Search

Introduction: Phase IV post-marketing surveillance studies are needed to evaluate the real-world safety and effectiveness of drug products. This study aimed to evaluate the safety and effectiveness of biosimilar etanercept (Altebrel, AryoGen Co., Iran) in patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA)., Methods: In this open-label, multicenter, prospective, observational, post-marketing surveillance study, 583 patients received biosimilar etanercept 25 mg twice weekly or 50 mg once weekly and were followed up to 12 months. The primary objective was to evaluate the safety of biosimilar etanercept by documenting all the adverse events in the case report forms throughout the study period. The secondary objective was to evaluate the effectiveness of biosimilar etanercept in study patients, where longitudinal changes in health assessment questionnaire (HAQ), pain, and disease activity scores were assessed., Results: A total of 583 patients (44.80 ± 13.09 years of age) were included and followed for an average of 8.12 ± 3.96 months. Among all patients, 172 (29.50%) experienced at least one adverse event, and injection site reaction, abdominal pain, and upper respiratory tract infection were the most common. HAQ scores decreased from 1.32 ± 0.77 at baseline to 0.81 ± 0.61 at 12 months in patients with RA/PsA (p < 0.01) and from 0.82 ± 0.58 at baseline to 0.66 ± 0.63 at 12 months in patients with AS (p = 0.18). Pain scores decreased from 6.49 ± 2.41 at baseline to 3.51 ± 2.39 at 12 months (p < 0.01)., Conclusion: The results demonstrated the real-world safety and effectiveness of biosimilar etanercept in patients with RA, PsA, and AS., Trial Registration: ClinicalTrials.gov identifier NCT04582084.

Background: Selenium is an essential trace element with fundamental effects on human biology. Trace elements deficiency is not an uncommon finding in autoimmune diseases. This deficiency may be a consequence of autoimmune diseases or may contribute to their etiology. With regard to evidence showing the association between selenium deficiency and generation of reactive oxygen species and subsequent inflammation, reviewing the role of selenium in collagen vascular diseases could help researchers to devise strategies for managing these diseases., Objective: The present study aimed to evaluate the role of selenium and autoimmune rheumatic diseases., Data Sources: PubMed, Scopus, Science Direct, and Google Scholar., Study Eligibility Criteria: All the studies on the use of selenium without any limitations in terms of the preparation method, administration route, or formulation process were included in the study. The exclusion criteria were: 1) Articles published in languages other than English, 2) Administration of chemical and hormonal drugs rather than selenium, 3) Investigation of the effects of selenium on the autoimmune problems in animal models, and 4) Insufficiency of the presented data or poor description of the applied methods. Furthermore, review articles, meta-analyses, expert opinions, editorial letters, case reports, consensus statements, and qualitative studies were excluded from the study., Data Extraction: In this systematic review, articles were evaluated through searching following keywords in combination with selenium: "autoimmune rheumatic diseases "or "scleroderma" or "systemic sclerosis" or "Behcet's disease" or "Sjögren syndrome" or "systemic lupus erythematosus" or "musculoskeletal diseases" or "rheumatoid arthritis" or "vasculitis" or "seronegative arthritis" or "antiphospholipid antibody syndrome"., Results: Of 312 articles, 280 were excluded and 32 articles were entered in this study. Based on the majority of studies assessing selenium level in patients with collagen vascular diseases, lower selenium levels were observed in these patients. Moreover, the majority of articles showed an improvement in clinical symptoms of collagen vascular diseases compared to controls after the treatment of patients with different dosages of L-selenomethionine., Conclusion: A decrease in the serum level of selenium was noted in patients with autoimmune diseases, which may be a risk factor for inflammation and initiation of autoimmunity in these patients. A sufficient quantity of selenium has been shown to contribute to the management of complications of autoimmune diseases and even improved survival in patients with autoimmune diseases, which may be due to the anti-inflammatory effects of selenium. Since this issue is of clinical importance, it can be considered in potential nutrition interventions and have beneficial effects on some autoimmune diseases., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Introduction: As a chronic autoimmune disease, Rheumatoid arthritis (RA) affects the joints. Studies have shown a complex and challenging link between cancer and RA. However, articles claim a significant relationship between cancer and treatment with DMARDs and biological DMARDs (e.g., Abatacept); however, the results are contradictory. Accordingly, this systematic review investigates the prevalence of cancer in RA patients taking Abatacept. Methods: We searched for articles published in four databases, namely Web of Science, Medline, PubMed, and Scopus up to September 29, 2023. The methodology followed recommendations from the Cochrane Handbook. During the search process, we selected articles using keywords such as "rheumatoid arthritis", "malignancy", and "cancer" with the Boolean operators "AND" and "OR"." Results: A total of 12 studies were considered, the majority highlighted the effectiveness of Abatacept as an anti-RA medicine in the risk of cancer prevalence. Most of the patients investigated in the trials were female. Lung cancer was the greatest malignancy in those suffering from RA diseases. However, these investigations found no significant link between Abatacept use and cancer risk. Conclusion: There is speculation regarding the potential use of rheumatoid arthritis drugs in treating RA and its potential association with cancer incidence. According to the findings presented in this review article, there was no statistically significant association between the utilization of Abatacept and the prevalence of cancer in patients who were administered Abatacept either as a standalone treatment or in combination with other anti-rheumatoid medications. However, it is advised that further clinical trials be conducted to thoroughly investigate this association. [ABSTRACT FROM AUTHOR]

Background: Systemic lupus erythematous (SLE) and rheumatoid arthritis (RA) are autoimmune diseases in which the antigen-antibody system plays an important role. As blood group and Rh are determined by the presence or absence of antigens on the surface of red blood cells (RBCs), we aimed to determine the distribution of ABO and Rh blood groups in SLE and RA patients and its association with disease manifestations. Methods: This short communication is based on a study that was conducted on 434 SLE and 828 RA patients. We evaluated the distribution of ABO and Rh blood groups in RA and SLE patients. Results: This study projected that in lupus patients, Coombs-positive autoimmune hemolytic anemia and arthritis were more common among the B blood type and Rh-positive group, respectively. Furthermore, there was no relation between ABO and Rh blood group and rheumatoid factor (RF) and anti-Cyclic Citrullinated Peptide (anti-CCP) seropositivity. Moreover, there was no difference in distribution of blood groups in RA and SLE patients. Conclusion: The higher frequency of blood group B in hemolytic anemia, and positive Rh in arthritis in lupus patients, develop the hypothesis of probable role of ABO blood group antigen in some manifestations of lupus. [ABSTRACT FROM AUTHOR]

Autoimmune diseases are characterized by the attack of the immune system to normal tissues. Patients with autoimmune diseases usually have the deficiency of dietary factors that may be related to the etiology of these conditions. Given the role of vitamin E as a physiologic stabilizer of lysosomal membranes, its deficiency can initiate the process of autoimmune diseases or accelerate its progress. It is supposed that vitamin E could reduce oxidative stress, which is an important factor in the pathogenesis of autoimmune diseases. The literature review is indicative of a decrease in the serum levels of vitamin E in almost all autoimmune diseases. Furthermore, there is evidence regarding the possible therapeutic value of vitamin E in the management of autoimmune diseases. Owing to the anti-inflammatory and protective effect of vitamin E against free radicals, and also its important effect on cytokines levels, this vitamin may play a powerful role in the prevention and treatment of rheumatoid arthritis, as well as joint inflammation and damage. Moreover, increased vitamin E intake might decrease the incidence and severity of certain autoimmune diseases through the regulation of the immune system. [ABSTRACT FROM AUTHOR]

Abstract: Aim: Human T lymphotropic virus type 1 (HTLV‐1) infection with high prevalence in the north‐east of Iran, particularly in Mashhad, can lead to adult T‐cell leukemia (ATL) and HTLV‐1‐associated myelopathy/tropical spastic paraparesis (HAM/TSP) and a variety of autoimmune diseases. The aim of the study was to examine the presence of autoimmune markers in HTLV carries. Methods: Serum samples were obtained from blood donors in Mashhad, northeastern Iran. One hundred and five HTLV‐1 positive (cases) and 104 age‐ and sex‐matched HTLV‐1 negative donors (controls) were assessed for presence of serum autoimmune markers by enzyme‐linked immunosorbent assay. Results: The mean ages of cases and controls were 40.8 ± 9.4 and 41.5 ± 9.3 years, respectively (P = 0.5). In the case group, 81.9% and in the control group 83.7% were male (P = 0.74). The frequency of positive antinuclear antibodies and anticyclic citrullinated peptide antibodies in the serum of the two groups were not significantly different (P = 0.68 and P = 0.62, respectively). Only one antineutrophil cytoplasmic antibody‐positive case (1%) was observed in the group and no anti‐phospholipid immunoglobulin G positivity was observed. The frequency of rheumatoid factor (RF) was greater in case group than in the control group, although the difference was not significant (P = 0.08). The amount of RF in all 12 RF positive sera were higher than normal levels (33–37 IU/mL). Conclusion: Because we failed to detect any significant relation between serum autoimmune markers and HTLV‐1 infection, and because of the relatively low prevalence of autoimmune diseases, it could be concluded that healthy HTLV‐1 carriers do not produce rheumatologic‐related auto‐antibodies more than the healthy population. [ABSTRACT FROM AUTHOR]

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease affecting various organs. Decreased numbers of regulatory T-cells (Treg cells; CD4+CD25highFoxp3+) are associated with the pathogenesis of SLE. A vitamin D deficiency was observed in many lupus patients. In the present study, peripheral blood mononuclear cells were isolated and cultured in the presence or absence of vitamin D, and total Tregs percentage was analyzed by flow cytometry. In addition, the level of expressions of Foxp3, TGFβ, and IL6 genes were analyzed by real-time-PCR. The results indicated that vitamin D treatment increased the percentage of Treg cells, and the expression of Foxp3 and TGFβ, and decreased the expression of IL6 in SLE patients. [ABSTRACT FROM PUBLISHER]

Immunoglobulin G4-related disease (IgG4-related disease) is a fibroinflammatory disorder defined by elevated serum IgG4 level and plasma cells tissue infiltration accompanied by fibrosis or sclerosis. In this article, we report two patients of IgG4 syndrome: a 60-year-old male with complaints of nasal congestion, rhinitis, anosmia and hearing loss, and a 28-year-old female with bilateral orbital and parotid gland swelling. Histopathological findings and high serum IgG4 level confirmed diagnosis of IgG4-related disease. Both patients were treated successfully with glucocorticoids and methotrexate. Herein, we also review clinical presentations of IgG4-related disease in head and neck, and related diagnostic and therapeutic approach. [ABSTRACT FROM AUTHOR]

Objective(s): Apoptosis is a tightly regulated process and plays a crucial role in autoimmune diseases. Because abnormalities in apoptosis are considered to be involved in the pathogenesis of systemic lupus erythematosus (SLE), in present study we studied the apoptosis in T lymphocytes from Iranian SLE patients at protein and gene expression levels for some molecules which are involved in apoptosis pathways. Materials and Methods: Thirty five SLE patients (23 female, 12 male), and 20 age matched controls (10 female, 10 male) participated in this study. T lymphocytes were isolated from peripheral blood mononuclear cells (PBMCs) using MACS method. Apoptosis rate was studied at protein level by flow cytometer using Annexin V, and at gene expression level using semi-quantitative RT-PCR method for detection of Fas, FasL, Bcl-2, caspase 8, and caspase 9 genes. Results: The percentage of apoptotic cells in SLE patients was not different in comparison with controls (20.2% ± 1.4 vs 21.1% ± 1.0), but the expression levels of FasL, caspase 8, and caspase 9 genes in all SLE patients and in female patients were significantly lower than controls; 0.45R vs 0.78R for FasL, 0.74R vs 1.0R for caspase 8, and 0.76R vs 1.26R for caspase 9 in all SLE patients and 0.37R vs 0.82R for FasL, 0.45R vs 1.6R for caspase 8, and 0.63R vs 1.56R for caspase 9 in female patients. Conclusion: The expression levels of FasL, caspase 8 and caspase 9 molecules involved in apoptosis decreased in female, but not in male SLE patients. [ABSTRACT FROM AUTHOR]

Systemic lupus erythematosus (SLE) is an autoimmune disease in which organs undergo damage. Hypoparathyroidism is a rare disease, which presents in two forms: hereditary and acquired. Cases of hypoparathyroidism and SLE rarely co-exist. Only six cases have been reported; five of them first presented with lupus and then hypoparathyroidism or simultaneously. We present here developing lupus disease in a woman who had idiopathic hypoparathyroidism. According to increasing data about the autoimmune origin of idiopathic hypoparathyroidism, these case reports suggest that there may be an autoimmune process linking these diseases. [ABSTRACT FROM AUTHOR]

Background: Soluble Fas (sFas) is a marker of apoptosis that appears to increase in the serum of systemic lupus erythematosus patients and may have a correlation with disease activity. The exact role of sFas in apoptosis is not clear. The purpose of this study is to assess the correlation between serum levels of soluble Fas (Apo/1-CD95) and the activity of systemic lupus erythematosus. Patients and Methods: Our study was performed on 114 systemic lupus erythematosus patients who were compared with 50 randomly selected sex, age and race-matched healthy controls. Disease activity was defined according to the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K). All physical exams and laboratory parameters were collected to determine the SLEDAI. sFas levels were determined using a commercially available ELISA kit. Results: There was a significant difference between serum levels of sFas in the case and control groups (P=0.001). A significant correlation coefficient existed between the sFas and SLEDAI2K variables (P=0.001, r=0.494). Significant statistical difference was found between serum levels of sFas in the active and inactive phases of disease according to SLEDAI= 9 or≥10, (P=0.002). The sFas levels were 270 - 300 pg/mL for SLEDAI≤9 and 355-502 pg/mL for SLEDAI≥10, with a confidence interval of 95%. Conclusion: This study shows a significant elevation of sFas levels in the sera of systemic lupus erythematosus patients with active disease; therefore it can be used as an appropriate marker for evaluation of disease activity. [ABSTRACT FROM AUTHOR]

Several data link vitamin D to many autoimmune diseases. Association between vitamin D receptor (VDR) gene BsmI polymorphisms and systemic lupus erythematosus has been reported. In this study, we examine whether the VDR gene BsmI polymorphisms are markers for susceptibility to or severity of SLE. This study incorporated 60 patients with SLE living in northeastern Iran. Three genotypes, BB, Bb and bb, were detected based on polymerase chain reaction–restriction fragment length polymorphism (PCR/RFLP). The distribution of VDR genotyping in patients with SLE was 23.3% for BB, 60% for Bb and 16.7% for bb and in the control group was 33.3% for BB, 46.7% for Bb and 20% for bb ( P = 0.334). No association of VDR gene BsmI polymorphisms with SLE disease activity index (SLEDAI), SLE damage score and major organ involvement was detected. The result of this study did not show any association between VDR gene BsmI polymorphisms and SLE. [ABSTRACT FROM AUTHOR]