Abstract
In the general population, the prevalence of peanut allergy has remained stable at 1.3%. However, in children, the prevalence appears to be increasing. There are no approved treatments for peanut allergy so current treatment involves educating the patient on avoiding products that contain peanut protein. Two drugs that allow controlled desensitization with controlled amounts of peanut protein have reached late stages of development.
Keywords: investigational drugs, formulary management / P & T, drug information, allergy
Epidemiology
An allergy or hypersensitivity to food is an abnormal immunologic reaction to food. Most allergies begin during the first 2 years of life. Parent’s perception of food allergies may overestimate the actual presence of an allergy. Researchers surveyed parents of infants and found 14.2% reported food allergies in the first 3 months, but this decreased to 7.2% at 12 months. When tested for food allergies at 12 months, 3.6% of infants were diagnosed with food allergies.1
A survey done in 1998 and repeated in 2002 and 2008 found the prevalence of peanut and tree nut allergies in adults to be 1.3%.2-4 However, the prevalence among children increased from 0.6% in 1997, to 1.2% in 2002 and 2.1% in 2008. Peanut allergy was reported in 0.4% in 1998, 0.8% in 2002, and 1.4% in 2008.3 It is estimated that 21% of peanut allergy patients may outgrow their allergy.5
Current Treatment
There are currently no approved treatments to desensitize patients who are allergic to peanuts. Current management of the allergy is centered on avoidance of peanuts or products that may contain peanuts. This can be a challenge due to cross contact during manufacturing and hidden ingredients. Some nonfood sources such as hair and skin products may also contain peanut protein. Patients with moderate to severe peanut allergies are advised to keep an epinephrine autoinjector for acute systemic reactions. Because 21% of patients may outgrow their allergy, patients are monitored to see whether their tolerance to peanut protein changes. This becomes less likely after age 6.6 Some physicians will use a desensitization protocol that slowly titrates exposure of peanut protein to increase tolerance.7
New Treatment Options
Two drugs that allow controlled desensitization have reached phase III trials (Table 1). Both AR101 and Viaskin Peanut have been designated Fast Track and Breakthrough Therapy status by the Food and Drug Administration (FDA).
Table 1.
New Treatment Options.
| Generic name | Sponsor | Drug class | Route of administration |
|---|---|---|---|
| AR101 | Aimmune Therapeutics | Peanut allergy desensitization | Oral tablet |
| Viaskin Peanut | DBV Technologies | Peanut allergy desensitization | Transdermal patch |
Note. Information adapted from the Prescribe Right Pharmaceutical Pipeline Tracker database.8
AR101 is an oral immunotherapy treatment consisting of a standardized preparation of peanut protein. Patients are initiated on a low dose and titrated to a maintenance dose to desensitize them for peanut protein. The initial dose and each dose titration are given under observation in a physician’s office in case rescue medication is needed. Doses are given at home between titrations and after the 300 mg maintenance dose is reached. In a 6-month, 55-patient, phase II trial, 79% of patients treated with AR101 tolerated a 443 mg peanut protein challenge compared with 19% in the placebo group. In addition, 62% were able to tolerate 1043 mg of peanut protein.9 Aimmune Therapeutics announced that in a 554-patient, phase III trial, 67% of patients who received AR101 were able to tolerate a 600 mg dose of peanut protein compared with 4% with placebo and 50% of patients tolerated 1000 mg of peanut protein.7
The Viaskin peanut allergy transdermal patch is an epicutaneous immunotherapy that delivers peanut protein to the immune system through intact skin. The amount of peanut protein exposure is titrated by adjusting the amount of time the patch is left on. For the first week, the patch is worn for 6 hours. The patient wears the patch for 12 hours in the second week and leaves the patch on for 24 hours beginning in the third week. Each patch is worn for one day and the site is rotated among 6 sites on the upper back each day.7
Two phase II trials have been published for the Viaskin peanut patch. Both trials used the amount of peanut protein that could be tolerated before eliciting allergic symptoms as the primary endpoint. In a 12-month, 221-patient, phase II trial, 50% of the patients who received a Viaskin Peanut 250 µg patch tolerated a 1000 mg dose of peanut protein or a 10 times increase from baseline in the amount of peanut protein they could tolerate before the development of clinical symptoms compared with 25% of placebo patients.10 In a 74-participant, 52-week, phase II trial, 48% of the patients who received a Viaskin Peanut 250 µg patch tolerated a 5044 mg dose of peanut protein or a 10 times increase from baseline in the amount of peanut protein they could tolerate before the development of clinical symptoms compared with 12% of placebo patients.11
Data from 2 unpublished Viaskin peanut patch phase III trial have also been presented. DBV Technologies announced that in a 12-month, 356-patient, phase III, trial, 35% of patients who received a Viaskin peanut patch increased the amount peanut protein they tolerated compared with 13% with placebo. However, the lower boundary of the confidence interval did not reach the prespecified level.7 DBV Technologies also announced that in a 6-month, 393-patient, phase III safety trial, the most common adverse effect with the patch were local application-site reactions. Serious adverse events were similar to placebo.
Footnotes
Author’s Note: Information is summarized from selected materials; additional information may be available from other sources. Due to the preapproval nature of the information, non-peer-reviewed data may be utilized. The information provided is meant to provide a way to assess the development status of a new drug and should not be used in making patient care decisions.
Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding: The author(s) received no financial support for the research, authorship, and/or publication of this article.
References
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