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 effects of conventional drugs in the treatment of rheumatoid arthritis on the serum lipids.

BACKGROUND: Rheumatoid arthritis (RA) is a common chronic autoimmune disorder that leads to damage of human joints. There are various treatment approaches in which different drugs are prescribed which have several alterations in serum lipids. This research aimed to study the effect of RA treatments on the serum lipids. MATERIALS AND METHODS: Two hundred randomly selected patients with RA were randomly assigned to three different groups. The first group of patients was treated with a combination of prednisolone (PRD) and hydroxychloroquine (HCQ). The second group was treated with three drugs including PRD, HCQ, and methotrexate (MTX). The third group was treated with four medications including PRD, HCQ, MTX, and sulfasalazine. Within each group, the lipid factors such as triglyceride (TG), total cholesterol (TC), low-density lipoprotein (LDL), and high-density lipoprotein (HDL), erythrocyte sedimentation rate, and visual analog scale were measured at the beginning of the experiment and 6 months after exposing the treatments. For each group, we also calculated the Disease Activity Score-28 (DAS-28). The analysis of variance revealed that the overall DAS-28 was significantly different among the three groups. RESULTS: In the first group, the level of TG and TC significantly decreased (P = 0.015 and P ≤ 0.001, respectively). In the second group, the level of TG and LDL significantly decreased (P = 0.009). In the third group, the LDL level increased considerably (P < 0.001). The HDL level significantly increased in all three groups (P = 0.012, P = 0.014, and P = 0.028, respectively). CONCLUSION: The treatment PRD + HCQ + MTX was more effective in reducing the LDL level and increasing the HDL level. To reduce the risk of cardiovascular diseases in patients with RA, it is important to prescribe the combination of drugs which leads and normalizes the lipid profile levels.

The association of immunoglobulin A, immunoglobulin G and anti-cyclic citrullinated peptide antibodies with disease activity in seronegative rheumatoid arthritis patients.

BACKGROUND: Rheumatoid arthritis (RA) is a common autoimmune disease that is associated with progressive disability, systemic complications, and early death. The present study was aimed to investigate the level of immunoglobulin G (IgG) and IgA isotypes and anti-cyclic citrullinated peptide (CCP) antibody and to assess their association with disease severity based on disease activity score (DAS-28) in patients with IgM rheumatoid factor (IgM-RF) negative RA. MATERIALS AND METHODS: In this cross-sectional study, 62 RA patients with IgM-RF negative were assessed. Radiographs were obtained for all RA patients. The RF (IgG, and IgA) and anti-CCP were measured by using the enzyme-linked immunosorbent assay. Values of cut-off points over 15 UI/mL for IgA IgA-RF, 20 UI/mL for IgG-RF and over 20 units for anti-CCP were considered positive. DAS-28 score was compared in regard to the IgA-RF and IgG-RF and anti-CCP positivity using Mann-Whitney test. RESULTS: DAS-28 score in IgA-RF positive was significantly higher than IgA-RF negative (mean score, 6.03 ± 0.33 vs. 5.44 ± 0.76 respectively, P = 0.035). In IgG-RF positive patients, DAS-28 score was similar to patients with IgG-RF negative (5.64 ± 0.59 vs. 5.46 ± 0.78 respectively, P = 0.396). Furthermore, in patients with anti-CCP positive DAS-28 score was significantly higher than patients with anti-CCP negative (5.72 ± 0.61 vs. 5.38 ± 0.79 respectively, P = 0.049). CONCLUSION: Findings indicated that there was a significant association between the amounts of IgA and anti-CCP with severity of disease in RF negative RA patients while there was no significant association between the amounts of IgG and severity of RA disease.

Effect of ethnic origin (Caucasians versus Turks) on the prevalence of rheumatic diseases: a WHO-ILAR COPCORD urban study in Iran.

The objective of this study was to compare the prevalence of musculoskeletal complaints and rheumatic disorders in Caucasians and Turks in an identical environment. Subjects were selected randomly for an interview from Tehran's 22 districts. The Community Oriented Program for Control of Rheumatic Diseases questionnaire was filled in, positive cases were examined, and if needed, laboratory or X-ray tests were performed. A total of 4,096 houses were visited, and 10,291 persons were interviewed. They were 71.4% Caucasians and 23.1% Turks with similar distribution of age and gender. Musculoskeletal complaints of the past 7 days were detected in 40.8% of Caucasians and 45.5% of Turks (p < 0.001). In Caucasians, the total of musculoskeletal complaints in men was 33.8% (95% CI, 31.4-36.2%) versus 48.3% in women (95% CI, 45.7-50.8%). In Turks, the total of musculoskeletal complaints in men was 36.6% (95% CI, 32.2-41.1%) versus 55.8% in women (95% CI, 55.8-60.6%). The data of Caucasians versus Turks were as follows: knee pain 20.2% (95% CI, 18.2-22.1) versus 24.1% (95% CI, 20.5-27.6), with p < 0.001; dorso-lumbar spine pain 15.1% (95% CI, 13.6-16.6) versus 18.4% (95% CI, 15.1-21.8), with p < 0.001; shoulder pain 10.7% (95% CI, 9.4-11.9) versus 12.3% (95% CI, 9.7-14.8), with p = 0.025; osteoarthritis 14.1% (95% CI, 12.8-15.2) versus 16.4% (95% CI, 14.3-18.6), p = 0.04; and knee osteoarthritis 12.3% (95% CI, 11.8-14.1) versus 15.3% (95% CI, 13.3-17.4), with p < 0.001). There were no significant differences regarding the prevalence of soft tissue rheumatism, rheumatoid arthritis, ankylosing spondylitis, Behcet's disease, fibromyalgia, and gout. Although musculoskeletal complaints were more frequent in Turks than in Caucasians, the prevalence of rheumatic disorders was rather similar except for knee osteoarthritis.

WHO-ILAR COPCORD Study (Stage 1, Urban Study) in Iran.

OBJECTIVE: To find the prevalence of musculoskeletal complaints and rheumatic disorders in Iran. METHODS: Tehran, with one-ninth of the population of Iran and of mixed ethnic origins, was selected as the field. Subjects were randomly selected from the 22 districts. Interviews were conducted once a week, on the weekend. The 3 phases of stage 1 were done on the same day, in parallel, like the fast-track Community Oriented Program for Control of Rheumatic Diseases (COPCORD). RESULTS: Four thousand ninety-six houses were visited and 10,291 persons were interviewed. Musculoskeletal complaints during the past 7 days were detected in 41.9% of the interviewed subjects. The distribution was: shoulder 14.5%, wrist 10%, hands and fingers 9.4%, hip 7.1%, knee 25.5%, ankle 9.8%, toes 6.1%, cervical spine 13.4%, and dorsal and lumbar spine 21.7%. Degenerative joint diseases were detected in 16.6% of subjects: cervical spondylosis 1.8%, knee osteoarthritis (OA) 15.3%, hand OA 2.9%, and hip OA 0.32%. Low back pain was detected in 15.4% and soft tissue rheumatism in 4.6%. Inflammatory disorders were rheumatoid arthritis 0.33%, seronegative spondyloarthropathies 0.23%, ankylosing spondylitis 0.12%, systemic lupus erythematosus 0.04%, and Behçet's disease 0.08%. Fibromyalgia was detected in 0.69% and gout in 0.13% of the studied population. CONCLUSION: The large urban COPCORD study in Iran showed a high prevalence of rheumatic complaints in the population over the age of 15 years, 41.9%. Knee OA and low back pain were the most frequent complaints.