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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.

美國免疫治療公司將在ACAAI上展示有關花生過敏的真實負擔以及美國臨牀實踐中使用PALFORZIA®的早期醫生經驗的新數據。
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 —

-花生過敏負擔研究(Pabs)表明,需要患者-醫生共同決策,以改善花生過敏管理-

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

-醫生調查表明,PALFORZIA很容易在臨牀實踐中實施,並突出了可能有助於促進在美國採用的現實世界經驗。

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.

加利福尼亞州布里斯班--(美國商業資訊)--雀巢健康科學公司(NestléHealth Science)開發和商業化藥物療法,以預防、管理和治療與食品和代謝相關的疾病亞洲網加利福尼亞州布里斯班11月17日電AImmune治療公司今天宣佈,它將提供有關花生過敏(PA)對患者和照顧者生活質量負擔的新數據。此外,該公司還將與PALFORZIA分享醫生對PALFORZIA的真實體驗的調查結果®[花生(花生過敏原粉劑-dnfp]這些數據將於2021年11月4日至8日在新奧爾良舉行的美國哮喘、過敏和免疫學會(ACAAI)年度科學會議上公佈。


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(以前稱為AR101)於2020年1月被美國食品和藥物管理局(FDA)批准為口服免疫療法(OIT),用於緩解4至17歲確診為花生過敏的患者因意外接觸花生而可能發生的過敏反應(包括過敏反應)。2020年12月,歐盟委員會(EC)批准PALFORZIA用於4至17歲被確診為花生過敏的患者,同時配合避免花生的飲食。PALFORZIA必須與避免食用花生的飲食一起使用,不適用於包括過敏反應在內的過敏反應的緊急治療。

"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."

美國免疫協會全球醫療事務高級副總裁穆罕默德·亞辛(Mohamed Yassine)説:“當我們繼續致力於揭示花生過敏對兒童及其家庭持續造成的負擔時,一個一直被放在首位的因素是聯合決策的重要性,以優化花生過敏管理,幫助那些受這種疾病影響的人。”PALFORZIA為許多對花生過敏的家庭提供了一個重要的選擇,根據來自現實世界治療經驗的早期數據,我們很高興地看到,許多過敏症專科醫生已經在用PALFORZIA治療他們的患者。“

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治療公司贊助的花生過敏負擔研究(PABS)證明瞭聯合決策在改善患者和管理PA的照顧者與健康相關的生活質量(HRQoL)方面的必要性和影響。會議上提交的其他數據表明,PALFORZIA可以很容易地在治療PA的臨牀環境中實施,並表明醫生之間的信息共享有助於促進治療的採用。此外,結果表明,PALFORZIA治療在沒有OIT經驗的情況下,被衞生保健提供者成功地納入到實踐中。

"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."

堪薩斯州兒童慈善醫學博士傑伊·波特諾伊説:“作為一名過敏症專科醫生,我經常看到許多患者每天都承受着花生過敏的負擔,我很高興有機會為我合適的患者提供治療選擇,同時也教育其他過敏症專科醫生,”傑伊·波特諾伊(Jay Portnoy)是堪薩斯州兒童慈善會(Children‘s Mercy)的醫學博士。在採用新療法時,重要的是與其他醫生分享經驗和提示,這將幫助他們學習如何將這些治療方法融入自己的實踐中。“

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

ACAAI的AImmune海報演示文稿完整名單如下:

  • 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,醫學博士。“花生過敏青少年健康相關生活質量相關因素的多因素分析“海報#P106;美國中部時間11月5日星期五下午4:30;B展廳,11號監視器
    • 花生過敏負擔研究(PABS)評估了現實世界中花生過敏的負擔,特別是與花生過敏青少年的HRQL相關的因素。
      • 102名13至17歲的青少年自報,提供者診斷為PA,參與了這項在線調查,收集了社會人口統計、醫療、治療史和兒科生活質量問卷(PedsQL)的數據,並使用單變量和多變量統計方法確定了PedsQL得分的潛在預測因素。
      • 調查結果顯示,雖然某些患者的特徵與較差的PedsQL評分有關,但患者經歷的實質性異質性表明,PA管理需要共同決策,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.
  • 馬裏蘭州S·穆斯塔法“美國臨牀實踐中花生過敏口服免疫療法的實施:十個小貼士”。“海報#P112;美國夏令時11月6日星期六上午11:35;B展廳,11號監視器
    • 對6名經驗豐富的PALFORZIA處方者的調查結果也被提出,並從現實世界的經驗中提供指導,以促進治療在實踐中的實施。
      • 參與訪談和諮詢小組的醫生分享了實施的關鍵提示,包括準備設施、臨牀醫生和工作人員以訪問、管理和監測PALFORZIA治療,支持共同決策,預測不良反應,以及保持劑量/治療的靈活性,與標籤劑量方案保持一致。
  • 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.
  • 馬裏蘭州J·波特諾伊“花生變應原粉劑治療小兒花生過敏症的內科經驗“海報#p114;美國中部時間11月6日星期六下午12點05分;B展廳,11號監視器
    • 一項對48名醫生的調查評估了開處方和調整實踐以提供PALFORZIA的真實經驗,顯示大多數接受調查的醫生將這種治療整合到實踐中沒有困難。
      • 調查結果確定了在某種程度上/極有可能開Ptah處方的醫生的百分比,包括患有多種食物過敏的患者。
      • 回答表明,大多數醫生更有可能給最近出現PA反應的患者開PTAH(≤,12個月)。
      • 調查結果詳細説明瞭醫生開Ptah的經驗,確定了在整個治療階段和不同治療階段,發現開Ptah容易/非常容易、中等或困難/非常困難的醫生的百分比。
  • 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.
  • 馬裏蘭州阿納諾斯圖“醫療保健提供者提供FDA批准的第一種花生過敏治療的真實世界視角。“海報#P117;美國中部時間11月7日星期日上午11:35;B展廳,11號監視器
    • 通過對8名過敏症專科醫生和3名護士從業人員的採訪,圍繞他們提供PALFORZIA的經歷,探討了四個關鍵主題,包括影響採用的因素、在日常實踐中提供治療的相關因素、學習和反思以及在新冠肺炎大流行期間提供PALFORZIA。
      • 答覆表明,在實踐中實施PALFORZIA並不需要OIT以前的經驗。
      • 有人建議借鑑他人的經驗,以幫助克服執行方面的感知和實際障礙。

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是一種口服免疫療法,用於減輕意外接觸花生可能發生的過敏反應,包括過敏反應。PALFORZIA被批准用於確診為花生過敏的患者。初始劑量遞增可能適用於4至17歲的患者。對於4歲及以上的患者,可以繼續增加劑量和維持劑量。

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

PALFORZIA將與避免食用花生的飲食配合使用。

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

使用限制:不適用於包括過敏反應在內的過敏反應的緊急治療。

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可引起過敏反應,可能危及生命,在PALFORZIA治療過程中隨時可能發生。

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

開可注射腎上腺素的處方,指導和培訓患者正確使用腎上腺素,並指導患者在使用腎上腺素時立即尋求醫療護理。

Do not administer PALFORZIA to patients with uncontrolled asthma.

不要給失控的哮喘患者使用PALFORZIA。

Dose modifications may be necessary following an anaphylactic reaction.

過敏反應後可能需要調整劑量。

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.

在給藥期間和給藥後,觀察患者的初始劑量遞增和每個遞增劑量水平的第一次劑量,持續至少60分鐘。

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

PALFORZIA只能通過名為PALFORZIA REMS的受限程序獲得。

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禁忌用於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腸道疾病病史的患者。

WARNINGS AND PRECAUTIONS

警告及預防措施

Anaphylaxis

過敏反應

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可引起過敏反應,可能危及生命。由於過敏反應的風險,PALFORZIA只能通過稱為PALFORZIA REMS的風險評估和緩解策略(REMS)下的限制性計劃獲得。只有處方醫生、醫療保健機構、藥房和註冊參加REMS計劃的患者才能開具處方、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.

據報道,在PALFORZIA給藥的所有階段,包括維持階段,以及在接受過推薦的劑量增加和劑量調整程序的受試者中,都有過敏反應的報道。

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.

對於在過去60天內出現嚴重或危及生命的過敏反應的患者,不要啟動PALFORZIA治療。PALFORZIA可能不適用於某些可能降低過敏性反應生存能力的醫療條件的患者,包括但不限於肺功能明顯受損、嚴重肥大細胞紊亂或心血管疾病。此外,PALFORZIA可能不適合服用可以抑制或增強腎上腺素作用的藥物的患者。

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

所有初始劑量遞增劑量和每個遞增劑量水平的第一劑量都必須在經過認證的衞生保健環境中進行管理。

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.

在存在運動、熱水暴露、併發疾病(如病毒感染)或禁食等輔助因素的情況下,患者可能更容易出現PALFORZIA治療後的過敏反應。其他潛在的輔助因素可能包括月經、睡眠不足、使用非類固醇消炎藥或哮喘失控。在存在這些輔助因素的情況下,應主動諮詢患者過敏反應風險增加的可能性。如果可能,調整給藥時間以避免這些輔助因素。如果無法避免這些輔助因素,可以考慮暫時停止使用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.

哮喘失控是過敏反應導致嚴重後果(包括死亡)的危險因素。在開始使用PALFORZIA之前,確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,應暫時停用PALFORZIA。在病情惡化解決後,應謹慎恢復PALFORZIA。重新評估反覆發作哮喘的患者,並考慮停用PALFORZIA。

Eosinophilic Gastrointestinal Disease

嗜酸性胃腸道疾病

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.

如果患者出現嚴重或持續的胃腸道症狀,包括吞嚥困難、嘔吐、噁心、胃食管反流、胸痛或腹痛,請停用PALFORZIA,並考慮診斷為嗜酸性食管炎。

Gastrointestinal Adverse Reactions

胃腸道不良反應

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的受試者中,胃腸道不良反應是常見的,報告這些反應的患者應該考慮調整劑量。對於嚴重或持續的胃腸道症狀,可以考慮診斷為嗜酸性食管炎。

ADVERSE REACTIONS

不良反應

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的受試者報告的最常見的不良事件(≥發生率為5%,≥為安慰劑的5%)是腹痛、嘔吐、噁心、口腔瘙癢、口腔感覺異常、喉嚨刺激、咳嗽、鼻漏、打噴嚏、喉嚨緊繃、喘息、呼吸困難、瘙癢、蕁麻疹、過敏反應和耳朵瘙癢。

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

請訪問www.PALFORZIA.com查看完整的預描述信息,包括盒裝警告和用藥指南。

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

有關PALFORZIA的更多信息,請致電1-844-PALFORZ(1-844-725-3679)或訪問www.PALFORZIA.com。

About Aimmune

關於美國免疫協會

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.

雀巢健康科學公司旗下的AImmune治療公司是一家生物製藥公司,開發和商業化藥物療法,以預防、管理和治療與食品和代謝相關的疾病,包括胃腸道疾病。AImmune有一種FDA和歐盟批准的治療花生過敏的藥物和其他正在開發的研究療法。欲瞭解更多信息,請訪問www.aimmune.com。

About Nestlé Health Science

雀巢健康科學簡介

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.

雀巢健康科學(NHSC)是雀巢的全資子公司,是全球公認的營養科學領域的領先者。在NHSC,我們致力於通過營養為消費者、患者和他們的醫療合作伙伴提供更健康的生活。我們提供廣泛的消費者健康產品組合,包括業界領先的醫療營養、消費者和維生素、礦物質和補充劑(VMS)品牌,這些品牌都是基於科學的解決方案,涵蓋從預防到維護,一直到治療的健康方方面面。NHSC正在重新定義我們在幾個關鍵領域的健康管理方式,如兒科健康、過敏、急性護理、腫瘤學、代謝健康、健康老齡化、胃腸健康和先天代謝錯誤。NHSC總部設在瑞士,在世界各地擁有5000多名員工,他們致力於改變人們的生活,創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.

帕爾福爾齊亞(PALFORZIA)®,免疫®和免疫治療學®是AImmune治療公司的商標.


Contacts
聯繫人

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

美國媒體:勞倫·巴比耶羅+1.646.564.2156 郵箱:lbarbiero@realChemistry.com

譯文內容由第三人軟體翻譯。


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