Unità Operativa di Allergologia Ospedale Civile Maggiore di Verona, Verona, 37100, Italy.
Expert Rev Clin Immunol. 2011 Jan;7(1):21-7. doi: 10.1586/eci.10.89.
Immunotherapy is the only treatment for allergy that alters the natural course of this disease. Sublingual immunotherapy has been developed to make immunotherapy more suitable for allergic patients. In the largest clinical program ever conducted with grass allergen-specific immunotherapy, over 2000 adults and more than 500 children have been exposed to Grazax(®) (ALK-Abello A/S, Hoersholm, Denmark). Grazax is an oral lyophilisate tablet (allergy immunotherapy tablet [AIT]) for sublingual administration, containing 75,000 standardized quality tablet units of allergen extract of grass pollen (Phleum pratense). Grazax is indicated for treatment of grass pollen-induced rhinitis and conjunctivitis in adult and pediatric patients. Results from the GT-08 trial (first, second and third treatment years) showed a reduction of 31, 36 and 29%, respectively, in symptom scores and a reduction of 38, 45 and 40% of medication scores, respectively, compared with placebo. Subjects treated with Grazax also had an increased number of well days and a relevant improvement in quality of life. More subjects experienced excellent and complete rhinoconjunctivitis control in comparison with patients treated with symptomatic medications only. Grazax treatment is also associated with a sustained and relevant increase of specific IgG4. This increase is also observed after stopping AIT treatment. The most common adverse events related to Grazax treatment are local reactions, such as oral itch, edema of the mouth, ear pruritus, throat irritation and sneezing. Clinical efficacy of Grazax is observed also after 1 and 2 years of follow-up after stopping the AIT treatment. Grazax is efficacious and safe for treatment of grass-pollen rhinoconjunctivitis in both adults and children. Grazax is the first AIT showing a disease-modifying effect on grass pollen-induced allergic rhinoconjuctivitis.
免疫疗法是改变这种疾病自然进程的唯一过敏治疗方法。舌下免疫疗法的发展使免疫疗法更适合过敏患者。在有史以来最大的针对草过敏原特异性免疫疗法的临床项目中，2000 多名成年人和 500 多名儿童接受了 Grazax®（ALK-Abello A/S，霍斯霍尔姆，丹麦）治疗。Grazax 是一种用于舌下给药的口服冻干片剂（过敏免疫治疗片剂[AIT]），含有 75000 个标准化质量的草花粉过敏原提取物片剂单位（Phleum pratense）。Grazax 适用于治疗成人和儿科患者的草花粉引起的鼻炎和结膜炎。GT-08 试验（第一年、第二年和第三年治疗）的结果显示，与安慰剂相比，症状评分分别降低了 31%、36%和 29%，药物评分分别降低了 38%、45%和 40%。与接受 Grazax 治疗的患者相比，接受 Grazax 治疗的患者也有更多的无症状日和生活质量的显著改善。与仅接受对症药物治疗的患者相比，更多的患者实现了极好和完全的鼻结膜炎控制。Grazax 治疗还与特异性 IgG4 的持续显著增加相关。这种增加也在停止 AIT 治疗后观察到。与 Grazax 治疗相关的最常见不良事件是局部反应，如口腔瘙痒、口腔肿胀、耳痒、咽喉刺激和打喷嚏。停止 AIT 治疗后 1 年和 2 年的随访中也观察到 Grazax 的临床疗效。Grazax 对成人和儿童的草花粉性鼻炎结膜炎均有效且安全。Grazax 是首个显示对草花粉引起的变应性鼻结膜炎具有疾病修饰作用的 AIT。
