Pariser David M, Lebwohl Mark G, Jaworski Janusz, Trefler Jakub, Daniluk Stefan, Dudek Anna, Baran Wojciech, Owczarek Witold, Brzewski Pawel, Sikora Mariusz, Krogulec Marek, Kim SungHyun, Suh JeeHye, Choi EunJin, Cha JungBin, Lee HyunJin, Lee SungJeong, Koo John Y
Eastern Virginia Medical School and Virginia Clinical Research, Inc., Norfolk, VA, USA.
Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Dermatol Ther (Heidelb). 2025 May;15(5):1079-1092. doi: 10.1007/s13555-025-01383-5. Epub 2025 Mar 27.
A 27-week analysis of this phase 3 study demonstrated the interchangeability of the adalimumab biosimilar CT-P17 and reference adalimumab. The current 52-week analysis reports secondary data from the open-label extension period (OLE) of the study.
In this randomized, double-blind, active-controlled phase 3 study, adults with moderate-to-severe chronic plaque psoriasis received (via prefilled syringe) 80 mg subcutaneous reference adalimumab on day 1, then 40 mg 1 week later, and every other week (EOW) until week 11. At week 13, patients were randomized (1:1) to continue reference adalimumab ("continuous" group) or undergo repeated switching between CT-P17 and reference adalimumab ("switching" group) until week 25. Thereafter, patients entered an OLE and received 40 mg CT-P17 EOW from week 27 to 49, with an end-of-study visit at week 52. Here we present findings from the OLE. Pharmacokinetics (PK), efficacy (including mean percent improvement from baseline in Psoriasis Area Severity Index [PASI] score), safety, and immunogenicity were evaluated. Post hoc subgroup analyses were also conducted.
Of 327 patients who initiated the OLE, 152 and 160 patients from the switching group and continuous group, respectively, completed the study. Mean serum concentrations were similar between groups throughout the OLE. Efficacy improvements observed up to week 27 were maintained during the OLE and were comparable between groups. At week 52, overall mean (standard deviation [SD]) improvement from baseline in PASI score was 90.34% (16.59). Safety profiles were similar between groups, and immunogenicity did not increase during the OLE. The mean (SD) percent improvement from baseline in PASI score was slightly lower in patients who were antidrug antibody (ADA)-positive versus those who were ADA-negative (89.57 [17.27] versus 97.29 [4.08]) at week 52.
PK, efficacy, safety, and immunogenicity findings remained consistent throughout the OLE, regardless of prior treatment, and were generally comparable across timepoints.
ClinicalTrials.gov: NCT05495568.
这项3期研究的27周分析证明了阿达木单抗生物类似药CT-P17与参比阿达木单抗的可互换性。当前的52周分析报告了该研究开放标签延长期（OLE）的二级数据。
在这项随机、双盲、活性对照3期研究中，中度至重度慢性斑块状银屑病成人患者在第1天接受（通过预填充注射器）80mg皮下参比阿达木单抗，1周后接受40mg，之后每隔一周（EOW）给药一次，直至第11周。在第13周，患者被随机分组（1:1），继续接受参比阿达木单抗治疗（“持续”组）或在CT-P17与参比阿达木单抗之间反复切换治疗（“切换”组），直至第25周。此后，患者进入OLE期，从第27周至第49周接受40mg CT-P17 EOW给药，并在第52周进行研究结束访视。在此我们展示OLE期的研究结果。评估了药代动力学（PK）、疗效（包括银屑病面积和严重程度指数[PASI]评分相对于基线的平均改善百分比）、安全性和免疫原性。还进行了事后亚组分析。
在327名开始OLE期治疗的患者中，分别有152名和160名来自切换组和持续组的患者完成了研究。在整个OLE期，两组的平均血清浓度相似。在OLE期维持了直至第27周观察到的疗效改善，且两组相当。在第52周，PASI评分相对于基线的总体平均（标准差[SD]）改善为90.34%（16.59）。两组的安全性概况相似，且在OLE期免疫原性未增加。在第52周，抗药抗体（ADA）阳性患者相对于ADA阴性患者，PASI评分相对于基线的平均（SD）改善百分比略低（89.57 [17.27] 对 97.29 [4.08]）。
无论先前治疗情况如何，在整个OLE期，PK、疗效、安全性和免疫原性结果均保持一致，且在各时间点总体上具有可比性。
ClinicalTrials.gov：NCT05495568。
