Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
J Investig Med. 2020 Aug;68(6):1152-1155. doi: 10.1136/jim-2020-001422. Epub 2020 Jul 14.
The US Food and Drug Administration's approval of a peanut oral immunotherapy product in January 2020 is a landmark development in the field of food allergy therapy. While food allergy prevalence has been increasing, this product is the first approved therapy for food allergy. Oral immunotherapy has many similarities to subcutaneous immunotherapy and drug desensitization protocols, but does not lead to sustained unresponsiveness. The studies leading to approval of the Palforzia product demonstrated increase in the amount of peanut protein able to be consumed, with 67% of subjects randomized to the treatment arm able to consume 600 mg of peanut protein in double-blind placebo-controlled food challenge at study exit. However, side effects are an important consideration, and dropout rates in studies of Palforzia ranged from 11% to 21%. Postmarketing surveillance of this product will be critical in assessing its long-term risks and benefits.
2020 年 1 月，美国食品和药物管理局批准了一种花生口服免疫疗法产品，这是食物过敏治疗领域的一个里程碑式的发展。虽然食物过敏的患病率一直在上升，但该产品是第一种获得批准的食物过敏治疗方法。口服免疫疗法与皮下免疫疗法和药物脱敏方案有许多相似之处，但不会导致持续的无反应。导致批准 Palforzia 产品的研究表明，能够食用的花生蛋白量增加，在研究结束时，随机分配到治疗组的 67%的受试者能够在双盲安慰剂对照食物挑战中食用 600mg 的花生蛋白。然而，副作用是一个重要的考虑因素，Palforzia 研究中的辍学率在 11%到 21%之间。该产品的上市后监测对于评估其长期风险和益处至关重要。
