Ebbers Hans C, Pieper Burkhard, Issa Amine, Addison Janet, Freudensprung Ulrich, Rezk Mourad F
Biogen International GmbH, Baar, Switzerland.
Biogen Idec UK, Maidenhead, UK.
Rheumatol Ther. 2019 Sep;6(3):317-338. doi: 10.1007/s40744-019-00169-4. Epub 2019 Aug 5.
In 2016, SB4 (Benepali) became the first etanercept (ETN) biosimilar to obtain marketing authorisation in Europe. Despite robust analytical and clinical comparisons, outstanding questions remain on SB4 use in routine practice.
A systematic search for publications on real-world evidence of SB4 effectiveness, safety and drug survival was undertaken using search terms (SB4 OR Benepali OR biosimilar etanercept OR innovator etanercept) in the BIOSIS Toxicology, BIOSIS Previews, Embase and MEDLINE databases up to 17 January 2019.
Of 959 articles identified, eight journal articles, two journal letters and 23 congress abstracts were selected on criteria of original real-world evidence with a clinical focus. As expected with real-world evidence, quality scoring showed that the evidence had high external validity but lower internal validity. A total of 13,552 patients were described across nine European countries and all approved SB4 indications: 2499 were ETN-naïve and 11,053 switched from reference ETN to SB4 (switchers). Switch acceptance rates (a combination of clinicians offering and patients accepting initiation on SB4) ranged between 51.6% and 99.0%; patient support programmes positively contributed to acceptance. Disease activity was generally similar pre- and post-switch (typically 3-month timeframe). Retention rates across studies were at least 75% (up to 12 months follow-up). No new safety signals were identified. Differences in discontinuation rates versus historic controls reported in some studies may have been influenced by differences in treatment practices, lack of clinician confidence and nocebo effects.
Nearly 2500 ETN-naïve patients have been initiated on SB4 and outcomes are similar to those patients receiving reference ETN. Overall this systematic review of real-world evidence provides additional reassurance that SB4 is as effective and safe as reference ETN in both switched and naïve patients.
Biogen International GmbH.
2016年，SB4（Benepali）成为欧洲首个获得上市许可的依那西普（ETN）生物类似药。尽管进行了充分的分析和临床比较，但SB4在常规临床应用中的一些重要问题仍有待解答。
在BIOSIS毒理学、BIOSIS预评、Embase和MEDLINE数据库中，使用检索词（SB4或Benepali或生物类似药依那西普或原研依那西普）对截至2019年1月17日的有关SB4有效性、安全性和药物留存率的真实世界证据的出版物进行系统检索。
在检索到的959篇文章中，根据以临床为重点的原始真实世界证据标准，筛选出8篇期刊文章、2篇期刊信函和23篇会议摘要。正如真实世界证据所预期的那样，质量评分显示该证据具有较高的外部效度，但内部效度较低。在9个欧洲国家及所有已获批的SB4适应症中，共描述了13552例患者：2499例为初治ETN患者，11053例从原研ETN转换为SB4（转换者）。转换接受率（临床医生提供并患者接受起始使用SB4的综合比例）在51.6%至99.0%之间；患者支持计划对接受率有积极贡献。转换前后的疾病活动度通常相似（通常为3个月时间范围）。各研究中的留存率至少为75%（随访长达12个月）。未发现新的安全信号。一些研究报告的停药率与历史对照的差异可能受到治疗方法差异、临床医生信心不足和安慰剂效应的影响。
近2500例初治ETN患者开始使用SB4，其结果与接受原研ETN的患者相似。总体而言，这项对真实世界证据的系统评价进一步证实，在转换患者和初治患者中，SB4与原研ETN一样有效且安全。
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