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

Author

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

Published
2022
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2. Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children: REALISE Randomized Clinical Trial Results

Author

Pongracic, Jacqueline A., Gagnon, Rémi, Sussman, Gordon, Siri, Dareen, Oriel, Roxanne C., Brown-Whitehorn, Terri F., Green, Todd D., Campbell, Dianne E., Anvari, Sara, Berger, William E., Bird, J. Andrew, Chan, Edmond S., Cheema, Amarjit, Chinthrajah, R. Sharon, Chong, Hey Jin, Dowling, Paul J., Fineman, Stanley M., Fleischer, David M., Gonzalez-Reyes, Erika, Kim, Edwin H., Lanser, Bruce J., MacGinnitie, Andrew, Mehta, Hemalini, Petroni, Daniel, Rupp, Ned, Schneider, Lynda C., Scurlock, Amy M., Sher, Lawrence D., Shreffler, Wayne G., Sindher, Sayantani B., Stillerman, Allan, Wood, Robert, Yang, William H., Bois, Timothée, Sampson, Hugh A., and Bégin, Philippe

Published
2022
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3. Participant characteristics and safety outcomes of peanut oral immunotherapy in the RAMSES and ARC011 trials

Author

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

Published
2022
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8. Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children: REALISE Randomized Clinical Trial Results

Author

Pongracic, Jacqueline A., Gagnon, Rémi, Sussman, Gordon, Siri, Dareen, Oriel, Roxanne C., Brown-Whitehorn, Terri, Green, Todd D., Campbell, Dianne E., Anvari, Sara, Berger, William E., Bird, J. Andrew, Chan, Edmond S., Cheema, Amarijit, Chinthrajah, Sharon, Chong, Hey, Dowling, Paul J., Fineman, Stanley M., Fleischer, David M., Gonzalez-Reyes, Erika, Kim, Edwin H., Lanser, Bruce J., MacGinnitie, Andrew, Mehta, Hemalini, Petroni, Daniel, Rupp, Ned, Schneider, Lynda C., Scurlock, Amy M., Sher, Lawrence D., Shreffler, Wayne G., Sindher, Sayantani B., Stillerman, Allan, Wood, Robert, Yang, William H., Bois, Timothée, Sampson, Hugh A., and Bégin, Philippe

Abstract

Treatment options for peanut allergy are limited. In previous clinical trials, epicutaneous immunotherapy with a patch containing 250-μg peanut protein (Viaskin Peanut 250 μg [VP250]) was well tolerated and statistically superior to placebo in desensitizing peanut-allergic children.

Published
2021
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12. AR101 Oral Immunotherapy for Peanut Allergy.

Author

Vickery BP, Vereda A, Casale TB, Beyer K, du Toit G, Hourihane JO, Jones SM, Shreffler WG, Marcantonio A, Zawadzki R, Sher L, Carr WW, Fineman S, Greos L, Rachid R, Ibáñez MD, Tilles S, Assa’ad AH, Nilsson C, Rupp N, Welch MJ, Sussman G, Chinthrajah S, Blumchen K, Sher E, Spergel JM, Leickly FE, Zielen S, Wang J, Sanders GM, Wood RA, Cheema A, Bindslev-Jensen C, Leonard S, Kachru R, Johnston DT, Hampel FC Jr, Kim EH, Anagnostou A, Pongracic JA, Ben-Shoshan M, Sharma HP, Stillerman A, Windom HH, Yang WH, Muraro A, Zubeldia JM, Sharma V, Dorsey MJ, Chong HJ, Ohayon J, Bird JA, Carr TF, Siri D, Fernández-Rivas M, Jeong DK, Fleischer DM, Lieberman JA, Dubois AEJ, Tsoumani M, Ciaccio CE, Portnoy JM, Mansfield LE, Fritz SB, Lanser BJ, Matz J, Oude Elberink HNG, Varshney P, Dilly SG, Adelman DC, and Burks AW

Subjects
Administration, Oral, Adolescent, Adult, Age Factors, Allergens adverse effects, Biological Products adverse effects, Biological Products immunology, Child, Child, Preschool, Desensitization, Immunologic adverse effects, Dose-Response Relationship, Immunologic, Double-Blind Method, Female, Gastrointestinal Diseases etiology, Humans, Male, Middle Aged, Plant Proteins adverse effects, Plant Proteins immunology, Young Adult, Allergens administration & dosage, Arachis adverse effects, Biological Products administration & dosage, Desensitization, Immunologic methods, Peanut Hypersensitivity therapy, Plant Proteins administration & dosage
Abstract

Background: Peanut allergy, for which there are no approved treatment options, affects patients who are at risk for unpredictable and occasionally life-threatening allergic reactions., Methods: In a phase 3 trial, we screened participants 4 to 55 years of age with peanut allergy for allergic dose-limiting symptoms at a challenge dose of 100 mg or less of peanut protein (approximately one third of a peanut kernel) in a double-blind, placebo-controlled food challenge. Participants with an allergic response were randomly assigned, in a 3:1 ratio, to receive AR101 (a peanut-derived investigational biologic oral immunotherapy drug) or placebo in an escalating-dose program. Participants who completed the regimen (i.e., received 300 mg per day of the maintenance regimen for approximately 24 weeks) underwent a double-blind, placebo-controlled food challenge at trial exit. The primary efficacy end point was the proportion of participants 4 to 17 years of age who could ingest a challenge dose of 600 mg or more, without dose-limiting symptoms., Results: Of the 551 participants who received AR101 or placebo, 496 were 4 to 17 years of age; of these, 250 of 372 participants (67.2%) who received active treatment, as compared with 5 of 124 participants (4.0%) who received placebo, were able to ingest a dose of 600 mg or more of peanut protein, without dose-limiting symptoms, at the exit food challenge (difference, 63.2 percentage points; 95% confidence interval, 53.0 to 73.3; P<0.001). During the exit food challenge, the maximum severity of symptoms was moderate in 25% of the participants in the active-drug group and 59% of those in the placebo group and severe in 5% and 11%, respectively. Adverse events during the intervention period affected more than 95% of the participants 4 to 17 years of age. A total of 34.7% of the participants in the active-drug group had mild events, as compared with 50.0% of those in the placebo group; 59.7% and 44.4% of the participants, respectively, had events that were graded as moderate, and 4.3% and 0.8%, respectively, had events that were graded as severe. Efficacy was not shown in the participants 18 years of age or older., Conclusions: In this phase 3 trial of oral immunotherapy in children and adolescents who were highly allergic to peanut, treatment with AR101 resulted in higher doses of peanut protein that could be ingested without dose-limiting symptoms and in lower symptom severity during peanut exposure at the exit food challenge than placebo. (Funded by Aimmune Therapeutics; PALISADE ClinicalTrials.gov number, NCT02635776 .).

Published
2018
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