PMID- 35973655 OWN - NLM STAT- MEDLINE DCOM- 20221206 LR - 20221210 IS - 1534-4436 (Electronic) IS - 1081-1206 (Linking) VI - 129 IP - 6 DP - 2022 Dec TI - Participant characteristics and safety outcomes of peanut oral immunotherapy in the RAMSES and ARC011 trials. PG - 758-768.e4 LID - S1081-1206(22)00657-3 [pii] LID - 10.1016/j.anai.2022.07.033 [doi] AB - 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. CI - Copyright (c) 2022 The Authors. Published by Elsevier Inc. All rights reserved. FAU - Ciaccio, Christina AU - Ciaccio C AD - The University of Chicago, Chicago, Illinois. Electronic address: cciaccio@bsd.uchicago.edu. FAU - Goldsobel, Alan B AU - Goldsobel AB AD - Allergy and Asthma Associates of Santa Clara Valley Research Center, San Jose, California. FAU - Anagnostou, Aikaterini AU - Anagnostou A AD - Texas Children's Hospital/Baylor College of Medicine, Houston, Texas. FAU - Beyer, Kirsten AU - Beyer K AD - Charite Universitatsmedizin Berlin, Berlin, Germany. FAU - Casale, Thomas B AU - Casale TB AD - University of South Florida, Tampa, Florida. FAU - Deschildre, Antoine AU - Deschildre A AD - Universite de Lille, CHU Lille, Pediatric Pulmonology and Allergy Unit, Hopital Jeanne de Flandre, Lille, France. FAU - Fernandez-Rivas, Montserrat AU - Fernandez-Rivas M AD - Allergy Department, Hospital Clinico San Carlos, UCM, IdISSC, Madrid, Spain. FAU - Hourihane, Jonathan O'B AU - Hourihane JO AD - Paediatrics and Child Health, Royal College of Surgeons in Ireland, Dublin, Ireland, UK. FAU - Krawiec, Marta AU - Krawiec M AD - Children's Allergy Service, Evelina London Children's Hospital, Guy's and St. Thomas' NHS Foundation Trust, London, UK. FAU - Lieberman, Jay AU - Lieberman J AD - The University of Tennessee Health Science Center, Memphis, Tennessee. FAU - Scurlock, Amy M AU - Scurlock AM AD - Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Arkansas. FAU - Vickery, Brian P AU - Vickery BP AD - Emory University School of Medicine, Atlanta, Georgia. FAU - Smith, Alex AU - Smith A AD - Aimmune Therapeutics, a Nestle Health Science company, Brisbane, California. FAU - Tilles, Stephen A AU - Tilles SA AD - Aimmune Therapeutics, a Nestle Health Science company, Brisbane, California. FAU - Adelman, Daniel C AU - Adelman DC AD - Aimmune Therapeutics, a Nestle Health Science company, Brisbane, California; Department of Medicine, University of California San Francisco, San Francisco, California. FAU - Brown, Kari R AU - Brown KR AD - Aimmune Therapeutics, a Nestle Health Science company, Brisbane, California. Electronic address: kbrown@aimmune.com. CN - RAMSES (ARC007) and ARC011 Study Groups: LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20220813 PL - United States TA - Ann Allergy Asthma Immunol JT - Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology JID - 9503580 RN - 0 (Allergens) RN - 0 (Immunologic Factors) SB - IM CIN - Ann Allergy Asthma Immunol. 2022 Dec;129(6):661-662. PMID: 36464393 MH - Child MH - Humans MH - *Arachis/adverse effects MH - *Peanut Hypersensitivity MH - Desensitization, Immunologic/adverse effects MH - Allergens MH - Skin Tests MH - Double-Blind Method MH - Administration, Oral MH - Immunologic Factors FIR - Assa'ad, Amal H IR - Assa'ad AH FIR - Bernstein, David I IR - Bernstein DI FIR - Bird, J Andrew IR - Bird JA FIR - Carr, Tara F IR - Carr TF FIR - Carr, Warner W IR - Carr WW FIR - Cheema, Amarjit S IR - Cheema AS FIR - Corren, Jonathan IR - Corren J FIR - Darter, Amy Liebl IR - Darter AL FIR - Dorsey, Morna J IR - Dorsey MJ FIR - Fineman, Stanley M IR - Fineman SM FIR - Fleischer, David M IR - Fleischer DM FIR - Fritz, Stephen B IR - Fritz SB FIR - Gogate, Shaila U IR - Gogate SU FIR - Greiner, Alexander N IR - Greiner AN FIR - Hampel, Frank C Jr IR - Hampel FC Jr FIR - Jacobs, Joshua S IR - Jacobs JS FIR - Jain, Sanjeev IR - Jain S FIR - Jarvinen-Seppo, Kirsi IR - Jarvinen-Seppo K FIR - Jeong, David K IR - Jeong DK FIR - Johnston, Douglas T IR - Johnston DT FIR - Kachru, Rita IR - Kachru R FIR - Kim, Edwin H IR - Kim EH FIR - Koleilat, Majed IR - Koleilat M FIR - Lanser, Bruce J IR - Lanser BJ FIR - Leonard, Stephanie A IR - Leonard SA FIR - Maier, Mary C IR - Maier MC FIR - Manning, Michael E IR - Manning ME FIR - Mansfield, Lyndon E IR - Mansfield LE FIR - Matz, Jonathan IR - Matz J FIR - Nadeau, Kari IR - Nadeau K FIR - Ohayon, Jason A IR - Ohayon JA FIR - Perez, Elena IR - Perez E FIR - Petroni, Daniel H IR - Petroni DH FIR - Pollard, Stephen J IR - Pollard SJ FIR - Ponda, Punita IR - Ponda P FIR - Portnoy, Jay M IR - Portnoy JM FIR - Rachid, Rima IR - Rachid R FIR - Ratner, Paul H IR - Ratner PH FIR - Robison, Rachel IR - Robison R FIR - Rupp, Ned T IR - Rupp NT FIR - Sanders, Georgiana M IR - Sanders GM FIR - Sharma, Hemant P IR - Sharma HP FIR - Sher, Ellen R IR - Sher ER FIR - Sher, Lawrence D IR - Sher LD FIR - Sher, Mandel IR - Sher M FIR - Shreffler, Wayne G IR - Shreffler WG FIR - Siri, Dareen D IR - Siri DD FIR - Skolnick, Helen S IR - Skolnick HS FIR - Soong, Weily IR - Soong W FIR - Soteres, Daniel F IR - Soteres DF FIR - Spergel, Jonathan M IR - Spergel JM FIR - Stillerman, Allan IR - Stillerman A FIR - Sussman, Gordon L IR - Sussman GL FIR - Tam, Jonathan IR - Tam J FIR - Varshney, Pooja IR - Varshney P FIR - Waserman, Susan IR - Waserman S FIR - Windom, Hugh H IR - Windom HH FIR - Wood, Robert IR - Wood R FIR - Yang, William H IR - Yang WH EDAT- 2022/08/17 06:00 MHDA- 2022/12/07 06:00 CRDT- 2022/08/16 19:34 PHST- 2022/06/07 00:00 [received] PHST- 2022/07/28 00:00 [revised] PHST- 2022/07/29 00:00 [accepted] PHST- 2022/08/17 06:00 [pubmed] PHST- 2022/12/07 06:00 [medline] PHST- 2022/08/16 19:34 [entrez] AID - S1081-1206(22)00657-3 [pii] AID - 10.1016/j.anai.2022.07.033 [doi] PST - ppublish SO - Ann Allergy Asthma Immunol. 2022 Dec;129(6):758-768.e4. doi: 10.1016/j.anai.2022.07.033. Epub 2022 Aug 13.