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Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis (Asqa): A Multicenter Post-Marketing Surveillance Study Publisher Pubmed



Gharibdoost F1 ; Salari AH2 ; Salesi M3 ; Ebrahimi Chaharom F4 ; Mottaghi P3 ; Hosseini M5 ; Sahebari M6 ; Nazarinia M7 ; Mirfeizi Z6 ; Shakibi M8 ; Moussavi H9 ; Karimifar M10 ; Mowla K11 ; Karimzadeh H10 Show All Authors
Authors
  1. Gharibdoost F1
  2. Salari AH2
  3. Salesi M3
  4. Ebrahimi Chaharom F4
  5. Mottaghi P3
  6. Hosseini M5
  7. Sahebari M6
  8. Nazarinia M7
  9. Mirfeizi Z6
  10. Shakibi M8
  11. Moussavi H9
  12. Karimifar M10
  13. Mowla K11
  14. Karimzadeh H10
  15. Anjidani N12
  16. Jamshidi A1

Source: Advances in Therapy Published:2021


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. © 2021, The Author(s), under exclusive licence to Springer Healthcare Ltd. part of Springer Nature.
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