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Background Psoriatic arthritis (PsA) is a chronic immune-mediated inflammatory musculoskeletal disease, manifesting as peripheral arthritis, enthesitis, dactylitis, spondylitis, and skin and nail psoriasis. A core set of domains for measuring the impact of PsA has been developed, including pain, patient global assessment, physical function, health-related quality of life (HRQoL), and fatigue. To understand the impact of PsA on health domains from a patient’s perspective, a global survey was developed and results reported in the context of the 12-item Psoriatic Arthritis Impact of Disease (PsAID-12) questionnaire. Methods An online patient-based global survey was conducted by The Harris Poll in Australia, Brazil, Canada, France, Spain, Taiwan, the UK, and the US between November 2, 2017 and March 12, 2018. Eligible patients were ≥ 18 years old with a diagnosis of PsA for > 1 year, had visited a rheumatologist/dermatologist in the past 12 months and reported using ≥ 1 synthetic/biologic disease-modifying antirheumatic drug for PsA. Patients reported on PsA severity and symptoms, and the impact of PsA on HRQoL. After survey completion, responses were aligned with PsAID health domains. Descriptive statistics and chi-square tests were conducted. Results This analysis included 1286 patients from eight countries. Most patients (97%) reported musculoskeletal symptoms relating to PsA in the past year. Common moderate/major impacts of PsA were on physical activity (78%), ability to perform certain activities (76%), work productivity (62%), and career path (57%). Skin/nail symptoms occurred in 80% of patients. Overall, 69% of patients reported that PsA had a moderate/major impact on emotional/mental wellbeing, 56% on romantic relationships/intimacy, and 44% on relationships with family and friends. Social impacts included emotional distress (58%), social shame or disapproval (32%), and ceased participation in social activities (45%). Over half of all patients experienced unusual fatigue over the past 12 months (52%). The health domains that patients reported as being impacted by PsA aligned with life impact domains of the patient-derived PsAID health domains. Conclusion These results highlight the impact of PsA on multiple health domains from a patient perspective that should be considered during shared decision-making processes between healthcare providers and patients.

Psoriatic arthritis (PsA) is an inflammatory, chronic and progressive musculoskeletal disease associated with psoriasis. The validation of the Spanish version of the Psoriatic arthritis UnclutteRed screening Evaluation (PURE-4) questionnaire has been published previously. The present analysis studied the performance of the PURE-4 questionnaire for the early detection of PsA one year before its diagnosis. This was an observational multicenter study, including two cross-sectional assessments, with primary data collection in routine clinical practice in Spain. Adult patients with psoriasis and confirmed not having PsA diagnosis during Assessment I completed Assessment II by the rheumatologist one year (±2 months) after answering the PURE-4 questionnaire. This work presents the results of Assessment II, to confirm/rule out the presence of PsA in patients with psoriasis one year after PURE-4 answering. The analysis, involving the results from Assessment II, will evaluate the performance of the PURE-4 questionnaire for the early detection of potential PsA in terms of sensitivity and specificity. There were 219 evaluable patients, 56.2% male, and the mean (standard deviation [SD]) age was 46.8 (12.5) years. At one year, the PsA diagnosis was confirmed in 12 (5.5%) patients, representing 26.1% of the total number of patients with PsA diagnosed since the beginning of the study. The mean (SD) PURE-4 score was 2.4 (1.1) for patients with PsA and 1.2 (1.2) for patients without a diagnosis of PsA (p = 0.0016). The area under the receiver-operating characteristic (ROC) curve confirmed the good quality of the questionnaire (0.7618; 95% CI: 0.6530-0.8706; n = 217). PURE-4 showed a sensitivity of 75.0% and a specificity of 62.9%. The PURE-4 questionnaire offers good clinimetric capabilities for the early detection of PsA with a score ≥2. Of the total number of patients with PsA, one in four were detected one year after answering positively to the questionnaire, which would help to predict which patients are at high risk of developing PsA. The authors reinforce the recommendation to closely follow up with these patients.

Background:Participants of randomized clinical trials may not reflect the full range of patients (pts) seen in routine clinical practice. Observational studies provide important information on a broader population of pts receiving an approved therapeutic as standard clinical care and can assess their real-world performance in the intended pt populations. In psoriatic arthritis (PsA), more recent treatment options include IL-17 inhibitors (IL-17i) and the interleukin-23 inhibitor (IL-23p19i) guselkumab (GUS). We currently have little data on who receives such treatments in a real-world setting.Objectives:To obtain an overview of the baseline (BL) profile of PsA pts initiating treatment with either GUS or an IL-17i in a real-world setting via an interim analysis of participants enrolled into an ongoing observational study (PsABIOnd).Methods:PsABIOnd (ClinicalTrials.gov ID: NCT05049798) is an ongoing, international (20 countries), prospective, observational, cohort study undertaken to assess the long-term persistence, effectiveness, and safety of treatment in adults with PsA initiating GUS or a marketed IL-17i (index agent) as a first-, second-, third-, or fourth-line biologic therapy per standard clinical practice.1 From August 2021 to May 2023, 586 of the planned 1,300 pts were enrolled, 483 of whom had available and analysable BL data. This interim analysis describes the socio-demographic characteristics, prior and concomitant PsA treatments, comorbidities, and BL disease parameters, including patient-reported outcomes (PROs), across the treatment cohorts.Results:Among 483 pts, 263 initiated GUS and 220 initiated an IL-17i (132 secukinumab, 88 ixekizumab). At BL, the GUS/IL-17i cohorts were generally well balanced for mean (SD) age (51.3 [12.8]/53.4 [12.0] y), PsA duration (7.6 [7.6]/7.2 [8.5] y), and sex (37%/40% male), with no significant differences observed between cohorts. Pt socio-demographic/disease characteristics and concomitant PsA treatments were also comparable between treatment cohorts (Tables 1&2). Both GUS and IL-17i were predominantly prescribed as 1st (33%/36%, respectively) or 2nd (27%/34%) line biologic treatment, while GUS was more commonly prescribed as a 4th-line biologic vs. IL-17i (19%/10%). Among biologic-experienced pts, more pts in the GUS than IL-17i cohort initiated the index agent due to primary failure of the previous biologic agent (30%/22%). Comorbidities were commonly reported across the GUS/IL-17i cohorts, the most common being cardiometabolic disease (48%/44%) and obesity (44%/34%). Approximately one-third of pts had a FiRST score suggesting fibromyalgia (39%/34%). Mean cDAPSA/DAPSA levels (26.4-28.8) indicated moderate-to-high joint disease activity across cohorts. Tender (4.3/4.6) and swollen (10.1/11.4) joint counts; proportions of pts with enthesitis (52%/56%), dactylitis (18%/20%), nail disease (44%/47%), and axial involvement (33%/34%); and PROs, e.g., pt pain, HAQ-DI, WPAI, also generally consistent across treatment cohorts, suggested multi-domain disease with substantial impact on physical function and productivity. However, a higher proportion of pts in the GUS cohort had severe psoriasis (14%/7% with BSA>10%) and mean Dermatology Life Quality Index (DLQI) was worse compared with the IL-17i cohort (7.9/5.5) (Table 2).Conclusion:In this interim analysis of PsA pts enrolled in the multinational PsABIOnd study, GUS and IL-17i were used as 1st- or 2nd-line biologic treatment in 60-70% of these real-world setting pts. On average, pts across treatments were characterized by moderate-to-severe joint disease activity, multi-domain disease, and impaired activity and work productivity. Compared with pts treated with IL-17i, GUS was more often given in pts with more severe skin disease and obesity. These findings show a cross-sectional snapshot of prescription patterns and can be helpful to interpret forthcoming real-world effectiveness data.REFERENCES:[1] Siebert S. Rheumatol Ther 2023;10:489.Acknowledgements:NIL.Disclosure of Interests:Laure Gossec consulting fees from AbbVie, Amgen, BMS, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Novartis, Pfizer, Samsung Bioepis, Sanofi-Aventis, UCB, research grants from Amgen, Eli Lilly, Galapagos, Pfizer, Sandoz, Xenofon Baraliakos consulting fees, grant/research support, and speakers bureau support from AbbVie, Biocad, Chugai, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Roche, and UCB, consulting fees, grant/research support, and speakers bureau support from AbbVie, Biocad, Chugai, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Roche, and UCB, consulting fees, grant/research support, and speakers bureau support from AbbVie, Biocad, Chugai, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Roche, and UCB, Ennio Lubrano speaker fees from AbbVie, Eli Lilly, Janssen, Novartis, Pfizer and UCB, Rubén Queiro speaker and/or consultancy fees from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, MSD, Novartis, and Pfizer, speaker and/or consultancy fees from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, MSD, Novartis, and Pfizer, restricted research grants from AbbVie, Janssen, and Novartis, Frank Behrens speaker and/or consultancy fees from AbbVie, Amgen, Affibody, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Chugai, Lilly, Galapagos, GSK, Janssen, MoonLake, Novartis, Pfizer, Sanofi Genzyme, Sandoz, UCB Pharma, speaker and/or consultancy fees from AbbVie, Affibody, Amgen, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Chugai, Eli Lilly, Galapagos, GSK, Janssen, MoonLake, Novartis, Pfizer, Sanofi Genzyme, Sandoz, UCB Pharma, research grants from AbbVie, Bionorica, Chugai, GSK, Janssen, Roche, Mohamed Sharaf shareholder of Johnson & Johnson, employee of EMEA Medical Affairs Janssen MEA, Dubai United Arab Emirates, Emmanouil Rampakakis employee of JSS Medical Research, paid consultant of Janssen, László Köleséri employee of IQVIA Data Science Staffing Solutions Statistical Services, paid consultant of Janssen, Frédéric Lavie owns stock or stock options in Johnson & Johnson, employee of Janssen Medical Affairs, LLC, Stefan Siebert speaker and/or consultancy fees from AbbVie, Biogen, Celgene, Eli Lilly, GSK, Janssen, Novartis and UCB, speaker and/or consultancy fees from AbbVie, Biogen, Celgene, Eli Lilly, GSK, Janssen, Novartis and UCB, institutional research funding from Amgen (previously Celgene), Boehringer-Ingelheim, Bristol-Myers-Squibb, Eli Lilly, Janssen and UCB.

Background:The HLA-Cw6 allele has been shown to be the main driver of the genetic burden of psoriatic disease and has also been associated with marked phenotypic traits. Recently, associations have been found between this biomarker and some cardiometabolic factors such as hypertension and visceral adiposity1-3.Objectives:We aimed to analyze the associations between some psoriasis-related genetic biomarkers and the presence of cardiometabolic risk factors.Methods:Cross-sectional observational study of 572 patients with psoriatic disease (30% PsA). The following genetic biomarkers were determined: HLA-Cw6*0602 allele (SNP rs1050414 C/G) and the IFIH1/MDA5 gene variants: rs35337543, intron8 + 1G>C; rs35744605, Glu627Stop; and rs1990760, Ala946Thr. The potential associations between these markers and cardiometabolic risk factors were investigated both by crude and adjusted regression models (software R 4.3.1 “Beagle Scouts”).Results:We included 309 (54%) men and 263 women (46%). Table 1 summarizes the main characteristics of the study population. Regarding PsA, associations with psoriasis severity (OR: 2.14), female sex (OR: 1.63), and the rs1990760 TT genotype (OR: 1.62) were found, while HLA-Cw6 positivity resulted protective (OR: 0.65). Cw6+ patients had a lower waist perimeter with an average of 2.37 cm less, however this difference was explained by age, female sex and arthritis. These subjects had on average 0.81 units less in BMI, but again this difference was explained by age, female sex, and arthritis. The Cw6+ patients weighed on average 2.3 kg less than the Cw6 negative patients, but this difference was explained by female sex and arthritis. The presence of this marker was associated with a reduction in the risk of hypertension (OR: 0.52, 95% CI: 20-66), however this difference lost significance after adjustment for age and arthritis. Cw6 positive subjects had a lower risk of diabetes (OR: 0.36, 95%CI: 0.19-0.63), however this association was lost after adjusting for age. We found no association between cardiometabolic comorbidity and IFIH1/MDA5 gene variants.Conclusion:The apparent protection conferred by HLA-Cw6 against the development of hypertension, diabetes or a greater visceral adiposity was explained by other variables such as age, sex or arthritis. Since the worldwide distribution of HLA-Cw6 is not uniform, these findings need further confirmation.REFERENCES:[1] Biomed Res Int 2022; 2022: 1451193.[2] J Invest Dermatol 2022; 142(6): 1617-1628.[3] Acta Derm Venereol 2023; 103: adv5209.Table 1.Distribution of study variables stratified by sexVariablesMen, n: 309Women, n: 263Total, n: 572Age (yrs), mean (SD)47.5 (14.6)45.7 (14.3)46.7 (14.5)Age at disease onset (yrs), median (min, max)24.5 [1.00, 74.0]20.0 [1.00, 78.0]23.0 [1.00, 78.0]Disease duration (yrs), mean (SD)18.7 (14.3)20.3 (15.4)19.4 (14.8)PsA, n (%)81 (26.2)90 (34.2)171 (30)Weight, mean (SD)85.4 (14.6)69.3 (13.9)77.9 (16.4)BMI, mean (SD)28.5 (4.43)26.7 (5.48)27.6 (5.02)Waist perimeter (cm), mean (SD)101 (11.6)91.4 (14.7)96.7 (14.1)PASI, mean (SD)16.0 (11.9)14.0 (12.0)15.1 (12.0)PASI ≥ 10, n (%)174 (56.3)120 (45.6%)294 (51.4%)Nail disease, n (%)192 (62.1)136 (51.7%)328 (57.3%)Plaque psoriasis, n (%)281 (90.9)216 (82.1)497 (86.9)Smoking, n (%)99 (32.0)97 (36.9)196 (34.3)alcohol consumption (SDU), median (min, max)0 [0, 2.00]0 [0, 30.0]0 [0, 30.0]T1D, n (%)11 (3.6)11 (4.2)22 (3.8)T2D, n (%)29 (9.4)16 (6.1)45 (7.9)Hypertension, n (%)68 (22.0)46 (17.5)114 (20.0)Dyslipidemia, n (%)68 (22.0)45 (17.1)113 (19.8)NAFLD, n (%)99 (32.0)30 (11.4)129 (22.6)Patients with adverse coronary events, n (%)20 (6.5)13 (4.9)33 (5.8)Patients on systemic therapy, n (%)203 (65.7)167 (63.5)370 (64.7)yrs: years; PsA: psoriatic arthritis; BMI: body mass index; PASI: psoriasis area and severity index; SDU: standard drink unit; T1D: type 1 diabetes; T2D: type 2 diabetes; NAFLD: non-alcoholic fatty liver disease.Acknowledgements:NIL.Disclosure of Interests:None declared.

Background:Persistence and safety data for tofacinitib (TOF) in psoriatic arthritis (PsA) are scarce and little known in real clinical practice[1]. This information is crucial to know the true value of this treatment in clinical practice, thus allowing better decisions to be made in the management of these patients.Objectives:We aimed to analyze the persistence and safety of TOF in patients with PsA under real-life conditions.Methods:The entire population with PsA exposed to at least one dose of TOF from a university hospital in northern Spain was included. The Kaplan-Meier survival curves of the drug were analyzed in the total population, by sex, according to the smoking status, and depending on the line of treatment (1st/2nd vs. 3rd or more). To analyze the explanatory factors of persistence, a multivariate Cox regression model was carried out. Adverse events were also recorded. The Hazard Ratio (HR) was used as measure of association.Results:Seventy-two patients were included, 54 women and 18 men. The majority were previously exposed to biologic therapies and targeted oral molecules (refractory PsA). Table 1 summarizes the main characteristics of the study population. The median survival of TOF was 13 months (IQR: 5.3-29). Persistence rate at first year was 52.7% (95%CI: 42.4-65.6). Figure 1 shows Kaplan-Meier curve of all-cause TOF discontinuation. Neither sex nor cardiometabolic factors (including obesity) nor the line of treatment influenced TOF survival. Younger patients [HR 0.96 (95%CI: 0.92-0.99), p=0.011] and those with enthesitis [HR 0.37 (95%CI: 0.15-0.92), p= 0.033] showed lower odds of TOF discontinuation. On the other hand, former smokers had a significantly higher risk of discontinuing TOF [HR 2.58 (95%CI: 1.05-6.39), p=0.04]. Patients with a history of exposure to methotrexate showed a trend towards a higher risk of discontinuation, although this did not reach statistical significance [HR 2.16 (95%CI: 0.96-4.86), p=0.063]. Of the 45 patients who discontinued the drug, 24 (53.3%) did so due to loss or lack of effectiveness, 10 (22.2%) due to intolerance, and the rest (11, 24.4%) due to adverse events during exposure.Conclusion:Tofacinitib showed good persistence in a PsA population mostly refractory to biologics and small oral molecules. Patients with enthesitis could be a group that responds especially well to the drug. Regarding safety, we did not detect new alarm signals.REFERENCES:[1] J Rheumatol 2021 Oct;48(10):1552-1558.Table 1.Study population characteristicsVariableWomen, n: 54Men, n: 18Total, n:72Age (yr), mean (SD)51.8 (10.5)52.1 (13.0)51.9 (11.1)Pso duration (yr), mean (SD)16.4 (11.9)15.2 (7.79)16.1 (11.0)PsA duration (yr), mean (SD)10.3 (7.51)10.8 (5.36)10.4 (6.99)Weight (Kg), mean (SD)75.3 (18.1)83.1 (14.0)77.7 (17.3)High blood pressure, n (%)17 (31.5)5 (27.8)22 (30.6)Dyslipidemia n (%)16 (29.6)3 (16.7)19 (26.4)Diabetes, n (%)5 (9.3)2 (11.1)7 (9.7)Current smokers, n (%)16 (29.6)3 (16.7)19 (26.4)Former smokers, n (%)16 (29.6)3 (16.7)19 (26.4)Joint pattern, n (%) Peripheral Axial Mixed38 (70.4)3 (5.6)13 (24.1)10 (55.6)0 (0)8 (44.4)48 (66.7)3 (4.2)21 (29.2) Plaque psoriasis, n (%)32 (59.3)16 (88.9)48 (66.7) Nail disease18 (33.3)10 (55.6)28 (38.9) Dactylitis, n (%)13 (24.1)7 (38.9)20 (27.8) Enthesitis, n (%)11 (20.4)4 (22.2)15 (20.8) Depression, n (%)36 (66.7)4 (22.2)40 (55.6)Tofacinitib line, n (%) 1 2 3 4 ≥ 51 (1.9)17 (31.5)11 (20.4)13 (24.1)12 (22.2)0 (0)1 (5.6)8 (44.4)5 (27.8)4 (22.2)1 (1.4)18 (25.0)19 (26.4)18 (25.0)16 (22.2)Tofacinitib current intake, n (%) yes no19 (35.2)35 (64.8)8 (44.4)10 (55.6)27 (37.5)45 (62.5)Treatment duration (mo), median [min, max]7.44 [0.23, 42.8]14.7 [0, 40.0]10.0 [0, 42.8]DAPSA, mean (SD)14.2 (7.9)9.2 (6.1)12.4 (6.5)PsAID, mean (SD)4.1 (2.2)3.6 (3.2)3.7 (3.3)Figure 1.Kaplan-Meier curve of all-cause treatment discontinuationAcknowledgements:NIL.Disclosure of Interests:None declared.

Background:Oligoarticular psoriatic arthritis (PsA, ≤4 joints affected), although common, is understudied, as most clinical trials require patients (pts) to have ≥3 swollen and tender joints. The FOREMOST study (NCT03747939) is the first large, phase 4, multicenter, randomized, placebo (PBO)-controlled trial to demonstrate efficacy of apremilast (APR) in clinical outcomes in pts with early oligoarticular PsA, and the first trial to investigate clinical outcomes in this pt population. Here we applied the PsA Impact of Disease (PsAID-12) Questionnaire, a 12-item pt-reported outcome measure, and its recently described cutoff values, to better understand the burden of oligoarticular PsA disease from the pt’s perspective.Objectives:To evaluate the efficacy of APR on impact of disease as measured by PsAID-12 total score in pts with early oligoarticular PsA.Methods:FOREMOST included pts with early PsA (duration ≤5 years) and limited joint involvement (>1 but ≤4 swollen and tender joint count). Pts were randomized 2:1 to APR (30 mg twice daily) or PBO for 24 wks (early escape at Wk 16), followed by an extension phase in which all pts received APR through Wk 48. The changes from baseline in PsAID-12 score were calculated at Wks 16 and 48 in both APR and PBO groups. The percentage of pts achieving a Patient Acceptable Symptom State (PASS) according to the PsAID-12 (PsAID-12 ≤4) through Wk 48 was also assessed in pts who were not in a PASS (PsAID-12 >4) at baseline. Additionally, using the PsAID-12 responder and disease activity thresholds,[1] we assessed the percentages of pts reaching PsAID-defined remission or low disease activity (REM/LDA) (PsAID-12 ≤1.95) and remission (REM) (PsAID-12 ≤1.15) when not in REM/LDA (PsAID-12 >1.95) and REM (PsAID-12 >1.15) at baseline through Wk 48. Summary is based on observed data.Results:A total of 308 pts were randomized (APR: n=203; PBO: n=105); mean PsA duration and PsAID-12 at baseline were 10 months (standard deviation [SD] 10.18) and 4.72 (2.09), respectively. At Wk 16, the mean change in PsAID-12 from baseline was −1.51 (1.9) in the APR group and −0.44 (1.9) in the PBO group; during the extension phase, pts continuing APR (APR/APR) and pts who switched from PBO to APR (PBO/APR) improved through Wk 48 (−1.63 [2.1] and −1.59 [1.8], respectively). At Wk 16, 62/116 (53.4%) of pts who were not in PsAID-12 PASS at baseline, achieved PsAID-12 PASS with APR compared with 14/54 (25.9%) in the PBO group (Figure 1A). At Wk 16, 48/154 (31.2%) of pts who were not in PsAID-REM/LDA at baseline reached the treatment goal of PsAID-REM/LDA with APR compared with 10/76 (13.2%) in the PBO group (Figure 1B), and 31/161 (19.3%) of pts who were not in PsAID-REM at baseline achieved PsAID-REM in the APR group vs 6/81 (7.4%) of control pts (Figure 1C). Through Wk 48, the APR/APR and PBO/APR groups maintained achievement of or improved in PsAID-12 PASS, REM/LDA, and REM (Figure 1).Conclusion:Greater percentages of pts with oligoarticular PsA receiving APR achieve the acceptable symptom state, symptom-based low disease activity, or symptom based-remission at Wk 16 compared with PBO and this is maintained through Wk 48. These results demonstrate the efficacy of APR on reducing the burden of oligoarticular PsA disease from the pt’s perspective. These results might inform shared decision-makings for pts with early PsA.REFERENCES:[1] Gossec L, et al. Ann Rheum Dis 2023;82(Suppl 1):565-566. (abstract).Figure 1.Percentage of patients with early oligoarticular PsA achieving PsAID PASS (A), REM/LDA (B), and REM (C) through week 48.Acknowledgements:This study was funded by Amgen Inc. Writing support was funded by Amgen Inc. and provided by Corey Burgin, PhD, of Peloton Advantage, LLC, an OPEN Health company, and Shannon Rao, employee of Amgen Inc.Disclosure of Interests:Laure Gossec AbbVie, Amgen, BMS, Celltrion, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, Sandoz, UCB – Personal fees, AbbVie, Biogen, Lilly, Novartis, UCB – Grant/research support, Laura C. Coates AbbVie, Amgen, Biogen, Bristol Myers Squibb, Celgene Corporation, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Medac, MoonLake, Novartis, Pfizer, UCB – Speaker honoraria, AbbVie, Amgen, Biogen, Bristol Myers Squibb, Celgene Corporation, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Medac, MoonLake, Novartis, Pfizer, UCB – Consulting fees, AbbVie, Amgen, Biogen, Bristol Myers Squibb, Celgene Corporation, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Medac, MoonLake, Novartis, Pfizer, UCB UCB – Grant/research support, Dafna D. Gladman AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, UCB – Consulting Fees, AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, UCB –Ggrant/research support, Alexis Ogdie AbbVie, Amgen Inc., Bristol Myers Squibb, CorEvitas’ Psoriatic Arthritis/Spondyloarthritis Registry, Eli Lilly, Gilead, GSK, Janssen, Novartis, Pfizer, UCB, and Takeda – Consultant, AbbVie, Amgen Inc., BMS, Janssen, Novartis, and Pfizer – Grant/research support, Peter Nash: None declared, Denis Poddubnyy AbbVie, Canon, DKSH, Eli Lilly, Janssen, MSD, Medscape, Novartis, Peervoice, Pfizer, and UCB – Speaker fees, AbbVie, Biocad, Bristol-Myers Squibb, Eli Lilly, Janssen, Moonlake, Novartis, Pfizer, and UCB – Consulting fees, AbbVie, Eli Lilly, MSD, Novartis, Pfizer – Research support, Arthur Kavanaugh AbbVie, BMS, Janssen, Moonlake, Novartis, Pfizer, Eli Lilly, UCB – Consultant, Amgen, AbbVie, BMS, Janssen, Moonlake, Novartis, Pfizer, Eli Lilly, UCB – Grant/research support, April Armstrong AbbVie, Almirall, Arcutis, ASLAN, Beiersdorf, BI, BMS, EPI, Incyte, Leo, UCB, Janssen, Lilly, Mindera, Nimbus, Novartis, Ortho Dermatologics, Sun, Dermavant, Dermira, Sanofi, Regeneron, and Pfizer – Research investigator and/or scientific advisor, Carlo Selmi AbbVie, Amgen, Alfa-Sigma, Biogen, Eli-Lilly, EUSA Pharma - Recordati, Galapagos, Janssen, Novartis, Octapharma, Pfizer, Recordati Rare Disease, SOBI – Speakers Bureau, AbbVie, Amgen, Alfa-Sigma, Biogen, Eli-Lilly, EUSA Pharma - Recordati, Galapagos, Janssen, Novartis, Octapharma, Pfizer, Recordati Rare Disease, SOBI – Consulting Fees, AbbVie, Amgen, Janssen, Novartis, Pfizer – Research Grants, Rubén Queiro AbbVie, Amgen, Celgene, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, UCB – Consulting fees, AbbVie, Amgen, Celgene, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, UCB – Grant/research support, Cynthia Deignan Amgen – Stock ownership, Amgen – Employment, Rebecca Wang Amgen - Stock Ownership, Amgen - Employment, Jyotsna Reddy Amgen - Stock Ownership, Amgen - Employment, Michele Brunori Amgen - Stock Ownership, Amgen - Employment, Philip J. Mease AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, UCB – Speakers bureau, Boehringer Ingelheim, GlaxoSmithKline – Consultant, AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, Sun, UCB – Grant/research support and consultant.

Background:The CASPAR classification criteria present a high sensitivity/specificity for the classification of psoriatic arthritis (PsA) patients (pts). Although initially designed for classification purposes, many authors have used them for diagnostic (dx) purposes with variable results. The Psoriatic arthritis UnclutteRed screening Evaluation (PURE-4) questionnaire has recently been validated for its use in the Spanish dermatological healthcare context, showing good sensitivity/specificity for the PsA detection [1].Objectives:To analyze the performance of the CASPAR criteria in the pts included in this validation study and who received a PsA dx by the rheumatologist.Methods:Cross-sectional, observational, multicenter study conducted with primary data collection under conditions of routine clinical practice in Spain. Adult pts with psoriasis that voluntarily accepted to participate. Two cross-sectional assesments: Assessment I allowed to validate the Spanish version of the PURE-4 questionnaire and assessment II (pts without PsA in assessment I were evaluated for PsA confirmation by the rheumatologist 1 year ±2 months later). The ability of the Spanish version of the PURE-4 questionnaire to screen for PsA among pts with psoriasis receiving routine dermatology care in Spain was previously confirmed.1 Main findings were: (i) the questionnaire showed an acceptable overall discrimination capacity (AUC=73% in assessment I, AUC=76% in assessment II), acceptable reliability (Cronbach’s α=0.610), and good construct validity; (ii) optimal cut-point of ≥2 points allows screening pts with or without PsA with good sensitivity (79.4%) and specificity (80.7%); (iii) PURE-4 was sensitive (75%) predicting an early PsA dx at 1-year follow-up; (iv) the cut-point of ≥2 is optimal, both for detecting PsA in the short term (1 month) and in the long term (1 year). Among the external anchors used to analyze the construct validity of the PURE-4, the CASPAR criteria were included. The performance and agreement of the CASPAR criteria against physician´s dx (gold standard) was analyzed. Mann-Whitney and Chi square tests were used to evaluate the differences in the characteristics of pts with and without PsA according to the rheumatologist’s dx.Results:Of the 268 evaluable pts in assessment I, 34 presented PsA. In assessment II, 219 pts were evaluable and 12 of these pts developed PsA after one year (Figure 1). At the end of the study, 46 pts with PsA were observed (18.3%, 46/251 with complete follow-up). In assessment I, 21/34 pts with PsA (61.8%) met CASPAR criteria, 4 (19%) did not meet them, and in the remaining 9 they were not available (26.5%). In assessment I, 95.2% of those who met the CASPAR classification criteria fulfilled the item of current psoriasis, 62% nail dystrophy, 24% dactylitis, and 24% radiographic criteria. Mean (SD) PURE-4 score [2.19 (1.29)] was significantly higher in pts who met CASPAR criteria than in pts who did not meet these criteria [1.29 (1.26); p=0.002). 66.7% of the pts who presented PsA according to the CASPAR criteria obtained PURE-4 score ≥2. The percentage of agreement between both criteria (PURE-4 and CASPAR) was 61.4%. In assessment II, of the 12 pts with PsA dx, 7 met the CASPAR criteria (58.3%), 3 did not (25%), and it was not available in 2 pts. In this second evaluation, all pts met the item for current psoriasis, 28.6% for nail dystrophy, 28.6% for dactylitis, while none met the radiographic criteria.Conclusion:The CASPAR criteria had adequate dx performance in the Spanish validation study of PURE-4 questionnaire, however the criterion that should prevail in the dx of PsA continues to be that of a rheumatologist experienced in this pathology.REFERENCES:[1] Ruben Queiro, et al. Poster POS1075. Congreso EULAR 2022.Figure 1.Study population flow chartPsA, psoriatic arthritis.Acknowledgements:The authors thank IQVIA and Carmen Barrull and Marco Pinel for providing medical editorial assistance with this presentation.Disclosure of Interests:Rubén Queiro Abbvie, Amgen-Celgene, Eli-Lilly, Janssen, MSD, Novartis, Pfizer, UCB, Amgen-Celgene, Eli-Lilly, Janssen, Novartis, UCB, Abbvie, Janssen, Novartis, Isabel Belinchón Janssen Pharmaceuticals Inc, Almirall SA, Lilly, AbbVie, Novartis, Celgene, Biogen, Amgen, Leo-Pharma, Pfizer-Wyeth, BMS, UCB, y MSD, Janssen Pharmaceuticals Inc, Almirall SA, Lilly, AbbVie, Novartis, Celgene, Biogen, Amgen, Leo-Pharma, Pfizer-Wyeth, BMS, UCB, y MSD, Alba Erra: None declared, Xabier Michelena Novartis, Lilly, Abbvie, Janssen, UCB, Novartis, Abbvie, Janssen, UCB, Beatriz Joven-Ibáñez Abbvie, Novartis, Lilly, Abbvie, Janssen, UCB, Amgen, UCB, Janssen, Abbvie, BMS, Janssen, Laura Crespi-Martinez Abbvie, Galapagos, Emma Beltrán AbbVie, Bristol, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche y UCB, AbbVie, Bristol, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche y UCB, Ana Laiz UCB, AMGEN, ABBVIE, MSD, JANSSEN, NOVARTIS, UCB, AMGEN, ABBVIE, MSD, JANSSEN, NOVARTIS., UCB, AMGEN, ABBVIE, MSD, JANSSEN, NOVARTIS., UCB, AMGEN, ABBVIE, MSD, JANSSEN, NOVARTIS., Vega Jovani: None declared, Delia Reina: None declared, Eva Galíndez-Agirregoikoa Abbvie, Novartis, Pfizer, Janssen, Amgen, UCB, Lilly, Abbvie, Novartis, Pfizer, Janssen, Amgen, UCB, Lilly, María L. García Vivar Abbvie, Bristol, Pfizer, Novartis, UCB. Janssen, Lilly, Sandoz, Abbvie, UCB, Novartis, Janssen, Guillermo Guinea Uzábal I am a Novartis employee, Lara Gómez Labrador I am a Novartis employee, Adriana Soler Salas I am a Novartis employee.

Background:Psoriatic arthritis (PsA) is a heterogenous, chronic, inflammatory musculoskeletal disease that can lead to peripheral and axial damage and loss of function. Axial involvement varying greatly from 25% to 70% of patients with PsA, depending on its definition, with the key manifestations being sacroiliitis and/or spondylitis. However, there are no agreed-upon classification or diagnostic criteria for axial involvement in PsA and no consensus on treatment paradigms, which complicates management of PsA. Few studies assessing biologics in patients with PsA with axial involvement, and most treatment plans are based on evidence from patients with axial spondyloarthritis, in addition to a current controversy about the efficacy of IL-12/23 and IL23 inhibitors in this domain.Objectives:To evaluate the effectiveness of ustekinumab (UST), guselkumab (GUS), and risankizumab(RSK) in patients with axial and/or mixed PsA, focusing on the axial domain, in real clinical practice.Methods:A multicenter retrospective study was conducted in 24 Spanish hospitals, recruiting 167 patients diagnosed with axial and/or mixed APs, treated with UST (65), GUS (80), and RSK (22). Demographic, clinical, and treatment data (307 variables) were collected. Efficacy was measured by comparing ASDAScrp and BASDAI at baseline, and at 1, 3, 6, and 12 months. The proportion of response based on clinically important improvement (CII) or BASDAI50 was also analyzed. The analysis was performed by comparing paired means from the start to each follow-up point and through analysis of variance of repeated measures with mixed models (adjusted for age, sex, and BMI).Results:Of the 167 patients included, 83 (50%) were women, with an age at treatment initiation of 50 (±11.1) years. The follow-up time for the different treatments was 24 (±24) months. 146 (87.4%) were mixed forms and 21 (12.6%) axial forms. 22.1% were HLA-B27 positive. The main comorbidities were dyslipidemia (39%), hypertension (37%), and obesity (36%). Globally a decrease in ASDAScrp and BASDAI was observed, both in men and women, at 1, 3, 6, and 12 months, all with statistical significance (p<.001) (Figure 1). When each drug was analyzed separately, this reduction was observed with GUS and RSK at 1, 3, 6, and 12 months: GUS 6.25/15/15/12.5; RSK 4.55/18.2/27.3/9.1; UST 1.54/10.8/7.7/4.6 (Figure 2).Comparing GUS vs UST, a BASDAI50 response was observed in 16.3% vs 4.6% (p=0.026), respectively. RSK vs UST an CII response was observed in 31.8% vs 12.3% (p=0.036), respectively. The only factors associated with clinical response were meeting ASAS criteria for axial SpA (OR 5.03), ASDAScrp>2.1 (OR 20.8) and enthesitis (OR 2.05).In the survival analysis, UST has a survival curve similar to GUS,while RSK showed better survival, but with a shorter follow-up time.Conclusion:In our experience in clinical practice, GUS and RSK demonstrate effectiveness at 1 year in the axial domain in patients with PsA.REFERENCES:NIL.Figure 1.Figure 2.Percentage of patients who reached a BASDAI50 response or clinically important improvement.Acknowledgements:NIL.Disclosure of Interests:RAQUEL ALMODOVAR Abbvie, Pfizer, Lilly, Novartis, Janssen, UCB., Abbvie, Pfizer, Lilly, Novartis, Janssen, UCB., Ramón Mazzucchelli: None declared, Elisa Trujillo: None declared, Pablo Navarro Palomo: None declared, Jesus Sanz: None declared, Beatriz Joven-Ibáñez: None declared, Cristina Valero: None declared, Rosario Garcia-Vicuña: None declared, Rubén Queiro: None declared, MARTA LOREDO MARTINEZ: None declared, Paula Alvarez: None declared, Lourdes Martín de la Sierra López: None declared, David Castro-Corredor: None declared, Marcos Paulino Huertas: None declared, Eva Galíndez-Agirregoikoa: None declared, Maria Luz García-Vivar: None declared, Cristina Vergara: None declared, Maria Andreina Teran: None declared, Laura Trives: None declared, Santiago Munoz-Fernández: None declared, María LLop Vilaltella: None declared, Mireia Moreno: None declared, Jordi Gratacós: None declared, Maria Aparicio: None declared, Lourdes Mateo: None declared, Laura González: None declared, Jose Antonio Pinto Tasende: None declared, Cristina Fernández-Carballido: None declared, Virginia Villaverde: None declared, Carolina Marín-Huertas: None declared, Teresa Navio-Marco: None declared, Jose Francisco Garcia LLorente: None declared, Manuel Moreno: None declared, Luis Linares: None declared, Maria jose Moreno: None declared, Carolina Álvarez Castro: None declared, Ismael González: None declared, Ana Urruticoechea-Arana: None declared, Julio Ramirez: None declared, LETICIA DEL OLMO PEREZ: None declared, Pedro Zarco-Montejo: None declared, Emma Beltrán Catalán: None declared.

BackgroundThe goal of treatment in psoriatic arthritis (PsA) according to the T2T strategy is remission, or at least, a low disease activity state1. Currently there is no clear agreement on how to measure these treatment goals.ObjectivesTo explore the relationship between very low disease activity (VLDA) state, according to the MDA 7/7 criteria2, and DAPSA remission3, as well as its association with the impact of the disease evaluated by the PsAID questionnaire4, in patients with PsA in routine clinical practice.MethodsPost-hoc analysis of the MAAPs study5. We included patients who met CASPAR criteria, with at least one year of disease evolution, and treated with biological and/or synthetic DMARDs according to the usual clinical practice in Spain. Patients were considered in VLDA if they met 7/7 of the MDA criteria, and in DAPSA/cDAPSA remission (this last without CRP) if they had a value ≤4. A PsAID <4 represented a patient-acceptable symptom state (PASS). The frequency of these states and kappa (κ) agreement between them were analysed.ResultsOf the 227 patients included in the original study, 26 (11.5%), 52 (30.6%), 65 (36.9%) and 125 (55%) were in VLDA, DAPSA remission, cDAPSA remission, and PASS, respectively. There was a moderate agreement between VLDA and DAPSA remission (κ=0.52) or the cDAPSA remission (κ=0.42). Patients in VLDA had a lower impact of the disease measured by PsAID [mean total score (SD): VLDA 1.1 (1.2); DAPSA remission 1.3 (1.5); cDAPSA remission 1.7 (1.6)]. There was a moderate agreement between DAPSA remission or cDAPSA remission and PASS (κ=0.55 and κ=0.58 respectively), while fair agreement was found between VLDA and PASS (κ=0.18).ConclusionsAbout one third of this series reached DAPSA remission, while only 11.5% reached VLDA state. On the other hand, more than half were in PASS situation. Agreement between VLDA and DAPSA was moderate. Although the MDA 7/7 criteria seem to be more stringent criteria for assessing remission, DAPSA remission shows better agreement with PASS. DAPSA and VLDA would be adequate treatment targets in daily practice.References[1] Smolen JS, et al. Treating axial spondyloarthritis and peripheral spondyloarthritis, especially psoriatic arthritis, to target: 2017 update of recommendations by an international task force. Ann Rheum Dis2018;77:3–17.[2] Coates LC, et al. Defining Low Disease Activity States in Psoriatic Arthritis using Novel Composite Disease Instruments. J Rheumatol2016;43:371–375.[3] Schoels MM, et al. Disease activity in psoriatic arthritis (PsA): defining remission and treatment success using the DAPSA score. Ann Rheum Dis2016;75:811–818.[4] Gossec L, et al. A patient-derived and patient-reported outcome measure for assessing psoriatic arthritis: elaboration and preliminary validation of the Psoriatic Arthritis Impact of Disease (PsAID) questionnaire, a 13-country EULAR initiative. Ann Rheum Dis2014;73:1012–1019.[5] Queiro R, et al. Minimal disease activity and impact of disease in psoriatic arthritis: a Spanish cross-sectional multicenter study. Arthritis Res Ther2017;19:72.Disclosure of InterestNone declared

BackgroundObesity (BMI ≥30 kg/m2) is a common cardiovascular risk factor in psoriatic disease1. Although the prevalence of obesity is high, the factors associated with it in psoriatic arthritis (PsA) are poorly understood.ObjectivesWe aimed to evaluate the prevalence and obesity-associated factors in patients with PsA.MethodsRetrospective cross-sectional study that included 205 consecutive patients with PsA according to CASPAR criteria. The prevalence of obesity was compared with that of 310 patients with skin psoriasis of similar age (±3 years). The factors associated with obesity were first analysed by a conditional logistic regression. The significant factors in this first model were then introduced in a multivariate model using a backward step approach (p-values<0.05 were considered significant).ResultsOne-hundred twelve men and 94 women were included, with a mean age of 53±13 years. Obesity was more prevalent among psoriatics (36.5%) compared to PsA patients (24%), OR 1.6 (1.1–2.3), p<0.05. The factors associated with obesity in the univariate analysis (p<0.05) were: onset of psoriasis >40 years (OR 2.4), onset of arthritis >40 years (OR 2.1), PsA family history (OR 3.1), polyarticular presentation (OR 1.9), axial presentation (OR 2.5), polyarticular evolution (OR 2.4), axial evolution (OR 4.2), diabetes (OR 3.6), HBP (OR 3.9), and dyslipidemia (OR 3.5). After correcting for age, sex, disease duration and other confounders, independent associations with obesity found in the multivariate model (p<0.05) were: PsA family history (OR 3.6, IC95%: 1.1–14.4), axial evolution (OR 4.4, IC95%: 1.0–22.4) and dyslipidemia (OR 3.5, IC95%: 1.5–8.6).ConclusionsObesity was more common among our patients with cutaneous psoriasis than in those with arthritis. The model that best explains obesity in this PsA series combines genetic factors (PsA family history), together with factors specific to the metabolic syndrome (dyslipidemia), with others owned to arthritis (axial evolution).Reference[1] Husni ME. Comorbidities in psoriatic arthritis. Rheum Dis Clin North Am2015;41:677–98.Disclosure of InterestNone declared