Blauvelt Andrew, Papp Kim, Trivedi Mona, Barragan Carolina, Chow Vincent, Mytych Daniel T, Yamauchi Paul, Crowley Jeff, Franklin Janet
Oregon Medical Research Center, Portland, OR, USA.
Alliance Clinical Trials Probity Medical Research, Waterloo, ON, Canada.
Br J Dermatol. 2025 Apr 28;192(5):826-836. doi: 10.1093/bjd/ljae402.
ABP 654 is a biosimilar to ustekinumab reference product (RP). ABP 654 has been shown to have an amino acid sequence identical to ustekinumab RP and they are similar in structure, purity and potency, as well as clinical pharmacokinetics and safety in healthy volunteers.
To compare the efficacy, safety and immunogenicity of ABP 654 and ustekinumab RP in patients with moderate-to-severe plaque psoriasis in a randomized double-blinded active-controlled single-transition comparative clinical study (NCT04607980).
Patients were randomized 1 : 1 to receive ABP 654 or ustekinumab RP at a weight-based dose of 45 mg or 90 mg administered subcutaneously on day 1 (week 0), week 4 and week 16. At week 28, patients with a ≥ 75% improvement in Psoriasis Area and Severity Index (PASI) were re-randomized such that those initially randomized to ABP 654 continued to receive ABP 654 and those initially randomized to ustekinumab RP were re-randomized to either continue on ustekinumab RP or transition to ABP 654. The primary efficacy endpoint was percentage improvement in PASI from baseline to week 12. Secondary endpoints included additional efficacy measurements, as well as an assessment of adverse events and antidrug antibodies.
At week 12, the observed mean (SD) percentage improvement in PASI from baseline was 81.9 (19.9) and 81.9 (19.6) for the ABP 654 and ustekinumab RP treatment groups, respectively. The point estimate of the mean difference in percentage PASI improvement from baseline to week 12 between the treatment groups was 0.14 with a two-sided 90% confidence interval (CI) of (-2.6 to 2.9), well within the prespecified similarity margin of (-10 to 10). In addition, throughout the study, secondary efficacy analyses and safety and immunogenicity profiles were similar across the treatment groups.
These results indicate that ABP 654 and ustekinumab RP are clinically similar in efficacy, safety and immunogenicity in patients with moderate-to-severe plaque psoriasis. Further, a single transition from ustekinumab RP to ABP 654 at week 28 had no impact on the efficacy, safety or immunogenicity results for the remainder of the 52-week study, supporting a conclusion of no clinically meaningful differences between ABP 654 and ustekinumab RP.
ABP 654是优特克单抗参比产品（RP）的生物类似药。已证明ABP 654的氨基酸序列与优特克单抗RP相同，且在结构、纯度和效价以及健康志愿者的临床药代动力学和安全性方面相似。
在一项随机双盲活性对照单转换比较临床研究（NCT04607980）中，比较ABP 654和优特克单抗RP在中度至重度斑块状银屑病患者中的疗效、安全性和免疫原性。
患者按1:1随机分组，在第1天（第0周）、第4周和第16周接受基于体重的45 mg或90 mg皮下注射ABP 654或优特克单抗RP。在第28周时，银屑病面积和严重程度指数（PASI）改善≥75%的患者重新随机分组，使得最初随机分配至ABP 654组的患者继续接受ABP 654治疗，而最初随机分配至优特克单抗RP组的患者重新随机分组，继续接受优特克单抗RP治疗或转换为ABP 654治疗。主要疗效终点为从基线至第12周PASI的改善百分比。次要终点包括额外的疗效测量，以及不良事件和抗药抗体的评估。
在第12周时，ABP 654和优特克单抗RP治疗组从基线观察到的PASI平均（标准差）改善百分比分别为81.9（19.9）和81.9（19.6）。治疗组之间从基线至第12周PASI改善百分比的平均差异的点估计值为0.14，双侧90%置信区间（CI）为（-2.6至2.9），完全在预先设定的相似性界限（-10至10）内。此外，在整个研究过程中，各治疗组的次要疗效分析以及安全性和免疫原性概况相似。
这些结果表明，ABP 654和优特克单抗RP在中度至重度斑块状银屑病患者中的疗效、安全性和免疫原性在临床上相似。此外，在第28周从优特克单抗RP单次转换为ABP 654对52周研究剩余时间的疗效、安全性或免疫原性结果没有影响，支持ABP 654和优特克单抗RP之间无临床意义差异的结论。
