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

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

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
Anjidani N¹²
Jamshidi A¹

Show Affiliations

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

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.

2. Strategies Toward Rheumatoid Arthritis Therapy; the Old and the New, Journal of Cellular Physiology (2019)

Experts (# of related papers)

Sayed Alireza Razavi (1)

Style	Citing Format
MLA	Gharibdoost F, et al.. "Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis (Asqa): A Multicenter Post-Marketing Surveillance Study." Advances in Therapy, vol. 38, no. 2, 2021, pp. 1290-1300.
APA	Gharibdoost F, Salari AH, Salesi M, Ebrahimi Chaharom F, Mottaghi P, Hosseini M, Sahebari M, Nazarinia M, Mirfeizi Z, Shakibi M, Moussavi H, Karimifar M, Mowla K, Karimzadeh H, Anjidani N, Jamshidi A (2021). Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis (Asqa): A Multicenter Post-Marketing Surveillance Study. Advances in Therapy, 38(2), 1290-1300.
Chicago	Gharibdoost F, Salari AH, Salesi M, Ebrahimi Chaharom F, Mottaghi P, Hosseini M, Sahebari M, et al.. "Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis (Asqa): A Multicenter Post-Marketing Surveillance Study." Advances in Therapy 38, no. 2 (2021): 1290-1300.
Harvard	Gharibdoost F et al. (2021) 'Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis (Asqa): A Multicenter Post-Marketing Surveillance Study', Advances in Therapy, 38(2), pp. 1290-1300.
Vancouver	Gharibdoost F, Salari AH, Salesi M, Ebrahimi Chaharom F, Mottaghi P, Hosseini M, et al.. Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis (Asqa): A Multicenter Post-Marketing Surveillance Study. Advances in Therapy. 2021;38(2):1290-1300.
BibTex	@article{ author = {Gharibdoost F and Salari AH and Salesi M and Ebrahimi Chaharom F and Mottaghi P and Hosseini M and Sahebari M and Nazarinia M and Mirfeizi Z and Shakibi M and Moussavi H and Karimifar M and Mowla K and Karimzadeh H and Anjidani N and Jamshidi A}, title = {Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis (Asqa): A Multicenter Post-Marketing Surveillance Study}, journal = {Advances in Therapy}, volume = {38}, number = {2}, pages = {1290-1300}, year = {2021} }
RIS	TY - JOUR AU - Gharibdoost F AU - Salari AH AU - Salesi M AU - Ebrahimi Chaharom F AU - Mottaghi P AU - Hosseini M AU - Sahebari M AU - Nazarinia M AU - Mirfeizi Z AU - Shakibi M AU - Moussavi H AU - Karimifar M AU - Mowla K AU - Karimzadeh H AU - Anjidani N AU - Jamshidi A TI - Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis (Asqa): A Multicenter Post-Marketing Surveillance Study JO - Advances in Therapy VL - 38 IS - 2 SP - 1290 EP - 1300 PY - 2021 ER -

Science Communicator Platform

Authors

Authors Affiliations

Abstract