Efficacy of botulinum toxin type A injection for Raynaud's phenomenon and digital ulcers in patients with systemic sclerosis.

Introduction: Systemic sclerosis (SSc) is an autoimmune, connective tissue disorder of unknown etiology which causes vasculopathy and fibrosis. Raynaud's phenomenon (RP) is a common complication of SSc, which leads to ischemia and gangrenes. Treatment of RP is a clinical problem and often remains insufficient.This study aimed to evaluate the therapeutic efficacy of local injections of botulinum toxin type A (BTX-A) in improving the symptoms of Raynaud's phenomenon (RP) secondary to scleroderma. Material and methods: This parallel single-blinded, placebo-controlled clinical trial enrolled 29 patients with scleroderma. Participants received BTX-A in the first, 2nd, 3rd, and 4th dorsal web spaces and the base of the thumb and small finger of the non-dominant hand and 2.5 ml of sterile normal saline in the opposite hand. Pre-injection measurements and post-injection follow-up evaluations at months 1 and 4 were performed. We compared the outcomes using the paired Student's t-test. Results: The change in pain severity between pre-injection and month 1 follow-up was significantly larger in the BTX-A group (p-value = 0.04). Between pre-injection and month 1 and month 4, the changes in the Raynaud's condition score (RCS) (p-value = 0.02, 0.004, respectively) and the number of Raynaud's attacks (p-value = 0.006, 0.001, respectively) were significantly greater in the BTX-A group. No significant difference was found in terms of paresthesia, skin thickening, upper extremity function, ulcer diameter, number of ulcers, or Raynaud's attack duration between the two groups (p-value > 0.05). In time, the decrease in pain severity, paresthesia, RCS, number of ulcers, and ulcer diameter, and the increase in upper extremity function were significantly greater in the BTX-A group as compared to the placebo group (p < 0.05). Conclusions: Our study showed that local injection of BTX-A is safe and has beneficial therapeutic effects on RP and RP-related digital ulcers in SSc patients.

Influence of biologic and conventional disease-modifying antirheumatic drugs on COVID-19 incidence among rheumatic patients during the first and second wave of the pandemic in Iran.

Introduction: During the SARS-CoV-2 virus pandemic, immunosuppressive agents in treating chronic disease have become a concern, and rheumatic patients are not an exception. The controversies about the deteriorating effects of such medications led this study to evaluate the influence of biologic and conventional disease-modifying antirheumatic drugs (DMARDs) on the incidence of COVID-19 infection in rheumatic patients. Material and methods: In the present cohort-analytical study, 512 patients with rheumatic diseases were enrolled during the COVID-19 pandemic (2020-2021). The incidence of COVID-19 infection was diagnosed according to the definition of the Iranian Ministry of Health. The frequency of COVID-19 infection in patients treated with biological and conventional DMARDs and glucocorticosteroids were compared. Results: Among 512 rheumatic patients, 19.9% were definitely infected with COVID-19, and 23.3% of infected patients were hospitalized. Only one patient with vasculitis died during the two outbreaks. Our study showed that adding biologic DMARDs to conventional DMARDs did not increase the risk of COVID-19 infection. However, unlike biologic DMARDs, in conventional DMARDs, methotrexate increased, and hydroxychloroquine decreased COVID-19 infection. Regression analysis showed that prednisolone at a dosage higher than 10 mg/day increased the risk of COVID-19 infection 5-fold; hydroxychloroquine had a protective impact and reduced the risk of infection by 40%. Conclusions: Biologic DMARDs and the type of selected rheumatic diseases in our study did not influence the susceptibility to COVID-19 infection. Prednisolone raised the coronavirus infection, and hydroxychloroquine played a protective role in the current study. Most of our patients showed good adherence to the health protocols. Further studies after worldwide vaccination are now required to reevaluate the influence of rheumatic diseases and DMARDs on COVID-19 infection.

Associations between vitamin D receptor polymorphisms and susceptibility to Behcet's disease: A meta-analysis.

BACKGROUND: The vitamin D receptor (VDR) gene polymorphisms have been reported to be related to the development of Behcet's disease (BD). However, the results have been inconsistent among diverse populations. Therefore, this comprehensive meta-analysis has been designed to assess a more accurate association between VDR polymorphisms and BD susceptibility. METHODS: An electronic literature search was conducted to identify eligible studies. Pooled odds ratios (OR) with corresponding 95% confidence interval (CI) were calculated in different genetic models to assess this association. RESULTS: A total of six separate comparisons comprised of 468 cases and 516 controls were included in the meta-analysis model. The meta-result demonstrated that A allele of ApaI (A vs. a: 1.54 95% CI = 1.04-2.26, P = 0.029), and F allele of FokI (F vs. f: OR = 0.58, 95% CI = 0.45-0.76, P = 0.007) polymorphisms were associated with the risk of BD in total and African populations, respectively. This significant association was also found in recessive and homozygotes models. Subgroup analysis indicated that FokI variant among Africans and ApaI variant among Caucasian were significantly associated with the risk of BD. No relationship was found between Bsmi and TaqI polymorphisms and BD risk. CONCLUSION: This meta-analysis demonstrated the association between FokI and ApaI polymorphisms in VDR gene with the risk of BD, providing insights into the potential role of vitamin D receptor in the pathogenesis of BD.

Epidemiology of Vasculitides in Khorasan Province, Iran.

Vasculitides are a heterogeneous group of more than 20 diseases defined by inflammation and destruction of blood vessels. We aimed to study the demographic characteristics of the primary vasculitides in the North East of Iran. We retrospectively studied the medical records of patients diagnosed with any kind of vasculitis at the Clinic and Department of Rheumatology of the Imam Reza Hospital, Mashhad, Iran between January 1, 2002, and December 31, 2012. Patients were classified according to the American College of Rheumatology 1990 criteria for the classification of vasculitis and the 2012 Revised International Chapel Hill Consensus Conference Nomenclature of Vasculitides. A total of 721 patients (51.5% male, 48.5% female) with a diagnosis of primary vasculitis was identified. The frequency distributions of vasculitic disorders were as follows: Behcet's disease, 63.6%; cutaneous leukocytoclastic angiitis, 8.2%; granulomatosis with polyangiitis (Wegener's), 6.8%; Takayasu's arteritis. 6%; giant cell arteritis, 4%; polyarteritis nodosa, 2.1%; microscopic polyangiitis, 0.6%; eosinophilic granulomatosis with polyangiitis (Churg-Strauss), 1.8%; cryoglobulinemic vasculitis, 0.3%; and IgA vasculitis (Henoch-Schonlein purpura), 3.5%. In our population, the most common forms of vasculitis are Behcet's disease, cutaneous leukocytoclastic angiitis, and granulomatosis with polyangiitis (Wegener's).

Diagnostic Value of Radiographic Singh Index Compared to Dual-Energy X-Ray Absorptiometry Scan in Diagnosing Osteoporosis: A Systematic Review.

Objectives: Since various medications can control the rate of fractures and subsequent complications of osteoporosis, the early detection of the disease is crucial. This systematic study aimed to compare the diagnostic accuracy of Singh index (SI) with dual-energy X-ray absorptiometry (DEXA) as a benchmark standard for diagnosing osteoporosis. Methods: The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) were utilized in the current study. A detailed search was carried out using PubMed and Scopus from inception to 30 May 2022. Examining quality of the studies was performed by the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2). Results: A total of 22 studies were included. In general, 50% of the studies considered SI a poor screening tool for detecting osteoporosis due to a negligible inter-observer agreement between SI and DEXA or a poor correlation of SI with the bone mineral density (BMD) category or DEXA T-score. A moderate inter-observer agreement was reported for SI in 5 (55.6%) studies. Among the studies assessing the sensitivity and specificity of SI compared to DEXA (n=13), six studies estimated a low sensitivity for SI. Conclusion: While there is supporting evidence indicating the potential usefulness of SI for predicting femoral neck fractures in individuals with suspected osteoporosis, numerous studies challenge its reliability and diagnostic value as a screening tool for identifying femoral neck osteoporosis. Further primary studies are required to verify the effectiveness of the SI index in identifying populations at risk of osteoporosis.

The association between women's pelvic organ prolapse and joint hypermobility.

OBJECTIVE: To determine whether joint hypermobility is associated with pelvic organ prolapse. METHODS: The case-control study was conducted from January to April 2011 and comprised 30 women with pelvic organ prolapse, stage > or = II and 30 controls with stages 0 and I with similar age and parity. They were recruited from the gynaecology clinic at Imam Reza Hospital in Mashhad, Iran. The condition was evaluated by a quantification system and, for the purposes of this study, pelvic organ prolapse was defined as stage > or = II. All the subjects were examined in the dorsal lithotomic position with an empty bladder. A separate investigator evaluated each subject for joint hypermobility by using Beighton score which was calculated by doing five simple manoeuvres. SPSS 11.5 was used for data analysis. RESULTS: The mean age of the 30 cases was 35.40 +/- 6.39 years, while for the controls it was 35.36 +/- 5.9 years. Overall clinical joint hypermobility was found in 24 of the 60 (40%) subjects. There were no significant difference in the prevalence of joint hypermobility between the two groups. The prevalence of hypermobility in the cases was 36.7% (n = 11) versus 43.3% (n=13) in the controls (p = 0.59). The prevalence of cystocele in subjects with joint hypermobility was 41.7% (n = 10) versus 38.9% (n=14), (p < 0.83); rectocele 33.3% (n = 8) versus 41.7% ( n =15), (p < 0.73) women with normal joint mobility. No Significant differences were found between the groups with regard to other markers of connective tissue weakness such as the presence of varicose veins (p < 0.37), easy bruising ( p < 0.43) and observed striae ( p < 0.42). CONCLUSION: Joint hypermobility was not associated with pelvic organ prolapse in the study population. Further studies involving more patients with pelvic organ prolapse are recommended.

The effect of hydroxychloroquine on symptoms of knee osteoarthritis: a double-blind randomized controlled clinical trial.

BACKGROUND: Osteoarthritis is a degenerative joint disorder of articular cartilage and is the most common type of arthritis in the elderly. There are only a few reports regarding the use of Hydroxychloroquine in the treatment of osteoarthritis. METHODS: To investigate the effects of Hydroxychloroquine on the symptoms of mild to moderate knee osteoarthritis (Kellgren and Lawrence grade II and III), we performed a double-blind, placebo-controlled study in 44 patients. The patients were randomly assigned to two groups: one group received Hydroxychloroquine pills (200 mg twice daily) and the other group received placebo pills. Symptoms were assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at baseline and at the end of weeks 4, 8, 12, 16, 20, and 24. RESULTS: Approximately, 98% of the patients were women at an average age of 47 years. There was no significant difference in the baseline characteristics between the two groups. In the placebo group, maximum improvement occurred at the 4(th) week; and during the remaining time, there was no significant improvement. In the Hydroxychloroquine group, maximum improvement occurred at the 8(th) week and persisted over the entire remaining follow-up period. There were significant differences between the two groups regarding the degree of reduction in the WOMAC total score and the WOMAC subscales scores of pain, stiffness, and function at the end of weeks 4, 8, 12, 16, 20, and 24. CONCLUSION: Hydroxychloroquine conferred significant improvement in the symptoms of mild to moderate knee osteoarthritis in our patients and may, accordingly, be recommended for knee osteoarthritis treatment.

Probiotics as a complementary treatment in systemic lupus erythematosus: A systematic review.

Introduction: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that primarily affects young women. SLE has no recognized etiology but it is believed to be triggered by a number of factors, including genetic predisposition, hormonal influences, and environmental conditions. Dysbiosis in the gut microbiota has emerged as a potential mechanism connecting the intestinal microbiome to the breakdown of self-tolerance and chronic inflammation. This review aims to investigate the role of probiotics in modulating the gut microbiome and their potential therapeutic benefits in managing SLE, providing insights for future research and clinical practice. Methods: We conducted a thorough search for papers published up to June 2023 in databases such as PubMed/MEDLINE, Web of Science, Scopus, and Cochrane Library. Results: The systematic review identified 22 articles examining the effects of probiotics on SLE. These studies-which include in vivo tests, in vitro research, and clinical trials-indicate that probiotics may be effective against inflammation, and improve immunological responses and metabolic profiles in SLE patients. Most in vivo studies were assessed as medium to high quality, while the randomized controlled trial was deemed of high quality. Conclusion: According to the findings of our systematic review, probiotics may be used in conjunction with other treatments to manage SLE. Nonetheless, current data is limited, and more randomized controlled trials would be required to fully examine their effectiveness.

Echocardiography Parameters in Behcet's Disease, A Comparative Study.

OBJECTIVE: Behçet's disease (BD) is a chronic inflammatory disease with multiple organ involvements. Although cardiac involvement is not common, it can increase patient morbidity and mortality and decrease life quality. In the present study, echocardiographic abnormalities in BD with no cardiac symptoms were investigated. METHODS: This cross-sectional descriptive-analytic study was performed on patients referred to Imam Reza Hospital in Mashhad from 2015 to 2018. The participants were divided into control and BD groups. Patients with BD were diagnosed based on ISG criteria. All participants underwent transthoracic echocardiography. Echocardiographic parameters were compared between BD and control groups. RESULTS: In this study, the severity of aortic (AR), mitral (MR), and tricuspid valve regurgitation (TR) was higher in BD than in the control group, while only TR severity showed a statistically significant difference (p-value < 0.001). Systolic Pulmonary Artery Pressure (sPAP) was significantly higher in BD compared to the control group (24.6 mmHg versus 22.81 mmHg, respectively) (pvalue = 0.019). CONCLUSION: It seems echocardiography is valuable in evaluating a cardiac function, even in asymptomatic patients. Cases with moderate mitral and aortic regurgitation were only observed in BD. Long-term follow-up is suggested, and further studies are required.

Association between levels of serum and urinary B cell-activating factor and systemic lupus erythematosus disease activity.

Objectives: This study investigated the correlation between serum and urinary B cell-activating factor (BAFF) levels and systemic lupus erythematosus (SLE) disease activity. Patients and methods: This case-control study was conducted with 87 participants between December 2020 and September 2021. Sixty-two SLE patients who fulfilled the eligibility criteria were enrolled. SLE patients were categorized into active (n=34) and inactive (n=28) groups based on their Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores. The control group consisted of 25 healthy subjects. Serum and urine samples were collected for the measurement of BAFF levels. Finally, the relationship between these variables and SLE disease activity was investigated. Results: The mean age of active (SLEDAI-2K >4) and inactive (SLEDAI-2K ≤4) SLE patients and healthy individuals were 32.8±7.8, 32.5±6.8, and 31.7±7.8 years, respectively (p=0.62). The median serum BAFF (s-BAFF) and urinary BAFF (u-BAFF) in active lupus patients (10.4 [2.3] ng/mL and 8.2 [3.7] ng/mL, respectively) were significantly higher than in inactive lupus patients (6 (7.1) ng/mL and 1.7 (4.7) ng/mL, respectively; p<0.001) and the control group (3 (3.7) ng/mL and 1.6 (2.2) ng/mL, respectively; p<0.001). However, s-BAFF (p=0.07) and u-BAFF (p=0.43) did not significantly differ between the inactive group and the control group. A significant positive correlation was observed between s-BAFF (r=0.41 and p=0.001) and u-BAFF (r=0.78 and p<0.001) levels and the SLEDAI-2K score. Conclusion: There is a significant positive correlation between serum and urinary BAFF levels and SLE disease activity. Furthermore, significantly higher levels of s-BAFF and u-BAFF have been observed in patients with active lupus compared to inactive and healthy subjects, indicating a possible role for BAFF in the pathogenesis of SLE disease activity.

Effects of Biologic Therapies on the Chance of COVID-19 Infection Among Rheumatoid Arthritis and Lupus Patients During the First Wave of the Pandemic.

Background: Patients with rheumatic diseases taking immunosuppressive medications might be at an increased risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Despite the effectiveness of using combined conventional and biological disease-modifying anti-rheumatic drugs(bDMARDs) in managing rheumatic diseases, there have been concerns that taking biological agents may have an additive effect on getting infected with COVID-19. This study evaluates the impact of taking biological agents on altering the chance of getting infected with SARS-CoV-2 in rheumatoid and lupus patients compared to traditional DMARDs. Methods: We carried out a cross-sectional survey study from February 2020 to January 2021 on patients diagnosed with lupus and rheumatoid arthritis disease. COVID-19 infection was confirmed by the presence of symptoms and signs of the disease and para-clinical findings such as lymphopenia and elevated C-reactive protein (CRP) and positive chest CT scan or polymerase chain reaction (PCR) of COVID-19. Results: Out of 591 patients included in this study, 422 (71.4%) had rheumatoid arthritis (RA), and 169 (28.6%) had systemic lupus erythematosus (SLE). Among them, 56 (9.5%) cases were diagnosed with COVID-19 infection. No association was found between age, gender, or type of rheumatological diseases and SARS-CoV-2. There was a significant association between COVID-19 infection and treatment with biological drugs (P-value<0.05) regardless of the type of rheumatologic disease. Interestingly, the analysis revealed that the type of biologic drug also altered the chance of COVID-19 infection; In fact, patients who took TNF inhibitors were significantly at a higher risk of disease than those taking Rituximab (P-value=0.000). Identical results were observed among RA patients (P-value<0.001), however, all 5 (3%) lupus cases treated with Rituximab infected with covid 19. Conclusion: This study develops a better understanding of the risk of immunosuppressive medications for SARS-CoV-2 infection. Patients treated with conventional and biological medicine had a higher disease risk than those taking exclusively conventional drugs. However, more studies are required to deliberate the relation of the reviewed factors with the severity of COVID-19.

Central nervous system infections in patients with systemic lupus erythematosus: a systematic review and meta-analysis.

We aimed to conduct a systematic review and meta-analysis of studies on central nervous system (CNS) infections in patients with SLE, in order to describe their clinical and microbiological characteristics, and outcomes. A systematic search of PubMed/Medline and Embase electronic databases was performed (March 2021) to identify all published studies on CNS infections and their characteristics in patients with SLE. A random-effects model was adopted and findings were reported with 95% CI. Overall, 6 studies involving 17 751 patients with SLE and 209 SLE cases with CNS infection were included in our meta-analysis. The frequency rate of CNS infections in patients with SLE was 0.012 (95% CI: 0.008 to 0.018). Meningitis was the most common clinical syndrome (93.5%, n=109/114, 95% CI: 82.6% to 97.8%) and Cryptococcus neoformans (35.9%, n=55, 95% CI: 27.2% to 45.7%) and Mycobacterium tuberculosis (27.1%, n=43, 95% CI: 14.6% to 44.8%) were the most common causative pathogens. Our patient-pool showed a mean SLE Disease Activity Index (SLEDAI) score of 7.9 (95% CI: 6.1 to 9.6), while 92.4% (n=72/76, 95% CI: 83.0% to 96.8%) of cases were on oral systemic corticosteroids, with a prednisone equivalent mean daily dose of 30.9 mg/day (95% CI: 18.0 to 43.7). Our meta-analysis revealed a mortality rate of 29.0% (95% CI: 15.0% to 48.6%). Clinicians should maintain a high index of suspicion for cryptococcal and tuberculosis (TB) meningitis in patients with SLE with suspected CNS infection, particularly in those with higher SLEDAI and on higher doses of systemic corticosteroids. In conclusion, initiation of empiric antituberculous treatment for patients with SLE who are highly suspected to have CNS TB is warranted while awaiting the results of diagnostic tests. Antifungals might also be potentially useful empirically in patients with SLE who are suspected to have fungal CNS infections. However, with respect to side effects such as toxicity and high cost of antifungals, decision regarding early antifungal therapy should be guided by early and less time-consuming fungal diagnostic tests.

Coronavirus disease 2019 in patients with Behcet's disease: a report of 59 cases in Iran.

OBJECTIVES: To present the clinical characteristics, disease course, management, and outcomes of COVID-19 infection in patients with Behcet's disease (BD). METHODS: In this retrospective cohort study, we retrieved BD patients with definite diagnosis of COVID-19 infection. Demographic data, comorbidities, features related both to BD and COVID-19 infection, treatments, and outcomes were collected. Comparisons between patients with or without hospitalization were performed. All statistical analyzes were performed using SPSS version 25. We considered p < 0.05 statistically significant. RESULTS: We identified 61 episodes of COVID-19 infection in 59 BD patients. The prevalence was 0.69%. The median age was 45 years (IQR = 20), and the median disease duration was 162 months (IQR = 195). BD features were similar except for higher rate of arterial involvement and positive pathergy test in infected patients. Thirty-five episodes (62.5%) happened in non-active patients; 39% had a comorbid disease. COVID manifestations were the same as the general population. Flu-like symptoms were the most common (85%), followed by fever (66%), ageusia/anosmia (56%), headache (51%), and pulmonary involvement (48%). There was no change in BD symptoms in 74%. Fifteen patients (25.4%) were hospitalized, and one patient (1.7%) died. Receiving glucocorticoids (p < 0.03) and cytotoxic drugs (p < 0.02) were associated with an increased rate of hospitalization. CONCLUSION: The incidence of COVID-19 infection in BD patients was not higher than general population in Iran. They showed milder form of disease with lower morbidity and mortality rate. Most were on immunosuppressive drugs, or had a comorbidity apart from BD. No significant effect on BD course was shown. Key Points • The incidence of COVID-19 infection in patients with Behcet's disease is not higher. • They showed milder form of infection with lower morbidity and mortality rate. • No significant effect on Behcet's disease course was shown with COVID19 infection. • BD patients can be managed according to the guidelines used for general population.

Efficacy and safety of the biosimilar denosumab candidate (Arylia) compared to the reference product (Prolia®) in postmenopausal osteoporosis: a phase III, randomized, two-armed, double-blind, parallel, active-controlled, and noninferiority clinical trial.

BACKGROUND/OBJECTIVE: Osteoporosis is a global health concern with an increasing prevalence worldwide. Denosumab is an antiresoptive agent that has been demonstrated to be effective and safe in osteoporotic patients. This study aimed to compare the efficacy and safety of the biosimilar denosumab candidate (Arylia) to the originator product (Prolia®) in postmenopausal osteoporotic patients. METHODS: In this randomized, double-blind, active-controlled, noninferiority trial, postmenopausal osteoporotic patients received 60 mg of subcutaneous Arylia or Prolia® at months 0, 6, and 12 and were followed up for 18 months. The primary endpoint was the noninferiority of the biosimilar product to the reference product in the percentage change of bone mineral density (BMD) in 18 months at the lumbar spine (L1-L4), total hip, and femoral neck. The secondary endpoints were safety assessment, the incidence of new vertebral fractures, and the trend of bone turnover markers (BTMs). RESULTS: A total of 190 patients were randomized to receive either biosimilar (n = 95) or reference (n = 95) denosumab. In the per-protocol (PP) analysis, the lower limits of the 95% two-sided confidence intervals of the difference between Arylia and Prolia® in increasing BMD were greater than the predetermined noninferiority margin of - 1.78 at the lumbar spine, total hip, and femoral neck sites (mean differences [95% CIs] of 0.39 [- 1.34 to 2.11], 0.04 [- 1.61 to 1.69], and 0.41 [- 1.58 to 2.40], respectively). The two products were also comparable in terms of safety, new vertebral fractures, and trend of BTMs. CONCLUSION: The efficacy of the biosimilar denosumab was shown to be noninferior to that of the reference denosumab, with a comparable safety profile at 18 months. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03293108 ; Registration date: 2017-09-19.

Investigation of the association between metabolic syndrome and disease activity in rheumatoid arthritis.

Rheumatoid arthritis (RA) is the most common form of autoimmune arthritis. Increased prevalence of metabolic syndrome (MetS) in RA may occur secondary to specific drug treatment and reduced physical activity associated with this condition. However, some recent studies suggest contradictory theories about the association of RA with MetS. This study was designed to evaluate the frequency of MetS in RA patients and the relationship between MetS with RA disease activity and body mass index (BMI). The study was conducted on 120 RA patients and 431 age- and sex-matched apparently healthy controls. A considerable proportion of patients were being treated with prednisolone and/or methotrexate and/or hydroxychloroquine. Disease activity was measured by the 28 joint count of disease activity score-Cerythrocyte sedimentation rate (DAS28ESR). MetS was evaluated according to International Diabetic Federation (IDF) and Adult Treatment Panel III (ATP III) criteria. The prevalence of MetS was significantly higher in the control group (p = 0.005). We did not find any difference in the prevalence of MetS between the patients with DAS < 3.2 and DAS ≥ 3.2. There was no association between the DAS28 score and the presence of MetS components by either definition. Multiple logistic regression analysis showed that the odds of a DAS > 3.2 in patients with BMI between 25 and 30 kg/m2 (OR = 0.1, p = 0.01) and BMI > 30 kg/m2 (OR = 0.3, p = 0.1), in comparison to BMI < 25 kg/m2, was 1/5 and 1/3, respectively. RA was not found to increase the risk of MetS. In addition, disease activity in RA patients was not influenced by the presence of MetS.

The Correlation between Helicobacter Pylori Infection and Disease Severity in Patients with Systemic Sclerosis.

BACKGROUND Systemic sclerosis (SSc) is a relatively common connective tissue disease, which is characterized by inflammation, progressive skin fibrosis, and injuries of small vessels, particularly in the lung and kidney. It seems that Helicobacter pylori (H. pylori) might contribute to the development of SSc as an extra-gastrointestinal autoimmune disease. We investigated the association between H. pylori infections and disease severity in patients with SSc. METHODS This is a cross-sectional study. Sampling method in this study was census method in such a way that all patients with SSc referred to Imam Reza Education and Research University Medical Center from May 2015 to August 2016 were included in the study. Finally, 74 patients were selected based on the inclusion criteria. Inclusion criteria were: 1. Definitive SSc based on American College of Rheumatology/ European League Against Rheumatism 2010 (ACR/EULAR) classification for scleroderma, which was diagnosed within the last two years. 2. Not taking any proton pump inhibitors. 3. Not taking any H. pylori treatment with a standard regimen within the recent 2 months. Disease severity was assessed and determined by two rheumatologists based on the Medsger's Disease Severity Scale (MDSS). H. pylori stool antigen was evaluated based on the test which sensitivity and specificity was proven. All obtained data were statistically analyzed by SPSS 16 using Fisher's exact test Spearman correlation test (RSpearman). RESULTS Forty one (55.4%) of the 74 patients had positive stool antigens. We found a significant positive association between the severity of disease based on MDSS and titer of H. pylori stool antigen (p ≤ 0.001). CONCLUSION This study reveals that H. pylori infection may play a significant role in the severity of organ involvement in SSc.

Evaluation and Comparison of Choroidal Thickness in Patients with Behçet Disease with versus without Ocular Involvement.

PURPOSE: To assess the subfoveal choroidal thickness (SFCT) in patients with Behçet disease (BD) and compare the SFCT in patients with and without ocular BD (OBD) and between patients with active and quiescent phases of the Behçet's posterior uveitis. METHODS: This prospective cross-sectional study was conducted on patients with BD (n = 51) between October 2016 and October 2018. Complete ocular examinations including slit lamp biomicroscopy and fundus examination with dilated pupils were performed for all patients. The SFCT values were compared between patients with and without OBD. Enhanced depth imaging optical coherence tomography (EDI-OCT) was done to measure the SFCT, and wide field fundus fluorescein angiography (WF-FAG) was performed to evaluate the ocular involvement and determine the active or quiescent phases of the Behçet's posterior uveitis. The correlation between the changes of SFCT and the WF-FAG scores was assessed. RESULTS: One hundred and two eyes of 51 patients with BD, aged 29 to 52 years were studied. Of these, 23 patients were male. The mean age ± standard deviation in patients with OBD and patients without ocular involvement was 38.71 ± 7.8 and 36.22 ± 10.59 years (P = 0.259) respectively. The mean SFCT in patients with OBD was significantly greater than in patients without OBD (364.17 ± 93.34 vs 320.43 ± 56.70 µm; P = 0.008). The difference of mean SFCT between the active compared to quiescent phase was not statistically significant when only WF-FAG criteria were considered for activity (368.12 ± 104.591 vs 354.57 ± 58.701 µm, P = 0.579). However, when the disease activity was considered based on both WF-FAG and ocular exam findings, SFCT in the active group was higher than the inactive group (393.04 ± 94.88 vs 351.65 ± 58.63 µm, P = 0.060). This difference did not reach statistical significance, but it was clinically relevant. CONCLUSION: Choroidal thickness was significantly increased in BD patients with ocular involvement; therefore, EDI-OCT could be a noninvasive test for evaluation of ocular involvement in patients with BD. The increased SFCT was not an indicative of activity in OBD; however, it could predict possible ocular involvement throughout the disease course.

ABO and Rh blood groups in patients with lupus and rheumatoid arthritis.

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.

Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis (ASQA): A Multicenter Post-marketing Surveillance Study.

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.

The Effect of Nanocurcumin in Improvement of Knee Osteoarthritis: A Randomized Clinical Trial.

OBJECTIVE: Osteoarthritis is a degenerative disease of the joints. Non-steroidal antiinflammatory drugs (NSAIDs) are being used for the treatment of osteoarthritis. However, their use is limited due to complications, such as gastrointestinal bleeding. Therefore, it is necessary to find alternative treatments for osteoarthritis. Recently, nanomicelle curcumin has been developed to increase the oral bioavailability of curcumin. The aim of this study was to evaluate the effect of nano curcumin on the alleviation of the symptoms of knee osteoarthritis patients. METHODS: In this randomized, double-blind controlled trial, the intervention group was administered 40 mg of nanocurcumin capsule every 12 hours over a period of six weeks, and the control group received the placebo (similar components of nanomicelle curcumin capsules yet without curcumin). In the final analysis, 36 patients in the nanocurcumin group and 35 patients in the placebo group were enrolled. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was filled for patients in their first visit and at the end of six weeks. Differences were statistically significant at P-value < 0.05. RESULTS: There were no significant differences between the two groups regarding gender, age, Kellgren score, and the duration of the disease before the intervention. A significant decrease was observed in the overall score, along with the scores of pain, stiffness and physical activity subscales of the WOMAC questionnaire in patients of the nano curcumin group compared with the placebo group. CONCLUSION: Nanocurcumin significantly improves the symptoms of osteoarthritis patients.