Grattan Clive, Dytyatkovska Yevgeniya, Springer Michał, Ratkova Maria, Krusheva Borislava, Krupa-Borek Izabella, Pulka Grazyna, Chełmińska Marta, Reich Adam, Kim Sunghyun, Bae Yunju, Kim Suyoung, Lee Sewon, An Eunjin, Park Jeong Eun, Ka Jieun, Kim Jongho, Saini Sarbjit S
St John's Institute of Dermatology, Guy's Hospital, London, UK.
Clinical Hospital of Emergency Medical Care of Dniprovska City Council, Dnipro, Ukraine.
Clin Transl Allergy. 2025 Jun;15(6):e70069. doi: 10.1002/clt2.70069.
A double-blind, randomized Phase 3 study (NCT04426890) confirmed that CT-P39 and European Union-approved reference omalizumab (ref-OMA) were comparable in terms of efficacy, quality of life (QoL), pharmacokinetics (PK), pharmacodynamics (PD), safety, and immunogenicity up to week 24. Here, we report results from the 16-week follow-up period.
The study included two 12-week treatment periods (TPs) and a 16-week off-treatment follow-up period. In TP1, 619 patients with chronic spontaneous urticaria (CSU) were randomized to CT-P39 300 mg, ref-OMA 300 mg, CT-P39 150 mg, or ref-OMA 150 mg. A total of 579 patients continued into TP2, in which patients treated with ref-OMA 300 mg were rerandomized to CT-P39 300 mg or to continue on ref-OMA 300 mg; patients initially randomized to CT-P39 300 mg continued this regimen; and patients initially randomized to CT-P39 or ref-OMA 150 mg increased their dose to 300 mg. Efficacy, PK, PD, QoL, safety, and immunogenicity were assessed during the follow-up period.
Improvements in efficacy outcomes observed in the TPs gradually decreased during the follow-up period, but did not return to baseline values. Omalizumab serum concentrations that had increased during treatment subsequently decreased during the follow-up period. After completing treatment at week 24, total and free immunoglobulin E levels returned toward baseline levels. No clinically meaningful differences in QoL, safety, or immunogenicity outcomes were observed across the treatment groups.
Follow-up results support the biosimilarity of CT-P39 and ref-OMA in terms of efficacy, PK, PD, QoL, safety, and immunogenicity in patients with CSU.
一项双盲、随机3期研究（NCT04426890）证实，在第24周时，CT-P39与欧盟批准的对照奥马珠单抗（ref-OMA）在疗效、生活质量（QoL）、药代动力学（PK）、药效学（PD）、安全性和免疫原性方面具有可比性。在此，我们报告16周随访期的结果。
该研究包括两个12周的治疗期（TPs）和一个16周的停药随访期。在TP1中，619例慢性自发性荨麻疹（CSU）患者被随机分为CT-P39 300mg组、ref-OMA 300mg组、CT-P39 150mg组或ref-OMA 150mg组。共有579例患者进入TP2，其中接受ref-OMA 300mg治疗的患者被重新随机分为CT-P39 300mg组或继续接受ref-OMA 300mg治疗；最初随机分为CT-P39 300mg组的患者继续该治疗方案；最初随机分为CT-P39或ref-OMA 150mg组的患者将剂量增加至300mg。在随访期评估疗效、PK、PD、QoL、安全性和免疫原性。
在治疗期观察到的疗效结果改善在随访期逐渐下降，但未恢复到基线值。治疗期间升高的奥马珠单抗血清浓度在随访期随后下降。在第24周完成治疗后，总免疫球蛋白E和游离免疫球蛋白E水平恢复至基线水平。各治疗组在QoL、安全性或免疫原性结果方面未观察到具有临床意义的差异。
随访结果支持CT-P39与ref-OMA在CSU患者的疗效、PK、PD、QoL、安全性和免疫原性方面具有生物相似性。
