Safety and efficacy of a new regimen of short-term oral immunotherapy with Cry j 1-galactomannan conjugate for Japanese cedar pollinosis: A prospective, randomized, open-label study

Daisuke Murakami, Motohiro Sawatsubashi, Sayaka Kikkawa, Masayoshi Ejima, Akira Saito, Akio Kato, Shizuo Komune

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Abstract

Abstract Background Short-term oral immunotherapy (OIT) using the Cry j1-galactomannan conjugate for Japanese cedar pollinosis may be effective and relatively safe. However, a treatment regimen has not been established. In the present study, we examined a new OIT regimen with a build-up phase and extended the maintenance phase of OIT to the peak period of the pollen season to enhance the therapeutic effect and safety of OIT. Methods A prospective, randomized, open-label trial was conducted over a period of 4 months. Participants were randomly divided into two groups. The OIT group comprised 23 subjects. The build-up phase was initiated 1 month before the expected pollen season. The maintenance phase was continued for 51 days during the peak pollen season. The control group comprised 24 subjects. The symptoms and medication score, levels of allergen-specific serum antibodies throughout the pollen season, and adverse effects with OIT were evaluated. Results Participants receiving OIT showed significant improvements in total symptom scores, medication score, and total symptom-medication scores throughout the pollen season compared with the control group. The levels of allergen-specific serum IgG4 were significantly increased in the OIT group but not in the control group throughout the cedar pollen season. Importantly, no severe adverse effects were observed with OIT. Conclusions The new regimen of short-term OIT using the Cry j1-galactomannan conjugate for Japanese cedar pollinosis is effective, relatively safe and induces immune tolerance. Thus, OIT using allergen-galactomannan conjugates may provide a rapid, effective, and thus convenient immunotherapy for pollinosis instead of SLIT or SCIT.

Original languageEnglish
Article number38
Pages (from-to)161-168
Number of pages8
JournalAllergology International
Volume64
Issue number2
DOIs
Publication statusPublished - Apr 1 2015

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Cryptomeria
Seasonal Allergic Rhinitis
Immunotherapy
Safety
Pollen
Allergens
Control Groups
galactomannan
Maintenance
Immunologic Desensitization
Immune Tolerance
Therapeutic Uses
Serum

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy

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Safety and efficacy of a new regimen of short-term oral immunotherapy with Cry j 1-galactomannan conjugate for Japanese cedar pollinosis : A prospective, randomized, open-label study. / Murakami, Daisuke; Sawatsubashi, Motohiro; Kikkawa, Sayaka; Ejima, Masayoshi; Saito, Akira; Kato, Akio; Komune, Shizuo.

In: Allergology International, Vol. 64, No. 2, 38, 01.04.2015, p. 161-168.

Research output: Contribution to journalArticle

Murakami, Daisuke ; Sawatsubashi, Motohiro ; Kikkawa, Sayaka ; Ejima, Masayoshi ; Saito, Akira ; Kato, Akio ; Komune, Shizuo. / Safety and efficacy of a new regimen of short-term oral immunotherapy with Cry j 1-galactomannan conjugate for Japanese cedar pollinosis : A prospective, randomized, open-label study. In: Allergology International. 2015 ; Vol. 64, No. 2. pp. 161-168.
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abstract = "Abstract Background Short-term oral immunotherapy (OIT) using the Cry j1-galactomannan conjugate for Japanese cedar pollinosis may be effective and relatively safe. However, a treatment regimen has not been established. In the present study, we examined a new OIT regimen with a build-up phase and extended the maintenance phase of OIT to the peak period of the pollen season to enhance the therapeutic effect and safety of OIT. Methods A prospective, randomized, open-label trial was conducted over a period of 4 months. Participants were randomly divided into two groups. The OIT group comprised 23 subjects. The build-up phase was initiated 1 month before the expected pollen season. The maintenance phase was continued for 51 days during the peak pollen season. The control group comprised 24 subjects. The symptoms and medication score, levels of allergen-specific serum antibodies throughout the pollen season, and adverse effects with OIT were evaluated. Results Participants receiving OIT showed significant improvements in total symptom scores, medication score, and total symptom-medication scores throughout the pollen season compared with the control group. The levels of allergen-specific serum IgG4 were significantly increased in the OIT group but not in the control group throughout the cedar pollen season. Importantly, no severe adverse effects were observed with OIT. Conclusions The new regimen of short-term OIT using the Cry j1-galactomannan conjugate for Japanese cedar pollinosis is effective, relatively safe and induces immune tolerance. Thus, OIT using allergen-galactomannan conjugates may provide a rapid, effective, and thus convenient immunotherapy for pollinosis instead of SLIT or SCIT.",
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AB - Abstract Background Short-term oral immunotherapy (OIT) using the Cry j1-galactomannan conjugate for Japanese cedar pollinosis may be effective and relatively safe. However, a treatment regimen has not been established. In the present study, we examined a new OIT regimen with a build-up phase and extended the maintenance phase of OIT to the peak period of the pollen season to enhance the therapeutic effect and safety of OIT. Methods A prospective, randomized, open-label trial was conducted over a period of 4 months. Participants were randomly divided into two groups. The OIT group comprised 23 subjects. The build-up phase was initiated 1 month before the expected pollen season. The maintenance phase was continued for 51 days during the peak pollen season. The control group comprised 24 subjects. The symptoms and medication score, levels of allergen-specific serum antibodies throughout the pollen season, and adverse effects with OIT were evaluated. Results Participants receiving OIT showed significant improvements in total symptom scores, medication score, and total symptom-medication scores throughout the pollen season compared with the control group. The levels of allergen-specific serum IgG4 were significantly increased in the OIT group but not in the control group throughout the cedar pollen season. Importantly, no severe adverse effects were observed with OIT. Conclusions The new regimen of short-term OIT using the Cry j1-galactomannan conjugate for Japanese cedar pollinosis is effective, relatively safe and induces immune tolerance. Thus, OIT using allergen-galactomannan conjugates may provide a rapid, effective, and thus convenient immunotherapy for pollinosis instead of SLIT or SCIT.

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