Global Assessment Of Disease Activity Research Articles

33236 Impact of risankizumab on improving symptoms and health-related quality of life and reducing fatigue and pain among psoriatic arthritis patients with moderate-to-severe skin involvement: Evidence from 2 phase III trials

Introduction: Psoriatic arthritis (PsA) greatly affects patient-reported health-related quality of life (HRQoL). This analysis integrated efficacy data from 2 phase III clinical trials (KEEPsAKE-1 and KEEPsAKE-2) to assess the impact of risankizumab (RZB) on patient-reported outcomes (PROs) in patients with high skin burden. Methods: Adult patients with PsA with inadequate response or intolerance to disease-modifying antirheumatic drugs were randomized 1:1 to receive RZB (150 mg) or placebo (PBO). Improvement from baseline in PROs (Patient’s Global Assessment of Disease Activity [PtGA] by visual analog scale [VAS], Short-Form 36 Health Questionnaire physical and mental component summary scores [SF-36 PCS and MCS], Health Assessment Questionnaire–Disability Index [HAQ-DI], EQ-5D 5-Level questionnaire [EQ-5D-5L] index and by VAS, Functional Assessment of Chronic Illness Therapy–Fatigue [FACIT-Fatigue], and pain by VAS) were assessed at Week 24 in patients with high skin burden (body surface area involvement ≥3% and Psoriasis Area Severity Index >10). Least squares mean (LSM) difference (95% confidence interval [CI]) between RZB and PBO groups based on mixed-model repeated measures regression is reported. Results: RZB- vs PBO-treated patients demonstrated greater improvements in PROs with notable LSM differences (95% CI) between groups (P < .01) in PtGA (-18.7 [-25.1, -12.2]), SF-36 PCS (6.3 [4.2, 8.4]) and MCS (4.4 [2.3, 6.6]), HAQ-DI (-0.4 [-0.5, -0.3]), EQ-5D-5L index (0.1 [0.1, 0.2]) and VAS (8.2 [2.5,13.9]), FACIT-Fatigue (4.9 [2.7, 7.2]), and pain (18.9 [-25.1, -12.7]). Conclusions: In patients with PsA with high skin burden, 24 weeks of RZB treatment, as compared with PBO, improved patients’ HRQoL, including fatigue and pain.

Juvenile Fibromyalgia in Patients With Juvenile Idiopathic Arthritis: Utility of the Pain and Symptom Assessment Tool.

To evaluate the proportion of children with juvenile idiopathic arthritis (JIA) who met criteria for comorbid juvenile fibromyalgia (FM) using the Pain and Symptom Assessment Tool (PSAT), and to identify clinical and demographic differences among JIA patients with and without juvenile FM. Patients ages 11-17 years with JIA were recruited from 4 North American pediatric rheumatology centers. Each patient completed the PSAT. Additional clinical and disease activity measures included pain visual analog scale, patient global assessment of disease activity (PtGA) and physician global assessment of disease activity (PhGA), the Functional Disability Inventory (FDI), and the Pain Catastrophizing Scale in children. Of 129 patients, 11 met criteria for juvenile FM. FDI scores were markedly higher in patients who tested positive for juvenile FM, with a mean of 24.8 compared to 6.9 in patients without juvenile FM (P < 0.001). Pain catastrophizing scores were also significantly higher, by ~14 points, in patients with juvenile FM. There was a significant tendency for patients to give higher disease activity scores than physicians, which was more marked among patients with juvenile FM. In patients with juvenile FM, PtGA scores exceeded PhGA scores by a mean of 3.7, compared to a mean of 0.7 among patients without juvenile FM (P < 0.001). A minority of JIA patients (8.5%) met criteria for juvenile FM. This group demonstrated markedly more functional impairment. PtGA scores were strikingly higher than PhGA scores among patients with JIA who met juvenile FM criteria, suggesting that providers might consider a more expansive approach to chronic pain and non-musculoskeletal symptom assessment and treatment in JIA patients.

The serum uric acid is longitudinally related to patients global assessment of disease activity in male patients with axial spondyloarthritis

ObjectivesTo investigate longitudinal relationship between serum uric acid (SUA) and disease activity among Chinese males with axial spondyloarthritis (axSpA).MethodsTwo-year data from the NASA study cohort of male patients with axial spondyloarthritis were analyzed. Patients global assessment of disease activity (PtGA), BASDAI, ASDAS-CRP, BASFI, and SF-36 were used as the outcomes. The autoregressive Generalized Estimation Equation (GEE) model was used to investigate the longitudinal relationship between SUA and the above outcomes. Age and gender and symptom duration were tested as effect modifiers or confounders.ResultsIn total, 102 male axSpA patients were included, 33.3% of who were hyperuricemia at baseline. Over time,serum uric acid levels associated with the global assessment of patient global assessment of disease activity (PtGA)[P=0.041, β=-2.059,95%CI(-4.032, -0.086)], SF-36: Vitality (VT) [P=0.01, β=1.751, 95%CI (0.415,3.087)], SF-36: Social Functioning (SF)[P=0.002, β= 2.968,95%CI (1.067,4.869)]). And these relationgships were independent of age, symptom duration, baseline uric acid levels, and medication use.ConclusionsIn summary, SUA levels is longitudinally related to PtGA and mental health assessment. Age, gender and symptom duration do not have an impact on the relationships.

Baseline characteristics of children with juvenile dermatomyositis enrolled in the first year of the new Childhood Arthritis and Rheumatology Research Alliance registry

BackgroundTo report baseline characteristics, patient reported outcomes and treatment of children with Juvenile Dermatomyositis (JDM) in the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry.MethodsChildren newly diagnosed with JDM were enrolled in the CARRA Registry from 41 pediatric rheumatology centers. Baseline patient demographics, disease characteristics, assessments, patient reported outcome and treatments were recorded.ResultsIn the first year, 119 JDM participants were enrolled. Most were female (63.4%), and white (72.3%) with a median diagnosis age 8.0 years (IQR 4.0–11.5), and median age of disease onset 7.0 years (IQR 3.5–7.5). They had characteristic rashes (92.4%), elevated muscle enzymes (83.2%), physician global score 4.0 (IQR 2.5–5.0) and manual muscle testing score 63.5 (IQR 51.0–75.0). Calcinosis (3.4%) and interstitial lung disease (< 1%) were uncommon. Myositis specific antibodies were measured and reported in nearly half of participants enrolled where anti-MJ followed by Anti-p155/140 were most common (11/49 and 7/53 respectively).Childhood Health Assessment Questionnaire (CHAQ) results showed mild-moderate disability (median 0.750, IQR 0.030–1.875), as did patient/parent global assessments of disease activity (median 3, patient IQR: 1.75–5.25; parent IQR: 1–7). Patient Reported Outcomes Measurement Information System (PROMIS®) Pediatric Global Health 7 scores, Pain Interference, Physical Function scores for Mobility, and Upper Extremity Function were commonly worse than 95% of the general pediatric population.ConclusionsIn its inaugural year, 119 JDM patients were successfully enrolled in participapte in the New CARRA Registy. This registry will provide the necessary foundation to advance clinical research to improve outcomes using traditional measures and patient reported outcomes. With the CARRA biorepository, this infrastructure will enable future translational research. Together, these efforts may aid in future clinical trials, including comparative effectiveness trials.

Validation of the parent global assessment as a health-related quality of life measure in juvenile idiopathic arthritis: results from ReACCh-Out.

To (i) validate the JIA parent global assessment (parent global) as a health-related quality of life (HRQoL) instrument; (ii) evaluate measurement properties of accepted HRQoL measures relative to those of the parent global; and (iii) assess causal pathways determining parent global scores. Data from the Research in Arthritis in Canadian Children emphasizing outcomes (ReACCh-Out) cohort were used. Measurement properties were assessed in 344 patients at enrolment and 6 months later. Causal pathways were tested by structural equation modelling to understand root causes and mediators leading to parent global scores. Construct validity was supported by Spearman correlations of 0.53-0.70 for the parent global with the Juvenile Arthritis Quality of Life Questionnaire, Quality of My Life health scale (HRQoML), Pediatric Quality of Life Inventory (PedsQL)-Parent, and Child Health Questionnaire (CHQ)-Physical. Exceptions were PedsQL-Child (0.44) and CHQ-Psychosocial (0.31). Correlations were lower (0.14-0.49) with disease activity measures (physician global assessment of disease activity, active joint count, ESR). Responsiveness of the parent global to improvement according to parent ratings (0.51) was acceptable and within the range (0.32-0.71) of that of other measures. Reliability estimates and measurement errors for all measures were unsatisfactory, likely due to the prolonged time between assessments. Causal pathways for the parent global matched those previously reported for HRQoML. Our results offer support for the parent global as a valid measure of HRQoL for JIA. If confirmed, existing studies using the parent global may be re-interpreted, enhancing our knowledge of HRQoL in children with JIA.

Myeloid-related protein 8/14 in plasma and serum in patients with new-onset juvenile idiopathic arthritis in real-world setting in a single center

ObjectiveThe aim of this study was to analyze the usefulness of myeloid-related protein 8/14 (MRP8/14) in the prediction of disease course in a real-world setting for patients with new-onset juvenile idiopathic arthritis (JIA), to identify the relationship between MRP8/14 and disease activity using the physician’s global assessment of disease activity (PGA), and determine whether the MRP8/14 levels measured in serum and plasma are equally useful.MethodsIn this prospective follow-up study, 87 new-onset non-systemic JIA patients were studied. Blood and synovial fluid samples were collected prior to any antirheumatic medication use. MRP8/14 was measured from serum (S-MRP8/14), plasma (P-MRP8/14), and synovial fluid samples using ELISA.ResultsThe baseline MRP8/14 blood levels were significantly higher in patients using synthetic antirheumatic drugs than in patients with no systemic medications at 1 year after diagnosis in serum (mean 298 vs. 198 ng/ml, P < 0.001) and in plasma (mean 291 vs. 137 ng/ml, P = 0.001). MRP8/14 levels at the time of JIA diagnosis were higher in patients who started methotrexate during 1.5-year follow-up compared to those who achieved long-lasting inactive disease status without systemic medications (serum: mean 298 vs. 219 ng/ml, P = 0.006 and plasma: 296 vs. 141 ng/ml, P = 0.001). P-MRP8/14 was the most effective predictive variable for disease activity (by PGA) in linear multivariate regression model (combined to ESR, CRP, leukocytes, and neutrophils), whereas S-MRP8/14 was not significant.ConclusionBlood MRP8/14 levels at baseline seem to predict disease course in new-onset JIA patients. P-MRP8/14 might be better than S-MRP8/14 when assessing disease activity at the time of JIA diagnosis.

Subjective symptoms contributing to the quality of life of rheumatoid arthritis patients with clinical remission from the IORRA database.

To explore patient-reported outcomes (PROs) related to quality of life (QOL) in patients with rheumatoid arthritis (RA) who achieved clinical remission. In the Institute of Rheumatology, Rheumatoid Arthritis dataset, RA patients >18 years old who met the simplified disease activity index (SDAI) remission criteria in April 2017 were enrolled in this analysis. Pain-visual analogue scale (pain-VAS) (0-100 mm), patient's global assessment of disease activity (Pt-GA; 0-100 mm), Japanese version of the Health Assessment Questionnaire, duration of morning joint stiffness, and fatigue [Checklist Individual Strength 8R (CIS)] were the tools used to evaluate PROs. To assess the contribution of each PRO to the European QOL-5 Dimensions-5 Level (EQ-5D-5L) score, an analysis of variance was conducted. Among the 2443 patients with remission, the mean EQ-5D-5L was 0.9. The mean pain-VAS and Pt-GA were 7.2 and 7.4, respectively. Factors that significantly contributed to the EQ-5D-5L were pain-VAS (48.8%), CIS score (18.1%), and Pt-GA (15.6%). Around 82.5% of the variance in EQ-5D-5L was explained by the three PROs. This study demonstrated that pain-VAS, CIS, and Pt-GA were significant contributors to the EQ-5D-5L score in patients with RA who achieved the simplified disease activity index remission criteria.

Improved patient-reported outcomes in patients with psoriatic arthritis treated with risankizumab: analysis of the Phase 3 trial KEEPsAKE 2

ObjectivesDetermine the impact of 24-week risankizumab (RZB) versus placebo (PBO) on patient-reported outcomes (PROs) in patients with psoriatic arthritis (PsA) and inadequate response to one or two biologics (Bio-IR) and/or...

Inflammatory correlates of the Patient Global Assessment of Disease Activity vary in relation to disease duration and autoantibody status in patients with rheumatoid arthritis

ObjectiveTo investigate the associations between the Patient Global Assessment (PGA) and measures of disease activity in patients with rheumatoid arthritis (RA) in relation to disease duration and autoantibody status.Methods1412 patients...

AB0904 Evaluating Numeric Rating Scale Versions of the 3 and 4 Visual Analog Scale (3/4-VAS) Composite Measures in Patients with Active Psoriatic Arthritis from the SELECT-PsA Program

BackgroundThe multifaceted nature of psoriatic arthritis (PsA) can make it challenging to evaluate treatment targets and disease activity. Moreover, most existing assessment tools are time-consuming and not always feasible in routine clinical care, indicating a need for new disease measures that are easy to perform and calculate. Composite measures using 3-visual analog scale (VAS; physician’s global assessment, patient’s global assessment, and skin) or 4-VAS (physician’s global assessment, joints, skin, and pain) have been proposed as simpler alternatives.1 Given potential advantages of numeric rating scales (NRS) over VAS, we here adapted 3/4-VAS for use with NRS components and tested its validity via post hoc analysis of the upadacitinib (UPA) SELECT-PsA program.ObjectivesEvaluate the ability of 3/4-NRS scores to assess treatment response in SELECT-PsA 1 and 2, as well as the correlation of 3/4-NRS with other common disease activity measures.MethodsData are from the SELECT-PsA 1 and 2 phase 3 trials in patients with prior inadequate response or intolerance to ≥1 non-biologic DMARD or ≥1 biologic DMARD, respectively. In both trials, patients received once daily UPA 15 mg, UPA 30 mg, or placebo (PBO); SELECT-PsA 1 also included the active comparator adalimumab (ADA) 40 mg every other week (wk). 3-NRS scores were determined using the mean of SAPS questions 1–10, physician’s global assessment of disease activity, and patient’s global assessment of disease activity; 4-NRS scores were determined using the mean of SAPS questions 1–10, physician’s global assessment of disease activity, patient’s assessment of pain, and BASDAI question 3 related to joint pain and swelling. The 3/4-NRS scale ranges from 0 (no disease activity) to 10 (severe activity). 3/4-NRS and cDAPSA (DAPSA without the CRP component) were assessed at all available visits through wk 56. Correlations between 3/4-NRS with PsA disease activity score (PASDAS), routine assessment of patient index data 3 (RAPID3), DAPSA, cDAPSA, and other disease activity measures were determined by nonparametric Spearman rank correlation coefficient for UPA 15 mg patients from both trials and ADA for SELECT-PsA 1. All data are shown as observed; nominal p-values are provided throughout.ResultsA total of 1281 and 423 patients were included from SELECT-PsA 1 and 2, respectively. For both cDAPSA and 3/4-NRS scores, patients receiving UPA 15 mg showed clear numerical improvements compared with PBO at wk 24 in both trials (Table 1). 3/4-NRS scores were highly correlated with RAPID3 and PASDAS measures (r &gt;0.6, P &lt;0.0001) for UPA 15 mg patients at baseline (Figure 1). Moderate correlations were observed between 3/4-NRS and DAPSA/cDAPSA (r = ~0.4, P &lt;0.0001), as well as physical function (HAQ-DI) and quality of life measures (SF-36). Nominally significant but weaker correlations were detected for joints, skin, and other disease activity assessments. Similar overall results were observed for patients receiving ADA.Table 1.3/4-NRS and cDAPSA Disease Activity Scores at Week 24 and 56 (As Observed)SELECT-PsA 1Wk 24Wk 56Mean score [n]PBOUPA 15 mgADAUPA 15 mgADA3-NRS3.7 [370]2.2 [398]2.4 [398]1.8 [372]2.0 [359]4-NRS3.8 [367]2.3 [392]2.6 [395]1.9 [367]2.2 [357]cDAPSA24.0 [372]14.9 [399]16.6 [400]10.2 [372]11.3 [358]SELECT-PsA 2Wk 24Wk 56Mean score [n]PBOUPA 15 mgUPA 15 mg3-NRS4.7 [172]2.9 [190]2.4 [164]4-NRS4.9 [170]3.1 [188]2.7 [162]cDAPSA37.1 [172]21.6 [190]15.3 [166]3/4-NRS ranges from 0–10; cDAPSA ranges from 0–154. Lower scores indicate decreased disease activity.Conclusion3/4-NRS was able to successfully discriminate between PBO and therapeutic groups in SELECT-PsA 1 and 2. 3/4-NRS scores correlated well with other clinical and patient reported outcome measures, including those focused on joints (DAPSA) or multiple manifestations (PASDAS), supporting 3/4-NRS as a viable and easy to use tool in daily clinical practice.

POS1039 DEUCRAVACITINIB, AN ORAL, SELECTIVE TYROSINE KINASE 2 INHIBITOR, IN A PHASE 2 TRIAL IN PSORIATIC ARTHRITIS: ACHIEVEMENT OF MINIMAL DISEASE ACTIVITY AND ITS COMPONENTS

BackgroundTyrosine kinase 2 (TYK2) is an intracellular kinase in the Janus kinase (JAK) family that mediates the signalling of multiple cytokines, including those central to the immunopathogenesis of psoriatic arthritis (PsA), such as IL-23. Deucravacitinib (DEUC) is a novel, oral, selective, allosteric inhibitor of TYK2 that acts by binding to the unique regulatory domain on the enzyme. In a Phase 2 trial in patients with active PsA, DEUC was significantly more efficacious than placebo (PBO) after 16 weeks of treatment and was well tolerated.1ObjectivesThis analysis further evaluated the effect of DEUC in this trial on achievement of individual components of minimal disease activity (MDA).MethodsThis double-blind, multicenter Phase 2 trial (NCT03881059) enrolled patients (n=203) with a PsA diagnosis ≥6 months who fulfilled Classification Criteria for Psoriatic Arthritis at screening and had active joint disease (≥3 tender and ≥3 swollen joints), high-sensitivity C-reactive protein ≥3 mg/L, and ≥1 plaque psoriasis lesion (≥2 cm). Eligible patients had failed or were intolerant to ≥1 nonsteroidal anti-inflammatory, conventional synthetic DMARD, and/or 1 tumour necrosis factor inhibitor (≤30%). Patients were randomized 1:1:1 to receive PBO, DEUC 6 mg once daily (QD), or 12 mg QD. The percentage of patients achieving MDA (5/7: tender joint count [TJC] ≤1, swollen joint count [SJC] ≤1, tender entheseal points [TEP] ≤1, Patient Global Assessment of disease activity [PtGA] ≤20, Patient Global Assessment of pain [Pain] ≤15, Health Assessment Questionnaire-Disability Index [HAQ-DI] ≤0.5, and Psoriasis Area and Severity Index [PASI] ≤1 or body surface area [BSA] ≤3%) as well as proportions of patients achieving each of the MDA components in all patients, MDA responders, and nonresponders were assessed through Week 16.ResultsOf 203 patients randomized, 180 (89%) completed 16 weeks of treatment (PBO, 58/66 [88%]; DEUC 6 mg QD, 63/70 [90%]; DEUC 12 mg QD, 59/67 [88%]). Demographic and baseline disease characteristics were generally similar across groups. Although no patient had met 5 of 7 criteria required for achieving MDA at baseline, several individual components of MDA were met at baseline, most frequently TEP ≤1 (PBO, 57.6%; DEUC 6 mg QD, 64.3%; DEUC 12 mg QD, 65.7%). After 16 weeks of treatment, 7.6%, 22.9%, and 23.9% of patients in the PBO, DEUC 6 mg QD, and DEUC 12 mg QD groups, respectively, achieved MDA response. Treatment with DEUC was associated with a numerically greater mean reduction from baseline in all MDA components versus PBO over 16 weeks of treatment in all patients. At Week 16, more patients receiving DEUC versus PBO achieved the threshold for each of the MDA components (Figure 1).ConclusionIn this study, patients treated with DEUC achieved a higher rate of MDA response compared with patients treated with PBO after 16 weeks of treatment. More patients receiving DEUC treatment achieved each of the MDA components compared with patients receiving PBO.

OP0148 THE ASAS CORE MEASUREMENT SET FOR AXIAL SPONDYLOARTHRITIS

BackgroundRecently, the core domains of the 20-years old core outcome set for ankylosing spondylitis were updated.1 The next step is to define the measurement core set, which includes at least one instrument for each domain.ObjectivesTo define the instruments for the ASAS-OMERACT core outcome set for axial spondyloarthritis (axSpA).MethodsThe scientific committee invited an international working group representing all key stakeholders (patients, rheumatologists, health professionals and pharmaceutical industry). The instrument selection process is presented in Figure 1.Figure 1.Development process to determine the core measurement setResultsThe updated core measurement set for axSpA is shown in Table 1. This includes seven instruments for six domains that are mandatory for all trials: ASDAS and NRS patient global assessment for disease activity, NRS total back pain for pain, composite index for morning stiffness, NRS fatigue for fatigue, BASFI for physical function, and ASAS Health Index for overall functioning and health. There are 9 additional instruments for disease modifying drugs (DMARDs): two MRI activity scores (SPARCC SIJ and SPARCC spine) for disease activity, the three extra-musculoskeletal manifestations uveitis, IBD and psoriasis assessed as recommended by ASAS2, the three peripheral manifestations (44 swollen joint count, MASES and Dactylitis count2) and mSASSS for structural damage. The imaging outcomes are mandatory to be included at least in one trial for a drug that is considered to be a DMARD. The other instruments specific for DMARDs should be included in every trial. This core set is applicable to patients with radiographic and non-radiographic axSpA. Furthermore, 11 other instruments were also endorsed by ASAS and can additionally be used in axSpA trials: BASDAI, CRP, Berlin MRI-SIJ and MRI-spine activity scores for disease activity, NRS back pain at night for pain, severity (BASDAI Q5) and duration (BASDAI Q6) for morning stiffness, SF-36 for overall functioning and health, 66 swollen joint count and SPARCC enthesitis for peripheral manifestations and MRI-SIJ erosions scores (SPARCC SSS) for structural damage.Table 1.Updated core measurement set for axial spondyloarthritis.Instruments mandatory for all trialsDomainInstrument Disease activityASDASPatient global assessment of disease activity (NRS) PainNRS total back pain (BASDAI Q2) Morning stiffnessSeverity and duration (BASDAI (Q5+Q6)/2)) FatigueNRS fatigue (BASDAI Q1) Physical functionBASFI Overall functioning &amp; healthASAS Health IndexAdditional instruments mandatory for disease modifying drugs trials Disease activitySPARCC MRI-SIJ*SPARCC MRI-spine* Extra-musculoskeletal manifestationsuveitis (ASAS CRF)2psoriasis (ASAS CRF)2inflammatory bowel disease (ASAS CRF)2 Peripheral manifestations44 Swollen joint countMASESDactylitis count (ASAS CRF)2 Structural damagemSASSS**Needs to be assessed at least once in a disease modifying drug programme; 2Dougados M, et al. Ann Rheum Dis 2012;71(6):1103-04. ASDAS: Ankylosing Spondylitis Disease Activity Score; NRS: Numerical Rate Scale; BASDAI: Bath Ankylosing Spondylitis Disease Activity Index; Q: question; BASFI: Bath Ankylosing Spondylitis Functional Index; SPARCC: SpondyloArthritis Research Consortium of Canada Scoring System; MRI: Magnetic Resonance Imaging; SIJ: Sacroiliac Joint; CRF: Case Report Form; MASES: Maastricht Ankylosing Spondylitis Enthesitis Score; mSASSS: modified Stoke Ankylosing Spondylitis Spinal Score.ConclusionThe previous core measurement set has been updated and endorsed by ASAS for the use in all axSpA trials.

POS1090 THE IMPACT OF NUMBER OF COMORBIDITIES ON ACHIEVEMENT REMISSION OR LOW DISEASE ACTIVITY BY DAPSA IN PSORIATIC ARTHRITIS. DATA FROM THE RUSSIAN OBSERVATIONAL COHORT

BackgroundThe goal of psoriatic arthritis (PsA) treatment is achievement remission (REM) or Low Disease Activity (LDA) by DAPSA. The impact of comorbidities, especially obesity, metabolic syndrome on PsA activity and on biological treatment response are shown in some registry [1]. Obesity, hypertension and Charlson Comorbidity Index ≥1 are prognostic factors for poorer treatment outcome rates in PsA [2]. But influence of number of comorbidities on treatment response has not been fully studied in real practiceObjectivesTo evaluate the impact of number of comorbidities on achievement remission by DAPSA in PsA ptsMethods528 pts (M/F=256 (48.5%)/272 (51.5%) with PsA according to CASPAR criteria were included in the Russian observational cohort. Mean age 48.7±12.33 years (yrs.), PsA duration 122.6±81.85 months (mo.), psoriasis (Ps) duration 239.0±155.45 mo. Pts who completed ≥2 visits were analyzed. Mean observational period 73.6±83.47 mo.All pts underwent standard clinical examination: tender joint count (TJC)/68, swollen joint count (SJC)/66, Pain (VAS), Patient global assessment of disease activity (PtGA, VAS), CRP mg/l, BSA (%), BMI, HAQ, comorbidities by ICD-10, X-ray of hands and foods. DAPSA&gt;28 indicates as high disease activity (HDA), &gt;14-28 - moderate activity (MoDA), &gt;4-14 – LDA, ≤4 – REM. Analyses were performed based on number of comorbidities: 1st group (gr) - without comorbidities, 2nd gr – pts with 1 comorbidity, and 3rd gr – pts with ≥ 2 comorbidities. M±SD, %, t-test, Peаrson-χ2, ORs with 95% CI were calculated. All p&lt;0.05 were considered to indicate statistical significanceResultsIn 236 out of 528 (44.7%) pts no comorbidity found, in 145 out of 528 (27.5%) found 1 comorbidity and 147 out of 528 (27.8%) pts had ≥ 2 comorbidities.Comparative analysis in groups showed the following features: pts of 3rd gr were significantly more often females, had longer Ps and PsA duration, they were older, had worse HAQ, higher BMI, TJC (p&lt;0.05). Joint erosions were found significantly more often in the 2nd gr compared to the 1st gr (p=0.02). No significant differences were in the frequency of axial PsA (p=0.906), Ps severity (BSA&gt;10%) (p=0.237), the number of pts receiving bDMARDs (p=0.078). REM/LDA achievement according to DAPSA was significantly lower in the 3rd gr (15 (10,2%)/69(46.9%) comparing to the 1st gr (62 (26,3%)/94 (39.8%), and to the 2nd gr (32 (22,1%)/69 (47.6%) (p=0.007). The probability of achieving REM/LDA is 1.6 times lower in the gr of pts with ≥2 comorbidities compared to the gr of pts without comorbidities (OR 0.608, 95% CI 0.394 to 0.936) and 1.3 times lower compared to gr of pts with 1 comorbidity (OR 0.789, 95% CI 0.489 to 1.243) (Figure 1)Figure 1.Chances of REM/LDA achievement in pts with ≥2 comorbidities compared to pts with 1 comorbidity and pts without comorbiditiesConclusionIn real clinical practice comorbidities were seen in more than half PsA pts. Third of PsA pts had number of comorbidities. PsA pts with number of comorbidities are associated with high disease activity, reduced quality of life and are 1,6 times more likely to have no chance to attain REM/LDA by DAPSA. It should be considered for personalized treatmentReferences[1]Ballegaard C, et al. Arthritis Care Res (Hoboken). 2018;70(4):592-599. doi: 10.1002/acr.23333[2]Ballegaard C, et al. Rheumatology, 60(7), 2021: 3289-300, https://doi.org/10.1093/rheumatology/keaa780AcknowledgementsThe RU-PsART study groupDisclosure of InterestsYulia Korsakova Speakers bureau: Novartis, ELENA GUBAR: None declared, Elena Loginova Speakers bureau: Janssen,, Tatiana Korotaeva Speakers bureau: Pfizer, Novartis, MSD, AbbVie, Janssen, JSC BIOCAD, UCB, Lilly and Novartis-Sandoz, Consultant of: Pfizer, Novartis, MSD, AbbVie, Janssen, JSC BIOCAD, UCB, Lilly and Novartis-Sandoz, Valentina Sorotskaya: None declared, Irina Patrikeeva: None declared, Pavel Shesternya: None declared, Irina Umnova: None declared, Evgeny Nasonov: None declared

POS1013 HOW DOES BODY MASS INDEX AFFECT SECUKINUMAB TREATMENT OUTCOMES AND SAFETY IN PATIENTS WITH PSORIATIC ARTHRITIS? – REAL WORLD DATA FROM THE GERMAN AQUILA STUDY

BackgroundThere is a higher prevalence of obesity in patients (pts) with psoriatic disease1. The German non-interventional study AQUILA provides real-world data on the influence of body mass index (BMI) of pts with psoriatic arthritis (PsA) on therapeutic effectiveness and safety under treatment with secukinumab, a fully human monoclonal antibody that selectively inhibits IL-17A.ObjectivesThe aims of this interim analysis are to describe selected baseline (BL) demographics and to evaluate secukinumab treatment outcomes on disease activity and impact of disease on health and to report safety profile depending on the BMI of PsA pts.MethodsAQUILA is an ongoing, multi-center study including up to 3000 pts with active PsA or ankylosing spondylitis. Pts were observed from BL up to week (w) 52. Real-world data were assessed prospectively and analyzed as observed. Data were collected on Psoriatic Arthritis Impact of Disease-12 items (PsAID-12 score) and Patient’s Global Assessment (PGA). For calculation of proportion of pts that experienced (serious) adverse events ((S)AEs), all PsA pts were included that received at least one dose of secukinumab. This interim analysis focuses on BMI subgroups ≤25 kg/m2 (normal weight), &gt;25 to ≤30 kg/m2 (overweight) and &gt;30 kg/m2 (obese) in PsA pts.ResultsAt BL, BMI data were available for 1228 PsA pts: 26.5% (n=325) normal weight, 35.0% (n=430) overweight and 38.5% (n=473) obese PsA pts. Proportion of men was lower in normal weight and obese PsA pts. As BMI increased, so did age and comorbidities/extraarticular manifestations (EAMs; Table 1); e.g. percentage of PsA pts with heart-related disease increased from 5.2% in normal weight to 9.3% in obese PsA pts.Table 1.Overview of baseline characteristics in PsA pts depending on BMIDemographicsBMI ≤25 kg/m2(N=325)BMI &gt;25 to ≤30 kg/m2(N=430)BMI &gt;30 kg/m2(N=473)Male*105 (32.3)219 (50.9)188 (39.7)Age, years**49.5 (±12.7)53.2 (±11.0)54.1 (±10.6)PsAID**4.7 (2.4)4.9 (2.2)5.4 (2.0)PGA**4.8 (2.6)5.4 (2.4)5.5 (2.4)Comorbidities/EAMs* Heart-related disease17 (5.2)29 (6.7)44 (9.3) Coronary heart disease10 (3.1)25 (5.8)35 (7.4) Stroke1 (0.3)9 (2.1)11 (2.3) Heart insufficiency9 (2.8)15 (3.5)15 (3.2) Uveitis5 (1.5)6 (1.4)10 (2.1) Depression137 (53.5)190 (55.2)231 (58.5)*variables are given as n (%); **variables given as mean (SD)Mean PsAID at BL was similar for all BMI subgroups (≤25: 4.7; &gt;25-≤30: 4.9; &gt;30: 5.4; Figure 1A). Mean improvement from BL to w52 was 1.9 (40.4%) for normal weight, 1.8 (36.7%) for overweight, and 1.7 (31.5%) for obese PsA pts.Figure 1.Impact of disease and PGA in PsA pts stratified by BMI.Note: p-values are of exploratory nature. Wilcoxon tests were used to show significant subroup differences.Mean PGA developed in a similar way over time with lowest scores for normal weight and highest scores for obese PsA pts (Figure 1B). Mean improvement from BL to w52 was 2.0 (41.6%) for normal weight, 2.2 (40.7%) for overweight, and 1.8 (32.7%) for obese PsA pts.The occurrence of AEs/SAEs with or without suspected relationship to secukinumab was most frequent in overweight and obese PsA pts. For example, the percentage of SAEs in normal weight PsA pts was 21.6%, in overweight 26.3% and in obese 25.9%. There were no unexpected safety signals in either subgroup. One male obese PsA patient died. Cause of death was not reported, however, treating physician did not suspect a causal relationship to secukinumab.ConclusionIn a real-world setting, secukinumab improved impact of disease and patient´s global assessment of disease activity in all BMI subgroups of PsA pts. However, normal weight PsA pts had numerically better PsAID and PGA scores than obese PsA pts. Altogether, real-world data of this interim analysis show that secukinumab is an effective treatment with a favorable safety profile up to 52 weeks in PsA pts in all BMI subgroups.

Disease characteristics in high versus low titers of rheumatoid factor or anti-citrullinated peptide antibody in rheumatoid arthritis patients

Aim of the workTo evaluate the impact of the level of rheumatoid factor (RF) or anti-citrullinated peptide antibody (ACPA) positivity on the clinical manifestations, disease activity, functional status, and treatment strategy among rheumatoid arthritis (RA) patients. Patients and methodsIn this study, 120 consecutive RA patients were grouped according to the level of RF or ACPA positivity. Group 1: patients with low positive RF or ACPA and Group 2: those with high titer. Disease activity score (DAS28) and functional status using modified health assessment questionnaire (MHAQ) were assessed ResultsThe patients mean age was 46.9 ± 10.9 years and female to male ratio was 7:1. 44 (36.7%) patients had low positive RF/ACPA titers, 59 (49.2%) had high titers and 17 (14.2%) had negative RF/ACPA and were excluded. Patients' global assessment of disease activity was significantly higher among patients with high RF/ACPA titer compared to those with low titer (p = 0.04) and MHAQ tended to be higher (p = 0.058). Subcutaneous nodules (p = 0.037) were more frequent among those with high RF/ACPA titer. The cumulative (p = 0.012) and the current (p = 0.006) steroid doses administered both turned out to be significantly higher in the high positive RF/ACPA patient group. ConclusionPatients with high titer RF and\\or ACPA have factors that may contribute to poor outcome as the presence of reduced functional status which indicated by the higher MHAQ score, the need for higher daily and cumulative steroid doses as an indirect indicator of increased disease activity and in turn poor outcome.

Effects of temporarily suspending low-dose methotrexate treatment for 2 weeks after SARS-CoV-2 vaccine booster on vaccine response in immunosuppressed adults with inflammatory conditions: protocol for a multicentre randomised controlled trial and nested mechanistic substudy (Vaccine Response On/Off Methotrexate (VROOM) study)

IntroductionIt is unknown if a temporary break in long-term immune-suppressive treatment after vaccination against COVID-19 improves vaccine response. The objective of this study was to evaluate if a 2-week interruption...

Musculoskeletal ultrasound may narrow the gap between patients and physicians in the assessment of rheumatoid arthritis disease activity.

To investigate the association between patient-physician discordance in the assessment of disease activity and residual US synovitis/tenosynovitis in a cohort of patients with RA in clinical remission. A post hoc analysis of the STARTER study, promoted by the Musculoskeletal-US (MSUS) Study Group of the Italian Society for Rheumatology, was performed using data from 361 consecutive patients with RA in clinical remission. The global assessment of disease activity by each patient (PGA) and evaluator/physician (EGA) was recorded on a 100-mm visual analogue scale. The PGA-EGA discordance was classified as positive (PGA>EGA) or negative (PGA<EGA) using a cut-off of ±10 mm. The association of discordance with greyscale (GS) and power Doppler (PD) synovitis (S) and tenosynovitis (T) scores was evaluated through logistic regression analysis. The odds ratio for each point of the scores, adjusted for prespecified confounders (adjOR), was calculated. The mean (s.d.) PGA and EGA scores were 6.1 (7.1) and 8.8 (12) mm, respectively, with a median (IQR) absolute difference of 4 (0-10) mm. Positive and negative discordances were recorded in 39 (10.8%) and 65(18.0%) patients, respectively. The GS-S (adjOR 1.099) and PD-S (adjOR 1.167) scores were associated with positive discordance (P < 0.01), while the GS-T (adjOR 1.083), GS-S (adjOR 1.063) and PD-S (adjOR 1.089) scores were associated with negative discordance (P < 0.05). The PGA-EGA discordance did not predict flares at 6 and 12 months. Patient-physician discordance is associated with the lack of US remission in patients with RA and may represent a further indication for MSUS.

P275 Association of the improvement of synovitis and enthesitis with quality of life/patient reported outcomes in patients with psoriatic arthritis treated with ixekizumab

Abstract Background/Aims Psoriatic arthritis (PsA) is an inflammatory rheumatic disease with manifestations including synovitis and enthesitis. During extensive study programs, IXE has shown a treatment effect across domains affected by PsA. Ixekizumab (IXE) is an IL17A inhibitor approved for the treatment of active PsA and axial SpA. We sought to determine whether there is any association between the improvement of synovitis with that of enthesitis from baseline (BL) through week (wk) 52 in patients (pts) with PsA treated with IXE. Additionally, the association between the improvement of synovitis and enthesitis on health-related quality of life and patient-reported outcomes was investigated. Methods Data from SPIRIT-P1 (NCT01695239), SPIRIT-P2 (NCT02349295) and SPIRIT-H2H (NCT03151551) were analysed. These were randomized, phase 3 trials involving pts with active PsA either biologic DMARD-naïve (P1, H2H) or TNF-inhibitor-experienced (P2). We examined the patient population randomised to IXE-treatment (80 mg of ixekizumab every 4 weeks [IXEQ4W]), that had both synovitis and enthesitis at BL. For each study, a standardisation procedure was applied to each study data in order to overcome the differences in score range between LEI and SJC. The Pearson correlation coefficient between improvement from BL in enthesitis and synovitis was calculated at each time point. The mean improvement in the SF-36 Physical Component Summary score [PCS], the Patient’s Global Assessment of Disease Activity [Pt GA], and the EuroQOL five dimensions [EQ5D]-visual analogue [VAS] score) was calculated over time for pts who reached or did not reach resolution of both enthesitis and synovitis at wk 52. Missing data were imputed with modified Baseline Carried Out Forward (mBOCF) for continuous outcomes. Non-responder imputation was used for pts with missing resolution of enthesitis or synovitis. Results At BL, 68 (63% of patients treated with IXEQ4W in the ITT population), 68 (56%) and 159 (56%) pts from P1, P2 and H2H respectively, had both synovitis and enthesitis. In all 3 trials, the standardized mean change from baseline in synovitis and enthesitis showed a similar pattern over time. When statistically significant, Pearson correlation coefficient values ranged from 0.16 to 0.40, indicating a positive association between mean improvement in synovitis and enthesitis. We observed an improvement of SF-36 over the 52 wks regardless of the resolution of synovitis or enthesitis. The most pronounced improvement was shown by pts achieving resolution of both synovitis and enthesitis, followed by the pts achieving one or the other. Conclusion Across the SPIRIT trials, treatment with IXE led to the significant improvement in synovitis and enthesitis with a positive association between the improvement of both. Furthermore, pts that resolved both measures at wk 52 experienced an earlier and greater improvement in the SF-36 Physical Component Scale. Disclosure D. McGonagle: Corporate appointments; D. McGonagle has undertaken research and/or educational program activity with: AbbVie, Celgene, Johnson &amp; Johnson, Merck Sharp &amp; Dohme, Pfizer, and UCB Pharma. L. Kristensen: Consultancies; AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Janssen, Merck Sharp &amp; Dohme, Novartis, Pfizer, and UCB Pharma. Member of speakers’ bureau; AbbVie, Amgen, Biogen, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Janssen, Merck Sharp &amp; Dohme, Novartis, Pfizer, and UCB Pharma. Grants/research support; Biogen, Janssen Cilag, and UCB Pharma. M. Rudwaleit: Consultancies; AbbVie, Bristol Myers Squibb, Celgene, Chugai Pharmaceutical/Roche, Eli Lilly and Company, Janssen, Merck Sharp &amp; Dohme, Novartis, Pfizer, and UCB Pharma. H. Kameda: Consultancies; AbbVie, Asahi Kasei Pharma, Astellas, Bristol Myers Squibb, Chugai Pharmaceutical, Eisai, Eli Lilly and Company, Janssen, Mitsubishi Tanabe Pharma, Novartis, Sanofi, and Takeda. Member of speakers’ bureau; AbbVie, Asahi Kasei Pharma, Astellas, Bristol Myers Squibb, Chugai Pharmaceutical, Eisai, Eli Lilly and Company, Janssen, Mitsubishi Tanabe Pharma, Novartis, Sanofi, and Takeda. T. Holzkaemper: Shareholder/stock ownership; Eli Lilly and Company. C. El Baou: Other; C. El Baou is an independent contractor working for: Eli Lilly and Company. J. Smolen: Consultancies; AbbVie, Amgen, AstraZeneca, Astro Pharma, Bristol Myers Squibb, Celgene, Celltrion, Chugai Pharmaceutical, Eli Lilly and Company. Grants/research support; Gilead Sciences, GlaxoSmithKline, ILTOO Pharma, Janssen, MedImmune, Merck Sharp &amp; Dohme, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi, and UCB Pharma.

Intensive Serum Urate Lowering With Oral Urate-Lowering Therapy for Erosive Gout: A Randomized Double-Blind Controlled Trial.

To determine whether a therapeutic approach of intensive serum urate lowering results in improved bone erosion scores in patients with erosive gout. We undertook a 2-year, double-blind randomized controlled trial of 104 participants with erosive gout who were receiving serum urate-lowering therapy orally and who had serum urate levels of ≥0.30 mmoles/liter at baseline. Participants were randomly assigned to either an intensive serum urate target of <0.20 mmoles/liter or a standard target of <0.30 mmoles/liter (considered the standard according to rheumatology guidelines). Oral serum urate-lowering therapy was titrated to target using a standardized protocol (with the maximum approved doses of allopurinol, probenecid, febuxostat, and benzbromarone). The primary end point was the total computed tomography (CT) bone erosion score. Outcome Measures in Rheumatology (OMERACT) gout core outcome domains were secondary end points. Although the serum urate levels were significantly lower in the intensive target group compared to the standard target group over the study period (P = 0.002), fewer participants in the intensive target group achieved the randomized serum urate target level by year 2 (62% versus 83% of patients in the standard target group; P < 0.05). The intensive target group required higher doses of allopurinol (mean ± SD 746 ± 210 mg/day versus 497 ± 186 mg/day; P < 0.001) and received more combination therapy (P = 0.0004) compared to the standard target group. We observed small increases in CT bone erosion scores in both serum urate target groups over 2 years, with no between-group difference (P = 0.20). OMERACT core outcome domains (gout flares, tophi, pain, patient's global assessment of disease activity, health-related quality of life, and activity limitation) improved in both groups over 2 years, with no between-group differences. Adverse event and serious adverse event rates were similar between the groups. Compared to a serum urate target of <0.30 mmoles/liter, more intensive serum urate lowering is difficult to achieve with an oral urate-lowering therapy. Intensive serum urate lowering leads to a high medication burden and does not improve bone erosion scores in patients with erosive gout.

Drivers of non-zero physician global scores during periods of inactive disease in juvenile idiopathic arthritis

ObjectiveTo investigate the frequency in which the physician provides a global assessment of disease activity (PhGA) >0 and an active joint count (AJC)=0 in children with juvenile idiopathic arthritis (JIA)...