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Aimmune Therapeutics to Present New Data at ACAAI on the Real-World Burden of Peanut Allergy and Early Physician Experience with PALFORZIA® in Clinical Practice in the U.S.

Aimmune Therapeutics to Present New Data at ACAAI on the Real-World Burden of Peanut Allergy and Early Physician Experience with PALFORZIA® in Clinical Practice in the U.S.

美国免疫治疗公司将在ACAAI上展示有关花生过敏的真实负担以及美国临床实践中使用PALFORZIA®的早期医生经验的新数据。
Businesswire ·  2021/11/05 20:40

— The Peanut Allergy Burden Study (PABS), demonstrates the need for joint patient-physician decision making to improve peanut allergy management —

-花生过敏负担研究(Pabs)表明,需要患者-医生共同决策,以改善花生过敏管理-

— Physician surveys indicate PALFORZIA was readily implemented in clinical practice and highlight real-world experience that may help facilitate adoption in the U.S. —

-医生调查表明,PALFORZIA很容易在临床实践中实施,并突出了可能有助于促进在美国采用的现实世界经验。

BRISBANE, Calif.--(BUSINESS WIRE)--Aimmune Therapeutics, Inc., a Nestlé Health Science company developing and commercializing pharmaceutical therapies to prevent, manage, and treat food and metabolic-related diseases, today announced it will present new data on the burden of peanut allergy (PA) on patients' and caregivers' Quality of Life. In addition, the company will share results from physician surveys on real-world experiences with PALFORZIA® [Peanut (Arachis hypogaea) Allergen Powder-dnfp] that explore treatment adoption in clinical practice in the U.S. The data will be presented at the American College of Asthma, Allergy, and Immunology (ACAAI) Annual Scientific Meeting on November 4-8, 2021, in New Orleans.

加利福尼亚州布里斯班--(美国商业资讯)--雀巢健康科学公司(NestléHealth Science)开发和商业化药物疗法,以预防、管理和治疗与食品和代谢相关的疾病亚洲网加利福尼亚州布里斯班11月17日电AImmune治疗公司今天宣布,它将提供有关花生过敏(PA)对患者和照顾者生活质量负担的新数据。此外,该公司还将与PALFORZIA分享医生对PALFORZIA的真实体验的调查结果®[花生(花生过敏原粉剂-dnfp]这些数据将于2021年11月4日至8日在新奥尔良举行的美国哮喘、过敏和免疫学会(ACAAI)年度科学会议上公布。


PALFORZIA (previously known as AR101) was approved by the U.S. Food and Drug Administration (FDA) in January 2020 as an oral immunotherapy (OIT) for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut in patients aged 4 through 17 years with a confirmed diagnosis of peanut allergy. In December 2020, the European Commission (EC) approved PALFORZIA for patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy in conjunction with a peanut-avoidant diet. PALFORZIA must be used in conjunction with a peanut-avoidant diet and is not indicated for the emergency treatment of allergic reactions, including anaphylaxis.

PALFORZIA(以前称为AR101)于2020年1月被美国食品和药物管理局(FDA)批准为口服免疫疗法(OIT),用于缓解4至17岁确诊为花生过敏的患者因意外接触花生而可能发生的过敏反应(包括过敏反应)。2020年12月,欧盟委员会(EC)批准PALFORZIA用于4至17岁被确诊为花生过敏的患者,同时配合避免花生的饮食。PALFORZIA必须与避免食用花生的饮食一起使用,不适用于包括过敏反应在内的过敏反应的紧急治疗。

"As we continue to dedicate our research to uncovering the ongoing burden of peanut allergy on children and their families, one factor that consistently rises to the top is the importance of joint decision making to optimize peanut allergy management and help those impacted by this condition," said Mohamed Yassine, MD, SVP Global Medical Affairs at Aimmune. "PALFORZIA offers an important option for many families living with peanut allergy and based on early data from real-world experience with the treatment, we are pleased to see that many allergists are already treating their patients with PALFORZIA."

美国免疫协会全球医疗事务高级副总裁穆罕默德·亚辛(Mohamed Yassine)说:“当我们继续致力于揭示花生过敏对儿童及其家庭持续造成的负担时,一个一直被放在首位的因素是联合决策的重要性,以优化花生过敏管理,帮助那些受这种疾病影响的人。”PALFORZIA为许多对花生过敏的家庭提供了一个重要的选择,根据来自现实世界治疗经验的早期数据,我们很高兴地看到,许多过敏症专科医生已经在用PALFORZIA治疗他们的患者。“

The Peanut Allergy Burden Study (PABS), sponsored by Aimmune Therapeutics Inc., demonstrates the need for and impact of joint decision making in improving health-related Quality of Life (HRQoL) of both patients and caregivers managing PA. Additional data presented at the meeting demonstrate that PALFORZIA can be readily implemented in clinical settings for the treatment of PA and suggest that information-sharing between physicians is useful to help facilitate treatment adoption. Additionally, results show that PALFORZIA treatment was successfully incorporated in practice by health care providers without prior OIT experience.

由AImmune治疗公司赞助的花生过敏负担研究(PABS)证明了联合决策在改善患者和管理PA的照顾者与健康相关的生活质量(HRQoL)方面的必要性和影响。会议上提交的其他数据表明,PALFORZIA可以很容易地在治疗PA的临床环境中实施,并表明医生之间的信息共享有助于促进治疗的采用。此外,结果表明,PALFORZIA治疗在没有OIT经验的情况下,被卫生保健提供者成功地纳入到实践中。

"As an allergist who regularly sees a number of patients living with the daily burden of peanut allergy, I have been excited about the opportunity to offer a treatment option to my appropriate patients and also educate other allergists," said Jay Portnoy, MD, Children's Mercy, Kansas. "When adopting novel therapies, it's important to share experiences and tips with other physicians that will help them learn how to incorporate these treatments into their own practices."

堪萨斯州儿童慈善医学博士杰伊·波特诺伊说:“作为一名过敏症专科医生,我经常看到许多患者每天都承受着花生过敏的负担,我很高兴有机会为我合适的患者提供治疗选择,同时也教育其他过敏症专科医生,”杰伊·波特诺伊(Jay Portnoy)是堪萨斯州儿童慈善会(Children‘s Mercy)的医学博士。在采用新疗法时,重要的是与其他医生分享经验和提示,这将帮助他们学习如何将这些治疗方法融入自己的实践中。“

The complete list of Aimmune poster presentations at ACAAI is as follows:

ACAAI的AImmune海报演示文稿完整名单如下:

  • W. McCann, MD. "Factors Associated with Health-Related Quality of Life in Adolescents with Peanut Allergy: A Multivariate Analysis." Poster #P106; Friday, Nov. 5, 4:30 p.m. CT; Exhibit Hall B, Monitor 11
    • The Peanut Allergy Burden Study (PABS) assessed the real-world burden of peanut allergy, specifically the factors associated with HRQoL in adolescents with peanut allergy.
      • 102 adolescents aged 13 to 17 years with self-reported, provider-diagnosed PA participated in the online survey, which collected socio-demographic, medical, treatment history and Pediatric Quality of Life Inventory (PedsQL) data and identified potential predictors of PedsQL scores using univariate and multivariate statistics.
      • Results from the survey showed that while some patient characteristics are associated with poor PedsQL scores, the substantial heterogeneity in patient experience indicates the need for shared decision making for PA management to improve HRQoL.
  • W.McCann,医学博士。“花生过敏青少年健康相关生活质量相关因素的多因素分析“海报#P106;美国中部时间11月5日星期五下午4:30;B展厅,11号监视器
    • 花生过敏负担研究(PABS)评估了现实世界中花生过敏的负担,特别是与花生过敏青少年的HRQL相关的因素。
      • 102名13至17岁的青少年自报,提供者诊断为PA,参与了这项在线调查,收集了社会人口统计、医疗、治疗史和儿科生活质量问卷(PedsQL)的数据,并使用单变量和多变量统计方法确定了PedsQL得分的潜在预测因素。
      • 调查结果显示,虽然某些患者的特征与较差的PedsQL评分有关,但患者经历的实质性异质性表明,PA管理需要共同决策,以改善HRQL。
  • S. Mustafa, MD. "Oral Immunotherapy Implementation for Peanut Allergy in Clinical Practice in the United States: Ten Tips." Poster #P112; Saturday, Nov. 6, 11:35 a.m. CT; Exhibit Hall B, Monitor 11
    • Results from a survey of six experienced PALFORZIA prescribers were also presented and offer guidance from real-world experience to facilitate delivery of the treatment in practice.
      • Physicians participating in interviews and an advisory panel shared key tips for implementation, including preparing facilities, clinicians, and staff to access, administer, and monitor PALFORZIA treatment, supporting shared decision-making, anticipating AEs, and maintaining flexibility with dosing/treatment consistent with the labeled dosing regimen.
  • 马里兰州S·穆斯塔法“美国临床实践中花生过敏口服免疫疗法的实施:十个小贴士”。“海报#P112;美国夏令时11月6日星期六上午11:35;B展厅,11号监视器
    • 对6名经验丰富的PALFORZIA处方者的调查结果也被提出,并从现实世界的经验中提供指导,以促进治疗在实践中的实施。
      • 参与访谈和咨询小组的医生分享了实施的关键提示,包括准备设施、临床医生和工作人员以访问、管理和监测PALFORZIA治疗,支持共同决策,预测不良反应,以及保持剂量/治疗的灵活性,与标签剂量方案保持一致。
  • J. Portnoy, MD. "Physician Experience with Prescribing Peanut (Arachis hypogaea) Allergen Powder-dnfp in Pediatric Patients with Peanut Allergy." Poster #P114; Saturday, Nov. 6, 12:05 p.m. CT; Exhibit Hall B, Monitor 11
    • A survey of 48 physicians assessed real-world experience in prescribing and adapting practices to deliver PALFORZIA, showing that the treatment was integrated into practice without difficulty by most physicians surveyed.
      • Results of the survey identified the percent of physicians that were somewhat/extremely likely to prescribe PTAH, including patients with multiple food allergies.
      • Responses indicated that most physicians were more likely to prescribe PTAH for patients with a recent PA reaction (≤12 months).
      • Survey results detailed physician experience prescribing PTAH, identifying the percent of physicians that found prescribing PTAH easy/very easy, moderate, or difficult/very difficult, both overall and at different phases of treatment.
  • 马里兰州J·波特诺伊“花生变应原粉剂治疗小儿花生过敏症的内科经验“海报#p114;美国中部时间11月6日星期六下午12点05分;B展厅,11号监视器
    • 一项对48名医生的调查评估了开处方和调整实践以提供PALFORZIA的真实经验,显示大多数接受调查的医生将这种治疗整合到实践中没有困难。
      • 调查结果确定了在某种程度上/极有可能开Ptah处方的医生的百分比,包括患有多种食物过敏的患者。
      • 回答表明,大多数医生更有可能给最近出现PA反应的患者开PTAH(≤,12个月)。
      • 调查结果详细说明了医生开Ptah的经验,确定了在整个治疗阶段和不同治疗阶段,发现开Ptah容易/非常容易、中等或困难/非常困难的医生的百分比。
  • A. Anagnostou, MD. "Real-World Perspectives of Health Care Providers Delivering the First FDA Approved Treatment for Peanut Allergy." Poster #P117; Sunday, Nov. 7, 11:35 a.m. CT; Exhibit Hall B, Monitor 11
    • In interviews with eight allergists and three nurse practitioners around their experiences delivering PALFORZIA, four key themes were explored, including factors influencing adoption, factors related to delivering treatment in everyday practice, learnings and reflections, and delivering PALFORZIA during the COVID-19 pandemic.
      • Responses showed that prior OIT experience was not essential for implementation of PALFORZIA in practice.
      • Learning from others' experiences was suggested to help overcome perceived and actual barriers to implementation.
  • 马里兰州阿纳诺斯图“医疗保健提供者提供FDA批准的第一种花生过敏治疗的真实世界视角。“海报#P117;美国中部时间11月7日星期日上午11:35;B展厅,11号监视器
    • 通过对8名过敏症专科医生和3名护士从业人员的采访,围绕他们提供PALFORZIA的经历,探讨了四个关键主题,包括影响采用的因素、在日常实践中提供治疗的相关因素、学习和反思以及在新冠肺炎大流行期间提供PALFORZIA。
      • 答复表明,在实践中实施PALFORZIA并不需要OIT以前的经验。
      • 有人建议借鉴他人的经验,以帮助克服执行方面的感知和实际障碍。

INDICATION

指示

PALFORZIA is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. PALFORZIA is approved for use in patients with a confirmed diagnosis of peanut allergy. Initial Dose Escalation may be administered to patients aged 4 through 17 years. Up-Dosing and Maintenance may be continued in patients 4 years of age and older.

PALFORZIA是一种口服免疫疗法,用于减轻意外接触花生可能发生的过敏反应,包括过敏反应。PALFORZIA被批准用于确诊为花生过敏的患者。初始剂量递增可能适用于4至17岁的患者。对于4岁及以上的患者,可以继续增加剂量和维持剂量。

PALFORZIA is to be used in conjunction with a peanut-avoidant diet.

PALFORZIA将与避免食用花生的饮食配合使用。

Limitations of Use: Not indicated for the emergency treatment of allergic reactions, including anaphylaxis.

使用限制:不适用于包括过敏反应在内的过敏反应的紧急治疗。

IMPORTANT SAFETY INFORMATION

重要安全信息

Boxed WARNING:

方框警告:

PALFORZIA can cause anaphylaxis, which may be life threatening and can occur at any time during PALFORZIA therapy.

PALFORZIA可引起过敏反应,可能危及生命,在PALFORZIA治疗过程中随时可能发生。

Prescribe injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use.

开可注射肾上腺素的处方,指导和培训患者正确使用肾上腺素,并指导患者在使用肾上腺素时立即寻求医疗护理。

Do not administer PALFORZIA to patients with uncontrolled asthma.

不要给失控的哮喘患者使用PALFORZIA。

Dose modifications may be necessary following an anaphylactic reaction.

过敏反应后可能需要调整剂量。

Observe patients during and after administration of the Initial Dose Escalation and the first dose of each Up-Dosing level, for at least 60 minutes.

在给药期间和给药后,观察患者的初始剂量递增和每个递增剂量水平的第一次剂量,持续至少60分钟。

PALFORZIA is available only through a restricted program called the PALFORZIA REMS.

PALFORZIA只能通过名为PALFORZIA REMS的受限程序获得。

CONTRAINDICATIONS

禁忌症

PALFORZIA is contraindicated in patients with uncontrolled asthma, or with a history of eosinophilic esophagitis and other eosinophilic gastrointestinal disease.

PALFORZIA禁忌用于哮喘未得到控制的患者,或有嗜酸性食管炎和其他嗜酸性胃肠道疾病病史的患者。

WARNINGS AND PRECAUTIONS

警告及预防措施

Anaphylaxis

过敏反应

PALFORZIA can cause anaphylaxis, which may be life threatening. PALFORZIA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the PALFORZIA REMS because of the risk of anaphylaxis. Only prescribers, healthcare settings, pharmacies, and patients certified and enrolled in the REMS Program can prescribe, receive, dispense or administer PALFORZIA.

PALFORZIA可引起过敏反应,可能危及生命。由于过敏反应的风险,PALFORZIA只能通过称为PALFORZIA REMS的风险评估和缓解策略(REMS)下的限制性计划获得。只有处方医生、医疗保健机构、药房和注册参加REMS计划的患者才能开具处方、接受、分配或管理PALFORZIA。

Anaphylaxis has been reported during all phases of PALFORZIA dosing, including Maintenance and in subjects who have undergone recommended Up-Dosing and dose modification procedures.

据报道,在PALFORZIA给药的所有阶段,包括维持阶段,以及在接受过推荐的剂量增加和剂量调整程序的受试者中,都有过敏反应的报道。

Do not initiate PALFORZIA treatment in a patient who has had severe or life-threatening anaphylaxis within the previous 60 days. PALFORZIA may not be suitable for patients with certain medical conditions that may reduce the ability to survive anaphylaxis, including but not limited to markedly compromised lung function, severe mast cell disorder, or cardiovascular disease. In addition, PALFORZIA may not be suitable for patients taking medications that can inhibit or potentiate the effects of epinephrine.

对于在过去60天内出现严重或危及生命的过敏反应的患者,不要启动PALFORZIA治疗。PALFORZIA可能不适用于某些可能降低过敏性反应生存能力的医疗条件的患者,包括但不限于肺功能明显受损、严重肥大细胞紊乱或心血管疾病。此外,PALFORZIA可能不适合服用可以抑制或增强肾上腺素作用的药物的患者。

All Initial Dose Escalation doses and the first dose of each Up-Dosing level must be administered in a certified health care setting.

所有初始剂量递增剂量和每个递增剂量水平的第一剂量都必须在经过认证的卫生保健环境中进行管理。

Patients may be more likely to experience allergic reactions following PALFORZIA administration in the presence of cofactors such as exercise, hot water exposure, intercurrent illness (e.g., viral infection), or fasting. Other potential cofactors may include menstruation, sleep deprivation, nonsteroidal anti-inflammatory drug use, or uncontrolled asthma. Patients should be proactively counseled about the potential for the increased risk of anaphylaxis in the presence of these cofactors. If possible, adjust the time of dosing to avoid these cofactors. If it is not possible to avoid these cofactors, consider withholding PALFORZIA temporarily.

在存在运动、热水暴露、并发疾病(如病毒感染)或禁食等辅助因素的情况下,患者可能更容易出现PALFORZIA治疗后的过敏反应。其他潜在的辅助因素可能包括月经、睡眠不足、使用非类固醇消炎药或哮喘失控。在存在这些辅助因素的情况下,应主动咨询患者过敏反应风险增加的可能性。如果可能,调整给药时间以避免这些辅助因素。如果无法避免这些辅助因素,可以考虑暂时停止使用PALFORZIA。

Asthma

哮喘

Uncontrolled asthma is a risk factor for a serious outcome, including death, in anaphylaxis. Ensure patients with asthma have their asthma under control prior to initiation of PALFORZIA.

哮喘失控是过敏反应导致严重后果(包括死亡)的危险因素。在开始使用PALFORZIA之前,确保哮喘患者的哮喘得到控制。

PALFORZIA should be temporarily withheld if the patient is experiencing an acute asthma exacerbation. Following resolution of the exacerbation, resumption of PALFORZIA should be undertaken cautiously. Re-evaluate patients who have recurrent asthma exacerbations and consider discontinuation of PALFORZIA.

如果患者哮喘急性加重,应暂时停用PALFORZIA。在病情恶化解决后,应谨慎恢复PALFORZIA。重新评估反复发作哮喘的患者,并考虑停用PALFORZIA。

Eosinophilic Gastrointestinal Disease

嗜酸性胃肠道疾病

Discontinue PALFORZIA and consider a diagnosis of eosinophilic esophagitis in patients who experience severe or persistent gastrointestinal symptoms, including dysphagia, vomiting, nausea, gastroesophageal reflux, chest pain, or abdominal pain.

如果患者出现严重或持续的胃肠道症状,包括吞咽困难、呕吐、恶心、胃食管反流、胸痛或腹痛,请停用PALFORZIA,并考虑诊断为嗜酸性食管炎。

Gastrointestinal Adverse Reactions

胃肠道不良反应

Gastrointestinal adverse reactions were commonly reported in PALFORZIA-treated subjects, and dose modification should be considered for patients who report these reactions. For severe or persistent gastrointestinal symptoms consider a diagnosis of eosinophilic esophagitis.

在服用PALFORZIA的受试者中,胃肠道不良反应是常见的,报告这些反应的患者应该考虑调整剂量。对于严重或持续的胃肠道症状,可以考虑诊断为嗜酸性食管炎。

ADVERSE REACTIONS

不良反应

The most common adverse events reported in subjects treated with PALFORZIA (incidence ≥ 5% and ≥ 5% than placebo) are abdominal pain, vomiting, nausea, oral pruritus, oral paresthesia, throat irritation, cough, rhinorrhea, sneezing, throat tightness, wheezing, dyspnea, pruritus, urticaria, anaphylactic reaction, and ear pruritus.

服用PALFORZIA的受试者报告的最常见的不良事件(≥发生率为5%,≥为安慰剂的5%)是腹痛、呕吐、恶心、口腔瘙痒、口腔感觉异常、喉咙刺激、咳嗽、鼻漏、打喷嚏、喉咙紧绷、喘息、呼吸困难、瘙痒、荨麻疹、过敏反应和耳朵瘙痒。

Please see full Prescribing Information, including Boxed WARNING, and Medication Guide at www.PALFORZIA.com.

请访问www.PALFORZIA.com查看完整的预描述信息,包括盒装警告和用药指南。

For more information about PALFORZIA, please call 1-844-PALFORZ (1-844-725-3679) or visit www.PALFORZIA.com.

有关PALFORZIA的更多信息,请致电1-844-PALFORZ(1-844-725-3679)或访问www.PALFORZIA.com。

About Aimmune

关于美国免疫协会

Aimmune Therapeutics, Inc., a Nestlé Health Science Company, is a biopharmaceutical company developing and commercializing pharmaceutical therapies to prevent, manage, and treat food and metabolic-related diseases, including gastrointestinal conditions. Aimmune has one FDA- and EU-approved medicine for peanut allergy and other investigational therapies in development. For more information, please visit www.aimmune.com.

雀巢健康科学公司旗下的AImmune治疗公司是一家生物制药公司,开发和商业化药物疗法,以预防、管理和治疗与食品和代谢相关的疾病,包括胃肠道疾病。AImmune有一种FDA和欧盟批准的治疗花生过敏的药物和其他正在开发的研究疗法。欲了解更多信息,请访问www.aimmune.com。

About Nestlé Health Science

雀巢健康科学简介

Nestlé Health Science (NHSc), a wholly owned subsidiary of Nestlé, is a globally recognized leader in the field of nutritional science. At NHSc we are committed to empowering healthier lives through nutrition for consumers, patients and their healthcare partners. We offer an extensive consumer health portfolio of industry-leading medical nutrition, consumer and vitamins, minerals and supplements (VMS) brands that are science-based solutions covering all facets of health from prevention to maintenance, all the way through to treatment. NHSc is redefining the way we approach the management of health in several key areas such as pediatric health, allergy, acute care, oncology, metabolic health, healthy aging, gastrointestinal health, and inborn errors of metabolism. Headquartered in Switzerland, NHSc employs over 5,000 people around the world who are committed to making a difference in people's lives, for a healthier today and tomorrow. www.nestlehealthscience.com.

雀巢健康科学(NHSC)是雀巢的全资子公司,是全球公认的营养科学领域的领先者。在NHSC,我们致力于通过营养为消费者、患者和他们的医疗合作伙伴提供更健康的生活。我们提供广泛的消费者健康产品组合,包括业界领先的医疗营养、消费者和维生素、矿物质和补充剂(VMS)品牌,这些品牌都是基于科学的解决方案,涵盖从预防到维护,一直到治疗的健康方方面面。NHSC正在重新定义我们在几个关键领域的健康管理方式,如儿科健康、过敏、急性护理、肿瘤学、代谢健康、健康老龄化、胃肠健康和先天代谢错误。NHSC总部设在瑞士,在世界各地拥有5000多名员工,他们致力于改变人们的生活,创造更健康的今天和明天。Www.nestleHealth Science ence.com。

PALFORZIA®, AIMMUNE® and AIMMUNE THERAPEUTICS® are trademarks of Aimmune Therapeutics, Inc.

帕尔福尔齐亚(PALFORZIA)®,免疫®和免疫治疗学®是AImmune治疗公司的商标.


Contacts
联系人

U.S. Media:
Lauren Barbiero
+1.646.564.2156
lbarbiero@realchemistry.com

美国媒体:劳伦·巴比耶罗+1.646.564.2156 邮箱:lbarbiero@realChemistry.com

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