Bernstein Clinical Research Center and Department of Medicine and Environmental Health, University of Cincinnati, Cincinnati, Ohio.
Allergy & Asthma Center Westend, Berlin, Germany.
Ann Allergy Asthma Immunol. 2018 Jul;121(1):105-110. doi: 10.1016/j.anai.2018.04.007. Epub 2018 Apr 12.
Allergic rhinitis with or without conjunctivitis (AR/C) is common, necessitating evaluation of SQ house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet efficacy in various subgroups.
To evaluate 12 SQ-HDM efficacy and safety across subgroups, and the onset, duration, and recurrence of local application site reactions.
Subgroup (age, sex, race, asthma status, and allergen sensitization) efficacy was assessed using pooled data from 2 previously described trials of daily 12 SQ-HDM vs placebo for AR/C (n = 2,138). Efficacy was measured by average total combined rhinitis score (TCRS; rhinitis daily symptom plus medication score) during the last 8 weeks of treatment. Safety in subgroups and local application site reaction onset, duration, and recurrence were evaluated using pooled data from 5 previously described trials of SQ HDM SLIT-tablet (n = 2,923).
Significant (based on 95% confidence intervals [CIs]) reduction in TCRS was seen with 12 SQ-HDM relative to placebo across all subgroups, with TCRS improvements ranging from 15% to 25%. The AE profile was generally similar within subgroups. Approximately 95% of local application site reactions were mild to moderate in severity. Median duration on day 1 of treatment for the most common local application site reactions (throat irritation, oral pruritus, ear pruritus, and lip swelling) ranged from 30 to 60 minutes; median first day of onset ranged from days 1 to 4 of treatment; median days that reactions recurred ranged from 3 to 12 days.
Treatment with 12 SQ-HDM consistently improved symptoms and was well tolerated in relevant subgroups of subjects with HDM AR/C. Local application site reactions to 12 SQ-HDM were typically mild to moderate and transient.
过敏性鼻炎伴或不伴结膜炎（AR/C）很常见，需要评估皮下注射屋尘螨（HDM）舌下免疫疗法（SLIT）片在各种亚组中的疗效。
评估 12 皮下注射 HDM 在各个亚组中的疗效和安全性，以及局部应用部位反应的发生、持续时间和复发。
使用之前两项每日 12 皮下注射 HDM 与安慰剂治疗 AR/C 的研究的汇总数据（n=2138）评估亚组（年龄、性别、种族、哮喘状态和过敏原致敏）的疗效。通过治疗最后 8 周期间平均总联合鼻炎评分（TCRS；鼻炎每日症状加药物评分）来衡量疗效。使用之前五项皮下注射 HDM SLIT 片的研究的汇总数据（n=2923）评估亚组安全性和局部应用部位反应的发生、持续时间和复发。
与安慰剂相比，12 皮下注射 HDM 在所有亚组中均显著（基于 95%置信区间[CI]）降低 TCRS，TCRS 改善幅度为 15%至 25%。亚组内的 AE 谱总体相似。大约 95%的局部应用部位反应的严重程度为轻度至中度。最常见的局部应用部位反应（咽喉刺激、口腔瘙痒、耳部瘙痒和嘴唇肿胀）在治疗第 1 天的中位持续时间为 30 至 60 分钟；中位第 1 天发病时间为治疗第 1 至 4 天；中位复发天数为 3 至 12 天。
在 HDM-AR/C 患者的相关亚组中，使用 12 皮下注射 HDM 治疗可一致改善症状，且耐受性良好。12 皮下注射 HDM 的局部应用部位反应通常为轻度至中度且短暂。
