Immunologic assessments from ARTEMIS: A European, phase 3, randomized, double-blind, placebo-controlled trial of AR101 in peanut-allergic subjects aged 4–17 years - 09/09/21
, C. Nilsson 2, K. Beyer 3, M. Fernández-Rivas 4, G. du Toit 5, P.J. Turner 6, K. Blümchen 7, M. Dolores Ibáñez 8, A. Deschildre 9, A. Muraro 10, V. Sharma 11, M. Erlewyn-Lajeunesse 12, J. Manuel Zubeldia 13, 14, F. De Blay 15, A. Byrne 16, J. Chapman 17, F. Boralevi 18, K. Hylands 19, D. Norval 19, A. Abbas 19, J.O.B. Hourihane 20, 21Bienvenue sur EM-consulte, la référence des professionnels de santé.
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Résumé |
Introduction |
In ARTEMIS, 58% of AR101-treated subjects vs. 2% of placebo-treated subjects tolerated 1000mg peanut protein as a single dose at exit double-blind, placebo-controlled food challenge (DBPCFC; P<0.0001) following treatment with AR101, an investigational oral biologic drug product for peanut oral immunotherapy. Immune responses to AR101 were assessed at 3 timepoints and compared with the placebo treatment group.
Methods |
All enrolled subjects had a clinical history of peanut allergy, demonstrated sensitization to peanut (skin prick test [SPT] mean wheal diameter ≥3mm and/or peanut-specific immunoglobulin E [psIgE] ≥0.35kUA/L), and reacted to ≤300mg peanut protein at screening DBPCFC. SPT wheal diameter (mm), psIgE (kUA/L) and psIgG4 (mgA/L) assessments were performed at screening, end of dose escalation and study completion (following 3 months at 300mg/day). Differences between treatment groups from screening to exit were analyzed using an ANCOVA model with terms fitted for group, country and screening value.
Results |
A total of 175 ARTEMIS subjects (AR101 n=132, placebo n=43) were treated. SPT wheal diameter, psIgE levels, psIgG4 levels and psIgE/IgG4 ratio are summarized in Table 1. From baseline to exit (AR101 vs. placebo), psIgG4 levels increased (P<0.0001); SPT wheal diameter (P<0.0001) and psIgE/psIgG4 (P<0.0001) decreased. In AR101-treated subjects, psIgE levels 2 increased at the end of dose escalation and decreased back to baseline levels, with no change between treatment groups (P=0.6089) from baseline to exit.
Conclusion |
Exposure to AR101 was associated with immunologic changes consistent with immunomodulation: increased psIgG4, decreased peanut SPT wheal size and transient changes in psIgE levels, as reported in previous peanut oral immunotherapy trials.
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Vol 61 - N° 5
P. 340-341 - septembre 2021 Retour au numéro
Article précédent
- Safety and efficacy comparison : ARTEMIS and PALISADE phase 3 studies of AR101 in peanut allergy
- A. Deschildre, E.R. Sher, J.O.B. Hourihane, W.W. Carr, K. Beyer, N.M. Griffin, A. Vereda, D. Norval, G.R. Toit, D.C. Adelman, E.H. Kim
- Description of two anaphylaxis phenotypes in children: The utility of a clustering analysis
- G. Pouessel, J.C. Dubus, S. Lejeune, H. Béhal, A. Deschildre, J. Corriger
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