Emergencies in inflammatory rheumatic diseases.

Inflammatory rheumatic diseases (IRDs), encompassing a broad spectrum of chronic disorders, typically necessitate prolonged therapeutic intervention. Nevertheless, these diseases can sometimes manifest as severe emergencies requiring prompt and extensive medical intervention. Urgent intervention is essential for effectively recognizing and managing these situations, as they have the potential to be life-threatening and can result in severe morbidity and mortality. Emergencies in IRDs can occur with different frequencies and manifestations, including nervous system issues, severe infections, thrombosis-emboli, renal crises, gastrointestinal issues, and cardiovascular events. The fact that these events can occur across different IRDs underscores the necessity for heightened awareness and readiness among healthcare professionals. The pathophysiologic mechanisms that cause rheumatic emergencies are complex and involve multiple factors. These emergencies frequently arise due to the interplay between the inflammatory characteristics of rheumatic diseases and different systemic triggers. Early detection and treatment can have a substantial impact on an individual's prognosis in cases of severe and life-threatening disorders that require prompt recognition. Rapid decision-making and urgent care are required to effectively address rheumatic emergencies, as well as the implementation of a diagnostic flowchart. This article provides an overview of the emergencies linked to IRDs, classifying and assessing them individually. This article aims to enhance healthcare professionals' knowledge and awareness of critical situations by examining current recommendations and pathophysiological information. Implementing standardized diagnostic and treatment methods, providing patient education, and conducting continuing research into the underlying mechanisms are essential for enhancing the management of these critical situations and improving patient outcomes.

Quantification of Longitudinal Patient-Reported Burden of Adverse Drug Reactions Attributed to the Use of TNF-α Inhibitors in inflammatory rheumatic diseases: an observational prospective cohort study.

BACKGROUND: There is a lack of knowledge on patient perspectives on adverse drug reactions (ADRs) attributed to the use of biologics. The aim of this study is to quantify the burden over time of ADRs attributed to TNF-α inhibitors in patients with inflammatory rheumatic diseases (IRDs) and investigate whether the burden over time differs between different types of ADRs. RESEARCH DESIGN AND METHODS: Data were used from the Dutch Biologic Monitor (DBM), an observational prospective cohort study for patient-reported ADRs attributed to biologics. Patients with an IRD using a TNF-α inhibitor reporting an ADR, lasting for three consecutive questionnaires, were included. Questionnaires were sent every two months and burden was scored on a 5-point Likert-type scale. Burden scores were analyzed using linear mixed models. RESULTS: Data from 166 unique patients reporting 274 ADRs were included. The burden score decreased every month by 0.29 points (95% CI -0.34 - -0.24) on average on a 5-point Likert-type scale. The burden score for infections and infestations decreased significantly faster than the burden score for injection site reactions. CONCLUSIONS: Patient-reported burden of ADRs attributed to the use of a TNF-α inhibitor in patients with IRDs decreased significantly over time, especially for infections and infestations.

A Distinct Instance of Palindromic Rheumatism Disguised as Polymyalgia Rheumatica.

In this case report, we highlight a rare case of palindromic rheumatism (PR) presenting as polymyalgia rheumatica (PMR). Many challenges and complexities are associated with diagnosing and treating PR. Literature reviews showed only a few case reports of this unique presentation. PR has a distinct presentation that often goes unnoticed and is misinterpreted by medical professionals. A more thorough clinical approach is required to identify and treat this condition. We hope sharing such uncommon cases will help the medical community better understand PR and develop improved diagnostic and therapeutic options. This case also demonstrates the need for further research to better understand the pathogenesis of this uncommon condition.

Research progress of Hippo pathway effector molecules in rheumatic immune system diseases. / Hippoä¿¡å·é€šè·¯æ•ˆåº”åˆ†å­åœ¨é£Žæ¹¿å ç–«æ€§ç–¾ç— ä¸­çš„ä½œç”¨ç ”ç©¶è¿›å±•.

The core components of the Hippo signaling pathway encompass upstream regulatory molecules, core kinase cascade complexes, and downstream transcriptional regulation complexes. This pathway modulates cellular biological behaviors by influencing the effector molecules of its core components and plays a pivotal role in immune regulation. Effector molecules,such as Yes-associated protein (YAP), transcriptional coactivator with PDZ-binding motif (TAZ), transcriptional enhanced associate domain transcriptional factor (TEAD), monopolar spindle-one binder (MOB1), large tumor suppressor (LATS), can stimulate fibroblast-like synovial cell migration and invasion in rheumatoid arthritis, regulate osteoarthritis disease progression, promote pathological new bone formation in ankylosing spondylitis, sustain submandibular gland development while delaying Sjogren's syndrome progression, mediate alpha-smooth muscle actin in systemic sclerosis, and refine the regulation of target genes associated with pulmonary fibrosis. This article provides an overview of the regulatory mechanisms involving Hippo signaling pathway-related effector molecules in the pathogenesis and progression of rheumatic immune system diseases, to serve as a reference for exploring novel therapeutic targets of rheumatic immune system diseases.

Novel electrical therapy to improve sleep disturbance in patients with autoimmune rheumatic diseases.

OBJECTIVES: Sleep disturbance is common in autoimmune rheumatism diseases (ARD) and it plays an important role in activating disease and affects the quality of life. This study aims to evaluate the efficacy and acceptability of the novel electrical therapy on sleep disturbance in ARD patients and its effect on immunologic factors. METHODS: A total of 51 ARD patients (26 treatment group and 25 control group) with sleep disturbance were enrolled in this study. Sleep parameters and immunological indicators (serum level of 12 cytokines and immune function) were collected. The novel electrical therapy was prescribed for 15-30 min 3-6 times a day. The Pittsburg Sleep Index (PSQI) was assessed before and after 3 months' treatment by Mi Energy equipment. Immune function and serum levels of cytokines of all participants at baseline and after treatment were tested with flow cytometry and flow immunofluorescence, respectively. Correlation analysis was used to analyze the relationship between sleep disturbance and immunologic factors. Multiple linear regression analysis was employed to investigate the risk of sleep disturbance in ARD. RESULTS: The global score of PSQI (Baseline: 12.81 ± 4.07, After novel electrical therapy: 4.88 ± 2.76) was effectively improved after 3 months of adjuvant therapy by electrical therapy. We also found that serum levels of IL-8 and IL-1ß statistically significantly decreased after novel electrical therapy. This adjuvant therapy can also significantly decrease the percentage of CD4 + CD8 + T cell, effector memory CD8 + T cell, Memory CD8 + T cell, Th17 cell, and plasma cell and significantly can increase the percentage of naïve CD8 + T cell, Th2 cell, and Tfh2 cell. Nevertheless, all serum level of 12 cytokines and the percentage of immune cells did not correlate with the PSQI global score except the Tc17 cell. Furthermore, age is an independent risk factor influencing PSQI scores (OR = 1.15, p < 0.05) in patients with autoimmune diseases through multiple linear regression analysis. CONCLUSIONS: Novel electrical therapy can effectively improve sleep disturbance in patients with ARD. It can also change the serum level of some cytokines (IL-8 and IL-1ß) and percentage of immune cells (CD4 + CD8 + T cell, effector memory CD8 + T cell, Memory CD8 + T cell, Th17 cell, naïve CD8 + T cell, Th2 cell, Tfh2 cell, and plasma cell).

Classifying Self-Reported Rheumatoid Arthritis Flares Using Daily Patient-Generated Data From a Smartphone App: Exploratory Analysis Applying Machine Learning Approaches.

BACKGROUND: The ability to predict rheumatoid arthritis (RA) flares between clinic visits based on real-time, longitudinal patient-generated data could potentially allow for timely interventions to avoid disease worsening. OBJECTIVE: This exploratory study aims to investigate the feasibility of using machine learning methods to classify self-reported RA flares based on a small data set of daily symptom data collected on a smartphone app. METHODS: Daily symptoms and weekly flares reported on the Remote Monitoring of Rheumatoid Arthritis (REMORA) smartphone app from 20 patients with RA over 3 months were used. Predictors were several summary features of the daily symptom scores (eg, pain and fatigue) collected in the week leading up to the flare question. We fitted 3 binary classifiers: logistic regression with and without elastic net regularization, a random forest, and naive Bayes. Performance was evaluated according to the area under the curve (AUC) of the receiver operating characteristic curve. For the best-performing model, we considered sensitivity and specificity for different thresholds in order to illustrate different ways in which the predictive model could behave in a clinical setting. RESULTS: The data comprised an average of 60.6 daily reports and 10.5 weekly reports per participant. Participants reported a median of 2 (IQR 0.75-4.25) flares each over a median follow-up time of 81 (IQR 79-82) days. AUCs were broadly similar between models, but logistic regression with elastic net regularization had the highest AUC of 0.82. At a cutoff requiring specificity to be 0.80, the corresponding sensitivity to detect flares was 0.60 for this model. The positive predictive value (PPV) in this population was 53%, and the negative predictive value (NPV) was 85%. Given the prevalence of flares, the best PPV achieved meant only around 2 of every 3 positive predictions were correct (PPV 0.65). By prioritizing a higher NPV, the model correctly predicted over 9 in every 10 non-flare weeks, but the accuracy of predicted flares fell to only 1 in 2 being correct (NPV and PPV of 0.92 and 0.51, respectively). CONCLUSIONS: Predicting self-reported flares based on daily symptom scorings in the preceding week using machine learning methods was feasible. The observed predictive accuracy might improve as we obtain more data, and these exploratory results need to be validated in an external cohort. In the future, analysis of frequently collected patient-generated data may allow us to predict flares before they unfold, opening opportunities for just-in-time adaptative interventions. Depending on the nature and implication of an intervention, different cutoff values for an intervention decision need to be considered, as well as the level of predictive certainty required.

Performance of existing diagnostic criteria for palindromic rheumatism.

BACKGROUND: Four criteria have been proposed for the diagnosis of palindromic rheumatism (PR), including those of Hannonen et al., Passero and Barbieri, Guerne and Weisman, and Gonzalez-López. But none of these criteria has been validated. In this research, we investigated the performance of these diagnostic criteria for diagnosing PR. METHODS: In this study, PR and control groups were consecutively recruited from a prospective cohort of intermittent arthritis. Inclusion criteria for PR group were diagnosing PR by an expert rheumatologist, age ≥ 18, having at least 6 months follow-up, and ruling out of other causes of intermittent arthritis. These criteria were applied to both groups. Sensitivity, specificity, positive predictive value, negative predictive value, diagnostic odds ratio (DOR), and Youden's index were calculated for each criteria. RESULTS: This study included 197 consecutive subjects diagnosed with PR and 208 subjects with a diagnosis other than PR. The sensitivity of Hannonen et al. criteria was higher than the Gonzalez-Lopez, Guerne and Weisman, and Pasero and Barbieri criteria (96.4% versus 95.4%, 79.2%, and 35.5%, respectively). The specificity of the Pasero and Barbieri criteria was higher than the other criteria. Hannonen al. criteria with a DOR of 325.7, had the highest DOR. In descending order, the best accuracy belonged to Hannonen et al., Gonzalez-Lopez, Guerne and Weisman, and Pasero and Barbieri criteria (94.3%, 94.1%, 86.4%, and 66.9% respectively). CONCLUSION: This study showed that the Hannonen et al. and Gonzalez-Lopez criteria have a better performance in diagnosing PR. Key Points • The sensitivity of Hannonen et al. criteria and the specifity of Passero and Barbieri criteria are higher than other proposed criteria for diagnosis of palindromic rheumatism. • Hannonen et al. criteria with a sensitivity of 96.4%, specifity of 92.3% and accuracy of 94.3% has the best performance in diagnosis of palindromic rheumatism between existing diagnostic criteria for palindromic rheumatism.

Genetic Rare Variants Affecting Multiple Pathways in Japanese Patients with Palindromic Rheumatism.

Palindromic rheumatism (PR) is a type of cryptogenic paroxysmal arthritis. Several genes may be involved in PR pathogenesis; however, conducting comprehensive case-control genetic studies for PR poses challenges owing to its rarity as a disease. Moreover, case-control studies may overlook rare variants that occur infrequently but play a significant role in pathogenesis. This study aimed to identify disease-related genes in Japanese patients with PR using whole-genome sequencing (WGS) and rare-variant analysis. Genomic DNA was obtained from two familial cases and one sporadic case, and it was subjected to WGS. WGS data of 104 healthy individuals obtained from a public database were used as controls. We performed data analysis for rare variants on detected variants using SKAT-O, KBAC, and SKAT, and subsequently defined significant genes. Significant genes combined with variants shared between the cases were defined as disease-related genes. We also performed pathway analysis for disease-related genes using Reactome. We identified 2,695,244 variants shared between cases; after excluding polymorphisms and noise, 74,640 variants were detected. We identified 540 disease-related genes, including 1,893 variants. Furthermore, we identified 32 significant pathways. Our results indicate that the detected genes and pathways in this study may be involved in PR pathogenesis.

Uncovering the link between inflammatory rheumatic diseases and male reproductive health: a perspective on male infertility and sexual dysfunction.

Inflammatory rheumatic diseases (IRDs) refer to a range of persistent disorders that have a major influence on several physiological systems. Although there is much evidence connecting IRDs to sexual dysfunction and fertility problems, research specifically focusing on male infertility in relation to these diseases is sparse. This review addresses the complicated connection between IRDs and male infertility, emphasising the physiological, psychological, and pharmacological aspects that influence reproductive health outcomes in men with rheumatic conditions. We explore the effects of IRDs and their treatments on many facets of male reproductive well-being, encompassing sexual functionality, semen characteristics, and hormonal balance. Additionally, we present a comprehensive analysis of the present knowledge on the impact of several categories of anti-rheumatic drugs on male reproductive function. Although there is an increasing awareness of the need of addressing reproductive concerns in individuals IRDs, there is a noticeable lack of research especially dedicated to male infertility. Moving forward, more comprehensive research is needed to determine the prevalence, risk factors, and mechanisms driving reproductive difficulties in males with IRDs. We can better assist the reproductive health requirements of male IRD patients by expanding our understanding of male infertility in the setting of rheumatic disorders and implementing holistic methods to care.

The Association Between Physical Activity and Fatigue Among Adults With Rheumatic Disease in a Nationally Representative Sample.

OBJECTIVE: Adults with rheumatic disease (RD) experience high levels of fatigue. Regular physical activity has been shown to reduce fatigue among adults. Despite this evidence, adults with RD are more likely to be physically inactive compared with those without RD. Little information is known about the association of physical activity level and fatigue among adults with RD. This study investigated the association of physical activity level and fatigue among adults with and without RD. METHODS: Adults (≥18 y) who participated in the 2018 National Health Interview Survey (unweighted n = 25,471) were included in this cross-sectional study. Physical activity and fatigue were self-reported. Statistical analyses were weighted to account for complex survey sampling design. RESULTS: Significantly more adults with RD experience fatigue compared with adults without RD (26.19% vs 13.23%). Adults with RD who were inactive had 2.81 times (95% CI, 2.37-3.34) higher odds of experiencing fatigue compared to adults with RD who were sufficiently active, after adjusting for covariates. CONCLUSIONS: Overall, fatigue was more common among adults with RD than it was in the population without RD.

Arthritis prevalence is associated with metabolic syndrome risk factors but not with physical activity in middle-aged and older patients - a cross-sectional study.

BACKGROUND: In light of the aging population, increasingly suffering from the metabolic syndrome (MS), strategies need to be developed to address global public health challenges known to be associated with MS such as arthritis. As physical activity (PA) may play a crucial role in tackling those challenges, this study aimed to determine the association between the number of MS risk factors, PA and arthritis in people ≥ 50 years old. METHODS: Data from the Survey of Health, Ageing, and Retirement in Europe (SHARE) were used to estimate the prevalence of arthritis and MS risk factors in the European population ≥ 50 years and to evaluate the associations between MS risk factors, PA and arthritis. Binary logistic regression was performed to calculate the odds ratio of different factors. RESULTS: 73,125 participants were included in the analysis. 55.75% of patients stated at least one of the three MS risk factors. The prevalence of rheumatoid arthritis (RA) and osteoarthritis (OA)/other rheumatism among ≥ 50 years population was 10.19% and 19.32% respectively. Females showed a higher prevalence of arthritis than males. Prevalence did not differ between groups with different levels of PA. Arthritis prevalence was positively correlated with the number of MS risk factors (P < 0.01) but not with PA (P > 0.05). CONCLUSION: Middle-aged and older Europeans with multiple comorbidities suffered from RA, OA or other rheumatism more frequently than participants with fewer comorbidities, while the level of physical activity was not associated with the number of metabolic risk factors in patients with RA and OA/other rheumatism.

Crystal induced arthropathies-a comparative study of 40 patients with apatite rheumatism, chondrocalcinosis and primary synovial chondromatosis.

Introduction: Apatite rheumatism (AR), chondrocalcinosis (Ch-C), and primary synovial chondromatosis (prSynCh) are regarded as distinct clinical entities. The introduction of the non-staining technique by Bély and Apáthy (2013) opened a new era in the microscopic diagnosis of crystal induced diseases, allowing the analysis of MSU (monosodium urate monohydrate) HA (calcium hydroxyapatite), CPPD (calcium pyrophosphate dihydrate) crystals, cholesterol, crystalline liquid lipid droplets, and other crystals in unstained sections of conventionally proceeded (aqueous formaldehyde fixed, paraffin-embedded) tissue samples. The aim of this study was to describe the characteristic histology of crystal deposits in AR, Ch-C, and prSynCh with traditional stains and histochemical reactions comparing with unstained tissue sections according to Bély and Apáthy (2013). Patients and methods: Tissue samples of 4 with apatite rheumatism (Milwaukee syndrome), 16 with chondrocalcinosis, and 20 with clinically diagnosed primary synovial chondromatosis were analyzed. Results and conclusion: Apatite rheumatism, chondrocalcinosis, and primary synovial chondromatosis are related metabolic disorders with HA and CPPD depositions. The authors assume that AR and Ch-C are different stages of the same metabolic disorder, which differ from prSynCh in amorphous mineral production, furthermore in the production of chondroid, osteoid and/or bone. prSynCh is a defective variant of HA and CPPD induced metabolic disorders with reduced mineralization capabilities, where the deficient mineralization is replaced by chondroid and/or bone formation. The non-staining technique of Bély and Apáthy proved to be a much more effective method for the demonstration of crystals in metabolic diseases than conventional stains and histochemical reactions.

Delivery of nano-emulgel carrier: optimization, evaluation and in vivo anti-inflammation estimations for osteoarthritis.

Aim: Optimization and evaluation of Aceclofenac nanoemulgel for treatment for rheumatoid arthritis and reduction of GI irritation and enhancement of bioavaibility. Materials & methods: Different batches of emulgel and selected batch was proceeded for characterization like particle size, scanning electron microscopy, drug ingredient, in vitro release, Fourier transform infrared and x-ray diffraction in vitro inflammation and gel evaluation such as (spreadability, swelling index), ex vitro permeation, skin irritation and in vivo anti-inflammatory. Result: Emulgel showed nanometri size sustained release (79.96% in 6 h), compatibility and anti-inflammatory activity compared with pure drug. Concluded that emulgels had better (nearly twice as good) anti-inflammatory action as the commercial product. Conclusion: Compared with the commercial gel, the emulgel's anti-inflammatory effect had a quicker onset and a longer duration of action.

A non-steroidal anti-inflammatory drug (NSAID) aceclofenac is used as the treatment for rheumatoid arthritis. It is generally taken orally. However, there are a few issues with it being taken this way. The main ones are: some of the drug reacts too early in the body, meaning only a small amount of it reaches the parts of the body where it is needed; it can irritate the digestive system; and it does not dissolve very well in water, which also makes it harder to reach the parts of the body where it is needed. The authors of this study created a new type of gel for people to rub into their skin, instead of taking a pill. They hoped that this would allow the drug to be absorbed more directly into the parts of the body where it was needed, without irritating the digestive system. They tested the gel to see how well it contained and released the drug, how well it absorbed into the skin, and whether it irritated the skin. They found that the gel contained and released the drug more effectively than similar gels which are already available and caused less irritation to the skin.

Management of Rheumatic Diseases During Pregnancy and Breastfeeding: Position Paper of the Working Group for Obstetrics and Prenatal Medicine in the German Society for Gynecology and Obstetrics e. V. (AGG - Section Maternal Diseases in Pregnancy).

Purpose These recommendations issued by the AGG (Section Maternal Diseases in Pregnancy) were developed as a rapid orientation on maternal rheumatic diseases for counselling and disease management in pregnancy and breastfeeding. Methods The standard literature, consensus and position papers, guidelines and recommendations by other specialist associations were evaluated by a task force of the Section and summarized in these recommendations following a joint consensus process. Recommendations This paper provides an orientating overview of the physiology, pathophysiology and definitions of rheumatic diseases which is relevant for gynecologists and obstetricians. The recommendations focus on the maternal, fetal and neonatal diagnostic workup in cases with underlying maternal rheumatic disease.

Phytochemical and antimicrobial properties of different plants and in silico investigation of their bioactive compounds in wound healing and rheumatism.

In the current study the assessment of the antimicrobial and phytochemical properties of Cassia fistula, Musa paradisiaca, Ficus religiosa and Murraya koenigii plants extracts was carried out. The antibacterial potential of these plants extracts was tested against S. aureus and E. coli. The Cassia fistula and Ficus religiosa leaves showed the larger zone of inhibition in aqueous and butanolic extract respectively against Escherichia coli. Musa paradisiaca and Murraya koenigii leaves showed larger zone of inhibition in ethanolic extract against S. aureus. Qualitative phytochemical analysis showed the presence of alkaloids, flavonoids, phenols, terpenoids, steroids, glycosides, saponins, carbohydrates, proteins and tannins in all extracts while phylobatannins, emodins, anthocyanins and leucoanthocyanins were not present in these extracts. Quantitative phytochemical analysis showed the highest alkaloid content in the Murraya koenigii leaves. Highest tannin content and flavonoid content was found in Ficus religiosa leaves, while highest phenolic content was found in case of Cassia fistula. In addition to this antioxidant potential of all the extracts was determined. Musa paradisiaca leaves showed highest antioxidant potential as compared to other plant extracts. In silico analysis of bioactive components present in plant extracts was performed by molecular docking. The rutin and Glu from Musa paradisiaca and Murraya koenigii respectively, were docked with Glycogen Synthase Kinase 3 beta (1GSK-3beta) protein. Quercetin and rutin from Cassia fistula and Ficus religiosa respectively, were docked with C- reactive protein (CRP). The tested bioactive compounds showed good binding affinity with significant number of hydrogen bonds and can be used as a good alternative of synthetic drugs to treat rheumatism and wounds.

Ability of the European League Against Rheumatism-Outcomes Measures in Rheumatology combined scoring system for grading dorsal joint space synovitis to accurately evaluate ultrasound-detected hand synovitis.

Background: The European League Against Rheumatism-Outcomes Measures in Rheumatology (EULAR-OMERACT) recommend only scanning dorsal spaces for scoring ultrasound-detected hand synovitis. This study evaluated the efficiency of the combined scoring system only depending on dorsal joint spaces synovitis in diagnosing and evaluating ultrasound-detected hand synovitis. Methods: The data of 56 patients who underwent hand joint ultrasonography exams in the Ultrasound Department of West China Hospital, Sichuan University were prospectively collected. The participants formed a random series. The images of each patient included gray-scale (GS) and power Doppler (PD) images of bilateral first to fifth metacarpophalangeal joints (MCP) and the thumb and second to fifth proximal interphalangeal joints (IP). The synovial thickness was measured quantitatively in GS images, and the synovial GS scores in the dorsal joint spaces and PD scores in the dorsal and volar joint spaces were calculated according to the combined EULAR-OMERACT scoring system. Results: The detection rate of synovitis in the first to fifth MCP, thumb and second to fifth proximal IP synovitis were 41.4% (232/560) and 33.9% (190/560), respectively. The sensitivity of only inspecting the dorsal joint spaces with GS ultrasound was 79.3% for MCP and 52.6% for the thumb and second to fifth proximal IPs. The PD scores were higher in the dorsal joint spaces than in the volar joint spaces (P value <0.001). The combined scores were higher than either the GS or PD scores alone in the dorsal joint spaces (P value of the combined scores vs. GS scores =0.001; P value of the combined scores vs. PD scores <0.001). Conclusions: Adopting the EULAR-OMERACT combined scoring standard is recommended to evaluate ultrasound-detected hand synovitis, as determined by the highest value of the GS scores or the PD scores. More specifically, PD scores can mainly be used to appraise the dorsal joint spaces. However, GS scores should be used to evaluate both the dorsal joint spaces and the volar joint spaces.

Tumor Necrosis Alpha (TNF-α) Antagonists Used in Chronic Inflammatory Rheumatic Diseases: Risks and their Minimization Measures.

Tumor necrosis factor alpha (TNF- α) inhibitors are widely employed for the management of chronic inflammatory rheumatism. However, their usage carries significant risks, including site and infusion reactions, serious infections, malignancy, heart failure autoimmune and demyelinating disorders. These risks are comprehensively outlined in risk management plans (RMPs) associated with these molecules. RMP provides information on the safety profile of a medicinal product as well as the measures that will be taken to minimize risks; these are known as risk minimization measures. These measures are divided into routine measures related to elements, such as the summary of product characteristics, labeling, pack size, package leaflet, or legal supply status of the product, while additional measures may include educational programs, including tools for healthcare providers and patients, controlled access or pregnancy prevention programs, among others. Additional measures can consist of one or more interventions that need to be implemented in a sustainable way in a defined target group, while respecting the timing and frequency of any intervention and procedures to reach the target population. An evaluation of the effectiveness of these measures is required to determine whether or not an intervention has been effective. This comprehensive review offers an in-depth exploration of the current treatment, uses, and associated risks of TNF-α inhibitors. Additionally, it provides a detailed account of risk minimization measures and risk management practices while shedding light on their real-world implementation and effectiveness.

Development of a nursing practice scale for rheumatoid arthritis treatment with biological disease-modifying anti-rheumatic drugs.

OBJECTIVE: The objective of the study was to develop a nursing practice scale for rheumatoid arthritis treatment with biological disease-modifying anti-rheumatic drugs. METHODS: An anonymous self-administered questionnaire survey was administered to 1826 nurses, 960 of whom were Certified Nurses by Japan Rheumatism Foundation (CNJRFs) and 866 were registered nurses (RNs). Using exploratory factor analysis, criterion validity, and known-groups technique, we assessed the reliability and validity of the self-created 19-item nursing practice scale to evaluate the care provided to patients with rheumatoid arthritis receiving biological disease-modifying anti-rheumatic drugs based on the nurse's role as clarified from a literature review of relevant studies. RESULTS: A total of 698 (38.4%) responses were collected from 407 CNJRFs and 291 RNs. Exploratory factor analysis was conducted on 18 items to examine three factors: 'nursing to enhance patients' capacity for self-care', 'nursing in which patients participate in decision-making', and 'nursing in which team medical care is promoted'. Cronbach's α was .95. The Spearman's coefficient was ρ = .738 for criterion validity. Using the known-groups technique, CNJRFs had higher total scale scores than RNs (P < .05). CONCLUSIONS: The results confirmed the reliability, criterion validity, and construct validity of the scale.

The effect of vitamin D treatment on quality of life in patients with fibromyalgia.

BACKGROUND: Fibromyalgia is a syndrome characterized by chronic widespread pain accompanied by fatigue, disrupted sleep quality, cognitive impairments, subjective soft tissue swelling, and somatic symptoms. There are conflicting results in the literature regarding the prevalence of vitamin D deficiency in fibromyalgia patients and the reduction of symptoms after supplementation. AIMS: Our study aims to evaluate the effectiveness and reliability of vitamin D supplementation in patients diagnosed with fibromyalgia. METHODS: In our cross-sectional clinical study, 180 female patients aged 18 to 65 diagnosed with fibromyalgia according to the 2010 American College of Rheumatology Diagnostic Criteria were included. Oral vitamin D3 replacement of 50,000 IU was administered for 12 weeks. Patients' Fibromyalgia Impact Questionnaire (FIQ)and Visual Analogue Scale (VAS) scores were evaluated before and after the study. RESULTS: Significant differences were observed in the FIQ scores of the 180 fibromyalgia patients before and after vitamin D supplementation (p < 0.05). There was also a significant improvement in VAS scores (p < 0.01). A negative correlation between vitamin D and VAS as well as FIQ scores was found in the study. CONCLUSION: We determined that vitamin D deficiency is significantly more prevalent in patients diagnosed with fibromyalgia. Vitamin D supplementation was observed to have a positive effect on quality of life and reduction of pain.

Vitamin D Status in Palindromic Rheumatism: A Propensity Score Matching Analysis.

OBJECTIVE: To determine whether there is a correlation between vitamin D levels and palindromic rheumatism (PR) as an at-risk phenotype of rheumatoid arthritis (RA). METHODS: A total of 308 participants were enrolled in this cross-sectional study. We recorded their clinical characteristics and performed propensity-score matching (PSM). Serum 25(OH)D3 levels were determined via enzyme-linked immunosorbent assay. RESULTS: Our PSM resulted in 48 patients with PR and 96 matched control individuals. The multivariate regression analysis we performed after the PSM did not show a significant increase in PR risk in patients with vitamin D deficiency/insufficiency. There was no significant correlation between levels of 25(OH)D3 and frequency/duration of attacks, number of joints affected, and duration of symptoms before diagnosis (P ≥ .05). Mean (SD) serum levels of 25(OH)D3 in patients with and without progression to RA were 28.7 (15.9) ng/mL and 25.1 (11.4) ng/mL, respectively. CONCLUSION: Based on the results, we found no clear association between vitamin D serum levels and the risk, severity, and rate of PR progressing into RA.