@article{1b3e88af65774d9790b5dd5d154d29ef,
title = "Participant characteristics and safety outcomes of peanut oral immunotherapy in the RAMSES and ARC011 trials",
abstract = "Background: Clinical trials (PALISADE [ARC003], ARTEMIS [ARC010]) proving efficacy and safety of peanut (Arachis hypogaea) allergen powder-dnfp (PTAH) have used double-blind, placebo-controlled food challenges (DBPCFCs) to screen for eligibility and to evaluate efficacy. In routine clinical practice, individuals with peanut allergy do not always undergo food challenges to confirm diagnosis or determine candidacy for treatment. Objective: To describe PTAH safety and tolerability in participants selected by clinical history and peanut sensitization parameters not undergoing DBPCFCs during trials and to compare findings with previously published data. Methods: RAMSES (ARC007) was a 6-month, phase 3, randomized, double-blind, placebo-controlled trial in children aged 4 to 17 years with physician-confirmed peanut allergy. ARC011 was the subsequent 6-month follow-on maintenance PTAH study. The primary end point for RAMSES and ARC011 was the frequency of treatment-emergent adverse events (AEs). We descriptively compared baseline characteristics and safety outcomes from RAMSES and ARC011 to participants undergoing DBPCFCs in phase 3 PALISADE and ARTEMIS trials. Results: In 506 patients randomized to study treatment, baseline characteristics appeared balanced among groups. Proportion of participants with at least 1 AE was 55% for PTAH vs 33.9% for placebo during initial dose escalation and 98.8% vs 94.0% during updosing, respectively. Most participants with AEs had mild or moderate events. The most common AEs were gastrointestinal. Comparisons to pooled PALISADE and ARTEMIS data revealed higher baseline median peanut-specific immunoglobulin E and skin prick test values for RAMSES participants. Safety outcomes during trial periods were comparable. Conclusion: Safety data from clinically selected children with peanut allergy receiving PTAH do not seem different from those in phase 3 trials requiring DBPCFC to enter trials.",
author = "Christina Ciaccio and Goldsobel, {Alan B.} and Aikaterini Anagnostou and Kirsten Beyer and Casale, {Thomas B.} and Antoine Deschildre and Montserrat Fern{\'a}ndez-Rivas and Hourihane, {Jonathan O.B.} and Marta Krawiec and Jay Lieberman and Scurlock, {Amy M.} and Vickery, {Brian P.} and Alex Smith and Tilles, {Stephen A.} and Adelman, {Daniel C.} and Brown, {Kari R.} and Assa'ad, {Amal H.} and Bernstein, {David I.} and Bird, {J. Andrew} and Carr, {Tara F.} and Carr, {Warner W.} and Cheema, {Amarjit S.} and Jonathan Corren and Darter, {Amy Liebl} and Dorsey, {Morna J.} and Fineman, {Stanley M.} and Fleischer, {David M.} and Fritz, {Stephen B.} and Gogate, {Shaila U.} and Greiner, {Alexander N.} and Hampel, {Frank C.} and Jacobs, {Joshua S.} and Sanjeev Jain and Kirsi Jarvinen-Seppo and Jeong, {David K.} and Johnston, {Douglas T.} and Rita Kachru and Kim, {Edwin H.} and Majed Koleilat and Lanser, {Bruce J.} and Leonard, {Stephanie A.} and Maier, {Mary C.} and Manning, {Michael E.} and Mansfield, {Lyndon E.} and Jonathan Matz and Kari Nadeau and Ohayon, {Jason A.} and Elena Perez and Petroni, {Daniel H.} and Pollard, {Stephen J.} and Punita Ponda and Portnoy, {Jay M.} and Rima Rachid and Ratner, {Paul H.} and Rachel Robison and Rupp, {Ned T.} and Sanders, {Georgiana M.} and Sharma, {Hemant P.} and Sher, {Ellen R.} and Sher, {Lawrence D.} and Mandel Sher and Shreffler, {Wayne G.} and Siri, {Dareen D.} and Skolnick, {Helen S.} and Weily Soong and Soteres, {Daniel F.} and Spergel, {Jonathan M.} and Allan Stillerman and Sussman, {Gordon L.} and Jonathan Tam and Pooja Varshney and Susan Waserman and Windom, {Hugh H.} and Robert Wood and Yang, {William H.}",
note = "Funding Information: Funding: This study was funded by Aimmune Therapeutics, a Nestl{\'e} Health Science company. Funding Information: Disclosures: Dr Ciaccio reports receiving personal fees from Aimmune, Novartis, and DBV, outside the submitted work. Dr Goldsobel reports receiving clinical research grants from Cour Pharmaceuticals, Aimmune Therapeutics, and Novartis and participating on an advisory board for Aimmune Therapeutics. Dr Anagnostou reports receiving grants from Aimmune Therapeutics during the conduct of the study; personal fees from DBV Technologies; grants and personal fees from FARE; and personal fees from ALK, outside the submitted work. Dr Beyer reports receiving grants from ALK and DBV made to their institution; receiving consulting fees from Aimmune Therapeutics, Bencard, DBV, Nestl{\'e}, and Novartis; receiving payments from Aimmune Therapeutics, Allergopharma, and Nestl{\'e} for lectures, presentations, speakers bureaus, manuscript writing, or educational events; having participated on a data safety monitoring board or advisory board for Aimmune Therapeutics, Bencard, DBV, Nestl{\'e}, and Novartis; and further holding an unpaid leadership or fiduciary role for Anaphylaxis Training and Education (AGATE), German Society for Pediatric Allergology & Environmental Medicine (GPA), German Society for Allergology & Clinical Immunology (DGKJ), and German Allergy and Asthma Association (DAAB). Dr Casale reports receiving other support from FARE, outside the submitted work. Dr Deschildre reports receiving consulting fees from Aimmune Therapeutics, DBV Technologies, Nestl{\'e} Health Science, Nutricia, and Novartis; receiving payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from ALK, DBV Technologies, and Aimmune Therapeutics; receiving support for attending meetings or travel from DBV Technologies, Nutricia, AstraZeneca, and Novartis; receiving payments from Aimmune Therapeutics and Novartis for participation on a data safety monitoring board or advisory board; and being a member of the Scientific committee of SFA (Soci{\'e}t{\'e} Fran{\c c}aise d'Allergologie) (ongoing) and SP2A (Soci{\'e}t{\'e} P{\'e}diatrique de Pneumologie et Allergologie) (stopped in 2019) and a president of the CICBAA (Cercle d'investigations Cliniques et Biologiques en Allergie Alimentaire) (2017-2020). Dr Fern{\'a}ndez-Rivas reports receiving lecture fees from Aimmune Therapeutics, ALK, Diater, Ga2LEN, and HAL Allergy; receiving payments for educational events for GlaxoSmithKline, MEDSCAPE, and Novartis; and having participated on a data safety monitoring board for DBV and on advisory boards for Aimmune Therapeutics, Novartis, and SPRIM. Dr Hourihane reports receiving advisory board fees from Aimmune Therapeutics; speakers bureau from Aimmune Therapeutics, DBV Technologies, Nutricia, and Mead Johnson; grants to institution or research funding and clinical trials within the past 2 years from Aimmune Therapeutics, DBV Technologies, Johnson & Johnson, National Children's Research Centre Ireland, and The City of Dublin Skin and Cancer Hospital Charity. Dr Lieberman reports receiving grants paid to their institution from Aimmune Therapeutics, DBV Technologies, and Regeneron; and honoraria for participating on an advisory board for Aimmune Therapeutics, DBV Technologies, and Genentech. Dr Scurlock reports receiving grants or contracts from Food Allergy Research and Education, National Institutes of Health and National Institute of Allergy and Infectious Diseases, DBV Technologies, and Regeneron; and consulting fees from DBV Technologies. Dr Vickery reports receiving advisory board or consultant fees from Aimmune, Allergenis, Aravax, DBV, FARE, Reacta, and Regeneron; serving as site investigator for Aimmune, DBV, Genentech, Novartis, Regeneron, and Siolta; having stock options from Moonlight; and receiving research grants from FARE and National Institute of Allergy and Infectious Diseases. Dr Smith, Dr Tilles, and Dr Brown are employees of Aimmune Therapeutics. Dr Adelman is currently serving as a consultant for Aimmune Therapeutics; and having patents pending for the following: US 16/542,198; PCT/US2019/046706; US 16/721,805; and PCT/US2019/067634. Dr Krawiec has no disclosures to report. Publisher Copyright: {\textcopyright} 2022 The Authors",
year = "2022",
month = dec,
doi = "10.1016/j.anai.2022.07.033",
language = "English (US)",
volume = "129",
pages = "758--768.e4",
journal = "Annals of Allergy, Asthma and Immunology",
issn = "1081-1206",
publisher = "American College of Allergy, Asthma and Immunology",
number = "6",
}