Full
Outline
To demonstrate equivalent clinical efficacy of all biosimilars of adalimumab (ADA), etanercept (ETA), infliximab (INF), and rituximab (RIT) with their reference drugs as well as to evaluate the relative safety and immunogenicity of biosimilars in the treatment of rheumatoid arthritis (RA).
Pubmed, Embase, Cochrane Library, Web of Science, Sinomed, ClinicalTrial.gov, CNKI and Wanfang database were searched to collect the randomized controlled trials (RCTs) about the comparisons between biosimilars and their reference drugs for the treatments of RA published from inception to December 17, 2019. Two researchers screened literature, extracted data and assessed risk of bias independently. STATA 15.0 software was used to perform data analysis. To reduce heterogeneity, subgroup analysis in accordance with the drug treatment duration was conducted.
A total of 27 RCTs were included (ADA: 10, ETA: 6, INF: 7, RIT: 4), involving 10 405 RA patients with inadequate response to the first-line treatment regimen. The clinical efficacy and safety of the four biosimilar drugs were comparable with their reference drugs. In terms of immunogenicity, no statistically significant differences were found between the other three groups except for ETA. It should be noted that the quality rating of the evidence related to the immunogenicity outcome was low, so the results of the immunogenicity need to be further verified by subsequent relevant studies.
This study supports the similarity of the four biosimilars to their respective reference drugs, which may serve as evidence for related clinical practice, guideline development, and policy making.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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