Nolte Hendrik, Bernstein David I, Nelson Harold S, Ellis Anne K, Kleine-Tebbe Jörg, Lu Susan
ALK, Bedminster, NJ.
Division of Immunology, Allergy and Rheumatology, University of Cincinnati College of Medicine, Cincinnati, Ohio.
J Allergy Clin Immunol Pract. 2020 Jul-Aug;8(7):2322-2331.e5. doi: 10.1016/j.jaip.2020.03.041. Epub 2020 Apr 15.
Ragweed sublingual immunotherapy (SLIT) tablet reduces symptoms and symptom-relieving medication use in adults with allergic rhinitis with or without conjunctivitis (AR/C) but has not been evaluated in children.
This international, multicenter, double-blind, placebo-controlled trial evaluated the efficacy and safety of ragweed SLIT-tablet in children with AR/C.
Children (N = 1025; 77.7% polysensitized) aged 5 to 17 years with ragweed pollen-induced AR/C with or without asthma (FEV ≥80% predicted) were randomized 1:1 to daily ragweed SLIT-tablet (12 Amb a 1-Unit) or placebo for up to 28 weeks (NCT02478398). The primary end point was the average total combined score (TCS; sum of rhinoconjunctivitis daily symptom score [DSS] and daily medication score [DMS]) during peak ragweed pollen season (RPS). Key secondary end points were TCS during the entire RPS, and DSS and DMS during the peak RPS.
Relative TCS (95% CI) improvements with ragweed SLIT-tablet versus placebo were -38.3% (-46.0% to -29.7%; least square [LS] mean difference, -2.73; P < .001) during peak RPS and -32.4% (-40.7% to -23.3%; LS mean difference, -1.86; P < .001) during the entire RPS. DSS and DMS during peak RPS improved with SLIT-tablet versus placebo by -35.4% (-43.2% to -26.1%; LS mean difference, -1.40; P < .001) and -47.7% (-59.8% to -32.5%; LS mean difference, -1.84; P < .001), respectively. Asthma DSS, short-acting β-agonist use, and nocturnal awakenings during peak RPS improved with SLIT-tablet versus placebo by -30.7%, -68.1%, and -75.1%, respectively (all nominal P ≤ .02). No events of anaphylaxis, airway compromise, or severe treatment-related systemic allergic reactions were reported.
Ragweed SLIT-tablet significantly improved symptoms and decreased symptom-relieving medication use in children with ragweed pollen-induced AR/C and was well tolerated.
豚草舌下免疫疗法（SLIT）片剂可减轻患有或不患有结膜炎的过敏性鼻炎（AR/C）成人的症状并减少缓解症状药物的使用，但尚未在儿童中进行评估。
这项国际多中心双盲安慰剂对照试验评估了豚草SLIT片剂在AR/C儿童中的疗效和安全性。
年龄在5至17岁、患有豚草花粉诱导的AR/C且伴有或不伴有哮喘（预计第一秒用力呼气容积[FEV]≥80%）的儿童（N = 1025；77.7%为多敏体质）按1:1随机分组，每日服用豚草SLIT片剂（12个Amb a 1单位）或安慰剂，持续长达28周（NCT02478398）。主要终点是豚草花粉高峰期（RPS）期间的平均总综合评分（TCS；鼻结膜炎每日症状评分[DSS]与每日药物评分[DMS]之和）。关键次要终点是整个RPS期间的TCS，以及RPS高峰期的DSS和DMS。
在RPS高峰期，与安慰剂相比，豚草SLIT片剂的相对TCS（95%CI）改善为-38.3%（-46.0%至-29.7%；最小二乘[LS]均值差异为-2.73；P <.001），在整个RPS期间为-32.4%（-40.7%至-23.3%；LS均值差异为-1.86；P <.001）。与安慰剂相比，SLIT片剂在RPS高峰期使DSS和DMS分别改善了-35.4%（-43.2%至-26.1%；LS均值差异为-1.40；P <.001）和-47.7%（-59.8%至-32.5%；LS均值差异为-1.84；P <.001）。与安慰剂相比，SLIT片剂使RPS高峰期的哮喘DSS、短效β受体激动剂使用和夜间觉醒分别改善了-30.7%、-68.1%和-75.1%（所有名义P≤.02）。未报告过敏反应、气道受损或严重的治疗相关全身性过敏反应事件。
豚草SLIT片剂显著改善了豚草花粉诱导的AR/C儿童的症状，并减少了缓解症状药物的使用，且耐受性良好。
