Section of Allergy and Clinical Immunology, Royal Brompton Hospital, Imperial College, NHLI, London, UK.
Ther Clin Risk Manag. 2008 Dec;4(6):1255-60. doi: 10.2147/tcrm.s3544.
Immunotherapy is the only treatment for allergy that has the potential to alter the natural course of the disease. Sublingual immunotherapy (SLIT) for grass pollen-induced rhino-conjunctivitis has been developed to make immunotherapy available to a broader group of allergic patients. In the largest clinical programme ever conducted with allergen-specific immunotherapy, over 1,700 adults and 260 children have been exposed to Grazax(®). Grazax is formulated as an oral lyophilisate (tablet) for sublingual administration, containing 75,000 SQ-T standardized allergen extract of grass pollen from Phleum pratense. Grazax is indicated for treatment of grass pollen-induced rhinitis and conjunctivitis in adult patients with clinically relevant symptoms and diagnosed with a positive skin prick test and/or specific IgE test to grass pollen. In phase I trials doses from 2,500 to 1,000,000 SQ-T were tested. All doses were well tolerated and 75,000 SQ-T, with approximately 15 mug major allergen protein, was chosen as the optimal dose. Three phase III trials are ongoing, one being a long-term trial. Results from GT-08 trial first and second treatment years showed a reduction of 30% and 36%, respectively, in daily rhino-conjunctivitis symptom scores and a reduction of 38% and 46% of daily rhino-conjunctivitis medication scores compared with placebo over the entire grass pollen season. Subjects treated with Grazax also had an increased number of well days and improved quality of life, and more subjects experienced excellent rhino-conjunctivitis control. The most common adverse events related to Grazax are local reactions, such as pruritus, edema mouth, ear pruritus, throat irritation, and sneezing. We conclude that Grazax is efficacious and safe for treatment of rhino-conjunctivitis due to grass pollen allergy.
免疫疗法是唯一有可能改变疾病自然进程的过敏治疗方法。舌下免疫疗法（SLIT）用于治疗草花粉引起的鼻结膜炎，旨在为更广泛的过敏患者提供免疫疗法。在有史以来最大的过敏原特异性免疫治疗临床项目中，已有超过 1700 名成年患者和 260 名儿童接受了 Grazax（®）治疗。Grazax 被制成舌下给药的口服冻干制剂（片剂），包含来自普通豚草花粉的 75000 SQ-T 标准化过敏原提取物。Grazax 用于治疗成年患者因草花粉引起的花粉症相关症状的鼻炎和结膜炎，这些患者经皮试和/或特异性 IgE 试验诊断为阳性。在 I 期临床试验中，测试了 2500 到 100 万 SQ-T 的剂量。所有剂量均耐受良好，选择 75000 SQ-T（约 15 微克主要过敏原蛋白）作为最佳剂量。目前正在进行三项 III 期临床试验，其中一项是长期试验。GT-08 试验第一年和第二年的结果显示，与安慰剂相比，每日鼻结膜炎症状评分分别降低了 30%和 36%，每日鼻结膜炎用药评分分别降低了 38%和 46%。与安慰剂相比，接受 Grazax 治疗的患者也有更多的缓解日和改善的生活质量，更多的患者实现了良好的鼻结膜炎控制。与 Grazax 相关的最常见不良事件是局部反应，如瘙痒、口腔肿胀、耳痒、咽喉刺激和打喷嚏。我们得出结论， Grazax 治疗草花粉过敏引起的鼻结膜炎有效且安全。
