Safety profile and immunological response of dual sublingual immunotherapy with house dust mite tablet and Japanese cedar pollen tablet.

Adolescent Adult Animals Antigens, Dermatophagoides / administration & dosage Child Cryptomeria / immunology Female Humans Male Middle Aged Pollen / immunology Pyroglyphidae / immunology Rhinitis, Allergic / drug therapy Sublingual Immunotherapy / adverse effects Tablets Young Adult

Allergic rhinitis Dual therapy Immunological response Safety Sublingual immunotherapy

Journal

Allergology international : official journal of the Japanese Society of Allergology

ISSN: 1440-1592

Titre abrégé: Allergol Int

Pays: England

ID NLM: 9616296

Informations de publication

Date de publication:
Jan 2020

Historique:

received: 06 06 2019

revised: 12 07 2019

accepted: 16 07 2019

pubmed: 20 8 2019

medline: 2 6 2020

entrez: 19 8 2019

Statut: ppublish

Résumé

There have been no studies of dual administration of sublingual immunotherapy (SLIT) tablets for perennial and seasonal allergic rhinitis. This trial (JapicCTI-184014) was conducted to investigate the safety profile and immunological response during dual therapy with SQ house dust mite (HDM) and Japanese cedar pollen (JCP) SLIT tablets. This was a multicenter, open-label, randomized trial of 109 Japanese patients with coexisting HDM and JCP allergic rhinitis who had positive tests for HDM- and JCP specific IgE (≥0.7 kU/L). Patients were allocated to receive HDM (N = 54) or JCP (N = 55) SLIT tablets alone for 4 weeks followed by 8 weeks of dual therapy with both SLIT tablets administered within 5 min of each other. Adverse events (AEs), adverse drug reactions (ADRs), and serum IgE and IgG4 specific for HDM (Dermatophagoides farinae, Dermatophagoides pteronyssinus) and JCP were recorded. The percentage of subjects with AEs and ADRs was similar between the two groups and between the two periods of monotherapy and dual therapy. Most AEs and ADRs were mild in severity, and no serious events were observed. The most common ADRs were local events in the oral cavity. Levels of IgE and IgG4 specific for HDM (D. farinae, D. pteronyssinus) and JCP were increased after treatment with HDM and JCP SLIT tablets, respectively. Dual therapy with both SLIT tablets administered within 5 min after 4 weeks of monotherapy with HDM or JCP tablet was well tolerated and induced the expected immunological responses.

Sections du résumé

BACKGROUND BACKGROUND

METHODS METHODS

This was a multicenter, open-label, randomized trial of 109 Japanese patients with coexisting HDM and JCP allergic rhinitis who had positive tests for HDM- and JCP specific IgE (≥0.7 kU/L). Patients were allocated to receive HDM (N = 54) or JCP (N = 55) SLIT tablets alone for 4 weeks followed by 8 weeks of dual therapy with both SLIT tablets administered within 5 min of each other. Adverse events (AEs), adverse drug reactions (ADRs), and serum IgE and IgG4 specific for HDM (Dermatophagoides farinae, Dermatophagoides pteronyssinus) and JCP were recorded.

RESULTS RESULTS

The percentage of subjects with AEs and ADRs was similar between the two groups and between the two periods of monotherapy and dual therapy. Most AEs and ADRs were mild in severity, and no serious events were observed. The most common ADRs were local events in the oral cavity. Levels of IgE and IgG4 specific for HDM (D. farinae, D. pteronyssinus) and JCP were increased after treatment with HDM and JCP SLIT tablets, respectively.

CONCLUSIONS CONCLUSIONS

Dual therapy with both SLIT tablets administered within 5 min after 4 weeks of monotherapy with HDM or JCP tablet was well tolerated and induced the expected immunological responses.

Identifiants

DOI: 10.1016/j.alit.2019.07.007 PMID: 31421989

pubmed: 31421989

pii: S1323-8930(19)30108-X

doi: 10.1016/j.alit.2019.07.007

pii:

doi:

Substances chimiques

Antigens, Dermatophagoides 0

Tablets 0

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

Pagination

104-110