NIH: A wearable patch that delivers small amounts of peanut protein
through the skin shows promise for treating children and young adults
with peanut allergy, with greater benefits for younger children,
according to one-year results from an ongoing clinical trial.
The treatment, called epicutaneous immunotherapy or EPIT, was safe and
well-tolerated, and nearly all participants used the skin patch daily as
directed.
“To avoid potentially life-threatening allergic reactions, people
with peanut allergy must be vigilant about the foods they eat and the
environments they enter, which can be very stressful,” said NIAID
Director Anthony S. Fauci, M.D. “One goal of experimental approaches
such as epicutaneous immunotherapy is to reduce this burden by training
the immune system to tolerate enough peanut to protect against
accidental ingestion or exposure.”
CoFAR researchers at five study sites randomly assigned 74
peanut-allergic volunteers aged 4 to 25 years to treatment with either a
high-dose (250 micrograms peanut protein), low-dose (100 micrograms
peanut protein), or placebo patch. The investigators assessed peanut
allergy at the beginning of the study with a supervised, oral food
challenge with peanut-containing food. The patches were developed and
provided by the biopharmaceutical company DBV Technologies under the
trade name Viaskin. Each day, study participants applied a new patch to
their arm or between their shoulder blades.
After one year, researchers assessed each participant’s ability to
consume at least 10 times more peanut protein than he or she was able to
consume before starting EPIT. The low-dose and high-dose regimens
offered similar benefits, with 46 percent of the low-dose group and 48
percent of the high-dose group achieving treatment success, compared
with 12 percent of the placebo group. In addition, the peanut patches
induced immune responses similar to those seen with other
investigational forms of immunotherapy for food allergy. Investigators
observed greater treatment effects among children aged 4 to 11 years,
with significantly less effect in participants aged 12 years and older.
“The clinical benefit seen in younger children highlights the promise
of this innovative approach to treating peanut allergy,” said Daniel
Rotrosen, M.D., director of NIAID’s Division of Allergy, Immunology and
Transplantation (DAIT). “Epicutaneous immunotherapy aims to engage the
immune system in the skin to train the body to tolerate small amounts of
allergen, whereas other recent advances have relied on an oral route
that appears difficult for approximately 10 to 15 percent of children
and adults to tolerate.”
Nearly all of the study participants followed the EPIT regimen as
directed. None reported serious reactions to the patch, although most
experienced mild skin reactions, such as itching or rash, at the site of
patch application.
“The high adherence to the daily peanut patch regimen suggests that
the patch is easy-to-use, convenient and safe,” said Marshall Plaut,
chief of DAIT’s Food Allergy, Atopic Dermatitis and Allergic Mechanisms
Section. “The results of this study support further investigation of
epicutaneous immunotherapy as a novel approach for peanut allergy
treatment.”
Additional studies in larger groups of children are needed before the
therapy could be approved for wider use. The CoFAR study continues to
assess the long-term safety and effectiveness of peanut EPIT. After the
first year, all participants began receiving high-dose daily patches,
and they will continue in the study for a total of two and a half years
of EPIT.
The work was funded by NIAID, NIH, under award numbers U19AI066738
and U01AI066560. Additional support was provided by NIH’s National
Center for Advancing Translational Sciences. The ClinicalTrials.gov identifier for the study Epicutaneous Immunotherapy for Peanut Allergy (CoFAR6) is NCT01904604.
The CoFAR clinical sites involved in the trial are Arkansas Children's
Hospital in Little Rock, National Jewish Health in Denver, The Johns
Hopkins University in Baltimore, Icahn School of Medicine at Mount Sinai
in New York and the University of North Carolina at Chapel Hill School
of Medicine.