Farhad Gharibdoost1, Amir-Hossein Salari2, Mansour Salesi3, Faegheh Ebrahimi Chaharom4, Peyman Mottaghi3, Mansour Hosseini5, Maryam Sahebari6, Mohammadali Nazarinia7, Zahra Mirfeizi6, Mohammadreza Shakibi8, Hamidreza Moussavi9, Mansour Karimifar10, Karim Mowla11, Hadi Karimzadeh10, Nassim Anjidani12, Ahmadreza Jamshidi13. 1. Rheumatology Research Center, Shariati Hospital, Tehran University of Medical, Tehran, Iran. 2. Department of Rheumatology, Baghiyatollah University of Medical Sciences, Tehran, Iran. 3. Department of Rheumatology, Isfahan University of Medical Sciences, Isfahan, Iran. 4. Connective Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. 5. Shiraz University of Medical Sciences, Shiraz, Iran. 6. Rheumatic Diseases Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. 7. Shiraz Geriatric Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. 8. Endocrinology and Metabolism Research Center, Institute of Basic and Clinical Physiology Sciences, Kerman University of Medical Sciences, Kerman, Iran. 9. Department of Rheumatology, Noor and Aliasghar Hospital, Isfahan University of Medical Sciences, Isfahan, Iran. 10. Department of Rheumatology, Alzahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran. 11. Department of Rheumatology, School of Medicine, Ahvaz Jundishapur Medical Sciences University, Ahvaz, Iran. 12. Medical Department, Orchid Pharmed Company, Tehran, Iran. 13. Rheumatology Research Center, Shariati Hospital, Tehran University of Medical, Tehran, Iran. dr.ahmadreza.jamshidi@gmail.com.
Abstract
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.
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.
Authors: George A Wells; Maarten Boers; Beverley Shea; Peter M Brooks; Lee S Simon; C Vibeke Strand; Daniel Aletaha; Jennifer J Anderson; Claire Bombardier; Maxime Dougados; Paul Emery; David T Felson; Jaap Fransen; Dan E Furst; Johanna M W Hazes; Kent R Johnson; John R Kirwan; Robert B M Landewé; Marissa N D Lassere; Kaleb Michaud; Maria Suarez-Almazor; Alan J Silman; Josef S Smolen; Desiree M F M Van der Heijde; Piet L C M van Riel; Fred Wolfe; Peter S Tugwell Journal: J Rheumatol Date: 2005-10 Impact factor: 4.666