Efficacy and safety of CT-P39, an omalizumab biosimilar, in chronic spontaneous urticaria: 16-week follow-up study

IF 4.6 2区医学 Q2 ALLERGY

Clinical and Translational Allergy Pub Date : 2025-06-02 DOI:10.1002/clt2.70069

Clive Grattan, Yevgeniya Dytyatkovska, Michał Springer, Maria Ratkova, Borislava Krusheva, Izabella Krupa-Borek, Grazyna Pulka, Marta Chełmińska, Adam Reich, Sunghyun Kim, Yunju Bae, Suyoung Kim, Sewon Lee, Eunjin An, Jeong Eun Park, Jieun Ka, Jongho Kim, Sarbjit S. Saini

{"title":"Efficacy and safety of CT-P39, an omalizumab biosimilar, in chronic spontaneous urticaria: 16-week follow-up study","authors":"Clive Grattan, Yevgeniya Dytyatkovska, Michał Springer, Maria Ratkova, Borislava Krusheva, Izabella Krupa-Borek, Grazyna Pulka, Marta Chełmińska, Adam Reich, Sunghyun Kim, Yunju Bae, Suyoung Kim, Sewon Lee, Eunjin An, Jeong Eun Park, Jieun Ka, Jongho Kim, Sarbjit S. Saini","doi":"10.1002/clt2.70069","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>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.</p>\n </section>\n </div>","PeriodicalId":10334,"journal":{"name":"Clinical and Translational Allergy","volume":"15 6","pages":""},"PeriodicalIF":4.6000,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/clt2.70069","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical and Translational Allergy","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/clt2.70069","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ALLERGY","Score":null,"Total":0}

引用次数: 0

Abstract

Background

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.

Methods

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.

Results

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.

Conclusion

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.

查看原文本刊更多论文

CT-P39治疗慢性自发性荨麻疹的疗效和安全性：16周随访研究

一项双盲、随机iii期研究（NCT04426890）证实，CT-P39和欧盟批准的参考药物omalizumab （nf - oma）在功效、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，直至第24周。在这里，我们报告了16周随访期的结果。方法研究包括两个12周的治疗期和一个16周的非治疗随访期。在TP1中，619例慢性自发性荨麻疹（CSU）患者被随机分配到CT-P39 300 mg， ref-OMA 300 mg， CT-P39 150 mg或ref-OMA 150 mg。共有579名患者继续进入TP2，其中接受300 mg ref-OMA治疗的患者被重新随机分配到300 mg CT-P39或继续接受300 mg ref-OMA治疗；最初随机分配到CT-P39 300 mg的患者继续该方案；最初随机分配到CT-P39或ref-OMA 150毫克的患者将剂量增加到300毫克。在随访期间评估疗效、PK、PD、生活质量、安全性和免疫原性。结果在随访期间，TPs的疗效改善逐渐下降，但未恢复到基线值。治疗期间升高的Omalizumab血清浓度随后在随访期间下降。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水平恢复到基线水平。各治疗组在生活质量、安全性或免疫原性结果方面没有观察到有临床意义的差异。结论随访结果支持CT-P39和nf - oma在CSU患者的疗效、PK、PD、QoL、安全性和免疫原性等方面具有生物相似性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Clinical and Translational Allergy Immunology and Microbiology-Immunology

CiteScore

7.50

自引率

4.50%

发文量

117

审稿时长

12 weeks

期刊介绍： Clinical and Translational Allergy, one of several journals in the portfolio of the European Academy of Allergy and Clinical Immunology, provides a platform for the dissemination of allergy research and reviews, as well as EAACI position papers, task force reports and guidelines, amongst an international scientific audience. Clinical and Translational Allergy accepts clinical and translational research in the following areas and other related topics: asthma, rhinitis, rhinosinusitis, drug hypersensitivity, allergic conjunctivitis, allergic skin diseases, atopic eczema, urticaria, angioedema, venom hypersensitivity, anaphylaxis, food allergy, immunotherapy, immune modulators and biologics, animal models of allergic disease, immune mechanisms, or any other topic related to allergic disease.