Impact of switching between reference biologics and biosimilars of tumour necrosis factor inhibitors for rheumatoid arthritis: a systematic review and network meta-analysis

被引:6
作者
Ascef, Bruna de Oliveira [1 ]
Almeida, Matheus Oliveira [2 ]
de Medeiros-Ribeiro, Ana Cristina [3 ]
Andrade, Danieli Castro de Oliveira [3 ]
de Oliveira Junior, Haliton Alves [2 ]
de Soarez, Patricia Coelho [4 ]
机构
[1] Univ Sao Paulo, Fac Med FMUSP, Dept Med Prevent, Av Dr Arnaldo 455, 2 Andar, Sala 2214, BR-01246903 Sao Paulo, SP, Brazil
[2] Hosp Alemao Oswaldo Cruz, Hlth Technol Assessment Unit, Sao Paulo, Brazil
[3] Univ Sao Paulo, Hosp Clin, Fac Med, Disciplina Reumatol, Sao Paulo, SP, Brazil
[4] Univ Sao Paulo, Fac Med FMUSP, Dept Med Prevent, Sao Paulo, SP, Brazil
关键词
INFLIXIMAB REFERENCE PRODUCT; ETANERCEPT REFERENCE PRODUCT; DOUBLE-BLIND; PARALLEL-GROUP; PHASE-III; SAFETY; EFFICACY; IMMUNOGENICITY; METHOTREXATE; SB4;
D O I
10.1038/s41598-023-40222-5
中图分类号
O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];
学科分类号
07 ; 0710 ; 09 ;
摘要
What is the impact of switching between biologics and biosimilars of adalimumab, etanercept, and infliximab on efficacy and safety for rheumatoid arthritis? A systematic review and network meta-analysis were performed to compare switching and non-switching groups of treatments. Pooled Risk Relative (RR) or standardised mean differences (SMD) with 95% credible intervals (95% CrIs) were obtained. Seventeen randomized trials with a switching phase involving 6,562 patients were included. Results showed that a single switch from biologics to biosimilars compared to continuing biologics had comparable effects for primary and co-primary outcomes, the American College of Rheumatology criteria with 20% response (ACR20) (7 trials, 1,926 patients, RR 0.98, 95% CrIs 0.93 to 1.03) and the Health Assessment Questionnaire-Disability Index (HAQ-DI) (5 trials, 1,609 patients, SMD - 0.07, 95% CrIs - 0.23 to 0.1), and within the equivalence margins: ACR20 [RR 0.94, 1.06] and HAQ-DI [SMD - 0.22, 0.22]. The risk of treatment-emergent adverse events, discontinuation, and positive anti-drug antibodies were comparable after switching. Safety results were imprecise, and the follow-up period might not be sufficient to evaluate long-term effects, especially malignancies. Overall, the practice of single switching between approved biologics and biosimilars of Tumour Necrosis Factor inhibitors is efficacious and safe for rheumatoid arthritis.
引用
收藏
页数:14
相关论文
共 69 条
[1]   The Automatic Substitution of Biosimilars: Definitions of Interchangeability are not Interchangeable [J].
Afzali, Anita ;
Furtner, Daniel ;
Melsheimer, Richard ;
Molloy, Philip J. .
ADVANCES IN THERAPY, 2021, 38 (05) :2077-2093
[2]   Diagnosis and Management of Rheumatoid Arthritis A Review [J].
Aletaha, Daniel ;
Smolen, Josef S. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2018, 320 (13) :1360-1372
[3]   Immunogenicity of a proposed adalimumab biosimilar, FKB327, and the reference product in patients with rheumatoid arthritis [J].
Alten, R. ;
Markland, C. ;
Kawakami, K. ;
Boyce, M. ;
Casty, F. ;
Muniz, R. ;
Genovese, M. C. .
JOURNAL OF CROHNS & COLITIS, 2019, 13 :S320-S320
[4]   EFFICACY AND SAFETY RESULTS OF A PHASE III STUDY COMPARING FKB327, AN ADALIMUMAB BIOSIMILAR, WITH THE ADALIMUMAB REFERENCE PRODUCT IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS [J].
Alten, R. ;
Glover, J. ;
Matsunaga, N. ;
Chisholm, D. ;
Genovese, M. .
ANNALS OF THE RHEUMATIC DISEASES, 2017, 76 :59-59
[5]   Immunogenicity of an adalimumab biosimilar, FKB327, and its reference product in patients with rheumatoid arthritis [J].
Alten, Rieke ;
Markland, Colin ;
Boyce, Malcolm ;
Kawakami, Kazuki ;
Muniz, Rafael ;
Genovese, Mark C. .
INTERNATIONAL JOURNAL OF RHEUMATIC DISEASES, 2020, 23 (11) :1514-1525
[6]   LONG-TERM SAFETY, IMMUNOGENICITY AND EFFICACY IN RANDOMIZED, DOUBLE-BLIND, AND OPEN-LABEL EXTENSION STUDIES COMPARING FKB327, AN ADALIMUMAB BIOSIMILAR, WITH THE ADALIMUMAB REFERENCE PRODUCT IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS [J].
Alten, Rieke ;
Genovese, Mark C. ;
Arai ;
Muniz, Rafael ;
Kellner, Herbert .
ANNALS OF THE RHEUMATIC DISEASES, 2019, 78 :1135-1135
[7]  
[Anonymous], 2009, Guidelines on evaluation of similar biotherapeutic products (SBPs)
[8]   Therapeutic Equivalence of Biosimilar and Reference Biologic Drugs in Rheumatoid Arthritis: A Systematic Review and Meta-analysis [J].
Ascef, Bruna de Oliveira ;
Almeida, Matheus Oliveira ;
de Medeiros-Ribeiro, Ana Cristina ;
Oliveira de Andrade, Danieli Castro ;
de Oliveira Junior, Haliton Alves ;
de Soarez, Patricia Coelho .
JAMA NETWORK OPEN, 2023, 6 (05) :E2315872
[9]   Equivalence and switching between biosimilars and reference molecules in rheumatoid arthritis: protocol for a systematic review and meta-analysis [J].
Ascef, Bruna O. ;
Almeida, Matheus O. ;
de Medeiros Ribeiro, Ana Cristina ;
Andrade, Danieli C. O. ;
de Oliveira Junior, Haliton A. ;
Pereira, Tiago, V ;
de Soarez, Patricia C. .
SYSTEMATIC REVIEWS, 2021, 10 (01)
[10]   Interchangeability of Biosimilars: Overcoming the Final Hurdles [J].
Barbier, Liese ;
Vulto, Arnold G. .
DRUGS, 2021, 81 (16) :1897-1903