BRISBANE, Calif.--(BUSINESS WIRE)--Aimmune Therapeutics, Inc., a Nestlé Health Science company developing pharmaceutical therapies to prevent, manage, and treat food, gastrointestinal (GI), and metabolic-related diseases, will present new data on PALFORZIA® [Peanut Allergen (Arachis hypogaea) Power-dnfp] at the European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress in Prague, Czech Republic on July 1-3, 2022.
Results from an analysis to be presented on health-related quality of life (HRQoL) among patients from the Phase 3 PALISADE, ARC004 (PALISADE follow-on), ARTEMIS, RAMSES and ARC011 (RAMSES follow-on) trials showed PALFORZIA for peanut allergy management in children and teenagers was associated with positive effects on HRQoL. Additional data to be presented suggested increased rates of satisfaction with PALFORZIA treatment convenience and effectiveness among patients treated in the PALISADE, ARC004, and ARTEMIS trials.
“We are pleased to be presenting these new important data for PALFORZIA at this meeting and share the overall positive clinical trial experiences of both patients and their caregivers with this treatment,” said Stephen Tilles, M.D., Senior Medical Director, and Global Head of Medical Affairs, Allergy for Aimmune Therapeutics. “As a company dedicated to transforming the lives of patients and their families, understanding the patient experience is a top priority for us; we are encouraged by these data as they allow us to better understand the potential benefits of this therapy for both patients and their caregivers.”
“Having worked with many families impacted by peanut allergy, I am aware that patients, and families often feel overwhelmed by the stress and anxiety related to the burden of food allergy and the resulting impact on their everyday activities,'' said Audrey Dunn Galvin, Ph.D., Pediatric Psychologist, University College Cork, and a co-author of the QoL related data presented at the meeting. “These data suggest that PALFORZIA presents a potential convenient and effective treatment option for children with peanut allergy, and, importantly, I am encouraged to see that it was also associated with treatment-related improvements in quality of life among the patients in the clinical trials and their caregivers that were surveyed.”
Key Highlights from the Data to be Presented Include:
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A. Dunn Galvin. “Health-Related Quality of Life Reported in Children, Teenagers, and Their Caregiver Proxy From Peanut Oral Immunotherapy Clinical and Follow-On Trials”
- HRQoL data, using the Food Allergy Quality of Life Questionnaire (FAQLQ) and Food Allergy Independent Measure (FAIM), from PALISADE (ARC003), ARC004 (PALISADE follow-on; daily dosing cohort), ARTEMIS (ARC010), RAMSES (ARC007), and ARC011 (RAMSES follow-on) were analyzed.
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Assessments were completed at prespecified time points by participants aged 8-17 years and caregiver proxies of participants aged 4-17 years.
- Baseline FAQLQ and FAIM total scores appeared comparable between PALFORZIA-and placebo-treated participants.
- Self-and caregiver proxy-reported total scores on the FAQLQ for PALFORZIA-treated participants generally improved at trial exit from baseline; change in total scores on the FAIM improved throughout all trials.
- PALFORZIA for peanut allergy management in children and teenagers was associated with an improvement in reported HRQoL in trials.
- Improvements were seen despite rigors of trial participation.
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V. Sharma. “Treatment Satisfaction With Oral Immunotherapy for Peanut Allergy: Results From Clinical Trials”
- 744 participants in PALISADE (ARC003), ARC004, and ARTEMIS (ARC010) completed the Treatment Satisfaction Questionnaire for Medication (TSQM-9) at the exit/early discontinuation visits after the exit double-blind, placebo-controlled food challenge.
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The TSQM-9 consists of nine questions across three domains evaluated using point scales: effectiveness (all items rated 1-7), convenience (all items rated 1-7), and global satisfaction (two items rated 1-5 and one item rated 1-7).
- Overall, participants were satisfied across all domains, with mean scores ≥4 for all questions on the TSQM-9.
- The mean score for participants satisfied with the medications ability to treat the condition was ≥5.6.
- The mean score for the relief from symptoms that the medication provided was a ≥5.4.
- The mean score for how easy patients found the medication to be used was ≥4.4, mean score for those who believed the medication was easy to plan ≥4.6 and that use was convenient ≥4.3.
- Overall, participants were globally satisfied with their medication (scores ≥5.7 on a 7-point scale).
About PALFORZIA® [Peanut Allergen (Arachis hypogaea) Power-dnfp]
PALFORZIA was approved in January 2020 by the U.S. Food and Drug Administration (FDA) 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. PALFORZIA was approved on December 17, 2020 by the European Commission (EC), on April 7, 2021 by the Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K., and on May 4, 2021 by Swissmedic. Use of PALFORZIA may be continued in patients 18 years of age and older. PALFORZIA is not indicated for the emergency treatment of allergic reactions, including anaphylaxis and must always be used in conjunction with a peanut-avoidant diet.
Boxed WARNING: PALFORZIA can cause anaphylaxis, which may be life threatening and can occur at any time during PALFORZIA therapy. Prescribe injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use. Do not administer PALFORZIA to patients with uncontrolled asthma.
Please see U.S. Important Safety Information and Boxed WARNING below, or for full Prescribing Information, including Boxed WARNING and Medication Guide, visit www.PALFORZIA.com.
INDICATION
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 is to be used in conjunction with a peanut-avoidant diet.
Limitations of Use: Not indicated for the emergency treatment of allergic reactions, including anaphylaxis.
IMPORTANT SAFETY INFORMATION
Boxed WARNING:
PALFORZIA can cause anaphylaxis, which may be life threatening and can occur at any time during PALFORZIA therapy.
Prescribe injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use.
Do not administer PALFORZIA to patients with uncontrolled asthma.
Dose modifications may be necessary following an anaphylactic reaction.
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.
PALFORZIA is available only through a restricted program called the PALFORZIA REMS.
CONTRAINDICATIONS
PALFORZIA is contraindicated in patients with uncontrolled asthma, or with a history of eosinophilic esophagitis and other eosinophilic gastrointestinal disease.
WARNINGS AND PRECAUTIONS
Anaphylaxis
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.
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.
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.
All Initial Dose Escalation doses and the first dose of each Up-Dosing level must be administered in a certified health care setting.
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.
Asthma
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.
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.
Eosinophilic Gastrointestinal Disease
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.
Gastrointestinal Adverse Reactions
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.
ADVERSE REACTIONS
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.
For more information about PALFORZIA, please call 1-844-PALFORZ (1-844-725-3679) or visit www.PALFORZIA.com.
Please see full U.S. Prescribing Information, including Boxed WARNING, and Medication Guide at www.PALFORZIA.com.
About Aimmune
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 US- and European-approved medicine for peanut allergy and other investigational therapies in development. For more information, please visit www.aimmune.com.
About Nestlé Health Science
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.
