High prevalence of Helicobacter pylori infection in Behcet’s disease

Background: Behcet’s disease (BD) is a multisystem disease of unknown etiology. There are several clues which may indicate an ethiopathogenesis role for Helicobacter pylori infection in this disease. Methods: In a case control study in an out patient department, 48 patients with BD were compared to age, sex matched controls regarding presence of H. pylori infection by serology and urea breath test (UBT). Results: Ongoing H. pylori infection was more prevalent among patients with BD using result of UBT with odds ratio of 3.1 (95% CI: 1.34 – 7.26, PV < 0.001). Conclusion: H. pylori infection may have a role in the pathogenesis of BD

Determination of serum visfatin level in patients with Behcet disease, comparing with normal population

Background: Behcet’s disease is an inflammatory, systemic and chronic disorder with unknown etiology affecting multiple systems of body (1). The cause is not clear but seems to be multifactorial, including immune system dysfunction (humoral and cellular immune defects), endothelial cell dysfunction and genetic predisposition (2). White adipose tissue produces variety of proteins in the name of adipocytokines, with important roles in body metabolism. One of these newly identified secreted adipocytokines is visfatin, which is secreted by the visceral fat and its plasma level increases during the obesity. It has insulinmimetic effects in metabolism of cultured cells and activates the insulin receptor (3). Visfatin stimulates inflammatory cells like monocytes and can induces increasing circulating level of IL-6 in mice. It have been considered as a new proinflammatory adipocytokine (4). Previous studies have evaluated visfatin level in immunologic disorders like rheumatoid arthritis and showed it was significantly higher in comparing to control subjects (4,5,6). There was no evaluation in patients with behcet disease yet. Objectives: We have evaluated visfatin level in patients with behcet disease finding inflammatory role of that in pathogenesis and clinical manifestations of behcet disease. Methods: We have evaluated 40 patients with Behcet’s disease fulfilled the International Study Group Criteria for the Diagnosis of Behc¸et’s Disease (ISG) and 40 healthy subjects from healthy candidates referring to behcet clinic of Shiraz medical university as a referral center for these patients in south Iran. Both groups have been matched for age, body mass index (BMI) and sex. Visfatin was checked in both groups using ELISA Kit. Results: There were no significant difference between cases and controls in mean concentration of visfatin level (P = 0.61). Difference in the visfatin level between patients with active and inactive manifestations of Behcet’s disease approximated to the significant levels (6.13 3.20 and 4.25 2.73, respectively; P = 0.07). Conclusion: In view of our study, we have concluded that visfatin levels may affect the clinical manifestations of BD maybe as a proinfalmmatory marker in pathogenesis and active manifestations of Behcet’s disease although more cases should be included in future works

2.20 Behcet’s disease and miscellaneous rheumatic conditions

Background: Behcet’s disease is an inflammatory, systemic and chronic disorder with unknown etiology affecting multiple systems of body (1). The cause is not clear but seems to be multifactorial, including immune system dysfunction (humoral and cellular immune defects), endothelial cell dysfunction and genetic predisposition (2). White adipose tissue produces variety of proteins in the name of adipocytokines, with important roles in body metabolism. One of these newly identified secreted adipocytokines is visfatin, which is secreted by the visceral fat and its plasma level increases during the obesity. It has insulinmimetic effects in metabolism of cultured cells and activates the insulin receptor (3). Visfatin stimulates inflammatory cells like monocytes and can induces increasing circulating level of IL-6 in mice. It have been considered as a new proinflammatory adipocytokine (4). Previous studies have evaluated visfatin level in immunologic disorders like rheumatoid arthritis and showed it was significantly higher in comparing to control subjects (4,5,6). There was no evaluation in patients with behcet disease yet. Objectives: We have evaluated visfatin level in patients with behcet disease finding inflammatory role of that in pathogenesis and clinical manifestations of behcet disease. Methods: We have evaluated 40 patients with Behcet’s disease fulfilled the International Study Group Criteria for the Diagnosis of Behc¸et’s Disease (ISG) and 40 healthy subjects from healthy candidates referring to behcet clinic of Shiraz medical university as a referral center for these patients in south Iran. Both groups have been matched for age, body mass index (BMI) and sex. Visfatin was checked in both groups using ELISA Kit. Results: There were no significant difference between cases and controls in mean concentration of visfatin level (P = 0.61). Difference in the visfatin level between patients with active and inactive manifestations of Behcet’s disease approximated to the significant levels (6.13 3.20 and 4.25 2.73, respectively; P = 0.07). Conclusion: In view of our study, we have concluded that visfatin levels may affect the clinical manifestations of BD maybe as a proinfalmmatory marker in pathogenesis and active manifestations of Behcet’s disease although more cases should be included in future works

A phase III, randomized, two-armed, double-blind, parallel, active controlled, and non-inferiority clinical trial to compare efficacy and safety of biosimilar adalimumab (CinnoRA (R)) to the reference product (Humira (R)) in patients with active rheumatoid arthritis

Background: This study aimed to compare efficacy and safety of test-adalimumab (CinnoRA (R), CinnaGen, Iran) to the innovator product (Humira (R), AbbVie, USA) in adult patients with active rheumatoid arthritis (RA). Methods: In this randomized, double-blind, active-controlled, non-inferiority trial, a total of 136 patients with active RA were randomized to receive 40 mg subcutaneous injections of either CinnoRA (R) or Humira (R) every other week, while receiving methotrexate (15 mg/week), folic acid (1 mg/day), and prednisolone (7.5 mg/day) over a period of 24 weeks. Physical examinations, vital sign evaluations, and laboratory tests were conducted in patients at baseline and at 12-week and 24-week visits. The primary endpoint in this study was the proportion of patients achieving moderate and good disease activity score in 28 joints-erythrocyte sedimentation rate (DAS28-ESR)-based European League Against Rheumatism (EULAR) response. The secondary endpoints were the proportion of patients achieving American College of Rheumatology (ACR) criteria for 20% (ACR20), 50% (ACR50), and 70% (ACR70) responses along with the disability index of health assessment questionnaire (HAQ), and safety. Results: Patients who were randomized to CinnoRA (R) or Humira (R) arms had comparable demographic information, laboratory results, and disease characteristics at baseline. The proportion of patients achieving good and moderate EULAR responses in the CinnoRA (R) group was non-inferior to the Humira (R) group at 12 and 24 weeks based on both intention-to-treat (ITT) and per-protocol (PP) populations (all p values >0.05). No significant difference was noted in the proportion of patients attaining ACR20, ACR50, and ACR70 responses in the CinnoRA (R) and Humira (R) groups (all p values >0.05). Further, the difference in HAQ scores and safety outcome measures between treatment arms was not statistically significant. Conclusion: CinnoRA (R) was shown to be non-inferior to Humira (R) in terms of efficacy at week 24 with a comparable safety profile to the reference product

QT dispersion in patients with systemic lupus erythematosus: the impact of disease activity

<p>Abstract</p> <p>Background</p> <p>Patients with systemic lupus erythematosus (SLE) have increased cardiovascular morbidity and mortality. Although autopsy studies have documented that the heart is affected in most SLE patients, clinical manifestations occur in less than 10%. QT dispersion is a new parameter that can be used to assess homogeneity of cardiac repolarization and autonomic function. We compared the increase in QT dispersion in SLE patients with high disease activity and mild or moderate disease activity.</p> <p>Methods and Results</p> <p>One hundred twenty-four patients with SLE were enrolled in the study. Complete history and physical exam, ECG, echocardiography, exercise test and SLE disease activity index (SLEDAI) were recorded. Twenty patients were excluded on the basis of our exclusion criteria. The patients were divided to two groups based on SLEDAI: 54 in the high-score group (SLEDAI > 10) and 50 in the low-score group (SLEDAI < 10).</p> <p>QT dispersion was significantly higher in high-score group (58.31 ± 18.66 vs. 47.90 ± 17.41 respectively; <it>P </it>< 0.004). QT dispersion was not significantly higher in patients who had received hydroxychloroquine (54.17 ± 19.36 vs. 50.82 ± 15.96, <it>P </it>= 0.45) or corticosteroids (53.58 ± 19.16 vs. 50.40 + 11.59, <it>P </it>= 0.47). There was a statistically significant correlation between abnormal echocardiographic findings (abnormalities of pericardial effusion, pericarditis, pulmonary hypertension and Libman-Sacks endocarditis) and SLEADI (<it>P </it>< 0.004).</p> <p>Conclusions</p> <p>QT dispersion can be a useful, simple noninvasive method for the early detection of cardiac involvement in SLE patients with active disease. Concerning high chance of cardiac involvement, cardiovascular evaluation for every SLE patient with a SLEDAI higher than 10 may be recommended.</p> <p>Trial registration</p> <p>Clinicaltrial.gov registration <a href="http://www.clinicaltrials.gov/ct2/show/NCT01031797">NCT01031797</a></p

Efficacy of methotrexate in patients with polymyalgia rheumatica

Introduction: The use of steroids especially for a long time is universally used for the treatment of polymyalgia rheumatica (PMR). Because the adverse effects of long-term steroid therapy are common and deleterious, steroids-sparing combination therapy has been found a vital role for treating PMR. The current study came to address comparing the efficacy and safety of prednisolone plus methotrexate as a steroids-sparing combination therapy and prednisolone alone in patients with PMR.Materials and Methods: Fifty eight untreated patients with newly diagnosed PMR were consecutively entered and randomly assigned to receive prednisolone plus methotrexate or prednisolone alone. A single dose of methotrexate (10 mg per week, orally) was administered for the case group. The both groups were administered oral prednisolone (15 mg/day for 4 weeks) and supplement of calcium-vitamin D (1000 mg/day). Subjects continued their active treatment with gradual tapering of the steroid dosage. The remission rate at a total of 44 weeks follow-up, and other measures of disease activity, i.e. erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) were the main outcome measures. Results: Fifty eight patients entered (29 cases and 29 controls) and 47 patients completed the trial (24 cases and 23 controls). On follow-up over the full 44 weeks, mean ESR level was significantly more decreased in the case compared to control group within the full 44 weeks (52.44 versus 39.38 mm/1st h, P=0.002). There was no difference in the decrease of mean CRP (75.86 versus 51.75 mm/1st h, P=0.312) and also last to first measures (79.39 versus 57.75 mm/1st h, P=0.356) between the case and control groups. Subsequent analyses at week 44 of follow-up showed a significant higher remission rate in the case compared to the control groups (43.5% versus 8.3%, P=0.006). However, the relapse rate was similar in both groups (34.8% versus 33.3%, P=0.917). Significant differences in cumulative steroid dosage per patient was also revealed in the two treatment groups at week 44 that the mean prednisolone equivalent in the case and control groups was 3225.00 ± 162.66 mg and 3715.85 ± 136.14 mg (P=0.026).Conclusion: Higher remission as well as reduced disease activity seems to be more achieved with steroids-sparing combination therapy (prednisolone plus methotrexate) compared with prednisolone alone in patients with PMR

The Effect of Educational Program on Self-efficacy of Women with Rheumatoid Arthritis: A Randomized Controlled Clinical Trial

Background: Rheumatoid Arthritis (RA) is a chronic and inflammatory disorder which is the major cause of disability in adults. Patient training is a vital aspect of nursing care for people with arthritis aiming to enable them to live as independently as possible. In the present study, we aimed to evaluate the effect of the educational program on self-efficacy on women with rheumatoid arthritis. Methods: This study was an open randomized controlled clinical trial during May to July 2013. Women (64 participants) with confirmed RA and a mean±SD age of 48.6±9.83 years were enrolled; they were randomly assigned into intervention and control groups (32 in each group). The patients in the intervention group participated in a training programs consisting of two 30-minute sessions per week for 8 consecutive weeks. Data were collected by using Arthritis Self-Efficacy Scale (ASES) and demographic questionnaire. ASES questionnaire was filled in three times by the participants: before, immediately after, and three months after the intervention. Data were analyzed using SPSS software, version 20, and statistical tests including Chi-square and t-test. Results: The results showed that the mean of self-efficacy scores of the intervention group, immediately and three months after the intervention, significantly enhanced in all dimensions compared with the control group (P<0.001, P<0.001). Conclusion: It can be concluded that training programs is effective for improving self-efficacy in the patients suffering from RA by raising their awareness towards their disease and methods of adaptation with it. But as to the sustainability of the impact of educational courses on self-efficacy, it seems that more research is required. Trial Registration Number: IRCT201308187531N

Serum vascular endothelial growth factor (VEGF), soluble VEGF receptor-1 (sVEGFR-1) and sVEGFR-2 in systemic sclerosis patients: Relation to clinical manifestations and capillaroscopy findings

Introduction: The role of angiogenesis in the pathogenesis of systemic sclerosis (SSc) is well known. The imbalance between vascular endothelial growth factor (VEGF) and their anti-angiogenic soluble receptors (sVEGFR-1 and VEGFR-2) has been proposed as a possible cause of microangiopathy. Aim of the work: To determine the levels of VEGF, sVEGFR-1 and sVEGFR-2 and the VEGF/sVEGFR1 and VEGF/sVEGFR2 ratios in SSc patients and to study their relation with clinical manifestations and capillaroscopy findings. Patients and methods: The study included 44 SSc patients and 44 controls. The sclerosis severity was assessed by the modified Rodnan skin score (mRss) and capillaroscopy performed in patients. Serum VEGF, sVEGFR-1 and sVEGFR-2 were measured in patients and control. Results: SSc patients had a mean age of 40.7 ± 12.8 years, M:F (1:9) and disease duration was 56.2 ± 60.6 months. 27 patients (61.4%) had diffuse-SSc and 17 (38.6%) limited. The mean VEGF was significantly higher (363.4 ± 133.9 pg/ml) and sVEGFR-2 lower (2039.6 ± 109 pg/ml) in patients compared to control (93.9 ± 25.2 pg/ml and 2366 ± 116.5 pg/ml; p = 0.05 and p = 0.04, respectively). Serum levels of sVEGFR-2 in patients with early, active and nonspecific scleroderma pattern of capillaroscopy was higher in comparison to patients with late scleroderma pattern (p = 0.05). There were no significant differences in the studied parameters between those patients with and without digital ulcerations and interstitial pulmonary fibrosis. A significant correlation was found between mRss and VEGF (p = 0.04). Conclusion: An overproduction of VEGF, a potent angiogenic molecule or down regulated production of its natural inhibitors (sVEGFR-2) might be involved in the development of vasculopathy in SSc patients

Indications, response, and side effects of biologic treatment in Behçet’s disease: an 8-year study with follow-up

Introduction The treatment of Behçet’s disease has improved significantly with the introduction of biologic therapies. However, there is still a need for more information about their use. This study aimed to evaluate the indications, response, and side effects of biologic agents in patients with refractory or severe Behçet’s disease in the south of Iran, their follow-up and reasons for changing the biologics. Material and methods A retrospective analysis was conducted on 44 patients aged 16–65 years who were prescribed biologic agents for at least 6 months. The clinical history, partial and complete remission at 6 and 12 months, occurrence of side effects, and need for switching to a second or third biologic agent were recorded. Results The most common indications for starting biologic agents were ophthalmic (68.2%), parenchymal brain involvement (15.9%), and arthritis (11.4%). Improvement was observed in various manifestations of Behçet’s disease, with complete remission in 86, 51.6, 92.8, 66.7, 42.9, 33.3, and 80.0% of oral aphthous lesions, ophthalmic activity, genital aphthous lesions, skin activity, arthritis, brain parenchymal lesions, and vascular activity, respectively, 6 months after starting biologic agents. These rates were unchanged or increased at the 12-month follow-up. In 25.0% of patients, a switch to a second biologic agent was necessary due to severe disease, side effects, or refractory disease. Side effects occurred in 16.3% and 33.3% of patients on the first and second biologic agents, respectively. The majority of side effects were not serious. Conclusions We found a promising improvement at 6-month and 12-month follow-ups with various biologic agents in treating Behçet’s disease with an acceptable safety profile