Utility of multi-biomarker panel on discriminating disease activity in patients with psoriatic arthritis.

OBJECTIVE: To investigate the correlation of serum protein biomarkers and disease activity in patients with PsA. METHODS: 176 patients fulfilled the CASPAR (ClASsification criteria for Psoriatic ARthritis) were recruited in this cross-sectional study. The level of 48 protein biomarkers, cartilage and bone turn-over markers were assessed. The patients were randomly divided into a derivation-cohort and a validation-cohort at a ratio of 7:3. Patients were further categorized based on their disease activity states using cDAPSA (remission/low disease activity and moderate/high disease activity). Least absolute shrinkage and selection operator (LASSO) was used to select biomarkers which were associated with moderate/high disease activity in the derivation cohort. Receiver operating characteristic (ROC) curve, GiViTI calibration belt were used to assess the performance of the model in both cohorts. RESULTS: The cohort [age: 55.5 (44.0-62.75) years, male: 80 (45.5 %)] had moderate disease activity [DAPSA: 15.9 (8.3-26.9); PASI: 3.2 (0.5-6.8)]. 101 PsA patients (57.4 %) had clinical DAPSA moderate/high disease activity. Biomarker levels associated with moderate/high disease activity included SAA (Serum amyloid A), IL-8 (Interleukin 8), IP10 (Interferon gamma-induced protein 10)/CXCL10, M-CSF (Macrophage colony-stimulating factor), SCGF-ß (Stem cell growth factor), SDF-1α (Stromal cell-derived factor 1α)/CXCL12. The model's equation including the 6 biomarker levels was applied to the validation-cohort. The area under the ROC curve (AUC) for discriminating moderate/high disease activity was 0.802 and 0.835 for the derivation-and-validation-cohorts, respectively. The multi-biomarkers panel model had higher-AUC when compared with that of C-reactive protein (CRP) (AUC = 0.727, p = 0.022). The P-values of calibration charts in the two sets were 0.902 and 0.123. CONCLUSIONS: The multi-biomarkers panel demonstrated the ability to discriminate patients with moderate/high disease activity from those with low disease activity/remission.

Cell-bound complement activation products in antiphospholipid antibody-positive patients without other systemic autoimmune rheumatic diseases.

The objective of this study was to analyze complement activation in antiphospholipid antibody (aPL)-positive patients without other systemic autoimmune rheumatic diseases, using C3/C4 and cell-bound complement activation products (CB-CAPs) (B-lymphocytes [BC4d], erythrocytes [EC4d], and platelets [PC4d]). Persistently aPL-positive patients with or without aPL-related clinical manifestations (thrombotic APS [TAPS], microvascular APS [MAPS], obstetric APS, thrombocytopenia [TP], and/or hemolytic anemia [HA]) were enrolled in a single center study. Blood and clinical data were collected at baseline; a subgroup of patients completed 6- or 12-month follow-up. At baseline, 4/31 (13%) patients had decreased C3/C4, while 7/29 (24%) had elevated BC4d, 11/33 (33%) EC4d, and 12/32 (38%) PC4d. Based on different aPL profiles, all patients with decreased C3/C4 or elevated BC4d, EC4d, and PC4d had triple aPL or isolated lupus anticoagulant positivity. Based on different aPL clinical phenotypes, the number of patients with strongly positive EC4d and PC4d were proportionally higher in those with MAPS/TP/HA, compared to TAPS or no APS. Compared to baseline, the frequencies of BC4d, EC4d, and PC4d positivity were not significantly different in the subgroup of patients during their 6- or 12-month follow-up. There was a weak correlation between C3/C4 and CB-CAPs, especially for PC4d. In summary, complement activation in aPL-positive patients varies based on aPL profiles and clinical phenotypes. Given the higher percentage of aPL-positive patients with abnormal CB-CAPs, compared to C3/C4, and the poor inverse correlation between CB-CAPs and C3/C4, our study generates the hypothesis that CB-CAPs have a role in assessing disease activity and thrombosis risk in aPL-positive patients.

Contribution of inflammation markers and quantitative sensory testing (QST) indices of central sensitisation to rheumatoid arthritis pain.

BACKGROUND: Pain, the primary complaint in rheumatoid arthritis (RA), is multifaceted, and may be driven by inflammatory disease activity and central sensitisation. We aimed to ascertain what proportion of RA pain severity is explained by markers of inflammation and quantitative sensory testing (QST) indices of central sensitisation. METHODS: This was a cross-sectional analysis of data from individuals with clinically active RA. Pain severity was assessed using numerical rating scales and inflammation via 28-joint Disease Activity Score (DAS28) and Ultrasound (Greyscale, Power Doppler). Pain sensitivity was assessed by 'static' (tibialis anterior or brachioradialis pressure pain detection threshold-PPT-TA/PPT-BR) and 'dynamic' (temporal summation-TS, conditioned pain modulation-CPM) QST. Bivariate associations used Spearman's correlation coefficients, and multivariable linear regression models determined relative contributions to pain severity. RESULTS: In bivariate analyses of N = 96 (age 65 ± 10y, 77% females) people with RA, pain severity was significantly associated with inflammation indices (r = 0.20 to 0.55), and CPM (r=-0.26). In multivariable models that included TS, CPM, age, sex, and body mass index, inflammation indices remained significantly associated with pain severity. Multivariable models explained 22 to 27% of pain variance. Heterogeneity was apparent for associations with pain between subscores for pain now, strongest or average over the past 4-weeks. CONCLUSIONS: In individuals with clinically active RA, markers of inflammatory disease activity best explain RA pain with only marginal contributions from QST indices of central sensitisation. Although inflammation plays a key role in the experience of RA pain, the greater proportion of pain severity remains unexplained by DAS28 and ultrasound indices of inflammation.

Valoración de la medida de Actividad Mínima de Enfermedad en Psoriasis en España: estudio transversal nacional.

INTRODUCTION: in 2017, the Spanish Academy of Dermatology and Venereology Psoriasis Working Group (PWG) designed the Minimal Disease Activity (MDA) criteria to determine the level of disease activity. We hereby present the results of an observational, cross-sectional, multicenter study of the nationwide application of these criteria. MATERIAL AND METHODS: we conducted a non-randomized sampling, stratified to achieve autonomic and provincial representation of consecutive patients with psoriasis (Ps) vulgaris without active arthritis. A total of 830 patients were included: 493 men (59.5%), with a mean age of 51.4 years (SD, 14.2), from all autonomous regions of Spain (except for Ceuta and Melilla) and 44 (88%) out of the 50 provinces. A questionnaire was obtained with demographic data, DLQI, subjective assessment-on a scale from 0 to 10-of itching, erythema, desquamation, visibility, and the patients' PASI and BSA. RESULTS: more than 50% failed to meet the MDA criteria (491; 59.2%), with significant differences being reported by region, sex, and age. Additionally, significant differences were reported based on the therapy used (p < 0.001). The use of biological therapies was associated with higher MDA compliance compared to other therapies (59.4% vs 23.3%). No differences were reported among various biological therapies. CONCLUSIONS: the overall rate of MDA compliance is low, with differences being based on geographic location, sex, age, and drug used, yet none of these factors separately justify them.

Does the Combined Arteritis Damage Score (CARDS) in the Diagnosis of Takayasu Arteritis Predict Prognosis and Need for Biologic Therapy?

BACKGROUND: We aimed to investigate the prognostic value of the combined arteritis damage score (CARDS) in Takayasu arteritis (TAK) patients to predict the need for biologic treatment at diagnosis and the possible contribution of wall thickness (WT). MATERIALS AND METHODS: Blind evaluation of MRA/CTA at the time of diagnosis was performed by a reader rheumatologist (RR) and an interventional radiologist (RIR). The CARDS damage score for 21 arterial regions was assessed as normal, mild or moderate/severe stenosis, occclusion or aneursym/dilatation. Additionally, WT was scored for all regions as present or absent. A modified CARDS (mCARDS) was calculated as the sum of CARDS and the number of WT areas. RESULTS: According to follow-up treatment, 10 patients with non-biologic treatment (non-BT) (F/M:8/2, median age 37.5 years) and 15 patients with biologic treatment (BT) (F/M:13/2, median age 30 years) were included. Indian Takatasu Arteritis Score (ITAS), CRP, and ESR levels were similar in both groups. CARDS (1.4 (0-7.2) vs 4.5 (.6-19), P: .003), WT (1.5 (0-8) vs 7 (1-21), P < .001), and mCARDS (4 (0-14.2) vs 11.4 (1.6-40), P < .001) scores were significantly higher in the BT group compared to nonBT group. Cohen's kappa coefficient between RR and RIR for WT was .99 with 99.6% aggrement, and CARDS was .98 with 99.6% agreement. The AUC values for CARDS, WT, and mCARDS scores were .748 (.605-.892), .837 (.723-.950), and .847 (.735-.958), respectively, and P value was <.0001. CONCLUSIONS: The prediction of prognosis and biologic treatment need at TAK diagnosis using non-invasive angiographic images can improve outcomes and prompt closer follow-up. The combination of CARDS and WT as mCARDS achieved the highest sensitivity and specificity, and all scores appear useful for predicting prognosis.

Clinical Profile and Outcomes of Patients With Systemic Lupus Erythematosus.

Background Systemic lupus erythematosus (SLE) is a complex autoimmune disorder characterized by relapsing-remitting immune system activation, affecting multiple organ systems. Despite significant advances in understanding SLE's pathogenesis, there remains a need for comprehensive clinical profiling at the time of diagnosis to improve early detection and management. This study addresses this gap by providing a detailed analysis of the clinical presentation, disease activity, and patient outcomes using the Systemic Lupus International Collaborating Clinics (SLICC) criteria and Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) index. Methodology This cross-sectional observational study included 80 patients diagnosed with SLE using the 2012 SLICC criteria. Patients were recruited from the Rheumatology department and other wards of Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospital, Pune, India. All participants provided informed consent and institutional ethical approval was obtained. Data were collected through detailed clinical history, physical examinations, and standard tests such as chest X-rays, CBC, RFT, LFT, urine microscopy, creatine phosphokinase, ANA, AntiDsDNA, complement consumption, and Coombs' tests, with 2D echocardiography performed as needed. Follow-ups every three months over 1.5 years assessed disease activity using SLEDAI criteria. Patients aged 12 and above who met the SLICC criteria were included and those with other connective tissue disorders were excluded. Associations between clinical symptoms and organ involvement were analyzed using the chi-square test with a p-value of <0.05 considered significant. Results The study evaluated 80 patients with SLE, revealing a predominantly female cohort (80%) with a mean age of 29.4 years and a standard deviation of 8.3 years, skewed towards younger age groups. Clinical manifestations were diverse; the most common symptoms were (83.75%), oral ulcers (98.75%), and alopecia (95%). Anemia (66.25%) was the most prevalent abnormality, followed by albuminuria and renal abnormalities. Organ involvement was highest in the renal system (50%) and mucocutaneous features, with lower incidences in cardiac, gastrointestinal, and vascular systems. Gender-specific analyses indicated significant differences in SLE nephritis (p=0.048) and autoimmune hemolytic anemia (p=0.046). Autoantibody profiles showed high positivity for ANA (98.8%) and DsDNA (61.3%). Clinical outcomes demonstrated that 68.8% of patients achieved remission and 16.3% experienced organ damage. The SLEDAI scores significantly improved over time, with substantial reductions from baseline to nine months (p<0.001). Conclusion In conclusion, this study provides a detailed examination of SLE, revealing that it predominantly affects young adults and is characterized by diverse manifestations including mucocutaneous symptoms, significant renal involvement, and notable autoantibody profiles. The high prevalence of anti-nucleosome and anti-dsDNA antibodies underscores their diagnostic and prognostic value. Clinically, the findings highlight the necessity for early detection and targeted management of SLE, particularly in addressing renal and mucocutaneous symptoms. Future research should focus on longitudinal studies to track disease progression, explore genetic and environmental influences, and investigate regional variations to enhance treatment strategies and patient outcomes.

Biomarkers for systemic lupus erythematosus: A scoping review.

BACKGROUND: In recent years, newly discovered potential biomarkers have great research potential in the diagnosis, disease activity prediction, and treatment of systemic lupus erythematosus (SLE). OBJECTIVE: In this study, a scoping review of potential biomarkers for SLE over several years has identified the extent to which studies on biomarkers for SLE have been conducted, the specificity, sensitivity, and diagnostic value of potential biomarkers of SLE, the research potential of these biomarkers in disease diagnosis, and activity detection is discussed. METHODS: In PubMed and Google Scholar databases, "SLE," "biomarkers," "predictor," "autoimmune diseases," "lupus nephritis," "neuropsychiatric SLE," "diagnosis," "monitoring," and "disease activity" were used as keywords to systematically search for SLE molecular biomarkers published from 2020 to 2024. Analyze and summarize the literature that can guide the article. CONCLUSIONS: Recent findings suggest that some potential biomarkers may have clinical application prospects. However, to date, many of these biomarkers have not been subjected to repeated clinical validation. And no single biomarker has sufficient sensitivity and specificity for SLE. It is not scientific to choose only one or several biomarkers to judge the complex disease of SLE. It may be a good direction to carry out a meta-analysis of various biomarkers to find SLE biomarkers suitable for clinical use, or to evaluate SLE by combining multiple biomarkers through mathematical models. At the same time, advanced computational methods are needed to analyze large data sets and discover new biomarkers, and strive to find biomarkers that are sensitive and specific enough to SLE and can be used in clinical practice, rather than only staying in experimental research and data analysis.

Responsiveness of different disease activity indices in moderate-to-severe ulcerative colitis.

BACKGROUND: Clinical, endoscopic, histological, and composite instruments are currently used to measure disease activity in patients with ulcerative colitis (UC). We compared the responsiveness of the Mayo Clinic score (MCS), modified MCS (mMS; excluding physician global assessment), partial MCS (pMS; MCS without endoscopic subscore), Robart's Histopathology Index (RHI), and UC-100 score to change after ustekinumab treatment in patients with moderately to severely active UC. METHODS: Post hoc analysis of the phase 3 UNIFI induction trial (ClinicalTrials.gov: NCT02407236) was conducted. Participants with moderately to severely active UC were randomized to receive ustekinumab or placebo. Treatment assignment was the criterion to assess responsiveness, which was quantified using the probability of a treated participant having a larger change in score than a placebo participant, termed the win probability (WinP), and estimated using nonparametric methods. FINDINGS: The UC-100 score demonstrated large responsiveness (WinP 0.72 [95% confidence interval: 0.66-0.78]), and the MCS (0.68 [0.62-0.73]), mMS (0.69 [0.63-0.75]), and pMS (0.65 [0.59-0.71]) demonstrated similar effect sizes. Of the component items of the Mayo score, the endoscopic subscore (WinP 0.76 [0.69-0.82]) and the stool frequency subscore (WinP 0.74 [0.69-0.79]) were the most responsive. The Inflammatory Bowel Disease Questionnaire (IBDQ) quality-of-life questionnaire was also responsive (WinP 0.78 [0.72-0.82]). CONCLUSIONS: UC disease activity indices are similarly responsive. Depending on the treatment setting, time point of evaluation, and feasibility of measurement, different scores may be used to demonstrate response. These results support the use of mMS as a composite primary endpoint, incorporating both patient-reported and endoscopic outcome measures. The UC-100 score may be more appropriate in settings that also routinely incorporate histological evaluation. FUNDING: There is no funding for this study.

Treat-to-target fixed dose rituximab retreatment versus fixed interval retreatment with disease activity-guided rituximab dose optimisation for patients with rheumatoid arthritis: study protocol for a multicentre randomised controlled superiority trial focusing on long-term disease impact (RITUXERA).

BACKGROUND: The optimal retreatment strategy with rituximab for rheumatoid arthritis (RA) remains a point of discussion. Depending on local guidelines, rituximab can either be administered at fixed intervals or when losing disease control, balancing therapeutic effectiveness with drug overexposure. However, treatment based on loss of disease control may significantly affect patients' lives, provoking uncertainty and potentially leading to progressive joint damage. Moreover, as low-dose rituximab proved to be effective in treating RA while decreasing toxicity, drug exposure may be limited by tapering down rituximab doses guided by disease activity. METHODS: RITUXERA is a 104-week open-label multicentre randomised controlled superiority trial. In total, 134 patients with RA treated with rituximab will be 1:1 randomised when in need of retreatment (DAS28-CRP ≥ 3.2 with previous rituximab administration at least 24 weeks earlier) to either a treat-to-target-driven fixed dose retreatment strategy (usual care group) or fixed interval disease-activity guided dose optimisation strategy (experimental group). The usual care group will be retreated with fixed rituximab doses (1 × 1000 mg IV) in case of loss of disease control (DAS28-CRP ≥ 3.2). The experimental group will receive a 24-weekly rituximab treatment while tapering down the dose in a decreasing sequence if DAS28-CRP ≤ 3.2: 1 × 1000 mg IV (maximal dose), 1 × 500 mg IV, and 1 × 200 mg IV (minimal dose). If DAS28-CRP exceeds 3.2 at the six-monthly retreatment, patients will receive and remain on the previous effective dose. Study visits are planned every 12 weeks. Primary outcome is the comparison of longitudinal patient-reported disease impact over 104 weeks, measured with the Rheumatoid Arthritis Impact of Disease (RAID) instrument, analysed using a linear mixed model. Main secondary outcome is the comparison of longitudinal disease activity (DAS28-CRP) over 104 weeks. DISCUSSION: The RITUXERA trial aims to explore the optimal retreatment strategy with rituximab for RA in terms of long-term patient-reported disease impact, by proposing a fixed interval disease activity-guided dose optimisation strategy as compared to a treat-to-target fixed dose strategy. TRIAL REGISTRATION: CTIS 2023-506638-59-01 (registration date: 07 September 2023), ClinicalTrials.gov NCT06003283 (registration date: 17 August 2023).

Physical component of SF-36 is associated with measures of disease activity in patients with psoriatic arthritis: a real-life study from a tertiary referral centre.

Psoriatic arthritis (PsA) can lead to chronic disability. The aim of this study was to explore the association between disease activity and quality of life (QoL) in patients with PsA from the usual clinical practice. The study involved 143 consecutive adult patients with PsA (49.6% women and 50.4% males), with mean age of 57.75 ± 10.91 years, and duration of disease 11.6 ± 9 years. Tender (TJC) and swollen joints count (SJC), Disease activity score (DAS) 28, patient's global assessment (PtGA), physician's global assessment (PhGA), enthesitis score, number of fingers with dactylitis, sedimentation rate (ESR) and C-reactive protein (CRP) were evaluated. The functional assessment of chronic illness therapy - fatigue scale (FACIT-F) questionnaire was used in fatigue assessment and physical health domains of Short Form (SF)-36 questionnaire were chosen to assess subjective QoL: physical functioning (PF), role limitations due to physical health (RP), bodily pain (BP) and general health (GH). Significant correlations (p < 0.001) were found between FACIT-F and all SF-36 domains. DAS28, PtGA and PhGA were significantly correlated to two or three SF-36 domains, while ESR and CRP were not significantly correlated to any of SF-36 domains. Regression analysis showed, when controlling for age, that FACIT-F, dactylitis and DAS28 were the most significant predictors of SF-36 physical health domains. Regression and factor analyses confirmed that FACIT-F was most consistently associated with SF-36 physical health domains. In our real-life study most of the analyzed clinical measures of PsA were significantly associated with physical health domains of SF-36 questionnaire. Considering the strength of those associations, we conclude that PsA activity has mild to moderate impact on health-related Qol.

Clinical performance of a novel and rapid bioassay for detection of thyroid-stimulating immunoglobulins in Graves' orbitopathy patients: a comparison with two commonly used immunoassays.

Background: For the selective detection of thyroid-stimulating hormone receptor antibodies with stimulating properties (thyroid-stimulating immunoglobulins; TSI), a novel and rapid bioassay (Turbo TSI) has been introduced. We evaluate the clinical performance of Turbo TSI in Graves' orbitopathy (GO) patients and compare it to a bridge-based TSI binding immunoassay and third generation TSH-R-binding inhibitory immunoglobulins (TBII) assay. Also, we investigate the association of Turbo TSI and TBII measurements with GO activity and severity, as well as response to intravenous methylprednisolone (IVMP), and compare results to previous findings on the bridge-based TSI binding immunoassay. Methods: Turbo TSI, TBII and bridge-based TSI binding immunoassay measurements were performed in biobank serum from 111 GO patients and control cases (healthy controls [HC; n=47], primary Sjögren's disease [SD; n=10], systemic sclerosis [SSc; n= 10], systemic lupus erythematosus [SLE; n=10]). Clinical characteristics and response to treatment were retrospectively retrieved from GO patient files. Results: Turbo TSI had the highest sensitivity (97.3%) and negative predictive value (96.1%), while bridge-based TSI binding immunoassay showed the highest specificity (100%) and positive predictive value (100%). Differentiating GO patients from control cases, receiver operating characteristic (ROC) analysis showed an area under the curve (AUC) of 98.5%, 95.7% and 99.8% for Turbo TSI, TBII and bridge-based TSI binding immunoassay, respectively. Turbo TSI (p<0.001) and TBII (p<0.01) levels were higher in patients with active compared to inactive GO. Correlation with CAS was stronger for Turbo TSI (r=0.42) than TBII (r=0.25). No statistically significant differences were observed in IVMP responders vs. non-responders for Turbo TSI (p=0.092) and TBII (p=0.21). For identifying active GO, an AUC of 75% with Turbo TSI and 67% with TBII was found. For IVMP response, AUC was 66.3% with Turbo TSI and 62.1% with TBII. In multivariate logistic regression analyses, both assays were independently associated with disease activity (p<0.01 for both assays) and IVMP response (p<0.01 for Turbo TSI; p<0.05 for TBII). Conclusions: The new Turbo TSI functional bioassay has good clinical performance. Although turbo TSI is a stronger marker of activity and IVMP response than TBII, results are comparable to our previously published findings on the bridge-based TSI binding immunoassay.

Correlation of Serum Vitamin D and High-Density Lipoprotein (HDL) Cholesterol Levels With Disease Activity in Rheumatoid Arthritis: A Single-Center Experience From Eastern India.

Background Rheumatoid arthritis (RA) is a progressive, symmetric, and erosive polyarthritis with a variety of extraarticular manifestations such as mononeuritis multiplex, central nervous system vasculitis, Felty's syndrome, dyslipidemia, carditis, and interstitial lung disease. Vitamin D plays a role in both adaptive and innate immunity, and its deficiency leads to the development of many autoimmune disorders. Additionally, RA patients have a lipid paradox consisting particularly of dysfunctional and low levels of high-density lipoprotein (HDL) with reduced low-density lipoprotein lowering effect, which increases cardiovascular morbidity and potentiates widespread systemic inflammation. Both are modifiable risk factors. Although there are numerous studies on vitamin D and HDL cholesterol in disease progression in RA, there is sparse literature from India studying both these factors in combination. In this study, we tried to establish the correlation of serum vitamin D and HDL cholesterol levels, if any, with disease activity using the Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28 ESR) score. Methods A descriptive cross-sectional study comprising 80 patients was conducted at a tertiary care center in Eastern India over 12 months. Newly diagnosed RA patients aged >17 years satisfying the diagnostic criteria were included. Serum vitamin D level and HDL cholesterol were measured. Then, the DAS28 ESR score was calculated, and a correlation was looked for between serum vitamin D and HDL cholesterol. Results Patients aged 35-43 years accounted for 32 (42.5%) of participants, of whom 58 (72.5%) were females. Almost half, 38 (47.5%), had vitamin D deficiency. The mean vitamin D level was 22.988 ± 10.01 ng/ml. The mean HDL cholesterol level was 42.3 ± 7.23 mg/dl. The mean DAS28-ESR score was 3.81 ± 1.19. A statistically significant inverse correlation was found between vitamin D levels and DAS28 ESR score (p -0.0003) and HDL (p -0.000349). Conclusions Vitamin D deficiency and low HDL cholesterol levels are more common in RA patients. These factors may contribute to increased disease activity. Both are treatable factors in addition to conventional therapies.

Patient perceptions of an electronic-health-record-based rheumatoid arthritis outcomes dashboard: a mixed-methods study.

BACKGROUND: Outcome measures are crucial to support a treat-to-target approach to rheumatoid arthritis (RA) care, yet their integration into clinical practice remains inconsistent. We developed an Electronic Heath Record-integrated, patient-facing side-car application to display RA outcomes (disease activity, functional status, pain scores), medications, and lab results during clinical visits ("RA PRO Dashboard"). The study aimed to evaluate patient perceptions and attitudes towards the implementation of a novel patient-facing dashboard during clinical visits using a mixed-methods approach. METHODS: RA patients whose clinicians used the dashboard at least once during their clinical visit were invited to complete a survey regarding its usefulness in care. We also conducted semi-structured interviews with a subset of patients to assess their perceptions of the dashboard. The interviews were transcribed verbatim and analyzed thematically using deductive and inductive techniques. Emerging themes and subthemes were organized into four domains of the Ecological Model of Health. RESULTS: Out of 173 survey respondents, 79% were interested in seeing the dashboard again at a future visit, 71% felt it improved their understanding of their disease, and 65% believed it helped with decision-making about their RA care. Many patients reported that the dashboard helped them discuss their RA symptoms (76%) and medications (72%) with their clinician. Interviews with 29 RA patients revealed 10 key themes: the dashboard was perceived as a valuable visual tool that improved patients' understanding of RA outcome measures, enhanced their involvement in care, and increased their trust in clinicians and the clinic. Common reported limitations included concerns about reliability of RA outcome questionnaires for some RA patients and inconsistent collection and explanation of these measures by clinicians. CONCLUSIONS: In both the quantitative and qualitative components of the study, patients reported that the dashboard improved their understanding of their RA, enhanced patient-clinician communication, supported shared decision-making, and increased patient engagement in care. These findings support the use of dashboards or similar data visualization tools in RA care and can be used in future interventions to address challenges in data collection and patient education.

Trajectories of disease evolution upon treatment initiation in systemic lupus erythematosus: results from four clinical trials of belimumab.

OBJECTIVE: Upon commencement of therapy for active disease, patients with systemic lupus erythematosus (SLE) show varying evolution regarding disease activity measures and patient-reported outcomes (PROs). Our objective was to identify disease evolution trajectories to gain a deeper understanding of SLE progression, ultimately improving future trial design. METHODS: Patients with ≥2 visits and available data on SLEDAI-2K, BILAG, PGA, FACIT-F, and glucocorticoid use were included in a post-hoc analysis of four randomised controlled trials of belimumab (BLISS-52, BLISS-76, BLISS-SC, EMBRACE). Growth mixture modelling identified latent classes. RESULTS: Among 2868 patients analysed, baseline median disease duration was 4.5 (IQR: 1.5-9.7) years and mean (± standard deviation) SDI 0.7 (±2.0), SLEDAI-2K 10.2 (±3.6), BILAG 17.0 (±7.8), PGA 1.5 (±0.5), FACIT-F 30.6 (±11.9), and prednisone dose 11.0 (±8.9) mg/day. In the initial model, glucocorticoid use and dose yielded high standard errors, indicating a weak link with the latent process. A refined model considered only clinical measures and FACIT-F, corrected for intervention and SDI; no other covariates improved the fit. Four classes best described disease evolution: highly active, responders; highly active, non-responders; moderately active, responders; moderately active, non-responders. LLDAS and DORIS remission attainment associated with latent classes. CONCLUSION: By linking disease activity measures with PROs, we identified four distinct trajectories describing SLE evolution following the initiation of therapy. This classification could be valuable for personalising treatment and guiding biological studies aimed at distinguishing patients with varying anticipated treatment responses, as no single clinical variable alone can predict disease progression.

A Comparative Analysis of Clinical Symptoms and Modified Pouchitis Disease Activity Index Among Endoscopic Phenotypes of the J Pouch in Patients With Inflammatory Bowel Disease.

Background: The modified pouchitis disease activity index (mPDAI) based on clinical symptoms and endoscopic findings is used to diagnose pouchitis, but validated instruments to monitor pouchitis are still lacking. We recently established an endoscopic classification that described 7 endoscopic phenotypes with different outcomes. We assessed symptoms and compared mPDAIs among phenotypes in inflammatory bowel disease (IBD). Methods: We retrospectively reviewed pouchoscopies and classified them into 7 main phenotypes: normal (n = 25), afferent limb (AL) involvement (n = 4), inlet involvement (n = 14), diffuse (n = 7), focal inflammation of the pouch body (n = 25), cuffitis (n = 18), and pouch-related fistulas (n = 10) with a single phenotype were included. Complete-case analysis was conducted. Results: One hundred and three IBD patients were included. The median mPDAI was 0 (IQR 0-1.0) in patients with a normal pouch. Among inflammatory phenotypes, the highest median mPDAI was 4.0 (IQR 2.25-4.75) in cuffitis, followed by 3.0 (IQR 2.5-4.0) in diffuse inflammation, 2.5 (IQR 1.25-4.0) in inlet involvement, 2.5 (IQR 2.0-3.5) in AL involvement, 2.0 (IQR 1.0-3.0) in focal inflammation, and 1.0 (IQR 0.25-2.0) in the fistula phenotype. Perianal symptoms were frequently observed in pouch-related fistulas (8/10, 80%) and cuffitis (13/15, 87%). Among patients with cuffitis, all had incomplete emptying (6/6, 100%). Conclusions: We correlated the mPDAI with the endoscopic phenotypes and described the limited utility of symptoms in distinguishing between inflammatory phenotypes. Further studies are warranted to understand which symptoms should be monitored for each phenotype and whether mPDAI can be minimized after pouch normalization.

Evaluation of disease activity in systemic lupus erythematosus using standard deviation of lymphocyte volume combined with red blood cell count and lymphocyte percentage.

Systemic lupus erythematosus (SLE) commonly damages the blood system and often manifests as blood cell abnormalities. The performance of biomarkers for predicting SLE activity still requires further improvement. This study aimed to analyze blood cell parameters to identify key indicators for a SLE activity prediction model. Clinical data of 138 patients with SLE (high activity, n = 40; moderate activity, n = 44; mild activity, n = 37; low activity, n = 17) and 100 healthy controls (HCs) were retrospectively analyzed. Data from 89 paired admission-discharge patients with SLE were collected. Differences and associations between blood cell parameters and disease indicators, as well as the relationship between the these parameters and organ damage, were examined. Machine-learning methods were employed to develop a prediction model for disease activity evaluation. Most blood cell parameters (22/26, 84.62%) differed significantly between patients with SLE and HCs. Analysis of 89 paired patients with SLE revealed significant changes in most blood cell parameters at discharge. The standard deviation of lymphocyte volume (SD-V-LY), red blood cell (RBC) count, lymphocyte percentage (LY%), hemoglobin(HGB), hematocrit(HCT), and neutrophil percentage(NE%) correlated with disease activity. By employing machine learning, an optimal model was established to predict active SLE using SD-V-LY, RBC count, and LY% (area under the curve [AUC] = 0.908, sensitivity = 0.811). External validation indicated impressive performance (AUC = 0.940, sensitivity = 0.833). Correlation analysis revealed that SD-V-LY was positively correlated with ESR, IgG, IgA, and IgM but was negatively correlated with C3 and C4. The RBC count was linked to renal and hematopoietic system impairments, whereas LY% was associated with joint/muscle involvement. In conclusion, SD-V-LY is associated with SLE disease activity. SD-V-LY combined with RBC count and LY% contributes to a prediction model, which can be utilized as an effective tool for assessing SLE activity.

Clinical Features and Survival Analysis of Lupus Nephritis among Patients with Systemic Lupus Erythematosus: A Three-Decade-Long Retrospective Cohort Study.

Background/Objectives: Lupus nephritis (LN) is one of the most severe organ manifestations of systemic lupus erythematosus (SLE). The aim of our retrospective cohort study was to compare the clinical characteristics, therapy, survival, causes of death, and prognostic factors of LN and non-LN lupus patients. Moreover, we compared a wide spectrum of clinical data of LN patients diagnosed before and since 2005 to determine any changes in disease course and outcomes. Methods: We assessed the clinical and laboratory data of 384 SLE patients, out of whom, 127 patients were diagnosed with LN between 1990 and 2020. Results: Based on our observations, discoid LE, subacute cutaneous LE, antiphospholipid syndrome, Sjögren's syndrome, and rheumatoid arthritis were more common in non-LN patients, while anemia and anti-RNP positivity were more frequent in LN patients. Development of LN did not affect survival rates; male sex and presence of APS were negative prognostic parameters in the non-LN group while achieving remission was a positive prognostic factor in both groups. Death caused by sepsis was more prevalent in the LN group. Serositis and neurological manifestations occurred less frequently in LN patients diagnosed after 2005. The use of mycophenolate mofetil became more common, and the cumulative corticosteroid dose decreased. The SLICC Damage Index score also decreased. Conclusions: Our study demonstrated that the disease course has changed in recent years, and the main therapeutic goal in both SLE and lupus nephritis should be to achieve remission because this significantly improves long-term prognosis and patient survival.

Disease Activity, Inflammation Markers, and Quality of Life Are Associated with Muscle Strength in Croatian Rheumatoid Arthritis Patients-A National-Based Study.

Background and Objectives: Rheumatoid arthritis (RA) patients experience sarcopenia and decreased muscle mass and handgrip strength, leading to decreased quality of life and disability. The prevalence of RA varies across regions. This study aimed to evaluate the factors associated with RA in Croatian regional centres and explore correlations between clinical parameters and muscle strength. Materials and Methods: Included in this study were 267 stable RA patients from four Croatian clinical centres. The patients' mean age was 60.4 ± 12.0 years, with 12.7% of them being male. For each study participant, information was gathered on their anthropometric characteristics, clinical and laboratory indicators, quality of life, disease activity, and sociodemographics. Results: The main results showed that in the female RA participants, the significant positive predictors are weight, height, exercise, VAS, and haemoglobin level. The negative predictors are the use of conventional synthetic disease-modifying anti-rheumatic drugs, the use of biological disease-modifying anti-rheumatic drugs, the number of tender joints, the number of swollen joints, the estimated sedimentation rate, the C-reactive protein, the disease activity score, the parameters of the EQ5D, and being prescribed with three or more medications. In the male RA participants, significant predictors of muscle strength are only weight, height, and anxiety/depression difficulties, according to the EQ5D. Conclusions: This study showed correlations between muscle strength and the parameters of disease activity, inflammation parameters, health-related quality of life, therapy, and exercise in the female RA participants in Croatia.

Interferon-Gamma-Inducible Protein-10 (IP-10) and Tumor Necrosis Factor-α (TNF-α) as Serological Predictors of Active Disease Status in Localized Scleroderma.

We investigated the ability of a panel of immune-related cytokines and chemokines to predict the disease activity state in localized scleroderma (LS) subjects followed longitudinally. A total of 194 sera samples were obtained from 45 LS subjects with diverse types of LS (40% linear, 20% mixed, 16% craniofacial, 13% generalized, and 11% circumscribed) in our cohort. Cytokines/chemokines that were significantly elevated at the baseline active disease visit compared to the inactive disease state at follow-up were Interferon-Gamma-Inducible Protein (IP)-10 (p < 0.021) and Tumor Necrosis Factor (TNF)-α (p < 0.033). Mixed effect logit modeling identified IP-10 (Odds Ratio (OR) [95% confidence interval] = 2.1 [1.4, 3.2], p < 0.001), TNF-α (OR = 1.8 [1.1, 3.0], p = 0.016), and Monocyte Chemoattractant Protein (MCP)-1 (OR = 2.0 [1.1, 3.9], p = 0.034) as significant predictors of active disease status. These findings support earlier correlations between IP-10 and TNF-α with disease activity parameters in a cross-sectional Luminex™ serological study and may enhance clinical decision-making when disease activity is challenging to assess by clinical examination alone.

Major Determinants of Well-Being in Patients With Axial Spondyloarthritis: 2 Year Follow-Up.

OBJECTIVES: Bath Ankylosing Spondylitis Patient Global Score (BAS-G) is a uni-dimensional scale that enables patients to evaluate the effects of their illness on their health. The aim of this study was to determine the impact of disease related outcomes on the BAS-G scores in patients with axSpA. METHODS: A total of 309 patients (56.6% of whom were male, mean age 44 ± 11) were included in the study. Socio-demographic characteristics (age, sex and education level) and clinical characteristics such as disease activity (BASDAI and CRP), spinal mobility (BASMI), functional status (BASFI), radiographic structural damage (mSASS, mNY, and BASRI-hip), and health related quality of life (SF-36 and ASQoL) of the patients were recorded at baseline. In addition, BASDAI total and each item score, BASFI, BAS-G, and CRP levels were collected at 6, 12, and 24 months. RESULTS: Female patients had significantly higher BAS-G scores (p = 0.037). Baseline BASDAI total score (p < 0.001) and all BASDAI item scores (p < 0.001 for each item), BASFI total score (p < 0.001), ASQoL total score (p < 0.001), and SF-36 PCS sum-score (p < 0.001) were moderately/highly correlated with BAS-G. Multivariate analysis revealed that back pain (BASDAI Q2) (p < 0.001) and the severity of morning stiffness (BASDAI Q5) (p < 0.001) were the main determinants of BAS-G in patients with axSpA. In 2-year follow-up, BASDAI Q1, BASDAI Q5, and BASFI scores were independent determinants of BAS-G in patients with axSpA. CONCLUSION: According to the results of the present study, patients with axSpA mainly rely on morning stiffness and back pain to determine their global health status. Moreover, fatigue, severity of morning stiffness and function are the determinants of BAS-G during follow-up.