Details

Autor(en) / Beteiligte

• Fleischer, David M.
• Shreffler, Wayne G.
• Campbell, Dianne E.
• Green, Todd D.
• Anvari, Sara
• Assa’ad, Amal
• Bégin, Philippe
• Beyer, Kirsten
• Bird, J. Andrew
• Brown-Whitehorn, Terri
• Byrne, Aideen
• Chan, Edmond S.
• Cheema, Amarjit
• Chinthrajah, Sharon
• Chong, Hey Jin
• Davis, Carla M.
• Ford, Lara S.
• Gagnon, Rémi
• Greenhawt, Matthew
• Hourihane, Jonathan O’B.
• Jones, Stacie M.
• Kim, Edwin H.
• Lange, Lars
• Lanser, Bruce J.
• Leonard, Stephanie
• Mahler, Vera
• Maronna, Andreas
• Nowak-Wegrzyn, Anna
• Oriel, Roxanne C.
• O’Sullivan, Michael
• Petroni, Daniel
• Pongracic, Jacqueline A.
• Prescott, Susan L.
• Schneider, Lynda C.
• Smith, Peter
• Staab, Doris
• Sussman, Gordon
• Wood, Robert
• Yang, William H.
• Lambert, Romain
• Peillon, Aurélie
• Bois, Timothée
• Sampson, Hugh A.

Titel

Long-term, open-label extension study of the efficacy and safety of epicutaneous immunotherapy for peanut allergy in children: PEOPLE 3-year results

Ist Teil von

• Journal of allergy and clinical immunology, 2020-10, Vol.146 (4), p.863-874

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2020

Quelle

MEDLINE

Beschreibungen/Notizen

• The PEPITES (Peanut EPIT Efficacy and Safety) trial, a 12-month randomized controlled study of children with peanut allergy and 4 to 11 years old, previously reported the safety and efficacy of epicutaneous immunotherapy (EPIT) for peanut allergy (250 μg, daily epicutaneous peanut protein; DBV712 250 μg). We sought to assess interim safety and efficacy of an additional 2 years of EPIT from the ongoing (5-year treatment) PEOPLE (PEPITES Open-Label Extension) study. Subjects who completed PEPITES were offered enrollment in PEOPLE. Following an additional 2 years of daily DBV712 250 μg, subjects who had received DBV712 250 μg in PEPITES underwent month-36 double-blind, placebo-controlled food challenge with an optional month-38 sustained unresponsiveness assessment. Of 213 eligible subjects who had received DBV712 250 μg in PEPITES, 198 (93%) entered PEOPLE, of whom 141 (71%) had assessable double-blind, placebo-controlled food challenge at month 36. At month 36, 51.8% of subjects (73 of 141) reached an eliciting dose of ≥1000 mg, compared with 40.4% (57 of 141) at month 12; 75.9% (107 of 141) demonstrated increased eliciting dose compared with baseline; and 13.5% (19 of 141) tolerated the full double-blind, placebo-controlled food challenge of 5444 mg. Median cumulative reactive dose increased from 144 to 944 mg. Eighteen subjects underwent an optional sustained unresponsiveness assessment; 14 of those (77.8%) maintained an eliciting dose of ≥1000 mg at month 38. Local patch-site skin reactions were common but decreased over time. There was no treatment-related epinephrine use in years 2 or 3. Compliance was high (96.9%), and withdrawals due to treatment-related adverse events were low (1%). These results demonstrate that daily EPIT treatment for peanut allergy beyond 1 year leads to continued response from a well-tolerated, simple-to-use regimen.