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
Department of Dermatology, Wake Forest University School of Medicine, Winston Salem, North Carolina.
Dermoklinika Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak, Łódź, Poland.
J Am Acad Dermatol. 2024 Sep;91(3):440-447. doi: 10.1016/j.jaad.2024.04.045. Epub 2024 Apr 27.
Ustekinumab (UST) is a safe and effective treatment for moderate-to-severe psoriasis.
To compare efficacy, safety, pharmacokinetics (PK), and immunogenicity of the proposed UST biosimilar SB17 with reference UST in subjects with moderate-to-severe plaque psoriasis.
In this randomized double-blind study, subjects were randomized to receive 45 mg of SB17 or UST subcutaneously at week 0, 4, and every 12 weeks. The primary endpoint was the percent change from baseline in Psoriasis Area and Severity Index at week 12 with an equivalence margin of [-15%, 15%]. Other secondary efficacy, safety, PK, and immunogenicity endpoints were measured through week 28.
Two hundred forty-nine subjects were randomized to SB17, 254 to UST. Adjusted difference of Psoriasis Area and Severity Index change from baseline at week 12 of -0.6% (95% confidence interval; -3.780, 2.579) was within the equivalence margin. Physician's Global Assessment and Dermatology Life Quality Index were also comparable. Overall treatment-emergent adverse events were comparable (SB17: 48.2%, UST: 48.8%). The overall incidence of antidrug antibodies up to Week 28 was 13.3% with SB17 and 39.4% with UST.
Data were only through week 28.
SB17 was clinically biosimilar to UST up to week 28.
乌司奴单抗（UST）是治疗中度至重度银屑病的一种安全有效的药物。
比较拟用的UST生物类似药SB17与参比UST在中度至重度斑块状银屑病患者中的疗效、安全性、药代动力学（PK）和免疫原性。
在这项随机双盲研究中，受试者在第0周、第4周及每12周随机接受皮下注射45mg的SB17或UST。主要终点是第12周时银屑病面积和严重程度指数相对于基线的变化百分比，等效性界限为[-15%，15%]。其他次要疗效、安全性、PK和免疫原性终点在第28周进行测量。
249名受试者被随机分配至SB17组，254名受试者被随机分配至UST组。第12周时银屑病面积和严重程度指数相对于基线变化的调整差异为-0.6%（95%置信区间：-3.780，2.579），在等效性界限内。医生整体评估和皮肤病生活质量指数也具有可比性。总体治疗中出现的不良事件具有可比性（SB17组：48.2%，UST组：48.8%）。至第28周时，SB17组抗药抗体的总体发生率为13.3%，UST组为39.4%。
数据仅至第28周。
至第28周时，SB17在临床上与UST具有生物相似性。
