在患有类风湿性关节炎的患者中,从参考利图西马布过渡到生物类似利图西马布 (DRL_RI) 后,比较免疫性和安全性:一项随机,双盲,第三阶段研究
Narendra Maharaj1, Dharma Rao Uppada2, Naveen Reddy2
1Clinical Development - Biologics, Dr. Reddy's Laboratories Ltd., Bachupally, Hyderabad, 500090, India. narendramaharaj@drreddys.com.
Arthritis research & therapy
|December 21, 2024
概括
这项研究发现,将类风湿性关节炎患者从rituximab (RP/RMP) 转换为生物类似的DRL_RI导致了可比的免疫性和安全性. 过渡到DRL_RI证明了与继续使用参考产品相似的安全概况.
科学领域:
- 类风湿病学 类风湿病学
- 免疫学 免疫学 免疫学
- 药理学 药理学是指药理学的学科.
背景情况:
- 风湿性关节炎 (RA) 是一种慢性自身免疫性疾病.
- 利图西马布是一种用于治疗RA的生物疗法.
- 评估生物类似药的疗效和安全性对于患者护理至关重要.
研究的目的:
- 评估DRL_RI (一种拟议的rituximab生物类似药) 在RA患者中的免疫性和安全性.
- 为了比较DRL_RI与参考产品 (RP/RMP) 在从rituximab转换的患者中.
- 在切换RA治疗后评估安全性和免疫性概况.
主要方法:
- 这是一项双盲,随机的第三期研究,涉及140名RA患者.
- 患者转换为DRL_RI (n=70) 或继续使用RP/RMP (n=70).
- 免疫性 (ADA,NAbs) 和安全性在12-26周内进行了评估.
主要成果:
- 在DLR_RI和RP/RMP组中,抗药抗体 (ADA) 的发病率低且可比.
- 中和抗体 (NAbs) 在DRL_RI组中仅在一名患者中检测到.
- 治疗引起的不良事件 (TEAE) 在不同组的频率和严重程度上相似.
结论:
- 过渡到DRL_RI的RA患者表现出与继续RP/RMP相比的可比免疫性.
- DRL_RI的安全概况与参考产品相似,与已知的Rituximab安全性保持一致.
- DRL_RI是 RA 患者的一种安全有效的治疗选择.
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