Expert Opinion on Biological Therapy ( IF 4.6 ) Pub Date : 2020-12-29 , DOI: 10.1080/14712598.2021.1851362 Alan Menter 1 , Petr Arenberger 2 , Sigrid Balser 3 , Stefan Beissert 4 , Ashley Cauthen 5 , Niklas Czeloth 6 , Jennifer Soung 7 , Sasha Jazayeri 8 , Peter Weisenseel 9 , Girish Jayadeva 6
ABSTRACT
Background: BI 695501 is an approved biosimilar to Humira® reference product (RP).
Research design and methods: In this randomized Phase III trial (VOLTAIRE-PSO), patients with moderate-to-severe chronic plaque psoriasis received BI 695501 or adalimumab RP (24-week treatment). Primary efficacy endpoint: the proportion of patients with ≥75% reduction in Psoriasis Area and Severity Index (PASI 75) response at week 16 (±18% equivalence limits for two-sided 95% confidence interval between treatment groups). Safety, pharmacokinetics, and immunogenicity were also assessed.
Results: Baseline characteristics were balanced between treated groups (BI 695501, n = 159; adalimumab RP, n = 158). PASI 75 response rates (full analysis set, n = 158; n = 157) were 68.2% (BI 695501) and 70.4% (adalimumab RP) at week 16 (95% CI: −14.4%, 8.7%), and 75.3% and 72.4%, at week 24, respectively. At week 24, 41.5% (BI 695501) and 44.9% (adalimumab RP) of treated patients had treatment-emergent adverse events (AEs), 3.1% and 4.4% had serious AEs, and 0.0% and 1.9% had AEs of special interest. Of treated patients, 75.3% (BI 695501) and 77.9% (adalimumab RP) were anti-drug antibody-positive.
Conclusion: These data demonstrate equivalent efficacy and highly similar safety and immunogenicity between BI 695501 and adalimumab RP in patients with chronic plaque psoriasis.
Study identifier: NCT02850965
中文翻译：
生物仿制药 BI 695501 和阿达木单抗参考产品在中重度慢性斑块状银屑病患者中的相似功效、安全性和免疫原性：随机 III 期 VOLTAIRE-PSO 研究的结果
摘要
背景：BI 695501 是 Humira® 参考产品 (RP) 的批准生物仿制药。
研究设计和方法：在这项随机 III 期试验 (VOLTAIRE-PSO) 中，中度至重度慢性斑块状银屑病患者接受 BI 695501 或阿达木单抗 RP（24 周治疗）。主要疗效终点：第 16 周时银屑病面积和严重程度指数 (PASI 75) 反应降低 ≥ 75% 的患者比例（治疗组间两侧 95% 置信区间的 ±18% 等效限值）。还评估了安全性、药代动力学和免疫原性。
结果：基线特征在治疗组之间平衡（BI 695501，n = 159；阿达木单抗 RP，n = 158）。PASI 75 响应率（完整分析集，n = 158；n = 157）在第 16 周分别为 68.2% (BI 695501) 和 70.4%（阿达木单抗 RP）（95% CI：-14.4%，8.7%）和 75.3%和 72.4%，分别在第 24 周。在第 24 周时，41.5% (BI 695501) 和 44.9% (adalimumab RP) 的接受治疗的患者出现治疗中出现的不良事件 (AE)，3.1% 和 4.4% 出现严重 AE，0.0% 和 1.9% 出现特别关注的 AE . 在接受治疗的患者中，75.3% (BI 695501) 和 77.9% (adalimumab RP) 为抗药物抗体阳性。
结论：这些数据证明了 BI 695501 和阿达木单抗 RP 在慢性斑块状银屑病患者中的等效疗效和高度相似的安全性和免疫原性。
研究标识符：NCT02850965
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