Health Assessment Questionnaire Research Articles

Safety and Efficacy of Radiosynoviorthesis: A Prospective Canadian Multicenter Study.

Radiosynoviorthesis is approved in several European countries and the United States to treat refractory synovitis in many inflammatory joint diseases, such as rheumatoid arthritis, spondyloarthropathies, and other arthritic joint diseases. No radiopharmaceuticals for radiosynoviorthesis are currently approved in Canada. The aim of this Health Canada-approved trial was to demonstrate the safety and efficacy of radiosynoviorthesis. Methods: Between July 2012 and November 2017, we conducted a multicenter, prospective, interventional Canadian trial. Patients (n = 360) with synovitis refractory to standard treatments after failing 2 intraarticular glucocorticoid injections were included. They were followed up at 3, 6, and 12 mo. Outcome measures included adverse events (AEs) and clinical signs of synovitis (pain, swelling, and joint effusion) measured with the Health Assessment Questionnaire Disability Index, the Disease Activity Score, and the Visual Analog Scale. Results: In total, 392 joints were treated, including those reinjected after 6 mo (n = 34). Of these, 83.4% (327/392) were injected with [90Y]Y-citrate for the knees and 9.9% (39/392) with [186Re]Re-sulfide for medium-sized joints. Of the joints treated, 82.7% (324/392) were knees. Fifty-five AEs, most of them of mild grade, occurred and resolved without sequelae and were not life-threatening. The incidence of radiosynoviorthesis-related AEs was 9.4% (34/360). The proportion of patients showing an improvement in synovitis symptoms after radiosynoviorthesis was significant at 3 mo and was maintained up to 12 mo (P < 0.001). Conclusion: This study confirmed the safety of radiosynoviorthesis in the treatment of patients with synovitis refractory to standard treatments. There is evidence of sustained clinical efficacy at 12 mo, suggesting that radiosynoviorthesis is an effective treatment for improving synovitis symptoms.

Safety and efficacy of monthly high-dose vitamin D3 supplementation in children and adolescents with sickle cell disease.

Little is known about the impact of vitamin D supplementation on hand grip strength (HGS) and health-related quality of life (HRQoL) in children and adolescents with sickle cell disease (SCD). We aimed to evaluate the safety and efficacy of monthly high-dose vitamin D3 supplementation and its implications on bone mineral density (BMD), HGS, and HRQoL in patients with SCD and healthy controls. The study included 42 children with SCD and 42 healthy matched controls. The study participants were supplemented with high-dose monthly oral vitamin D3. Changes in the serum level of 25(OH) vitamin D3, maximum HGS, and BMD from baseline to 6months were assessed, and the HRQoL questionnaire and Childhood Health Assessment Questionnaire (CHAQ) were used to evaluate the functional capacity. At baseline, SCD subjects had poorer growth status indicated by negative Z scores. Suboptimal BMD was detected by significantly lower Z score, and lower HGS and worse HRQL parameters were found compared to the controls (P < 0.001). Median 25(OH) vitamin D3 was significantly lower in SCD patients compared to controls (16.5 vs. 28ng/mL, respectively (P < 0.001)). After 6months of vitamin D supplementation, there was significant improvement in the DEXA Z-score (P < 0.001), limitation of physical health (P = 0.02), pain scores (P < 0.001), and CHAQ grades (P = 0.01) in SCD patients. A significant improvement in HGS (P < 0.001 and P = 0.005) as well as the CHAQ score (P < 0.001 and P = 0.003) was detected in the SCD group and controls, respectively. There were no reported clinical adverse events (AEs) or new concomitant medications (CMs) during the study duration, and safe levels of Ca and 25 (OH) D3 were observed at 3 and 6months for both groups. There was a significant positive correlation between HGS and total physical score (r = 0.831, P < 0.001) and a negative correlation with CHAQ score (r = - 0.685, P < 0.001). We also detected a significant positive correlation between vitamin D levels at 6months and HGS (r = 0.584, P < 0.001), pain score (r = 0.446, P < 0.001), and a negative correlation with CHAQ score (r = - 0.399, P < 0.001). Conclusion: Monthly oral high-dose vitamin D supplementation was safe and effective in improving vitamin D levels, HGS, and HRQoL in SCD children and healthy subjects, and BMD scores in SCD patients. Further randomized controlled trials are warranted to assess an optimal dosing strategy and to investigate the impact on clinically significant outcomes in children and adolescents with SCD and their healthy counterparts. Trial registration: ClinicalTrials.gov , identifier NCT06274203, date of registration: 23/02/2024, retrospectively registered. What is known: • Several studies have reported a high prevalence of vitamin D deficiency and suboptimal bone mineral density (BMD) in sickle cell disease (SCD) patients. • Musculoskeletal dysfunction is reported in SCD patients with a negative impact on physical activity and health-related quality of life (HRQL). • Little is known regarding the impact of vitamin D3 supplementation in children and adolescents with SCD. What is new: • We found that monthly oral high-dose vitamin D3 supplementation was safe, tolerated, and effective in improving serum vitamin D levels, HGS, BMD scores, and HRQL in SCD patients.

Long term use of interleukin-1 inhibitors reduce flare activity in patients with fibrodysplasia ossificans progressiva.

Fibrodysplasia ossificans progressiva (FOP) is one of the most catastrophic forms of genetic heterotopic ossification (HO). FOP is characterized by severe, progressive inflammatory flare-ups, that often lead to HO. The flare-ups are associated with increased inflammatory cytokine production, suggesting auto-inflammatory features driven by interleukin-1β (IL-1β). This study describes the short- and long-term responses of FOP patients to anti-IL-1 therapy. Previously, we reported that a patient with FOP treated with anti-IL-1 agents showed dramatically lower rates of flare-ups, improved flare-up symptoms, decreased use of glucocorticoids, and apparently decreased size of residual lesions. Plasma analyses also showed marked elevation in IL-1β levels during a FOP flare, further supporting a role of IL-1β in the pathogenesis of FOP flares. Here, we report results from long-term therapy with IL-1 inhibitors in that patient, and describe 3 additional patients, from two medical centers. All 4 patients showed persistent improvement in flare activity during treatment with IL-1 inhibitors, with minimal formation of new HO sites. Two patients who stopped therapy experienced resurgence of flare activity that was re-suppressed upon re-initiation. These patients had IL-1β levels comparable to those in IL-1β-driven diseases. Child Health Assessment Questionnaires confirmed extensive subjective improvements in the pain and general health visual analogue scales. This case series demonstrates significant benefits from IL-1 inhibitors for reducing flare activity and improving the general health of patients with FOP. These data provide strong support for additional studies to better understand the function of IL-1 inhibition, primarily in reducing formation new HO. RH received support from the International FOP Association ACT grant; ECH received support from NIH/NIAMS R01AR073015 and the UCSF Robert Kroc Chair in Connective Tissue and Rheumatic Diseases III.

Comprehensive analysis of the clinical manifestations and hematological parameters associated with secondary immune thrombocytopenia in patients with primary Sjögren syndrome: An observational study.

Primary Sjögren Syndrome (pSS) is a chronic autoimmune disease that primarily affects exocrine glands and can lead to various extraglandular manifestations, including secondary immune thrombocytopenia (ITP). Understanding the clinical and hematological differences in pSS patients with and without secondary ITP is crucial for improved patient management and treatment strategies. This retrospective study, conducted from January 2020 to December 2023, involved a cohort of pSS patients, dividing them into 2 groups: those with secondary ITP and those without. Patients were evaluated using the European League Against Rheumatism Sjögren Syndrome Disease Activity Index (ESSDAI), EULAR Sjögren Syndrome Patient-Reported Index (ESSPRI), Health Assessment Questionnaire, and other hematological parameters. Inclusion criteria were based on the American-European Consensus Group or ACR/EULAR classification criteria for pSS. Exclusion criteria included other autoimmune or hematological disorders, prior splenectomy, recent blood transfusions, and lack of informed consent. Statistical analysis was performed using SPSS software, with various tests applied to analyze the data, including logistic regression to identify risk factors for secondary ITP. Significant differences were noted in fatigue, lymphadenopathy, arthritis, mean age, and ESSDAI scores between the secondary ITP and non-secondary ITP groups. Patients with secondary ITP exhibited higher platelet counts, more prevalent lymphopenia, higher immunoglobulin G (IgG) levels, lower complement 3 levels, and reduced white blood cell and hemoglobin levels. Logistic regression analysis identified lymphadenopathy as a risk factor and arthritis as a protective factor for the development of secondary ITP. The study reveals distinct clinical and hematological characteristics in pSS patients with secondary ITP, suggesting a higher disease activity in this subset. These findings underscore the need for further exploration of these associations to develop more precise treatment approaches for pSS, focusing on preventing secondary ITP and improving patient outcomes.

Factors associated with discrepancies in disease activity as assessed by SDAI and RAPID3 in patients with rheumatoid arthritis: Data from a multicenter observational study (T-FLAG).

The present study aimed to examine discrepancies between assessments based on Routine Assessment of Patient Index Data 3 (RAPID3) and Simple Disease Activity Index (SDAI) in RA patients with controlled disease activity. Data from 464 RA patients in SDAI remission or low disease activity (REM/LDA) were analyzed. Patient-reported outcome (PRO) measures, including Health Assessment Questionnaire Disability Index (HAQ-DI), 25-question Geriatric Locomotive Function Scale (GLFS-25), and Kihon checklist (KCL), were assessed. Logistic regression models were used to identify factors associated with RAPID3 moderate or high disease activity (MDA/HDA). Cutoff values of RAPID3 MDA/HDA for each PRO evaluation item were determined using receiver operating characteristic curve analysis. Among RA patients in SDAI REM/LDA, 84.9% were in RAPID3 REM/LDA. Multivariable analysis revealed that HAQ-DI, GLFS-25, and KCL were independently associated with RAPID3 MDA/HDA. Subdomain analysis of KCL revealed that activities of daily living, physical function, cognitive function, and depressive mood were significantly associated with RAPID3 MDA/HDA. Cutoff values for HAQ-DI and KCL were 0.38 and 8, respectively. In RA patients with controlled disease activity, discrepancies between RAPID3 and SDAI assessments were observed, with factors such as HAQ-DI, GLFS-25, and KCL being independently associated with RAPID3 MDA/HDA.

Factors contributing to the improvement in J-HAQ after 3 years of treatment with abatacept in biologic-naïve rheumatoid arthritis patients: Interim results of a long-term, observational, multicentre study in Japan (ORIGAMI).

We investigated the long-term effectiveness, safety, and factors affecting Japanese Health Assessment Questionnaire (J-HAQ) improvement during abatacept treatment in Japanese rheumatoid arthritis (RA) patients. The ORIGAMI study is an ongoing observational study of biologic-naïve RA patients with moderate disease activity treated with subcutaneous abatacept (125 mg, once-weekly). Patients treated with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) were extracted from the Institute of Rheumatology, Rheumatoid Arthritis (IORRA) registry as an historical, weighted control group. The primary endpoint for this interim analysis was the proportion of patients with J-HAQ remission (score ≤0.5) at 3 years. Among 279 abatacept-treated and 220 csDMARD-treated patients, J-HAQ remission was achieved at 3 years in 40.5% (95% confidence interval [CI] 34.7%-46.2%) and 28.9% (95% CI 9.9%-47.8%), respectively. Age, RA duration <1 year, baseline J-HAQ score, and Simplified Disease Activity Index remission at 6 months were associated with 3-year J-HAQ remission in the abatacept group. Overall, 24/298 patients (8.1%; safety analysis set) experienced serious adverse drug reactions with an incidence of 5.3 per 100 person-years. This study confirmed the 3-year effectiveness and safety, and revealed potential factors associated with J-HAQ remission in biologic-naïve RA patients treated with abatacept in real-world clinical practice.

Influence of childhood trauma and traumatic stress on a woman's risk of having a child with a fetal alcohol spectrum disorder.

Maternal risk factors for having a child diagnosed on the fetal alcohol spectrum disorders (FASD) continuum are complex and include not only the quantity, frequency, and timing of alcohol use but also a woman's physical stature, socio-economic status, and pregnancy-related factors. Exposure to trauma may predispose women to a range of physiological and mental disorders. A woman's mental and physical health may in turn influence her probability of having a child with FASD. This study investigated the role of maternal childhood trauma and lifetime traumatic stress on prenatal alcohol consumption and on the risk of having a child with FASD. A nested, case-control study was conducted for maternal risk assessment. Study participants were mothers of first-grade learners from five rural communities in the Western Cape Province of South Africa who were assessed for FASD. Face-to-face surveys were conducted, which included mental health and trauma assessment questionnaires. In logistic regression analyses, higher maternal childhood trauma scores were associated with an increased likelihood of having a child diagnosed with FASD, although the increase in risk was modest (OR = 1.014, p = 0.015). In addition, structural equation modeling investigated relationships between maternal drinking, childhood trauma, traumatic stress, and a child's FASD diagnosis. Traumatic stress and drinking during pregnancy, but not lifetime alcohol use, were associated with maternal childhood trauma. Lifetime alcohol use influenced drinking during pregnancy, which in turn was significantly associated with having a child diagnosed on the continuum of FASD. No direct influence of maternal childhood trauma on FASD diagnosis could be demonstrated. However, maternal trauma may indirectly contribute to the risk of having a child diagnosed with FASD.

Axial Involvement in Psoriatic Arthritis: A Cross-sectional Clinical and Radiologic Studies.

This study aimed to investigate spinal involvement in psoriatic arthritis (PsA) patients using clinical and radiographic methods. A cross-sectional clinical study was conducted on 50 PsA patients diagnosed according to the CASPAR criteria. Clinical examinations and functional assessments were performed. A radiographic assessment of the spine was performed. Out of 50 PsA patients (mean age of 45.50 ± 9.90 years), (males and females constituted 27 (54.0%) and 23 (46.0%) respectively), 76% had radiological axial involvement; (26%) with inflammatory axial pain and (50%) without inflammatory axial pain (subclinical). Three axial radiographic patterns were detected including spondylitis without sacroiliitis (15.78%), spondylitis with sacroiliitis (78.94%), and sacroiliitis without spondylitis (5.26%). In axial PsA patients, males were more affected than females (χ2=11.679, p = 0.003), with older age (H = 15.817, p < 0.001) and higher body mass index (BMI) (F = 5.145, p = 0.010), increased psoriasis duration (H = 9.826, p = 0.007) and severity (Η=25.171, p < 0.001), and more spinal movement limitations than PsA patients without axial involvement (F = 26.568, p < 0.001). Cervical involvement was higher than lumbar involvement. Axial radiographic severity assessed by the PsA Spondylitis Radiology Index was associated with increased disability as assessed by the Health assessment questionnaire (rs = 0.533, p = 0.001) and decreased quality of life assessed by short form-36 score (rs = -0.321, p = 0.050). This study shows that a high percentage of PsA patients had axial involvement with a high percentage of them having asymptomatic radiological findings. The cervical spine is more frequently and severely affected than the lumbar spine. Axial PsA occurs in males more than females with characteristic older age and higher BMI, increased psoriasis duration, and more limitation of spinal mobility.

Correlation between disease activity and patient-reported health-related quality of life in rheumatoid arthritis: a cross-sectional study

ObjectiveWe aimed to provide a comprehensive assessment of health-related quality of life (HRQoL) in patients with rheumatoid arthritis (RA) of different activities and to evaluate the correlation between clinical activity...

Identifying internalizing transdiagnostic profiles through motivational and cognitive control systems: Relations with symptoms, functionality, and quality of life

BackgroundThe diversity of patients' symptomatology among people seeking treatment on community-based mental health services poses significant challenges to traditional models of care. Recent approaches favor identifying transdiagnostic factors that allow a better understanding of patient heterogeneity and designing more effective and quality interventions. This study examines the heterogeneity of patients with internalizing symptoms based on profiles identified with cognitive and motivational control variables. Differences between these profiles on dimensional measures of psychopathology and quality of life are examined. Methods263 patients were selected by non-probabilistic sampling procedures on mental health services in the province of Huelva (Spain). A latent class analysis on the standardized scale scores of The Behavioral Inhibition/Behavioral Activation System Scales and the Effortful Control Scale of the Adult Temperament Questionnaire Short-Form was conducted. Profiles were compared on the scores of the Inventory of Depression and Anxiety Symptoms-II, the WHO Disability Assessment Schedule II, and the Health Assessment Questionnaire SF-36. ResultsThe four latent profile solution is the one that showed the best fit indicators and substantive interpretability, with a kappa of 0.94 in the cross-validation procedure with 75% of the sample. No sex differences were found between the profiles (c32 = 5.17, p = .160). Profiles #1 and #3, both characterized by an imbalance between low activation and high inhibition, had lower well-being, lower functionality, and quality of life. When comparing profile #2 (featuring the highest inhibitory control) lower scores on most internalizing scales are observed, specially claustrophobia, social anxiety, panic mania. Profile #4 (low control, high activation, and high inhibition) showed greater scores on both mania and euphoria and lower scores on emotional role. ConclusionsWe identified four distinctive profiles that had overly increased behavioral inhibition (as expected in internalizing disorders) and differed in the degree of imbalance between inhibition and activation systems, and between motivational systems and top-down cognitive control. The profile characterized by high activation and reduced cognitive (inhibitory) control was the one showing greater mood-related symptoms and lower levels of quality of life. These profiles could be generated by treatment providers to guide clinical management in an evidence-based manner.

The Impact of Prolotherapy and Steroid Injection on De Quervain's Tenosynovitis: A Retrospective Outcome Study

Aim: Patients with De Quervain's stenosing tenosynovitis (DQT) experience problems in daily living activities due to the chronic inflammatory process and tenderness around the wrist. This study aimed to compare the effects of prolotherapy and steroid injection on short-term functional outcomes in DQT patients. Methods: In this retrospective study between January 2022 and 2023, a cohort of 34 patients with complete demographic data and elbow pain and functional scores, which were recorded at pre-treatment, two weeks, and six weeks post-treatment, was divided into the steroid injection (n=17) and prolotherapy (n=17) groups. Demographic and clinical data of all patients were recorded. The outcomes of the Visual Analogue Scale (VAS) score for wrist pain, Quick Disability Assessment of Arm, Shoulder, and Hand Problems (QuickDASH), and the Health Assessment Questionnaire (HAQ) for wrist functions were examined. Results: Initial assessments did not reveal any differences between groups in terms of VAS (p=0.756), QuickDASH (p=0.168), and HAQ (p=0.615). In the second week post-treatment, there was a significant reduction in VAS, QuickDASH, and HAQ in steroid injection compared to the prolotherapy (p=0.001). This difference continued at sixth-week post-treatment; VAS (p=0.007), QuickDASH (p=0.003), and HAQ (p=0.011) were found to be significantly lower in steroid injection than in the prolotherapy. Conclusion:Our findings underscore the superior effectiveness of steroid injection compared to prolotherapy in reducing wrist pain and improving functional outcomes in patients with DQT. These findings benefit orthopedic settings in choosing treatment options logically, though further research is needed to understand long-term effects and mechanisms.

Level of glial cell derived neurotrophic factor in the blood plasma of rheumatoid arthritis patients and its relationship with alexithymia

ObjectivesGlial cell derived neurotrophic factor (GDNF) has an important role in the pathogenetic mechanisms and clinical manifestations of rheumatoid arthritis (RA). Alexithymia is associated with a severe clinical course and worse prognosis, while the relationship between alexithymia and GDNF in RA patients has not been investigated before. The aims of the study were to investigate the GDNF level in blood plasma in RA patients depending on the presence of alexithymia and to evaluate the relationship of GDNF level with clinical manifestation and quality of life.Material and methodsFifteen men and 73 women with RA were examined using the Disease Activity Score with 28-joint count (DAS28) with erythrocyte sedimentation rate (ESR) index, the Simple Disease Activity Index (SDAI), the Rheumatoid Arthritis Clinical Disease Activity Index (CDAI), the Visual Analogue Scale (according to the assessment of the patient – VAS-P and the assessment of the doctor – VAS-D), the Health Assessment Questionnaire (HAQ), the Toronto Alexithymia Scale (TAS-20), the Disability Rating Index (DRI) and SF-36 indexes. Glial cell derived neurotrophic factor level in the blood plasma was determined by enzyme-linked immunosorbent assay (ELISA).ResultsForty percent of RA patients had alexithymia. Glial cell derived neurotrophic factor level in the examined patients was 3.73 ±2.59 pg/ml, in patients with alexithymia 4.08 ±2.87 pg/ml, without alexithymia 3.48 ±2.37 pg/ml (p = 0.295). Patients with alexithymia had a higher erythrocyte sedimentation rate (ESR) and index scores than patients without alexithymia – ESR: 34.29 ±14.22 vs. 22.73 ±12.03 mm/h (p = 0.017), DAS28: 6.53 ±0.66 vs. 6.09 ±0.55 (p = 0.017), VAS-D: 7.19 ±0.81 vs. 6.53 ±0.83 (p = 0.020), HAQ: 1.78 ±0.58 vs. 1.51 ±0.54 (p = 0.040). Also they had worse SF-36 indicators – physical functioning: 39.52 ±13.78 vs. 51.00 ±14.90 (p = 0.019), role functioning due to physical condition: 30.95 ±20.77 vs. 46.67 ±24.76 (p = 0.041), physical component of health: 31.47 ±11.44 vs. 41.61 ±15.88 (p = 0.028). In patients with alexithymia, a correlation was found between the GDNF level and severity of pain according to VAS-P: rS = 0.338, p = 0.044, and VAS-D: rS = 0.446, p = 0.006.ConclusionsAlexithymia was found in 40% of RA patients. Rheumatoid arthritis patients with alexithymia had a nonsignificantly higher GDNF level compared to patients without alexithymia. In RA patients with alexithymia, an association of GDNF level in the blood plasma with RA activity, loss of functional capacity and reduced quality of life was established. Alexithymia in RA patients is an important factor in the clinical manifestation of RA and modification of the pathophysiological role of GDNF.

Physician estimate of inflammation vs global assessment in explaining variations in swollen joint counts in rheumatoid arthritis patients

Abstract Objective To analyze patients with rheumatoid arthritis (RA) for inflammatory activity by physician estimate of global assessment (DOCGL) vs an estimate of inflammatory activity (DOCINF) to explain variation in swollen joint count (SJC). Methods Patients with RA were studied at routine care visits. Patients completed a multidimensional health assessment questionnaire (MDHAQ), and the physician completed a 28-joint count for swollen (SJC), tender (TJC) and deformed (DJC) joints, and a RheuMetric checklist with a 0–10 DOCGL visual numeric scale (VNS), and 0–10 VNS estimates of inflammation (DOCINF), damage (DOCDAM) and patient distress (DOCSTR). Disease activity score 28 (DAS28-ESR), clinical disease activity index (CDAI) and routine assessment of patient index data (RAPID3) were calculated. Individual scores and RA indices were compared according to Spearman correlation coefficients and regression analyses. Results 104 unselected patients were included, with median age and disease duration of 55.0 and 5 years respectively. Median (IQR) DAS28-ESR was 2.89 (1.64), indicating low activity. DOCINF was correlated significantly with DOCGL (rho= 0.775). Both DOCGL and DOCINF were correlated significantly with most other measures; correlations with DOCGL generally were higher than with DOCINF other than for SJC. In regression analyses, DOCINF was more explanatory of variation in SJC than DOCGL and other DAS28-ESR components. Conclusions Variation in SJC is explained more by a 0–10 DOCINF VNS than the traditional DOCGL or any other measure in routine care RA patients. DOCINF on a RheuMetric checklist can provide informative quantitative scores concerning inflammatory activity in RA patients monitored over long periods.

P175 The Psoriatic Arthritis Impact of Disease 12-item questionnaire can replace other patient-reported outcome measures to facilitate disease monitoring in clinical practice

Abstract Background/Aims The Psoriatic Arthritis Impact of Disease 12-item questionnaire (PsAID-12) was developed and validated to improve assessment of disease activity from the patient’s perspective. Several patient-reported outcome measures (PROMs) are relevant to PsA but completing several questionnaires at each clinic visit creates a time and administrative burden for patients and clinicians. Furthermore, the Minimal Disease Activity (MDA) for assessing disease activity in PsA requires the Health Assessment Questionnaire (HAQ) to be collected; however, a Canadian study found that PsAID-12 can replace HAQ in the MDA using a cut-off of &amp;lt; 3.7. A previous study also found sex-specific differences in PsAID-12 scores, with scores being higher in females. The aim of this study was to assess whether PsAID-12 correlates well and could replace other PROMs in clinical practice, and to validate previously published findings related to the use of PsAID-12 instead of HAQ in determining MDA, and sex-specific differences in PsAID-12 scores. Methods Clinical data were collected from 75 consecutive patients attending a PsA clinic in a tertiary centre at their first review in 2023. Clinical characteristics, PROMs, examination findings, and measures of disease activity were recorded. Correlation with PsAID-12 was assessed using Spearman’s rank correlation coefficient. Sex-specific differences were assessed using Mann-Whitney U tests. Bonferroni correction was used to adjust for multiple comparisons. Results PsAID-12 scores were significantly correlated with all PROMs, and with composite measures of disease activity (DAPSA, MDA), but not with clinical measures of disease activity (TJC, SJC, PASI, BSA), or acute-phase reactants (CRP, ESR). PsAID-12 scores were not affected by age or disease duration. There was no sex-dependent difference in PsAID-12 scores; however, female patients had significantly higher HAQ and HAD scores. MDA scores using PsAID-12 correlated significantly with MDA scores using HAQ. Conclusion PsAID-12 is a suitable replacement for other PROMs in clinical practice, and for HAQ when determining MDA status to reduce the time and administrative burden on patients and clinicians, and to facilitate monitoring of disease activity in patients with PsA regardless of age or disease duration. Contrary to previous studies, there were no sex-dependent differences in PsAID-12 scores. Disclosure R.M. Hum: None. K. Hasanein: None. L.T. Hao: None. J.C. Williams: None. A. Cheung: None. A. Adhikarla: None. A. Choyce: None. A. Newton: None. C. Clegg: None. A. Barton: None. P. Ho: None.

P168 The impact of psoriatic arthritis on quality of life and lifestyle: a systematic review

Abstract Background/Aims Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects adults of all ages. It is common for patients to experience a wide variety of physical and psychological problems. The objective of this systematic review was to determine how PsA impacts a person's quality of life (QoL). Methods A systematic literature search of CENTRAL, CINAHL, AMED, EMBASE, Global Health, MEDLINE and PsycINFO databases was conducted on 28th May 2021. Title, abstract and whole text screening, and data extraction were completed by two independent authors. The primary outcomes of this study were PsA activity and severity, impact of PsA on lifestyle and QoL. As per the protocol (PROSPERO CRD42021257395), studies which reported at least one of these primary outcomes were included. The quality assessment was conducted using the Joanna Briggs Institute Critical Appraisal criteria. Results Of the 20,316 papers identified by the search strategy, 42 papers which reported on at least one of the study primary outcomes were included in the review. 38 studies reported on PsA activity and severity, 26 on impact of PsA on lifestyle and 23 on QoL. 7 different measures were used to assess impact of PsA on lifestyle, including Health Assessment Questionnaire (HAQ) (n = 13), modified HAQs (n = 10), PsA impact of disease measure (n = 2), functional capacity ACR (n = 1), functional assessment of chronic illness therapy (n = 1), Bath ankylosing spondylitis functional index (n = 1) and a patient-directed question (n = 1). 13 papers reported an average HAQ score between 0.13 and 1.3 for PsA participants. Two studies which reported HAQ disability index compared PsA participants to other groups. Thus, the impact of disease on lifestyle is worse for PsA compared to psoriasis, rheumatoid arthritis and healthy controls, psoriasis. DAPSA and PASI were the most used disease activity scores in addition to various patient-reported outcomes. The average DAPSA was 15.5, suggesting that the majority of PsA patients have moderate disease activity. Although the average PASI (skin) score showed mild disease among the PsA (3.82) group, a high PASI score was associated with late/never minimal disease activity and obesity. 8 different measures were used to assess QoL, including Psoriatic Arthritis Quality of Life (n = 6, average), EQ-5D (n = 4), EQ-3D (n = 1), DLQI (n = 7), SF-36 (n = 3), SF-12 (n = 1), WHOQOL-BREF (n = 2), PSQI (n = 1), Rosenberg Self-Esteem Scale (n = 1) and Psoriasis disability index (n = 1). Except for QoL for skin (DLQI), PsA was associated with worse outcomes in all these measures, in comparison with spondylarthritis, healthy control and psoriasis only groups. Conclusion PsA significantly affects a patient's life and health-related QoL. The degree of activity and severity of the disease have a substantial impact. Therefore, for patients with high disease activity, specific management plans should be discussed and facilitated to maintain their mobility and functional abilities. Disclosure L. James: None. R. Suribhatla: None. L.H. Hailey: None. R. Amarnani: None. C. Bundy: None. D. McGagh: None. S. Kirtley: None. D. O'Sullivan: None. I. Steinkoenig: None. L.C. Coates: None.

OA04 Efficacy and safety of nipocalimab in patients with moderate to severe active rheumatoid arthritis: the multicenter, randomised, double-blinded, placebo-controlled phase 2a IRIS-RA study

Abstract Background/Aims Rheumatoid arthritis (RA) is a chronic inflammatory disease associated with autoantibodies. Despite the use of targeted therapies, up to half of patients fail to achieve remission or low disease activity (LDA). Anti-citrullinated protein antibodies (ACPAs), key autoantibodies that predict progression of joint destruction in RA, are largely an immunoglobulin G (IgG) isotype. Nipocalimab is a high affinity, fully human, IgG1 monoclonal antibody that is designed to selectively block the neonatal Fc receptor (FcRn), preventing recirculation and thereby lowering IgG levels, potentially including ACPAs and other pathogenic antibodies. In this phase 2a proof-of-concept study (IRIS-RA; NCT04991753), we report the efficacy and safety of nipocalimab in patients with moderate to severe, active RA. Methods Eligible adult patients with moderate to severe RA (≥6 swollen/tender joints), positive for ACPA or rheumatoid factor, and ≥1 advanced therapies, were randomized 3:2 to receive intravenous 15 mg/kg nipocalimab or placebo every 2 weeks for 10 weeks. The primary endpoint was the change from baseline in the Disease Activity Score 28 using C-reactive protein (DAS28-CRP) at Week 12. Secondary endpoints included the proportion of patients who achieved ACR20, ACR50, ACR70, and ACR90 responses, DAS28-CRP remission, and change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 12. Results In total, 53 patients were enrolled (nipocalimab, n = 33; placebo, n = 20). Most patients were female (67.9%) and white (90.6%) with a median age of 59 (range, 26-74) years. Demographic and baseline disease characteristics were comparable between groups except higher CRP in placebo. At Week 12, patients treated with nipocalimab showed a numerically greater mean (standard deviation [SD]) change in DAS28-CRP score compared to the placebo group (-1.17 [1.34] vs -0.62 [0.96]; mean difference [95% confidence interval], -0.45 [-1.17-0.28]; p=0.224). A numerically higher proportion of patients achieved ACR20, ACR50, ACR70, and ACR90 responses compared to placebo. In the nipocalimab group, 7 (21.2%) patients achieved DAS28-CRP remission compared to 2 (10.0%) patients in the placebo group (treatment difference, 9.9% [-9.5-29.3%]; p=0.456). Similarly, patients in the nipocalimab group had a numerically greater mean (SD) improvement in HAQ-DI score (-0.27 [0.55] vs -0.11 [0.36], respectively). The proportion of patients with treatment-emergent adverse events (TEAEs) were 81.8% vs 60.0% in the nipocalimab vs placebo groups. In the nipocalimab group, 3 serious TEAEs were reported, including burn infection, infusion-related reaction, and deep-vein thrombosis. There were no TEAEs that led to death. Conclusion Treatment with nipocalimab resulted in consistent and numerically higher improvements across ACR20, ACR50, ACR70, and ACR90 responses, as well as DAS28-CRP, DAS28-CRP remission, and HAQ-DI, with acceptable safety profile. Nipocalimab showed activity in patients with moderate to severe RA and warrants further investigation to understand the predictors of nipocalimab response. Disclosure P.C. Taylor: Consultancies; AbbVie, Biogen, Eli Lilly, Fresenius, Galapagos, Gilead Sciences, GlaxoSmithKline, Janssen, Nordic Pharma, Pfizer Inc, Sanofi, Aqtual, and UCB. Grants/research support; Galapagos. G. Schett: None. F. Ibrahim: Corporate appointments; Employee of Janssen Research &amp; Development. B. Zhou: Corporate appointments; Employee of Janssen Research &amp; Development. J. Leu: Corporate appointments; Employee of Janssen Research &amp; Development. S. Liva: Corporate appointments; Employee of Janssen Research &amp; Development. Q. Wang: Corporate appointments; Employee of Janssen Research &amp; Development. R. Rojo Cella: Corporate appointments; Employee of Janssen Research &amp; Development. C.S. Karyekar: Corporate appointments; Employee of Janssen Research &amp; Development. K. Fei: Corporate appointments; Employee of Janssen Research &amp; Development.

OA20 Serious infections hospital admissions and mortality in patients with early inflammatory arthritis: results from the National Early Inflammatory Arthritis Audit

Abstract Background/Aims To identify the risk of serious infections (SI) according to initial treatment strategy, using conventional synthetic disease modifying anti-rheumatic drugs (csDMARD) and corticosteroids, in patients recruited to the National Early Inflammatory Arthritis Audit (NEIAA). Methods An observational cohort study design was used. The population included adults in England with a new onset rheumatoid arthritis (RA), fulfilling ACR/EULAR 2010 criteria, between April 2018-March 2021. Outcomes studied were SI, defined by infections requiring hospitalisation (primary admission diagnosis/nosocomial acquisition) or death (SI stated on death certificate), identified using NHS Digital linkage. Patients' characteristics were tabulated by treatment strategies. Hazard ratios (HR) were calculated using single failure Cox proportional-hazards models, with confounders-adjusted models (age, gender, smoking status, comorbidities, social deprivation) and fully-adjusted models including disease factors (seropositivity, DAS28). Individuals were considered at risk from the date of RA diagnosis, and censored at SI event, death, or March 2021 (whichever was earliest). Results 20,060 patients with RA were included. Initial DMARD therapy was known for 19,572 patients, of whom 11,966 were on methotrexate/MTX based strategies (mono or combo), 5,059 on csDMARD combination strategies (other than MTX) and 2,547 on no DMARD strategy. 15,319 patients were on corticosteroids at baseline. Mean age 59.5 years (+/-15); 63% female; smoking status (20% current; 30% ex-smokers); comorbidities (21% hypertension; 10% diabetes; and 12% lung disease). Rheumatoid Factor/CCP antibodies were positive in 68%. At presentation, median disease scores were 5.1 (interquartile range [IQR]: 4.0-5.9) for DAS28, 1.1 (IQR: 0.6-1.7) for health assessment questionnaire (HAQ) and 24 (IQR: 16.0-33.0) for musculoskeletal health questionnaire (MSKHQ).There were 519 SI admissions and 17 SI deaths, corresponding to incidence rates per 100 person-years for admissions: 3.19 (95% CI: 2.93-3.48) and deaths: 0.10 (95% CI: 0.06-0.16). In fully-adjusted models, increasing age predicted both SI admissions and deaths. Being a smoker, having a comorbidity, higher disease activity (DAS28), symptom burden (MSKHQ) and disability (HAQ) at presentation associated with more SI admissions. For each 1 unit increase in DAS28, the risk of SI increased by 8% (HR 1.08 [95% CI:1.01-1.16]). Seropositivity did not associate with SI. MTX-based strategies 0.75 (95% CI:0.62-0.91) and csDMARD combination therapy 0.70 (95% CI:0.53-0.94) associated with fewer SI admissions compared to no DMARD. In unadjusted models, corticosteroid associated with more SI admissions 1.29 (95% CI:1.10 -1.62); however, in fully-adjusted models this association was no longer statistically significant. csDMARD strategies did not associated with SI deaths in any of the models. Conclusion Patient and disease factors at diagnosis appear to be important predictors of admissions and mortality for serious infections. Infection risk appears to be greatest in those with higher RA disease activity. An important limitation is that NEIAA does not capture data on treatment changes over time and steroid use beyond baseline. Disclosure M. Adas: None. K. Bechman: None. M. Russell: Honoraria; Lilly and Menarini. Other; upport for attending conferences from Lilly, Pfizer, Janssen, and UCB, and advisory board fees from Biogen.. I. Karafotias: None. D. Nagra: None. S. Patel: None. S. Gallagher: None. E. Price: None. M. Garton: None. A. Rutherford: None. A. Cope: None. S. Norton: None. J. Galloway: Honoraria; from Abbvie, Biovitrum, Bristol Myers Squib (BMS), Celgene, Chugai, Gilead, Janssen, Lilly, Novartis, Pfizer, Roche, Sanofi, Sobi, and UCB.

OA40 Clinical and psychological factors associated with adherence based on a patient self-reported questionnaire: results from the biologics in rheumatoid arthritis genetics and genomics study syndicate (BRAGGS) cohort

Abstract Background/Aims To explore the relationship of clinical and psychological factors with adherence based on a patient self-reported questionnaire from a prospective longitudinal study of patients receiving TNFi biologic treatment for rheumatoid arthritis, recruited since 2008. Methods Analysis of data collected from a prospective longitudinal UK study (Biologics in Rheumatoid Arthritis Genetics and Genomics Study Syndicate [BRAGGSS]) of patients with moderate to severe RA commencing TNFi biologic treatment. Clinical data including Disease Activity Score-28 (DAS28), serological status (Rheumatoid Factor positivity) and body mass index (BMI) were collected. Patients also completed self-reported questionnaires, the health assessment questionnaire (HAQ), hospital anxiety and depression scale (HAD), beliefs about medicine questionnaire (BMQ), brief illness perception score (B-IPQ) and a self-reported adherence questionnaire. Adherence was defined as any deviation from prescribed medication regime such as altering the dose, forgetting a dose, stopping treatment, missing a dose, and taking less than instructed. Associations between demographic and psychological variables and adherence were evaluated using regression models and a multivariable logistic regression model was used to further evaluate associations, controlling for BMI. Results 1,513 patients (75.7% female, age 58.1 [IQR 16.0], disease duration 9.6 ± 9.6 years and pre-treatment DAS28 scores 5.7 ± 0.8) were included. 70% of patients self-reported adherence to their medication. When comparing the different TNFi treatments, etanercept had the lowest levels of adherence at the 3 and 6 month time-points. Adherence was higher in those with older age (β = 0.03, p&amp;lt; 0.01), higher baseline CRP levels (β = 0.01, p= 0.03) and higher necessity beliefs (β = 0.04, p= 0.03). Adherence was lower in those with higher tender joint counts at baseline (β=-0.03, p= 0.04) and 3 months (β = 0.03, p= 0.02) (Table I). These associations persisted after controlling for the effects of BMI using a multivariable logistic model. Conclusion Self-reported adherence was 70% in this BRAGGS population. Factors associated with non-adherence included higher tender joint counts and lower necessity beliefs pre-treatment, which may allow targeting of interventions to optimise adherence in these groups. Disclosure T.K.Y. Chong: None. N. Nair: None. A.W. Morgan: None. J.D. Isaacs: None. A.G. Wilson: None. K.L. Hyrich: Honoraria; Abbvie. Grants/research support; K.H has grants from BMS and Pfizer. D. Plant: None. A. Barton: Grants/research support; A.B has received funding/speaker fees from BMS, Pfizer and Galapagos.

P047 Mortality in patients with rheumatic disease over a three year period encompassing the COVID-19 pandemic: clinically extremely vulnerable status and short form 12 scores are predictive

Abstract Background/Aims In the United Kingdom (UK), to combat the coronavirus disease 2019 (COVID-19) pandemic, social distancing measures were implemented to varying degrees between March-2020 and December-2021. UK policy deemed patients with rheumatic disease (RD) at higher risk from COVID-19 and many were categorised as ‘clinically extremely vulnerable’ (CEV), these patients were required to follow more stringent social distancing measures. Social isolation and loneliness are implicated as predictors of mortality; the impact of these strict social distancing measures in patients with RD on mortality is unknown. In addition, Health related quality of life (HRQoL) measures provide useful insights into a patients physical and mental wellbeing. HRQoL is recognised as an important measure of health outcomes and there is limited evidence suggesting HRQoL measures such as the Health Assessment Questionnaire (HAQ) and the Short Form-36 questionnaire (SF-36) are associated with mortality in patients with rheumatoid arthritis. The predictive value of the SF-12 (a validated, shortened version of the SF-36) in RD patient’s mortality is unknown. In this UK-based, observational cohort study we evaluated the impact of stricter social distancing measures during the pandemic on 3-year mortality and assessed the utility of the SF-12 in predicting mortality in patients with RD. Methods We distributed a web-based survey via a linked mobile-phone SMS message, to all rheumatology patients, with a validated mobile number, under follow-up at the Royal Wolverhampton Trust, April-2020. We collected demographics, CEV status, and Short Form-12 mental (MCS) and physical health component scores (PCS) for health-related quality of life. Mortality was audited July-2023. Data were analysed using SPSS version 26 and R. Results There were 7,911 active follow up patients with linked mobile numbers. Survey responses were received from 1605 (20%); responders were female (69%), white (94%), CEV (47%), had a mean age of 61years, and most had autoimmune rheumatic disease (78%). Of the responders, 58 (4%) had died by July-2023 - compared to the alive group these patients had significantly worse MCS (p &amp;lt; 0.001) and PCS (p = 0.004) at baseline; significantly more in those that had died were CEV (p &amp;lt; 0.001), and older (p &amp;lt; 0.001), while gender, ethnicity, and diagnosis did not differ. Conclusion These data demonstrate in a large cohort of patients with RD over a 3-year period those patients considered CEV, advised to follow more stringent social isolation measures were at significantly greater risk of death. Further, baseline SF-12 scores for both mental and physical components were lower in patients that died over a 3-year period. These data potentially highlight the utility of the SF-12 and assessing social isolation and loneliness in patients with RD to predict mortality. In addition, our methods demonstrate the merits of communicating with patients through SMS-messaging and can be used in delivering important health-care communications in future. Disclosure N. Cox: None. J. Bateman: None.

P132 Longitudinal changes in the Scleroderma Health Assessment Questionnaire visual analogue scales in patients with systemic sclerosis: a retrospective cohort study

Abstract Background/Aims The aim was to examine the course, impact of baseline predictors, and relationship with functional ability, of the six Scleroderma Health Assessment Questionnaire (SHAQ) visual analogue scales (VAS) over time in patients with SSc. Methods A retrospective analysis of patients attending annual review visits at a tertiary SSc center between 2005 and February 2020. Linear Mixed-effect models were used to assess longitudinal trajectories and effect of potential prognostic factors on the six different SHAQ VAS, except finger ulcers where the VAS scale was dichotomised (presence/absence) and analysed using a random intercept logistic regression model. To assess whether longitudinal changes in SHAQ VAS correlated with the HAQ-DI/11-point scleroderma functional index, we obtained the gradients of individual linear regression models, overall and by disease type. Results 537 patients (75% lcSSc) with at ≥ 2 available time-points were included. Mean follow-up time and number of review visits were 6.8 (SD = ±4.2) years 6.4 (SD = ±3.7) visits, respectively. The mean (SD) RP and disease duration (defined as the first non-RP symptom) were 7.6 (11.9) and 8.0 (8.2) years, respectively. Time-in-study (Table 1) was associated with increase in VAS intestinal (p = 0.004), overall disease (p = 0.001) and presence of ulcers (p = 0.013). There was a trend observed concerning RP VAS (p = 0.068) and VAS breathing (p = 0.074), and no difference with VAS pain (p = 0.183). Time since RP onset showed a significant negative association with VAS pain (b=-0.01, [95%CI= -0.01 to 0.00], p = 0.032). Age had a significant negative effect on intestinal VAS (b=-0.01 [95%CI= -0.01 to -0.00], p = 0.040). Presence of ulcers increased with disease duration (OR = 0.97 [95%Cl= 0.94 to 1.00], p = 0.026), and in those with diffuse disease (OR = 0.54 [95%CI= 0.31 to 0.95], p = 0.033). For patients who were anti-RNP positive (compared to negative), the overall disease score VAS was higher (b = 0.23, 95%Cl= 0.00 to 0.45, p = 0.048) higher. All correlations between SHAQ VAS scales and function (HAQ-DI and 11-point scleroderma functional index) were positive (Table 2), and were almost exclusively stronger in patients with diffuse disease. Conclusion Longitudinal assessment of the SHAQ VAS scales provides important insights into disease trajectory. We have identified baseline factors associated with VAS outcomes, and associations with function over time. Disclosure M. Hughes: None. Y. Sylvestre: None. J. Manning: None. M. Mandzuk: None. M. Samaranayaka: None. G. Dinsdale: None. A. Herrick: None.