Participant characteristics and safety outcomes of peanut oral immunotherapy in the RAMSES and ARC011 trials

Christina Ciaccio, Alan B. Goldsobel, Aikaterini Anagnostou, Kirsten Beyer, Thomas B. Casale, Antoine Deschildre, Montserrat Fernández-Rivas, Jonathan O.B. Hourihane, Marta Krawiec, Jay Lieberman, Amy M. Scurlock, Brian P. Vickery, Alex Smith, Stephen A. Tilles, Daniel C. Adelman, Kari R. Brown, Amal H. Assa'ad, David I. Bernstein, J. Andrew Bird, Tara F. CarrWarner W. Carr, Amarjit S. Cheema, Jonathan Corren, Amy Liebl Darter, Morna J. Dorsey, Stanley M. Fineman, David M. Fleischer, Stephen B. Fritz, Shaila U. Gogate, Alexander N. Greiner, Frank C. Hampel, Joshua S. Jacobs, Sanjeev Jain, Kirsi Jarvinen-Seppo, David K. Jeong, Douglas T. Johnston, Rita Kachru, Edwin H. Kim, Majed Koleilat, Bruce J. Lanser, Stephanie A. Leonard, Mary C. Maier, Michael E. Manning, Lyndon E. Mansfield, Jonathan Matz, Kari Nadeau, Jason A. Ohayon, Elena Perez, Daniel H. Petroni, Stephen J. Pollard, Punita Ponda, Jay M. Portnoy, Rima Rachid, Paul H. Ratner, Rachel Robison, Ned T. Rupp, Georgiana M. Sanders, Hemant P. Sharma, Ellen R. Sher, Lawrence D. Sher, Mandel Sher, Wayne G. Shreffler, Dareen D. Siri, Helen S. Skolnick, Weily Soong, Daniel F. Soteres, Jonathan M. Spergel, Allan Stillerman, Gordon L. Sussman, Jonathan Tam, Pooja Varshney, Susan Waserman, Hugh H. Windom, Robert Wood, William H. Yang

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish (US)
Pages (from-to)758-768.e4
JournalAnnals of Allergy, Asthma and Immunology
Issue number6
StatePublished - Dec 2022

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Immunology and Allergy
  • Immunology


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