West Timothy, Katelaris Constance H
Campbelltown Hospital, Campbelltown, Australia.
Western Sydney University, Campbelltown, Australia.
J Allergy Clin Immunol Glob. 2024 Apr 10;3(3):100255. doi: 10.1016/j.jacig.2024.100255. eCollection 2024 Aug.
House dust mite (HDM) allergen immunotherapy (AIT) has an established role in the treatment of perennial allergic rhinitis (AR) and allergic asthma (AA) triggered by HDM sensitization. We aimed to identify all double-blind, randomized, placebo-controlled trials of HDM AIT for the treatment of AR and AA in humans and to summarize the evidence for AIT products that are currently manufactured and available for clinical use. A total of 56 eligible double-blind, randomized, placebo-controlled trials of HDM AIT for the treatment of AA and/or AR in humans fit the inclusion criteria and investigated a total of 14 commercial AIT products; together, the 56 studies enrolled a total of 14,619 patients. Of the 56 studies, 39 studies investigated the current manufacturer-recommended maintenance dose (MRMD) of the product, and 17 investigated other doses. We identified 39 studies (12,539 patients randomized) for 8 sublingual immunotherapy (SLIT) products and 17 studies (2,080 patients randomized) for subcutaneous immunotherapy products. For AR, 3 products, the ALK 12 standardized-quality (SQ-HDM) SLIT tablet, the ALK 6 SQ-HDM tablet, and the SG 300 index of reactivity SLIT tablet, had both dose-finding studies (DFSs) and phase III definitive studies (DSs) to demonstrate efficacy of the MRMD of the product. For AA, 2 products, the ALK 12 SQ-HDM SLIT tablet and the ALK 6 SQ-HDM tablet, had both DFSs and DSs for the MRMD. No subcutaneous immunotherapy product had a paired DFS and DS supporting the MRMD. A total of 30 studies of products no longer commercially manufactured were excluded. This study will help to inform clinical care and product selection for the treatment of HDM-induced AR and AA.
屋尘螨（HDM）变应原免疫疗法（AIT）在治疗由HDM致敏引发的常年性变应性鼻炎（AR）和变应性哮喘（AA）方面具有既定作用。我们旨在识别所有关于HDM AIT治疗人类AR和AA的双盲、随机、安慰剂对照试验，并总结目前生产且可用于临床的AIT产品的证据。共有56项符合纳入标准的关于HDM AIT治疗人类AA和/或AR的双盲、随机、安慰剂对照试验，共研究了14种商业AIT产品；这56项研究共纳入了14,619例患者。在这56项研究中，39项研究调查了产品当前制造商推荐的维持剂量（MRMD），17项研究调查了其他剂量。我们识别出8种舌下免疫疗法（SLIT）产品的39项研究（12,539例患者随机分组）和皮下免疫疗法产品的17项研究（2,080例患者随机分组）。对于AR，3种产品，即ALK 12标准化质量（SQ - HDM）SLIT片剂、ALK 6 SQ - HDM片剂和SG 300反应性指数SLIT片剂，既有剂量探索研究（DFS）又有III期确定性研究（DS）来证明产品MRMD的疗效。对于AA，2种产品，即ALK 12 SQ - HDM SLIT片剂和ALK 6 SQ - HDM片剂，有关于MRMD的DFS和DS。没有皮下免疫疗法产品有支持MRMD的配对DFS和DS。总共排除了30项关于不再商业生产的产品的研究。这项研究将有助于为HDM诱导的AR和AA的临床治疗及产品选择提供参考。
