Experts construct guidelines to broaden use of peanut oral immunotherapy

Key takeaways:

• Allergy specialists in the U.K. urged the use of Palforzia for desensitizing children with peanut allergy.
• Researchers found that a voting panel agreed that more patients should be made aware of OIT.

New guidance was established for clinicians in the U.K. in order to implement the use of Palforzia in oral immunotherapy for patients with a peanut allergy, according to a study published in Clinical & Experimental Allergy.

A voting panel achieved a consensus on guidance statements that were made to assess eligibility on peanut challenges, governance processes to prioritize patient interest and how to transition patients to other services while taking daily peanut supplements, Tom Marrs, PhD, MA(Cantab), MSc, RCPCH, HFEA, consultant in pediatric allergy, director of Allergy Academy and adjunct senior lecturer at King’s College London, and colleagues wrote.

The study consisted of a Delphi consensus exercise to determine guidance statements for implementing Palforzia (Peanut [Arachis hypogaea] Allergen Powder-dnfp, Aimmune Therapeutics), which has defatted peanut powder as its active ingredient, as an effective form of OIT in the U.K.

The goals of the guidance statements are to inform and support health care professionals in providing Palforzia as a treatment option for peanut allergy. Researchers aimed to gather information on patient experiences during and after receiving OIT and address the current process for optimization.

Panel members were recruited from the Pediatric Allergy Committee of the British Society of Allergy and Clinical Immunology and included allergy specialists. Focus groups of approximately 1 hour with a maximum of four participants included children who had undergone OIT for peanut allergies and participated in previous clinical studies, as well as their parents.

Researchers gathered common themes and notable experiences from the focus groups and shared them with panel members.

For the Delphi exercise, two rounds of anonymous voting took place using a Likert scale to assess panel members’ views on importance of the participant statements. Scores included “critical” (score 7-9), “important” (score 4-6) or “not important” (score 1-3). The panel included 18 specialists and incorporated a final consensus workshop to develop the final guidance statements.

The focus groups included 11 participants aged 10 to 22 years who underwent OIT within the last 6 years as well as 22 parents. Three children discontinued treatment.

In total, eight workshops were held, and the resulting themes and experiences were used to inform 31 candidate statements for two rounds of panel voting.

In the first round of voting, 28 of 31 statements received scores of 7-9 for importance from more than 70% of the panel. The final 29 statements had a 91% consensus and scores of 7-9 after the second round of voting. These final statements were split into four categories: ethical framework and equity, eligibility and consent, induction/up-dosing/safety, and monitoring and maintenance treatment.

Ethical and equitable treatment are goals, despite limited capacity to treat allergy in the U.K., the researchers said. Shared decision-making and patient-centered pathways should drive treatment decisions, they continued.

Further, panel consensus indicated that local units should consider how to plan the availability of OIT and of local resources, with information shared in a culturally appropriate manner, among other recommendations.

The panel also agreed unanimously, in its second round of voting, that hospital-based peanut challenges should be routine in determining eligibility for Palforzia even though such challenges carry risks for anaphylaxis and other reactions.

For example, the panel said that patients with histories of severe anaphylaxis should delay Palforzia treatment and that those with severe asthma may be at higher risk for adverse events and not use treatment.

Next, the focus groups noted that updosing during treatment considerably changed family routines, prompting the panel to advise that consent should balance risks and benefits for the patients themselves as well as for other members of the family.

These conversations between providers and families before and during also should include patients even when they are young, the panel continued, adding that patients may elect to halt treatment at any time without impacting their ongoing clinical care.

Researchers noted that in order to safely implement Palforzia, it must be considered in several tiers. Firstly, in individual patients, then, within the service infrastructure and most broadly, at the national service-provision level. Thorough communication and documentation to keep track of consent, dosing and any treatment-related issues is essential to safety and monitoring procedures, researchers wrote. The focus groups stressed the importance of a clear route to contact with their health care team, specifying a 72 hour response deadline as well as having at least two health care professionals to cover OIT services to ensure a continuity of care. For those patients who discontinue treatment due to adverse events, an alternative management plan should be in place.

Researchers explain that the updosing regimen of Palforzia lasts a minimum of 22 weeks after which patients take a daily maintenance dose of 300 mg. The focus groups unanimously preferred consuming commercially available peanut products to maintain their desensitization, with children specifically noting preference for real-world peanuts. The panel noted that conversion options to real-world peanuts should be discussed during treatment and that the conversion should be considered once the maintenance dose has been tolerated for at least 3 months. Each patient should be reviewed at least once 12 months after showing stability to contemplate discharge. At discharge, emergency treatment plans should be established that include referrals for further treatment.

Study authors emphasize that the high consensus demonstrates common principles among providers as well as patients and will aid in implementing Palforzia as an accessible treatment for peanut allergy. The final guidelines outline what the U.K. National Health Services need to do in order to better offer this treatment.