哮喘联盟

   摘要
   背景：奥马珠单抗，一种重组人源化抗IgE单克隆抗体，被用于治疗不能控制症状的中-重度或重度持续性过敏性哮喘，该药物已被研制为粉末制剂，预充式液体制剂正在研制中。本研究的目的旨在评估预充式液体制剂的免疫原性和安全性。
   方法：这是一项国际、非盲、单臂研究，≥非盲岁的中-重度过敏性哮喘患者接受奥马珠单抗液体制剂(75 或150mg 预充式注射器)每2周或4周一次治疗24周。免疫原性使用人类抗体水平(ATA)进行评估。安全性通过监测不良事件应(AEs)、血液学、生化学、尿液和生命体征来评估。
   结果：共155例患者纳入该项研究。无1例患者被确认为ATA阳性结果。最常见的AEs是哮喘(17.4%)、鼻窦炎(17.4%)和上呼吸道感染(11.6%)。14例（9.0%）出现严重AEs、1例死亡（与治疗无关）。根据诊断标准无1例出现过敏性反应。大多数患者血液学、生化学变量仍在正常范围内。
   结论：预充式注射器中的奥马珠单抗与免疫原性无关。这种新剂型（无需重构）的安全性与粉末制剂一致。该研究的局限在于奥马珠单抗治疗哮喘的疗效在文章中还未明确。
 

（刘国梁 审校）
Curr Med Res Opin.2013 Oct 1. [Epub ahead of print]

 

Immunogenicity and safety of omalizumab in pre-filled syringes in patients with allergic (IgE-mediated) asthma.

Somerville L, Bardelas J, Viegas A, D'Andrea P, Blogg M, Peachey G.
 

Abstract
ABSTRACT BACKGROUND: Omalizumab, a humanised anti-immunoglobulin E monoclonal antibody for treatment of uncontrolled moderate-to-severe or severe persistent allergic asthma, was developed as a lyophilised powder for reconstitution. A liquid formulation in pre-filled syringes has now been developed. The purpose of this study was to assess the immunogenicity and safety of this liquid formulation.
METHODS: In this multinational, open-label, single-arm study, patients (≥12 years) with moderate-to-severe allergic asthma were treated for 24 weeks with the liquid formulation of omalizumab (75 or 150 mg in a pre-filled syringe) at 2 or 4 week intervals. Immunogenicity was assessed by measurement of human anti-therapeutic antibody (ATA) levels. Safety was assessed by monitoring adverse events (AEs), haematology, blood chemistry, urine analysis and vital signs.
RESULTS: A total of 155 patients were enrolled in the study. No patient had a confirmed positive ATA test result. Most frequent individual AEs were asthma (17.4%), sinusitis (17.4%) and upper respiratory tract infection (11.6%). Fourteen patients (9.0%) had serious AEs and there was one death (not treatment related). There were no cases of anaphylaxis according to Sampson criteria. Most patients remained within normal ranges for haematology and biochemistry laboratory variables.
CONCLUSIONS: Omalizumab in pre-filled syringes was not associated with immunogenicity. This novel formulation, which does not require reconstitution, had a safety profile consistent with the lyophilised formulation. A limitation of this study is that efficacy of omalizumab in the treatment of asthma was not specifically addressed herein.
 

Curr Med Res Opin.2013 Oct 1. [Epub ahead of print]