SAFETY OF FIRST DOSE OF SQ HOUSE DUST MITE SUBLINGUAL IMMUNOTHERAPY TABLET IN CLINICAL TRIALS

Abstract

Introduction Supervision in the physician's office for 30 minutes following the first dose of SQ house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet is required to monitor for potential adverse reactions. Clinically important adverse events (AEs) occurring in connection to administration of the first dose were evaluated. Methods Safety data from 14 DBPC trials (N=6784) of SQ HDM SLIT-tablet were analyzed for clinically important treatment-related AEs associated with the first dose. IRB approval was obtained. Data for the Europe/US approved dose of 12 SQ-HDM (N=2139) are presented. Results The majority of treatment-related AEs with the first dose were mild or moderate local allergic reactions. In all, 2/2139 (0.09%) subjects experienced AEs requiring treatment with epinephrine within minutes of administration of the first dose. One subject developed laryngeal edema assessed as mild by the investigator, which was treated with epinephrine and resolved after 30 minutes; the subject completed the trial. The other subject discontinued treatment after experiencing a systemic allergic reaction (reported as moderate hypersensitivity), which was treated with epinephrine and resolved after 1 hour. Four additional subjects discontinued treatment on day 1 due to AEs, mainly mild/moderate local allergic reactions, all of which resolved within 2 hours. No late-phase allergic reactions occurred. No serious AEs related to first dose were observed. Conclusions Clinically important AEs related to the first dose of SQ HDM SLIT-tablet occurred within minutes and were manageable with conventional allergy pharmacotherapy.