POISED (Peanut Oral Immunotherapy: Safety, Efficacy, and Discovery)

Phase 2 POISED (Peanut Oral Immunotherapy: Safety, Efficacy, Discovery) Study In this randomized, double-blind, placebo-controlled (DBPC) clinical trial, blinded placebo group received oat flour, whereas in active participants, dosage was built-up for over ~ 52 weeks and subsequently maintained on 4000 mg peanut protein, daily for next 52 weeks. 80 (98.77%) per-protocol active participants passed the food challenge at week 104. Subsequently, for 12 weeks, peanut ingestion was avoided in a randomized group of 51 blinded active participants (i.e., peanut avoidance group). 21 (41.2%) participants in the peanut avoidance group passed the 4000 mg double-blind, placebo-controlled food challenge (DBPCFC) without any allergic reaction at week 117, thus demonstrating sustained unresponsiveness. These 21 participants continued oral immunotherapy (OIT) for every three months and afterwards were allowed to continue peanut OIT discontinuation if they passed. 8 participants passed the DBPCFCs, 12 months after peanut discontinuation (week 156), i.e. they achieved long-term sustained unresponsiveness with no allergic reaction in response to food challenge. For detailed description, please refer to Chinthrajah et al., PMID: 31522849.]]>
Peanut-allergic adults and pediatric participants aged 7–55 years were screened. The inclusion criteria was a positive double-blind placebo-controlled food challenge (DBPCFC) with ≤500 mg of peanut protein, peanut-specific IgE of >4 kU/L and a positive skin prick test (SPT) result with ≥5 mm wheal diameter above the negative control. Exclusion criteria included a history of eosinophilic gastrointestinal disease, severe or uncontrolled asthma, and a history of sensitivity to oats. Participants recruited for screening were from referrals to our Sean N. Parker Center and our registry.]]>

Ⅱ期POISED（花生口服免疫治疗：安全性、有效性、探索性，Peanut Oral Immunotherapy: Safety, Efficacy, Discovery）研究。本项随机双盲安慰剂对照（double-blind, placebo-controlled, DBPC）临床试验中，设盲的安慰剂组受试者接受燕麦粉干预；活性治疗组受试者的给药剂量在约52周内逐步递增，后续维持每日4000mg花生蛋白剂量，持续52周。第104周时，80名符合方案集的活性治疗组受试者（占比98.77%）通过了食物激发试验。随后，将51名设盲的活性治疗组受试者随机分为花生回避组，暂停花生摄入12周。第117周时，花生回避组中有21名受试者（占比41.2%）通过了4000mg剂量的双盲安慰剂对照食物激发试验（double-blind, placebo-controlled food challenge, DBPCFC），未出现任何过敏反应，证实了持续无应答状态。该21名受试者每3个月继续接受口服免疫治疗（oral immunotherapy, OIT），若后续通过激发试验，则可停止花生口服免疫治疗。在停止花生摄入12个月后（第156周），有8名受试者通过了DBPCFC，即实现了长期持续无应答，食物激发时无过敏反应。详细研究描述请参考Chinthrajah等人发表的研究，PMID:31522849。
本研究招募7~55岁的花生过敏成人及儿童受试者进行筛查。纳入标准为：≤500mg花生蛋白剂量的双盲安慰剂对照食物激发试验（DBPCFC）结果阳性、花生特异性IgE＞4kU/L、皮肤点刺试验（skin prick test, SPT）结果阳性且风团直径较阴性对照≥5mm。排除标准包括嗜酸性粒细胞性胃肠道疾病病史、重度或未控制的哮喘，以及燕麦过敏史。参与筛查的受试者均来自Sean N. Parker中心的转诊病例及本中心登记库。