A Phase IV Study of the Safety and Efficacy of CinnoPar® in Iranian Patients with Osteoporosis.

The safety of teriparatide has been studied in various phase III and phase IV trials. However, a postmarketing study of the biosimilar of teriparatide, CinnoPar®, has not been conducted on Iranian patients. This was a phase IV study conducted on osteoporotic patients who received an Iranian teriparatide biosimilar with a dose of 20 µg daily. The primary outcome of this study was to monitor for adverse events (AEs). Effectiveness as the secondary outcome was measured using the EQ-5D quality-of-life questionnaire and back pain Visual Analogue Scale (VAS) score. Among 193 analyzed patients between September 2015 and March 2019, the most common AEs were hypercalcemia (4%), nausea, and pain (3%). No deaths, serious AEs, or other significant AEs occurred in this study. The mean EQ-5D scores decreased after the course of the treatment from 2.3 ± 0.66 at the baseline to 2 ± 0.66. The mean back pain VAS scores also decreased from 4.9 ± 3.6 at baseline to 1.8 ± 2.1 at the end of the study. Both changes were statistically significant (p < 0.001). Consistent with the findings of previous studies and the drug monograph, no new safety concern was observed with this biosimilar teriparatide, and the drug was effective based on the VAS score and EQ-5D in osteoporotic patients.

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.

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.

The prevalence of oral aphthosis in a normal population in Iran: a WHO-ILAR COPCORD study.

This study was conducted to determine the prevalence of oral aphthosis in a normal population in Iran, using the data of the WHO-ILAR COPCORD study in Iran. We conducted this study in Tehran, the capital of Iran which was selected as the COPCORD study field. In 22 districts of Tehran, 50 clusters were randomly selected. Of the selected houses, 4,096 households were visited and 10,291 persons were interviewed (response rate of 75%). Out of the 10291 subjects interviewed, 2592 had aphthous ulcers which translated to a prevalence of 25.2% (95% confidence interval: 24.4% to 26.0%). The prevalence of oral aphthosis was rather high in this normal population.