This article is part of Pulmonology Advisor‘s coverage of the ACAAI 2019 meeting, taking place in Houston, TX. Our staff will report on medical research related to allergies, asthma, and more conducted by experts in the field. Check back regularly for more news from ACAAI 2019.
HOUSTON — The oral biologic drug AR101 has demonstrated consistent efficacy and safety in providing oral peanut immunotherapy in both the PALISADE and ARTEMIS phase 3 trials (ClinicalTrials.gov Identifiers: NCT02635776 and NCT03201003). This research was presented at the 2019 American College of Allergy, Asthma, & Immunology Annual Scientific Meeting, held November 7 to 11, 2019, in Houston, Texas.
This study included 496 (n=372 AR101; n=124 placebo) individuals in the PALISADE trial and 175 (n=132 AR101; n=43 placebo) in the ARTEMIS trial. All participants were 4 to 17 years old and had a medical history of peanut allergy and sensitization (skin-prick test ≥3 mm and/or peanut-specific immunoglobulin E [IgE] ≥0.35 kUA/L), as well as a reaction to ≤100 mg or ≤300 mg (PALISADE and ARTEMIS, respectively) in a double-blind, placebo-controlled food challenge.
Dose escalation to AR101 300 mg daily took place over 6 months, after which 300 mg/d dosage was administered for 6 and 3 months in PALISADE and ARTEMIS, respectively. The end-of-trial food challenge, treatment-emergent adverse events (TEAEs), and timing of dose-escalation TEAEs were compared with intention-to-treat and safety populations.
At end of the trial food challenges in both PALISADE and ARTEMIS, participants showed similar tolerance of 300 mg, 600 mg, and 1000 mg peanut protein regardless of dosing durations (PALISADE vs ARTEMIS; AR101 group: 76.6% vs 73.5%, 67.2% vs 68.2%, 50.3% vs 58.3%, respectively; placebo group: 8.1% vs 16.3%, 4.0% vs 9.3%, 2.4% vs 2.3%, respectively).
Both trials had largely mild-moderate TEAEs in both AR101 and placebo groups (PALISADE: 94.4% vs 94.4%, respectively; ARTEMIS: 97.7% vs 97.7%, respectively), with a lower frequency of TEAEs from dose escalation to 300 mg daily. Both trials also showed similar median times to initial symptom onset after ingestion and durations between initial symptom onset and final symptom resolution for AR101 vs placebo (PALISADE: onset, 4.0-5.5 min vs 8.0-38.5 min; resolution, 16.0-32.5 min vs 15.0-38.0 min; ARTEMIS: onset, 2.0-10.0 min vs 1.5-15.0 min; resolution, 14.0-47.8 min vs 7.0-85.0 min).
The study researchers concluded that both efficacy and safety results for AR101 are “consistent across trials despite different entry criteria,” with mostly mild-moderate and transient TEAEs. AR101’s safety profile is also readily manageable, with “high desensitization rates possible as early as 3 months after 300 mg/d dosing.”
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Sher E, Hourihane J, Carr W, et al. Safety and efficacy comparison: ARTEMIS and PALISADE phase 3 studies of AR101 in peanut allergy. Presented at: American College of Allergy, Asthma, & Immunology Annual Scientific Meeting 2019; November 7-11, 2019; Houston, TX. Abstract P303.