Publication

AR101 Oral Immunotherapy for Peanut Allergy

PALISADE Grp Clinical, Vickery, B. P., Vereda, A., Casale, T. B., Beyer, K., du Toit, G., Hourihane, J. O., Jones, S. M., Shreffler, W. G., Marcantonio, A., Zawadzki, R., Sher, L., Carr, W. W., Fineman, S., Greos, L., Rachid, R., Ibanez, M. D., Tilles, S., Assa'ad, A. H., Nilsson, C., Rupp, N., Welch, M. J., Sussman, G., Chinthrajah, S., Blumchen, K., Sher, E., Spergel, J. M., Leickly, F. E., Zielen, S., Wang, J., Sanders, G. M., Wood, R. A., Cheema, A., Bindslev-Jensen, C., Leonard, S., Kachru, R., Johnston, D. T., Hampel, F. C., Kim, E. H., Anagnostou, A., Pongracic, J. A., Ben-Shoshan, M., Sharma, H. P., Stillerman, A., Windom, H. H., Yang, W. H., Muraro, A., Zubeldia, J. M., Sharma, V., Dorsey, M. J., Dubois, A. E. J. & Oude Elberink, J. N. G., 22-Nov-2018, In : New England Journal of Medicine. 379, 21, p. 1991-2001 11 p.

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  • AR101 Oral Immunotherapy for Peanut Allergy

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DOI

  • PALISADE Grp Clinical
  • Brian P. Vickery
  • Andrea Vereda
  • Thomas B. Casale
  • Kirsten Beyer
  • George du Toit
  • Jonathan O. Hourihane
  • Stacie M. Jones
  • Wayne G. Shreffler
  • Annette Marcantonio
  • Rezi Zawadzki
  • Lawrence Sher
  • Warner W. Carr
  • Stanley Fineman
  • Leon Greos
  • Rima Rachid
  • M. Dolores Ibanez
  • Stephen Tilles
  • Amal H. Assa'ad
  • Caroline Nilsson
  • Ned Rupp
  • Michael J. Welch
  • Gordon Sussman
  • Sharon Chinthrajah
  • Katharina Blumchen
  • Ellen Sher
  • Jonathan M. Spergel
  • Frederick E. Leickly
  • Stefan Zielen
  • Julie Wang
  • Georgiana M. Sanders
  • Robert A. Wood
  • Amarjit Cheema
  • Carsten Bindslev-Jensen
  • Stephanie Leonard
  • Rita Kachru
  • Douglas T. Johnston
  • Frank C. Hampel
  • Edwin H. Kim
  • Aikaterini Anagnostou
  • Jacqueline A. Pongracic
  • Moshe Ben-Shoshan
  • Hemant P. Sharma
  • Allan Stillerman
  • Hugh H. Windom
  • William H. Yang
  • Antonella Muraro
  • Jose M. Zubeldia
  • Vibha Sharma
  • Morna J. Dorsey
  • Anthony E. J. Dubois
  • Joanna N.G. Oude Elberink

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

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.

Original languageEnglish
Pages (from-to)1991-2001
Number of pages11
JournalNew England Journal of Medicine
Volume379
Issue number21
Publication statusPublished - 22-Nov-2018

    Keywords

  • FOOD ALLERGY, NATURAL-HISTORY, DOUBLE-BLIND, GUIDELINES, CHILDREN, PREVALENCE, DIAGNOSIS, SAFETY

ID: 79508646