Department of Medicine and Aging Sciences, University "G. d'Annunzio" Chieti-Pescara, Chieti, Italy.
Department of Philosophical, Pedagogical and Economic-Quantitative Sciences, University "G. d'Annunzio" Chieti-Pescara, Pescara, Italy.
Gynecol Endocrinol. 2021 May;37(5):406-414. doi: 10.1080/09513590.2020.1792437. Epub 2020 Jul 11.
Recently published multicentre, randomized phase III studies suggested the therapeutic equivalence of biosimilar follitropin alpha medicaments compared to the reference product. The aim of this meta-analysis is to pool the results of the three phase III trials in order to provide an overall analysis about the clinical bioequivalence between biosimilars and the originator.
The studies included in the analysis were pooled together in order to estimate the log odds ratio (OR) for binary outcomes and the weighted mean difference (WMD) for continuous outcomes along with the corresponding 95% confidence intervals (CI) by using a random effects model. The heterogeneity between the studies was evaluated with the Higgins and Chi-square tests.
No differences were found in term of number of oocytes retrieved at ovum pick-up, the primary endpoint recommended by the European Medicines Agency. No statistical differences were also found for biochemical pregnancy rate, take home baby rate, total follitropin alpha dose, duration of stimulation, and OHSS risk. A significantly higher clinical pregnancy rate ( = .03) was observed in the originator group in comparison to the biosimilar follitropin alpha.
Biosimilar follitropin alpha medicaments resulted comparable in comparison to the reference product with respect to the number of oocytes retrieved, that is the primary endpoint recommended by the European Medicines Agency .Further study is needed to evaluate the therapeutic bioequivalence between follitropin alpha biosimilar and the reference medication with respect to secondary endpoints.
最近发表的多中心、随机 III 期研究表明，与参比产品相比，生物类似物卵泡刺激素 α 药物在治疗上具有等效性。本荟萃分析的目的是汇总这三项 III 期试验的结果，以便对生物类似物与原研药之间的临床生物等效性进行总体分析。
为了估计二分类结局的对数比值（OR）和连续结局的加权均数差（WMD）及其相应的 95%置信区间（CI），我们将纳入分析的研究合并在一起，采用随机效应模型。使用 Higgins 和 Chi-square 检验评估研究间的异质性。
在取卵时获得的卵母细胞数量（欧洲药品管理局推荐的主要终点）方面，没有发现差异。生化妊娠率、活产率、总卵泡刺激素 α 剂量、刺激持续时间和 OHSS 风险也没有统计学差异。与生物类似物卵泡刺激素 α 相比，原研药组的临床妊娠率显著更高（P<0.05）。
与参比产品相比，生物类似物卵泡刺激素 α 药物在取卵数量方面具有可比性，这是欧洲药品管理局推荐的主要终点。需要进一步研究来评估卵泡刺激素 α 生物类似物与参比药物在次要终点方面的治疗生物等效性。
