved work productivity at week 100 ranged from $16,529 to $19,409. CONCLUSION: Patients with active PsA treated with guselkumab demonstrated reduced impairment in work productivity and nonwork daily activity, together with improvement in general health status and substantial potential cost savings, over a 2-year period. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT03158285.
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OBJECTIVE: To assess current evidence for effectiveness of sequential lines of biologic and targeted small-molecule disease-modifying anti-rheumatic drugs (b/tsDMARDs) when used beyond first-line for psoriatic arthritis (PsA). METHODS: A systematic search of the literature (Medline, Embase, bibliographic searches) was undertaken (October and December 2022) to find studies meeting the criteria of assessing effectiveness of b/tsDMARDs beyond first-line in adults with PsA (PROSPERO CRD42022365298). Risk of bias assessment was undertaken (ROBINS-I/Cochrane RoB2). RESULTS: Of 2666 abstracts identified and following a full text review of 177 psoriatic disease studies, 12 manuscripts and two abstracts were eligible. Of the 12 manuscripts, 11 were observational and one was a sub-analysis of a RCT (n = 16 081: average age 49.5 years, female 53.3%). Two abstracts (n = 7186) were included. All studies comparing first- and second-line (three studies) found a reduced response in second-line. On average, DAPSA remission (most reported outcome, eight studies) was achieved in 26%, 19% and 10% first-, second- and third-line TNFi, and 22%, 13% and 11% first-, second- and third-line other bDMARDs, respectively. Responses varied to third-line bDMARDs; four studies found comparable second- and third-line responses, five studies found diminishing responses in sequential lines. CONCLUSION: Predominantly observational studies, inherently at high risk of bias, indicate bDMARDs can be effective to third-line in PsA, but that response is reduced after first line. There is very limited data for more advanced lines of b/tsDMARD. Prospective studies are required to better understand clinical response to advanced lines of treatment in PsA.
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Antirreumáticos , Artritis Psoriásica , Productos Biológicos , Artritis Psoriásica/tratamiento farmacológico , Humanos , Antirreumáticos/uso terapéutico , Productos Biológicos/uso terapéutico , Resultado del TratamientoRESUMEN
OBJECTIVES: The objective of this study was to compare the performance of three PsA screening questionnaires in a primary care psoriasis surveillance study. METHODS: Participants with psoriasis, and not known to have PsA, were identified from general practice databases and invited to attend a secondary care centre for a clinical assessment. The three patient-completed screening questionnaires (PEST, CONTEST and CONTESTjt) were administered, along with other patient-reported measures, and a clinical examination of skin and joints was performed. Participants who demonstrated signs of inflammatory arthritis suggestive of PsA were referred, via their GP, for a further assessment in a secondary care rheumatology clinic. RESULTS: A total of 791 participants attended the screening visit, and 165 participants were judged to have signs and symptoms of inflammatory arthritis, of which 150 were referred for assessment. Of these, 126 were seen and 48 were diagnosed with PsA. The results for each questionnaire were as follows: PEST: sensitivity 0.625 (95% CI 0.482, 0.749), specificity 0.757 (0.724, 0.787); CONTEST: sensitivity 0.604 (0.461, 0.731), specificity 0.768 (0.736, 0.798); and CONTESTjt: sensitivity 0.542 (0.401, 0.676), specificity 0.834 (0.805, 0.859). CONTESTjt demonstrated marginally superior specificity to PEST, though the area under the ROC curve was similar for all three instruments. CONCLUSION: Minimal differences between the three screening questionnaires were found in this study, and no preferred questionnaire is indicated by these results. The choice of which instrument to choose will depend on other factors, such as simplicity and low patient burden.
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Artritis Psoriásica , Psoriasis , Humanos , Artritis Psoriásica/complicaciones , Sensibilidad y Especificidad , Psoriasis/epidemiología , Encuestas y Cuestionarios , Atención Primaria de Salud , Tamizaje Masivo/métodosRESUMEN
OBJECTIVE: Medication-related beliefs, for example, beliefs that medicines are unnecessary or that side effects are likely, can influence medication behaviors and experiences, potentially impacting quality of life and mortality. At times, it may be useful to change medication-related beliefs, for example, to reduce patients' concerns about side effects when extensive evidence suggests side effects are rare. Currently we do not know the most effective methods to address medication beliefs. METHOD: Systematic review and meta-analysis of randomized controlled trials that measured medication-related beliefs in people prescribed medication for long-term condition(s). We extracted data on behavior change techniques (BCTs), belief measure, study and patient characteristics, risk of bias, and quality of description. RESULTS: We identified 56 trials randomizing 8,714 participants. In meta-analysis, interventions led to small-to-medium effects (n = 36, Hedges' g = .362, 95% confidence interval [CI] [.20, .52], p < .001) in increasing beliefs about medication need/benefit and reducing concerns about medication (n = 21, Hedges' g = -.435, 95% CI [-0.72, -0.15], p < .01). Effect sizes were higher for interventions that reported a significant effect on adherence. Problem solving, information about health consequences, and social support (unspecified) were the most prevalent BCTs. Fourteen BCTs were associated with significant effects on need/benefit beliefs and four BCTs were associated with significant effects on concern beliefs. CONCLUSION: It is possible to modify medication-related beliefs using a range of interventions and techniques. Future research should explore the best ways to operationalize these BCTs for specific health conditions to support medication beliefs and improve adherence. (PsycInfo Database Record (c) 2024 APA, all rights reserved).
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Terapia Conductista , Calidad de Vida , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Terapia Conductista/métodos , Cumplimiento de la MedicaciónRESUMEN
OBJECTIVE: There is a need for a widely accepted comprehensive disease activity measure for use in daily practice in patients with psoriatic arthritis (PsA). For this reason, the 3-item Visual Analogue Scale (3VAS) and 4-item Visual Analogue Scale (4VAS) were developed. This study aimed to test construct validity and responsiveness of the 3VAS and 4VAS in a population of patients with newly diagnosed PsA receiving usual care. METHODS: Components of the 3VAS (physician global, patient global, patient skin) and 4VAS (physician global, patient pain, patient joint, patient skin) were scored on 0-10 VAS scales. Agreement of low disease activity (LDA) state between 3VAS/4VAS and other composite measures was tested using Venn diagrams. Construct validity and responsiveness (3-month interval) were assessed using Spearman correlation coefficients and standardised response means (SRM) with effect sizes (ES), respectively, following hypothesis generation. Both 3VAS/4VAS were also compared with several patient-reported outcome measures. RESULTS: Data from 629 patients were used. Both 3VAS (ES=0.48, SRM 0.52) and 4VAS (ES=0.48, SRM=0.50) showed responsiveness similar to Disease Activity in PSoriatic Arthritis (DAPSA) and Disease Activity Score-28 (DAS28). Both measures had a strong correlation with DAPSA (r=0.80-0.87), Psoriatic Arthritis Disease Activity Score (PASDAS) (r=0.89) and Routine Assessment of Patient Index Data 3 (RAPID3) (r=0.84-0.92). 3VAS and 4VAS had the highest agreement with PASDAS in categorising patients to LDA at 12 months. CONCLUSION: This is the first study assessing the performance of the 3VAS and 4VAS in an observational cohort of patients with early PsA. Both measures have promising performance characteristics, showing strong correlations and good discrimination with existing composite measures. The 4VAS may be the preferred version with better face validity.
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Artritis Psoriásica , Humanos , Artritis Psoriásica/diagnóstico , Índice de Severidad de la Enfermedad , Reproducibilidad de los Resultados , Medición de Resultados Informados por el PacienteRESUMEN
BACKGROUND: Nail psoriasis is a common, physiologically, and psychologically disruptive, and yet often under-treated manifestation of psoriasis. The objectives of this analysis were to investigate the trajectory of nail psoriasis, a risk factor for psoriatic arthritis (PsA), with guselkumab vs adalimumab treatment followed by withdrawal, and determine characteristics associated with nail response in patients treated with guselkumab. METHODS: This post hoc analysis of the phase III trial VOYAGE 2 included patients with moderate-to-severe plaque psoriasis and baseline nail involvement. Nail Psoriasis Severity Index (NAPSI) and Psoriasis Area and Severity Index (PASI) were analyzed through week 48 in patients randomized to guselkumab or adalimumab. Multiple logistic regression analyzed factors associated with NAPSI 0/1 at week 24/week 48 following guselkumab treatment. In a separate analysis, patients were stratified by prior biologic experience. RESULTS: Overall, 272 vs 132 patients receiving guselkumab vs adalimumab had nail psoriasis at baseline. Lower baseline NAPSI and week 16 PASI were associated with achieving NAPSI 0/1 at week 24 (NAPSI, odds ratio 0.685 [95% confidence interval: 0.586, 0.802]; week 16 PASI, 0.469 [0.281, 0.782]) and week 48 (NAPSI, 0.784 [0.674, 0.914]; week 16 PASI, 0.557 [0.331, 0.937]) with guselkumab. Previous biologic experience did not impact NAPSI response. Following treatment withdrawal at week 28, mean NAPSI was maintained in the guselkumab arm (week 24 1.7, week 48 1.9) and increased slightly in the adalimumab arm (week 24 1.4, week 48 2.3). Mean PASI increased across both treatment arms. CONCLUSIONS: Higher skin efficacy at week 16 was associated with better nail responses during guselkumab treatment. Nail psoriasis improvements reflected skin improvements. Following guselkumab withdrawal, nail response was maintained longer than skin response. Future studies should investigate whether such improvements in nail response reduce patients' risk of later PsA development. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02207244. Registered July 31, 2014.
Asunto(s)
Artritis Psoriásica , Productos Biológicos , Psoriasis , Humanos , Artritis Psoriásica/tratamiento farmacológico , Adalimumab/uso terapéutico , Psoriasis/tratamiento farmacológico , Piel , Productos Biológicos/efectos adversosRESUMEN
The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) leadership congregated for a strategic planning meeting before the 2022 GRAPPA annual meeting in New York, USA. Meeting aims were to review GRAPPA's performance in relation to its 2016 goals and identify successes and areas for further improvement, identify key GRAPPA priorities and activities for the next 5 years, and explore committee structures to best support these aims.
Asunto(s)
Artritis Psoriásica , Dermatología , Psoriasis , Reumatología , HumanosRESUMEN
OBJECTIVES: To assess the long-term safety and efficacy of upadacitinib in patients with psoriatic arthritis (PsA) and an inadequate response (IR) to biologic disease-modifying anti-rheumatic drugs (bDMARDs) who completed up to 152 weeks of treatment in the SELECT-PsA 2 study (ClinicalTrials.gov: NCT03104374). METHODS: Patients were randomised to receive blinded upadacitinib 15 or 30 mg once daily (QD), or placebo for 24 weeks followed by upadacitinib 15 or 30 mg QD. After 56 weeks, patients were eligible to enter an open-label extension (OLE) in which they continued their assigned dose of upadacitinib. Efficacy and safety were assessed through 152 weeks. A subanalysis of patients with IR to tumour necrosis factor inhibitors (TNFis) was also conducted. RESULTS: In total, 450 patients entered the OLE and 358 completed 152 weeks of treatment. Improvements in efficacy outcomes observed at week 56, including the proportion of patients achieving: 20/50/70% improvement in American College of Rheumatology criteria, minimal disease activity, and 75/90/100% improvement in Psoriasis Area and Severity Index, were maintained through week 152. Efficacy outcomes in the TNFi-IR subgroup were similar to those reported in the overall population. Upadacitinib was well tolerated throughout long-term treatment, with no cumulative adverse effects observed through 152 weeks. CONCLUSIONS: Efficacy of upadacitinib was maintained up to 152 weeks of treatment in this highly treatment-refractory population of patients with PsA. The long-term safety profile of upadacitinib 15 mg was consistent with its known safety profile across indications; no new safety signals were identified.