Safety and efficacy comparison : ARTEMIS and PALISADE phase 3 studies of AR101 in peanut allergy - 09/09/21
, E.R. Sher 2, J.O.B. Hourihane 3, 4, W.W. Carr 5, K. Beyer 6, N.M. Griffin 7, A. Vereda 8, D. Norval 8, G.R. Toit 9, D.C. Adelman 7, 10, E.H. Kim 11Bienvenue sur EM-consulte, la référence des professionnels de santé.
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Résumé |
Introduction |
AR101, an investigational oral biologic drug for peanut oral immunotherapy, was studied in PALISADE and ARTEMIS phase 3 trials. Efficacy and safety are compared.
Methods |
Subjects demonstrated clinical history of peanut allergy; peanut-specific immunoglobulin E≥0.35kUA/L and/or skin-prick test ≥3mm; reacted to ≤100mg (PALISADE)/≤300mg peanut protein (ARTEMIS) at screening double-blind, placebo-controlled food challenge (DBPCFC). After dose escalation to 300mg/day (6 months), 300mg/day dosing continued (PALISADE, 6 months; ARTEMIS, 3 months). Results are reported in subjects 4-17-years-old (intention-to-treat/safety populations).
Results |
A total of 496 PALISADE (AR101 n=372, placebo n=124) and 175 ARTEMIS (n=132, n=43) subjects were treated. Ability to tolerate 300mg, 600mg or 1000mg peanut protein at exit DBPCFC was similar (PALISADE vs ARTEMIS; AR101 : 76.6% vs 73.5%, 67.2% vs 68.2%, 50.3% vs 58.3%; placebo : 8.1% vs 16.3%, 4.0% vs 9.3%, 2.4% vs 2.3%). Most treatment-emergent adverse events (TEAEs) were mild/moderate (AR101, placebo : PALISADE 94.4%, 94.4%; ARTEMIS 97.7%, 97.7%); frequency decreased from dose-escalation to 300mg/day dosing (X). For dose-escalation in-clinic TEAEs, range of median times to symptom onset following ingestion and times from first symptom onset to last symptom resolution were similar (AR101, placebo: PALISADE onset 4.0–5.5min, 8.0–38.5min; resolution 16.0–32.5min, 15.0–38.0min; ARTEMIS onset 2.0–10.0min, 1.5–15.0min; resolution 14.0–47.8min, 7.0–85.0min) (Fig. 1).
Conclusion |
AR101 efficacy and safety results are consistent across trials despite different entry criteria. Most TEAEs were mild/moderate and transient. AR101 has a readily manageable safety profile with high desensitization rates possible as early as 3 months after 300mg/day dosing.
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Vol 61 - N° 5
P. 339-340 - septembre 2021 Retour au numéro
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- M. Moyart, S. Rogeau, E. Drumez, A. Deschildre
- Immunologic assessments from ARTEMIS: A European, phase 3, randomized, double-blind, placebo-controlled trial of AR101 in peanut-allergic subjects aged 4–17 years
- C. Delebarre Sauvage, C. Nilsson, K. Beyer, M. Fernández-Rivas, G. du Toit, P.J. Turner, K. Blümchen, M. Dolores Ibáñez, A. Deschildre, A. Muraro, V. Sharma, M. Erlewyn-Lajeunesse, J. Manuel Zubeldia, F. De Blay, A. Byrne, J. Chapman, F. Boralevi, K. Hylands, D. Norval, A. Abbas, J.O.B. Hourihane
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