Viaskin Peanut patch increases protection from allergy over time
In the largest long-term peanut immunotherapy trial to date, the epicutaneous immunotherapy patch known as Viaskin Peanut increased patients’ protection over time from allergic reactions, according to researchers.
The company stated in a press release that the Viaskin Peanut (DBV Technologies) patch delivers biologically active compounds to the immune system through intact skin. The patch is intended to reduce the risk for reactions to accidental peanut ingestion, Todd Green, MD, vice president of clinical development and medical affairs at DBV Technologies, told Healio Primary Care.
“[Viaskin Peanut] exposes patients who are allergic to about 1/1,000th worth of one peanut,” he said. “The nice thing about this approach is it avoids any detectable absorption into the bloodstream. It doesn’t involve having to eat or swallow peanut protein, which we know many patients don’t like to do.”
Green collaborated on PEOPLE, a 5-year, ongoing, open-label extension of the phase 3 randomized controlled PEPITES trial, which evaluated the safety, tolerability and efficacy of the patch in children. In the original trial, participants were randomly assigned 2:1 to receive the patch or placebo daily on the interscapular area. PEOPLE included 298 children aged 4 to 11 years who had completed 12 months of the PEPITES study, including a double-blind, placebo-controlled food challenge in which 198 children received a daily 250 µg dose of Viaskin Peanut and 100 received placebo. All children in PEOPLE were required to remain on a peanut-free diet.
Interim 36-month results were scheduled to be presented at the American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting, which was canceled because of the COVID-19 pandemic.
Green and colleagues found that, after 3 years:
- 51.8% of participants (73/141) reached an eliciting dose of 1,000 mg or more of peanut protein, compared with 40.4% (57/141) at month 12 (11.3% difference; 95% CI, 2.8-19.6).
- 75.9% of children (107/141) had an increase in their eliciting dose of peanut from their PEPITES baseline.
- 67.4% of children (62/92) who had baseline eliciting doses of 100 mg or less reached an eliciting dose of at least 300 mg.
- 13.5% of participants (19/141) tolerated the maximum cumulative dose of 5,444 mg during the food challenge (approximately 18 peanuts) at month 36.Among participants with a baseline eliciting dose of 10 mg or less (n = 18), there was a 22.5-fold increase in geometric mean eliciting dose (95% CI, 10.7-47.3).
- Among participants with a baseline eliciting dose greater than10 mg (n = 123), the geometric mean eliciting dose increased approximately fourfold by month 36 (95% CI, 3.2-5).
- At Month 36, the mean cumulative reactive dose was 1768.8 mg, (approximately 6 peanuts).
- At month 36, 24.1% of participants (34/141) reached a cumulative reactive dose of 3444 mg at month 36 compared with 15.6% of participants (22/141) at month 12.
“We saw some pretty encouraging results that demonstrate continued accrual of benefit beyond the first year,” Green said. “We [also] see generally high compliance and low numbers of people dropping out from adverse events.
Risk from peanut residues reduced
Researchers also used PEPITES trial participants to estimate the probability of an allergic reaction from peanut residues on kitchen utensils or equipment used to prepare Asian dishes. There were 238 children who received 250 µg Viaskin Peanut and 118 children who were assigned a placebo.
According to researchers, after 12 months of therapy, the absolute risk for reaction from using shared, uncleaned utensils and using utensils that were quickly rinsed with warm water dropped. The placebo groups’ risks in both scenarios remained unchanged.
High rates of compliance
To examine compliance and adverse events tied to Viaskin Peanut’s use, researchers randomly assigned 393 children aged 4 to 11 years with a clinical history of peanut allergy to 250 µg Viaskin Peanut (n = 294) or placebo (n = 99) for 6 months as part of the phase 3 REALISE study. This real-life use and safety study, unlike previous studies of Viaskin Peanut, did not require a food challenge.
Researchers reported that 98.3% of the children who received Viaskin Peanut and 97.9% of the children assigned placebo were compliant with their respective therapy. In addition, patient diaries revealed that 100% of the Viaskin Peanut recipients and 83.8% of placebo recipients reported local skin reactions, such as redness, itching and swelling, which decreased over time Other treatment-emergent adverse events were reported in 29.9% of Viaskin Peanut recipients and 12.1% of placebo recipients.
“The safety profile of Viaskin Peanut was consistent with that observed in the clinical program to date in nearly 1,000 patients,” Green said. “The majority of treatment-emergent adverse events were mild or moderate local administration site reactions, and low rates of treatment related epinephrine use were observed. Overall, Viaskin Peanut was observed to be well tolerated in this population of peanut-allergic children, consistent with previous Phase 2b and 3 efficacy and safety studies.”
“We see encouraging safety results from our trials,” said Green, who is also an allergist and immunologist at the Children’s Hospital of Pittsburgh. “All these results are consistent with what we saw in phase 2 and [some of] phase 3 as well.”
Approximately 1 week after the Viaskin Peanut data were to be released at AAAAI, DBV Technologies announced that the FDA’s review of the Viaskin Peanut’s biologics license application led to questions regarding the patch’s adhesion, DBV Technologies added that it still expects the FDA to rule on its application by Aug. 5.
“We appreciate the ongoing dialogue with the FDA and look forward to further discussions in the coming weeks,” Daniel Tassé, CEO of DBV Technologies, said in a press release. “We believe in the clinical benefit observed in Viaskin Peanut clinical trials to date and will continue to work closely with the FDA to potentially bring Viaskin Peanut to children as quickly as possible.” – by Janel Miller
DBV Technologies. DBV Technologies provides update on Viaskin Peanut BLA for children ages 4-11 Years. https://www.globenewswire.com/news-release/2020/03/16/2001453/0/en/DBV-Technologies-Provides-Update-on-Viaskin-Peanut-BLA-for-Children-Ages-4-11-Years.html. Accessed March 24, 2020.
Fleischer DM, et al. Open-label follow-up of the PEPITES Study (PEOPLE) to evaluate the long-term efficacy and safety of epicutaneous peanut immunotherapy in peanut-allergic children. American Academy of Allergy, Asthma and Immunology; March 13-16, 2020 (meeting canceled).
Pongracic JA, et al. Results of the REALISE (Real-life Use and Safety of EPIT) Study: A multicenter blinded randomized controlled trial investigating the safety of epicutaneous immunotherapy for peanut allergy in peanut-allergic children. American Academy of Allergy, Asthma and Immunology; March 13-16, 2020 (meeting canceled).
Remington B, et al. Modeled quantitative risk reduction through epicutaneous immunotherapy for peanut allergy: Restaurant meal preparation with shared cooking utensils and equipment. American Academy of Allergy, Asthma and Immunology; March 13-16, 2020 (meeting canceled).
Disclosures: Green is vice president of clinical development and medical affairs at DBV Technologies. Tassé is CEO of DBV Technologies.