UNASSIGNED: To evaluate the performance of a disease activity (DA) model developed to detect DA in participants with neovascular age-related macular degeneration (nAMD).
UNASSIGNED: Post hoc analysis.
UNASSIGNED: Patient dataset from the phase III HAWK and HARRIER (H&H) studies.
UNASSIGNED: An artificial intelligence (AI)-based DA model was developed to generate a DA score based on measurements of OCT images and other parameters collected from H&H study participants. Disease activity assessments were classified into 3 categories based on the extent of agreement between the DA model\'s scores and the H&H investigators\' decisions: agreement (\"easy\"), disagreement (\"noisy\"), and close to the decision boundary (\"difficult\"). Then, a panel of 10 international retina specialists (\"panelists\") reviewed a sample of DA assessments of these 3 categories that contributed to the training of the final DA model. A panelists\' majority vote on the reviewed cases was used to evaluate the accuracy, sensitivity, and specificity of the DA model.
UNASSIGNED: The DA model\'s performance in detecting DA compared with the DA assessments made by the investigators and panelists\' majority vote.
UNASSIGNED: A total of 4472 OCT DA assessments were used to develop the model; of these, panelists reviewed 425, categorized as \"easy\" (17.2%), \"noisy\" (20.5%), and \"difficult\" (62.4%). False-positive and false negative rates of the DA model\'s assessments decreased after changing the assessment in some cases reviewed by the panelists and retraining the DA model. Overall, the DA model achieved 80% accuracy. For \"easy\" cases, the DA model reached 96% accuracy and performed as well as the investigators (96% accuracy) and panelists (90% accuracy). For \"noisy\" cases, the DA model performed similarly to panelists and outperformed the investigators (84%, 86%, and 16% accuracies, respectively). The DA model also outperformed the investigators for \"difficult\" cases (74% and 53% accuracies, respectively) but underperformed the panelists (86% accuracy) owing to lower specificity. Subretinal and intraretinal fluids were the main clinical parameters driving the DA assessments made by the panelists.
UNASSIGNED: These results demonstrate the potential of using an AI-based DA model to optimize treatment decisions in the clinical setting and in detecting and monitoring DA in patients with nAMD.
UNASSIGNED: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

OBJECTIVE: There is an urgent need to discover blood-based biomarkers of multiple sclerosis (MS) to better define the underlying biology of relapses and monitor disease progression. The main goal of this study is to search for candidate biomarkers of MS relapses associated with circulating extracellular vesicles (EVs), an emerging tool for biomarker discovery.
METHODS: EVs, purified from unpaired plasma and CSF samples of RRMS patients by size-exclusion chromatography (SEC), underwent proteomic analysis to discover novel biomarkers associated with MS relapses. The candidate biomarkers of disease activity were detected by comparison approach between plasma- and CSF-EV proteomes associated with relapses. Among them, a selected potential biomarker was evaluated in a cohort of MS patients, using a novel and highly reproducible flow cytometry-based approach in order to detect low abundant EV subsets in a complex body fluid such as plasma.
RESULTS: The proteomic profiles of both SEC-purified plasma EVs (from 6 patients in relapse and 5 patients in remission) and SEC-purified CSF EVs (from 4 patients in relapse and 3 patients in remission) revealed a set of proteins associated with MS relapses significant enriched in the synaptic transmission pathway. Among common proteins, excitatory amino-acid transporter 2, EAAT2, responsible for the majority of the glutamate uptake in CNS, was worthy of further investigation. By screening plasma samples from 110 MS patients, we found a significant association of plasma EV-carried EAAT2 protein (EV-EAAT2) with MS relapses, regardless of disease-modifying therapies. This finding was confirmed by investigating the presence of EV-EAAT2 in plasma samples collected longitudinally from 10 RRMS patients, during relapse and remission. Moreover, plasma EV-EAAT2 levels correlated positively with Expanded Disability Status Scale (EDSS) score in remitting MS patients but showed a negative correlation with age in patients with secondary progressive (SPMS).
CONCLUSIONS: Our results emphaticize the usefulness of plasma EVs as a source of accessible biomarkers to remotely analyse the CNS status. Plasma EV-EAAT2 showed to be a promising biomarker for MS relapses. Further studies are required to assess the clinical relevance of this biomarker also for disability progression independent of relapse activity and transition from RRMS towards SPMS.

UNASSIGNED: Fatigue is a common, disabling, and poorly understood aspect of Rheumatoid arthritis (RA) treatment. Better understanding of fatigue is required for holistic treatment of RA. The present study was conducted to evaluate factors (disease activity, pain, sleep quality, and vitamin D) contributing to fatigue in RA.
UNASSIGNED: A cross-sectional study was conducted on 204 patients of RA. Fatigue was measured using CFQ-11 scale, pain and sleep impairment were assessed on visual analogue scale, disease activity by DAS 28 ESR, and vitamin D levels by enzyme chemiluminescence immunoassay. Univariate and multivariate binary logistic regression analyses were done to study association.
UNASSIGNED: Mean age of study subjects was 51±11.63 years with majority (89.7%) being females and mean duration of RA was 8.54 years. Prevalence of fatigue was 66.2% (CFQ-11 score >4/11). Deficiency of vitamin D was found in 12.3% subjects. Mean sleep impairment and pain score on VAS were 32.60±21.53 and 26.37±21.65 respectively. Univariate analysis revealed that CFQ-11 fatigue score was independently associated with disease activity, pain, sleep, and vitamin D deficiency. Further Multivariate binary logistic regression analysis showed strongest association of vitamin D deficiency with fatigue (OR of 6.38 with 95% confidence interval of 1.58, 25.71). Disease activity (OR - 1.714, 95% CI- 1.14, 2.55) and sleep impairment (OR - 1.038, 95% CI- 1.005, 1.071) have also been found to be significantly associated with fatigue.
UNASSIGNED: Fatigue in RA is multifactorial, and it is mediated by disease-related factors (disease activity, sleep impairment) and non-disease-related factors (vitamin D deficiency).

BACKGROUND: Systemic Lupus Erythematosus (SLE) is an autoimmune disease affecting multiple organs, characterized by flares and remission. Treatment aims to reduce flare severity and prevent long-term damage, but remission is often elusive, and patients may still experience flares and a reduced quality of life (QoL). This had led to a growing interest in non-pharmacological therapies to improve patient wellbeing.
OBJECTIVE: We aimed to assess and summarize the efficacy of lifestyle interventions in SLE patients on disease activity and QoL.
METHODS: A systematic search on lifestyle interventions, SLE, disease activity, and QoL was conducted in PubMed/Medline, Embase and Clinicaltrials.gov in August 2024. Included studies were randomized controlled trials on lifestyle interventions in adult SLE patients. Each trial was appraised using Scottish Intercollegiate Guidelines Network (SIGN) criteria, with participant numbers, study duration, intervention type and outcome measures detailed in separate tables.
RESULTS: A total of 3564 articles were screened, resulting in the inclusion of 25 randomized controlled trials with 1521 patients. Study quality varied from high (11 studies) to low (6 studies) with considerable intervention heterogeneity. The interventions fell into five categories: physical activity, psychotherapy, lifestyle coaching, supplements and dietary interventions. Physical activity (2 studies, 116 patients), psychotherapy (5 studies, 507 patients) and coaching (1 study with 30 patients) had no significant effect on disease activity, while fish oil supplementation showed a slight benefit in two studies with a total of 102 patients. Quality of life generally improved with physical activity (4 studies with in total 253 patients) and psychotherapy (9 studies with in total 623 patients), with significant mental health benefits, but coaching (3 studies with in total 186 patients) showed no effect.
CONCLUSIONS: Various lifestyle interventions influence quality of life in SLE patients. Consistent with recent guidelines, both exercise and psychotherapy may positively impact the health-related quality of life in these patients. However, some studies were biased due to self-reported outcomes and the Hawthorne effect, where participants\' behavior changed from receiving extra attention. Further research with larger patient cohorts is necessary to reduce the influence of heterogeneity across different studies and to better understand the potential of these promising therapies.

UNASSIGNED: Systemic lupus erythematosus (SLE) is a multi-system autoimmune disease that significantly affects both the physical and mental health of patients. Psychosocial support systems play a crucial role in managing chronic diseases, yet their specific impact on the disease activity of SLE patients remains unclear. This study aims to explore the dynamic relationship between disease activity in SLE patients and various types of psychosocial support systems.
UNASSIGNED: We conducted a retrospective longitudinal observational study, including 150 SLE patients who received treatment at our hospital from January 2022 to January 2023. Emotional support, tangible support, social interaction support, and informational support were assessed using the revised Social Support Rating Scale. Disease activity was quantified using the European Consensus Lupus Activity Measurement. The relationship between psychosocial support and disease activity was analyzed using Spearman\'s rank correlation coefficient and multiple linear regression models, with Bootstrap resampling employed to test the robustness of the results.
UNASSIGNED: We found a significant negative correlation between psychosocial support and SLE disease activity, with emotional support, social interaction support, and informational support showing stronger negative correlations. Multiple regression analysis revealed that the inhibitory effects of emotional support, social interaction support, and informational support on disease activity increased over time. Although the impact of tangible support was not statistically significant, it gradually became more apparent over time.
UNASSIGNED: Our findings indicate a significant negative correlation between psychosocial support and SLE disease activity, particularly with emotional support, social interaction support, and informational support. Over time, the impact of tangible support also becomes evident. These findings provide important references for the comprehensive treatment and management of SLE patients. However, due to the observational nature of the study, the causality of this relationship requires further exploration.

Background and Objectives: This study investigated the impact of nutritional status and foods consumed on inflammation and disease activity in patients with rheumatoid arthritis (RA). Materials and Methods: We designed a cross-sectional observational study, involving 110 patients diagnosed with RA. The patients included were between 18 and 75 years old, diagnosed with rheumatoid arthritis two years ago or earlier, with stable treatment for the last 8 weeks. Data on anthropometric parameters, body mass composition, nutritional status, individual food consumption records, inflammation, disease activity, quality of life, clinical, and laboratory parameters were collected for each study participant. The evaluation parameters of the patients were the simple disease activity index (SDAI), clinical disease activity index (CDAI), systemic immune-inflammation index (SII) and individual food consumption records. A bioimpedance device and measuring tape were used to take body composition and anthropometric measurements of the patients. Results: According to the body mass index, waist circumference and waist-to-height ratio, in our study, we found that 60% of the patients were obese, 80% were at a very high health risk, and approximately 91% were in need of nutritional treatment. There was a significant negative correlation between the dietary intake of total energy, total fat, omega 3, calcium, zinc, cobalamin and the disease activity (SDAI, CDAI). There was a significant negative correlation between polyunsaturated fatty acids, omega 3, carotene, vitamin E, selenium and the SII. Additionally, there was a positive correlation between omega 6 and the SII, SDAI, CDAI (p < 0.05). Conclusions: The results of this study show that the foods consumed in the nutrition of RA patients may have effects on their inflammation and disease activity.

Recent evidence suggests that whole-body cryostimulation (WBC) may be beneficial for patients with fibromyalgia (FM), but little is known about the duration of such effects. The purpose of this study was to verify the duration of clinical-functional benefits after one cycle of WBC. We conducted a follow-up study on the medium and long-term effects of WBC on well-being, use of pain-relieving/anti-inflammatory medications, pain level, fatigue, sleep quality, and psychological aspects such as mood and anxiety. Twelve months after discharge, we administered a 10 min follow-up telephone interview with FM patients with obesity who had undergone ten 2 min WBC sessions at -110 °C as part of a multidisciplinary rehabilitation program (n = 23) and with patients who had undergone rehabilitation alone (n = 23). Both groups reported positive changes after the rehabilitation program, and similar results regarding fatigue, mood, and anxiety scores; however, the implementation of ten sessions of WBC over two weeks produced additional benefits in pain, general well-being status, and sleep quality with beneficial effects lasting 3-4 months. Therefore, our findings suggest that adding WBC to a rehabilitation program could exert stronger positive effects to improve key aspects of FM such as general well-being, pain level, and sleep quality.

Juvenile idiopathic arthritis (JIA) is a chronic arthritis of unknown cause that develops in patients younger than 16 years of age and persists for at least 6 weeks. It is an important cause of short- and long-term physical and mental impairments in children. The goal of treatment for JIA is remission. A T2T (treatment-to-target) has been proposed and practiced as a means of achieving remission. The method of evaluating the disease activity of JIA depends on the disease type. For systemic JIA, disease activity is determined by comprehensively considering joint findings, systemic inflammatory findings, changes in inflammatory and synovitis markers, imaging findings, and other factors. For articular JIA other than systemic JIA, the Juvenile Arthritis Disease Activity Score (JADAS-27) is used to evaluate disease activity. The CHAQ (Childhood Health Assessment Questionnaire) and the Japanese version of the modified Rankin Scale (mRS) are mainly used to assess the physical function and ADL. The CHAQ is a global standard assessment method with the advantage that it can be transitioned to the HAQ used in adults, making it useful for international comparisons. The mRS is used to classify the severity of JIA as a chronic disease, and is an indispensable evaluation method in the specific disease procedure in Japan. It is necessary to have pediatric-specific knowledge of growth and development and routine childhood immunizations and to consider transition support tailored to the patient\'s situation. Ultimately, the goal is to foster the patient\'s independence and to provide an uninterrupted follow-up in the adult care department. Continuous follow-up will be provided during the schooling (and later, employment) period, and the relationship with the patient will be tailored to their developmental stage. It is also important to understand and communicate the importance of contraception and the drugs that cannot be used during pregnancy.

Background/Objectives: We examined the frequency of zinc deficiency in patients with Sjögren\'s syndrome (SS) and the relationship between zinc deficiency and each of the subjective symptoms and disease activity. Methods: We enrolled 164 patients aged ≥ 20 years with primary SS (pSS) based on the revised diagnostic criteria of the Ministry of Health, Labor and Welfare (1999) and 144 patients with RA diagnosed according to the ACR/EULAR classification criteria for RA (2010) as a comparison group. Subjective symptoms were confirmed using an original questionnaire, and disease activity was determined using the European League Against Rheumatism Sjögren\'s Syndrome Disease Activity Index (ESSDAI). The serum zinc concentrations were measured in both SS and RA patients. Results: The rate of zinc deficiency in the SS group was 26.1%, significantly higher than that in the RA group (7.6%). The rate of zinc deficiency was significantly higher in the pSS group compared with Japanese health checkup recipients reported in the literature. The mean serum zinc concentration in primary SS was 60.6 ± 7.3 µmol/L in the high disease activity group with an ESSDAI of ≥5 points, which was significantly lower than the concentration of 69.7 ± 10.2 µmol/L in patients with an ESSDAI of ≤4 points. Conclusions: The frequency of zinc deficiency was higher in patients with pSS than in patients with RA. Disease activity was also higher in patients with zinc deficiency, suggesting an association between zinc concentration and organ involvement in pSS.

Helicobacter pylori infection has significant epidemiological relevance due to the carcinogenic nature of this bacterium, which is potentially associated with cancer. When detected, it should ideally be eradicated using a treatment that currently involves a combination of gastric acid suppressors and multiple antibiotics. However, this treatment raises questions regarding efficacy and safety profiles in patients with specific comorbidities, including inflammatory bowel diseases (IBD). Eradication therapy for H. pylori includes components associated with adverse gastrointestinal events, such as Clostridioides difficile colitis. This necessitates quantifying this risk through dedicated studies to determine whether this antimicrobial treatment could be significantly associated with IBD relapse or exacerbation of pre-existing IBD, as well as whether it could potentially lead to the de novo onset of IBD. Although the available evidence is reassuring about the safety of eradication therapy in patients with IBD, it is limited, and there are no specific recommendations for this particular situation in the leading international IBD and H. pylori guidelines. Therefore, studies need to evaluate the efficacy and safety profiles of the available antimicrobial regimens for H. pylori eradication in patients with IBD, both in clinical trial settings and in real-life studies.