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Anaphylaxis in Clinical Trials of Sublingual Immunotherapy Tablets.

BACKGROUND: There is no consensus method to identify anaphylaxis in sublingual immunotherapy (SLIT) trials. Standardized MedDRA Queries (SMQs) are standardized groupings of MedDRA terms used in drug safety monitoring.

OBJECTIVE: To develop a method to identify potential anaphylaxis in SLIT-tablet trials using SMQ searches and case definitions of anaphylaxis adopted from the National Institute of Allergy and Infectious Disease.

METHODS: The SMQ search tool contained 2 criteria including treatment-emergent adverse events (AEs): 1) narrow MedDRA terms related to anaphylaxis, and 2) all AEs with broad MedDRA terms from at least 2 of 3 categories (respiratory/skin/cardiovascular) occurring on the same day. Criteria were applied to a pooled dataset of all subjects from 48 timothy grass, ragweed, house dust mite and tree SLIT-tablet trials (SLIT-tablet, N=8200; placebo, N=7033). Additional search strategies were any treatment-emergent AE with MedDRA preferred term "hypersensitivity" and epinephrine administrations. Identified potential cases underwent blinded independent medical expert review. Non-anaphylaxis cases were designated local AEs or mild-to-moderate systemic reactions.

RESULTS: Using the SMQ search tool and after subsequent medical review, 8 anaphylaxis cases were identified; 3 were considered treatment-related, resulting in a proportion of anaphylaxis cases/subject of 0.02% (2/8200) with SLIT-tablet and 0.01% (1/7033) with placebo. One additional anaphylaxis case related to SLIT-tablet was identified by the preferred term "hypersensitivity". The 3 anaphylaxis cases associated with SLIT-tablet treatment were not life-threatening. The epinephrine administration rate was 17/8200 (0.2%) with SLIT-tablet treatment and 2/7033 (0.03%) with placebo.

CONCLUSION: SMQ search criteria for identifying potential anaphylaxis related to SLIT were developed. Anaphylaxis was rare for SLIT-tablets.

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