Epicutaneous immunotherapy for peanut allergy found safe, tolerable through 5 years
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Key takeaways:
- The VP250 patch includes 250 µg of peanut protein.
- Only two of 87 participants experienced anaphylaxis related to treatment.
- Most events were mild or moderate local application reactions.
WASHINGTON — Treatment-emergent adverse events with epicutaneous immunotherapy for peanut allergy grew less frequent and severe over 5 years, according to a poster at the American Academy of Allergy, Asthma & Immunology Annual Meeting.
These results indicate a favorable safety and tolerability profile with potential for use over multiple years of treatment, David M. Fleischer, MD, associate professor of pediatrics, Children’s Hospital Colorado, and colleagues wrote.
“The only current options for peanut immunotherapy are oral immunotherapy and now omalizumab,” Fleischer told Healio.
But oral immunotherapy comes with restrictions on exercise, he continued. Also, patients must schedule their bathing or showering around dosing, and if they get sick, dosing is suspended.
“And the risk of anaphylaxis can be as high as 15%,” Fleischer said.
Meanwhile, omalizumab (Xolair; Genentech/Novartis) requires a single injection or multiple injections every 2 to 4 weeks, he added.
“With epicutaneous immunotherapy (EPIT), the risk of anaphylaxis from therapy is only 1% to 2%, and there are no restrictions on exercise, bathing/showering, or holding therapy with illness,” Fleischer said. “So, it is much safer than OIT and more practical to use compared to OIT, and without the pain from injections.”
The study examined 87 children (56.3% boys; mean age at enrollment, 11.1 years) with peanut allergy treated with the VP250 patch (Viaskin Peanut, DBV Technologies), which includes 250 µg of peanut protein, through 5 years.
“It is applied on the skin of the back between the shoulder blades (scapula), worn for 24 hours, with sites rotated every 24 hours of patch application to six different sites in that area,” Fleischer said.
The cohort included 40 who began the study on placebo before moving to treatment with the patch and 47 who used the patch for all 5 years. The mean treatment compliance rate at 5 years was 93.1%.
All 87 participants experienced a treatment-emergent adverse event during the 5-year study period. No patients discontinued treatment due to these events. The researchers classified most of these events as local application reactions that were mild or moderate, with 93% related to VP250.
One of these participants experienced a serious treatment-related adverse event during the first year of treatment. The one treatment-related adverse event that led to epinephrine use took place during the first year of treatment as well. Also, two participants experienced anaphylactic reactions during the first and second years.
Corticosteroid use for treatment-emergent adverse events fell during the 5-year period. Specifically, the percentage of patients who used a topical corticosteroid fell from 54% in year 1 to 6.8% in year 5. The percentage of patients who used a systemic or inhaled corticosteroid fell from 23% in year 1 to 1.7% in year 5.
Percentages of patients who experienced a treatment-related adverse event fell from 72.4% in year 1 to 57.5% in year 2 and then to 34.5% in year 3, 26.7% in year 4 and 15.3% in year 5.
Percentages of patients who experienced mild treatment-emergent adverse events fell from 95.4% in year 1 to 87.4% in year 2 and then to 77% in year 3, 60.5% in year 4 and 35.6% in year 5.
Similarly, percentages of patients who experienced moderate treatment-emergent adverse events fell from 47.1% in year 1 to 32.2% in year 2 and then to 25.3% in year 3, 18.6% in year 4 and 15.3% in year 5.
The percentages of patients with severe treatment-emergent adverse events varied, however, including 4.6% for year 1, 2.3% for year 2, 3.4% for year 3, 2.3% for year 4 and 3.4% for year 5.
The percentages of patients with severe treatment-emergent adverse events related to VP250 generally fell over 5 years, from 3.4% in year 1 to 2.3 in year 2, followed by 1.1% in year 3 and 1.2% in year 4 before reaching 0% in year 5.
“This was a further report on safety data using the patch. It continued to show impressive safety data, consistent with previous data from other studies,” Fleischer said.
Based on these findings, the researchers concluded that the frequency and severity of treatment-emergent adverse events with the VP250 patch fell through 5 years, with high compliance, indicating its safe and tolerable use for multiple years.
“The studies continue to show that EPIT is a very safe mode of treatment, making it hopefully an option for patients and families soon,” Fleischer said.