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:5
|
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.
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页数:14
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