生物类似药SB17与对照药物优特克单抗在转换治疗后用于中重度斑块状银屑病的疗效比较：一项至第52周的3期研究结果
Biosimilar SB17 versus reference ustekinumab in moderate to severe plaque psoriasis after switching: phase 3 study results up to week 52.
作者信息
Feldman Steven R, Narbutt Joanna, Girolomoni Giampiero, Brzezicki Jan, Reznichenko Nataliya, Zegadło-Mylik Maria Agnieszka, Pulka Grazyna, Dmowska-Stecewicz Magdalena, Kłujszo Elżbieta, Rekalov Dmytro, Rajzer Lidia, Lee Jiyoon, Lee Minkyung, Rho Young Hee
机构信息
Department of Dermatology, Wake Forest University School of Medicine, Winston Salem, North Carolina, USA.
Dermoklinika Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak, Łódź, Poland.
出版信息
J Dermatolog Treat. 2024 Dec;35(1):2436607. doi: 10.1080/09546634.2024.2436607. Epub 2024 Dec 10.
INTRODUCTION
SB17 is a biosimilar to reference ustekinumab (UST). We compared the efficacy, safety, and immunogenicity of SB17 to UST up to Week 52, including switching from UST to SB17.
METHODS
Subjects were randomized to receive 45 mg of SB17 or UST subcutaneously up to Week 40. At Week 28, subjects from the UST treatment group were re-randomized to either switch to SB17 or continue UST. Efficacy, safety, and immunogenicity were assessed up to Week 52.
RESULTS
Among baseline randomized 503 subjects, 481 subjects were re-randomized at Week 28; continuing SB17 (SB17 + SB17, = 237), switching from UST to SB17 (UST+SB17, = 122) or continuing UST (UST+UST, = 122). The percent change from baseline in Psoriasis Area and Severity Index (PASI) was comparable between treatment groups up to Week 52 (SB17 + SB17: 95.8%, UST+SB17: 95.6%, UST+UST: 94.5% at Week 52). Other efficacy endpoints were also comparable. The incidence of treatment-emergent adverse events (SB17 + SB17: 16.5%, UST+SB17: 13.9%, UST+UST: 23.8%) and the overall incidence of anti-drug antibodies occurring after transition were comparable between treatment groups (SB17 + SB17: 5.6%, UST+SB17: 5.1%, and UST+UST: 6.7%).
CONCLUSION
SB17 demonstrated clinical biosimilarity to UST after switching from UST, and maintained long-term comparable efficacy and safety with UST up to Week 52.
引言
SB17是参照优特克单抗（UST）的生物类似药。我们比较了SB17与UST在第52周时的疗效、安全性和免疫原性，包括从UST转换为SB17的情况。
方法
受试者被随机分配皮下注射45毫克SB17或UST，直至第40周。在第28周时，UST治疗组的受试者重新随机分组，改为使用SB17或继续使用UST。评估至第52周时的疗效、安全性和免疫原性。
结果
在基线随机分组的503名受试者中，481名受试者在第28周重新随机分组；继续使用SB17（SB17+SB17，n=237），从UST转换为SB17（UST+SB17，n=122）或继续使用UST（UST+UST，n=122）。直至第52周，各治疗组银屑病面积和严重程度指数（PASI）较基线的变化百分比相当（第52周时，SB17+SB17组：95.8%，UST+SB17组：95.6%，UST+UST组：94.5%）。其他疗效终点也相当。治疗中出现的不良事件发生率（SB17+SB17组：16.5%，UST+SB17组：13.9%，UST+UST组：23.8%）以及转换后出现抗药抗体的总体发生率在各治疗组间相当（SB17+SB17组：5.6%，UST+SB17组：5.1%，UST+UST组：6.7%）。
结论
从UST转换后，SB17显示出与UST的临床生物相似性，并且在第52周时与UST保持了长期相当的疗效和安全性。
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