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. Carr; Warner 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

doi:10.1016/j.anai.2022.07.033

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 journal › Article › peer-review

3 Scopus citations

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.

Original language	English (US)
Pages (from-to)	758-768.e4
Journal	Annals of Allergy, Asthma and Immunology
Volume	129
Issue number	6
DOIs	https://doi.org/10.1016/j.anai.2022.07.033
State	Published - Dec 2022

ASJC Scopus subject areas

Immunology and Allergy
Immunology
Pulmonary and Respiratory Medicine

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Ciaccio, C., Goldsobel, A. B., Anagnostou, A., Beyer, K., Casale, T. B., Deschildre, A., Fernández-Rivas, M., Hourihane, J. O. B., Krawiec, M., Lieberman, J., Scurlock, A. M., Vickery, B. P., Smith, A., Tilles, S. A., Adelman, D. C., Brown, K. R., Assa'ad, A. H., Bernstein, D. I., Bird, J. A., ... Yang, W. H. (2022). Participant characteristics and safety outcomes of peanut oral immunotherapy in the RAMSES and ARC011 trials. Annals of Allergy, Asthma and Immunology, 129(6), 758-768.e4. https://doi.org/10.1016/j.anai.2022.07.033

Ciaccio, C, Goldsobel, AB, Anagnostou, A, Beyer, K, Casale, TB, Deschildre, A, Fernández-Rivas, M, Hourihane, JOB, Krawiec, M, Lieberman, J, Scurlock, AM, Vickery, BP, Smith, A, Tilles, SA, Adelman, DC, Brown, KR, Assa'ad, AH, Bernstein, DI, Bird, JA, Carr, TF, Carr, WW, Cheema, AS, Corren, J, Darter, AL, Dorsey, MJ, Fineman, SM, Fleischer, DM, Fritz, SB, Gogate, SU, Greiner, AN, Hampel, FC, Jacobs, JS, Jain, S, Jarvinen-Seppo, K, Jeong, DK, Johnston, DT, Kachru, R, Kim, EH, Koleilat, M, Lanser, BJ, Leonard, SA, Maier, MC, Manning, ME, Mansfield, LE, Matz, J, Nadeau, K, Ohayon, JA, Perez, E, Petroni, DH, Pollard, SJ, Ponda, P, Portnoy, JM, Rachid, R, Ratner, PH, Robison, R, Rupp, NT, Sanders, GM, Sharma, HP, Sher, ER, Sher, LD, Sher, M, Shreffler, WG, Siri, DD, Skolnick, HS, Soong, W, Soteres, DF, Spergel, JM, Stillerman, A, Sussman, GL, Tam, J, Varshney, P, Waserman, S, Windom, HH, Wood, R & Yang, WH 2022, 'Participant characteristics and safety outcomes of peanut oral immunotherapy in the RAMSES and ARC011 trials', Annals of Allergy, Asthma and Immunology, vol. 129, no. 6, pp. 758-768.e4. https://doi.org/10.1016/j.anai.2022.07.033

@article{843cd5b2d5ea468d838eb84b67957591,

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 = "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",

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TY - JOUR

T1 - Participant characteristics and safety outcomes of peanut oral immunotherapy in the RAMSES and ARC011 trials

AU - Ciaccio, Christina

AU - Goldsobel, Alan B.

AU - Anagnostou, Aikaterini

AU - Beyer, Kirsten

AU - Casale, Thomas B.

AU - Deschildre, Antoine

AU - Fernández-Rivas, Montserrat

AU - Hourihane, Jonathan O.B.

AU - Krawiec, Marta

AU - Lieberman, Jay

AU - Scurlock, Amy M.

AU - Vickery, Brian P.

AU - Smith, Alex

AU - Tilles, Stephen A.

AU - Adelman, Daniel C.

AU - Brown, Kari R.

AU - Assa'ad, Amal H.

AU - Bernstein, David I.

AU - Bird, J. Andrew

AU - Carr, Tara F.

AU - Carr, Warner W.

AU - Cheema, Amarjit S.

AU - Corren, Jonathan

AU - Darter, Amy Liebl

AU - Dorsey, Morna J.

AU - Fineman, Stanley M.

AU - Fleischer, David M.

AU - Fritz, Stephen B.

AU - Gogate, Shaila U.

AU - Greiner, Alexander N.

AU - Hampel, Frank C.

AU - Jacobs, Joshua S.

AU - Jain, Sanjeev

AU - Jarvinen-Seppo, Kirsi

AU - Jeong, David K.

AU - Johnston, Douglas T.

AU - Kachru, Rita

AU - Kim, Edwin H.

AU - Koleilat, Majed

AU - Lanser, Bruce J.

AU - Leonard, Stephanie A.

AU - Maier, Mary C.

AU - Manning, Michael E.

AU - Mansfield, Lyndon E.

AU - Matz, Jonathan

AU - Nadeau, Kari

AU - Ohayon, Jason A.

AU - Perez, Elena

AU - Petroni, Daniel H.

AU - Pollard, Stephen J.

AU - Ponda, Punita

AU - Portnoy, Jay M.

AU - Rachid, Rima

AU - Ratner, Paul H.

AU - Robison, Rachel

AU - Rupp, Ned T.

AU - Sanders, Georgiana M.

AU - Sharma, Hemant P.

AU - Sher, Ellen R.

AU - Sher, Lawrence D.

AU - Sher, Mandel

AU - Shreffler, Wayne G.

AU - Siri, Dareen D.

AU - Skolnick, Helen S.

AU - Soong, Weily

AU - Soteres, Daniel F.

AU - Spergel, Jonathan M.

AU - Stillerman, Allan

AU - Sussman, Gordon L.

AU - Tam, Jonathan

AU - Varshney, Pooja

AU - Waserman, Susan

AU - Windom, Hugh H.

AU - Wood, Robert

AU - Yang, William H.

PY - 2022/12

Y1 - 2022/12

N2 - 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.

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.

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DO - 10.1016/j.anai.2022.07.033

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AN - SCOPUS:85142151493

SN - 1081-1206

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SP - 758-768.e4

JO - Annals of Allergy, Asthma and Immunology

JF - Annals of Allergy, Asthma and Immunology

IS - 6

ER -

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

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