Efficacy of Palforzia in childhood peanut allergy increases over time

9th August 2021

Over a two-year period, daily use of Palforzia in those with a childhood peanut allergy led to higher level of allergen desensitisation.

An estimated approximately 2% of the population of Western nations has a peanut allergy. However, the prevalence in the paediatric population is likely to be higher with one study of 3218 finding that 24.8% had a childhood peanut allergy. The presence of a peanut allergy has the potential to cause life-threatening reactions and elicit anaphylaxis in both children and adults.

While the standard approach for those with a peanut allergy is allergen avoidance and the use of adrenaline auto-injection as a treatment for any allergic reactions following accidental ingestion, a peanut allergen powder, Palforzia, has been approved for use in the EU since 2020. Palforzia contains peanut protein as a defatted powder and has a marketing authorisation for the treatment of patients aged 4 to 17 years with a confirmed diagnosis of childhood peanut allergy.

Treatment with Palforzia is a form of oral immunotherapy that involves ingesting, small and controlled amounts of peanut protein with the aim of desensitising children and ultimately reducing the risk of life-threatening allergic reactions. However, continued treatment is required because once therapy is discontinued, reactivity to peanuts reoccurs.

The efficacy of Palforzia in childhood peanut allergy has been demonstrated in two Phase III randomised, controlled trials. In the first trial (PALISADE), 67% of participants who received Palforzia were able to ingest a dose of 600mg of peanut protein without any problems, compared to 4% of those assigned to placebo. In the second and more recent trial (ARTEMIS), 58% of those given Palforzia could tolerate 1000mg of peanut protein without problems compared with only 2% in the placebo group.

The same group have now reported follow-up data for patients who completed the PALISADE study in an open-label extension study. Individuals with childhood peanut allergy received 300mg/day for either 1.5 years (group A) or a total of 2 years (Group B). The primary outcome of the trial was a double-blind, placebo-controlled food challenge (DBPCFC), which involves supervised and gradual ingestion of the suspected food allergen (peanuts) disguised or hidden in another food.

Findings
The extension study included 142 participants aged 4–17 years (110 in Group A). The median age of group A was 10 years (52.7% male) whereas the median age of group B was 8 years (56.2% male). The percentage of participants able to tolerate the highest DBPCFC (2000mg peanut protein) and without any dose-limiting symptoms was 80.8% in group B compared with 48.1% in group A. In addition, the proportion of individuals requiring adrenaline as a rescue medication was 24% (group A) and only 3.8% (group B).

The researchers described how the data indicated that the extent of desensitisation to childhood peanut allergy was clearly time-dependent in how efficacy appeared to increase over time. They concluded that longer-term data will be captured from this ongoing study to determine whether continued therapy improves DBPCFC response.

Citation
Fernandez-Rivas M et al. Open-label follow-on study evaluating the efficacy, safety, and quality of life with extended daily oral immunotherapy in children with peanut allergy. Allergy 2021

Allergy information can be difficult for consumers to interpret

27th July 2021

Effective food safety requires an understanding of allergy information but a study has revealed consumers found this difficult to interpret.

Self-reported food allergy is relatively common, with one European analysis identifying a pooled lifetime prevalence of 17.3%. Furthermore, the presence of a food allergy negatively affects an individuals’ quality of life across all ages, with one study finding that the risk of accidental allergen ingestion and limitations in social life are associated with a worse health-related quality of life. The provision of allergy information has been incorporated into EU law since 2016 and requires that there is a clearer and harmonised presentation of allergens such as nuts, soy etc, on pre-packed foods and mandatory allergy information on non-prepacked foods in outlets such as bars and cafes. The introduction of precautionary allergen labelling (PAL), is the voluntary way used by food producers to warn consumers of the risks from the unintended presence of specific allergens in products, though PAL is not formally regulated in the EU. Despite the legal labelling requirements, allergic reactions remain common, with one study finding that 46% of adults reported an allergic reaction and 41% of these reactions occurred to pre-packed foods. However, it has also been found that consumers find a wide and inconsistent range of ways in which allergy information is presented on labels.

In an attempt to better understand how both allergy and non-allergy sufferers interpret and assess allergen information, a team from the Institute for Health Services Research, Utrecht, The Netherlands, evaluated consumer understanding of allergy information on foods in a controlled, environment. The team looked at how consumers interpreted the information presented in three scenarios. In the first, consumers rated the risk of consumption by someone with an allergy from a mixed set of 18 products which contained the allergy information. Secondly, six of the 18 products were labelled “may contain peanut”, six had “peanut as an ingredient” and for the remaining six, there was no mention of peanut as an ingredient. Finally, individuals were asked to assess three different PAL labels, i.e., “may contain peanut” vs “may contain traces of peanut” vs “produced in a factory which also processes peanut”, using a 5-point scale.

Findings
For the ingredient experiment, 102 individuals with a mean age of 33.9 years (79% female) and 48 nonallergic consumers, similarly rated the risk of eating an allergen containing food. The PAL experiment involved 99 participants and found that those without an allergy judged the risk assessment to higher than those with an allergy (82% vs 58%, p < 0.01). The PAL for which participants expressed the highest preference was “may contain nuts” (65.7%), whereas the least preferred was “produced in a factory which also processes peanuts” (26.3%).

In their discussion, the authors noted how consumers appeared to attribute different risks, depending on the presentation of allergy information on a food label. However, overall, only around 50% of consumers judged that the allergy information was clear. They concluded by calling for allergy information guidelines to ensure that the information is much clearer and understood by consumers.

Citation
Holleman BC et al. Poor understanding of allergen labelling by allergic and non- allergic consumers. Clin Exp Allergy 2021