Sayami Ito1, Sachiko Hirobe2,3, Yu Kuwabara4, Mizuho Nagao4, Mio Saito5, Ying-Shu Quan5, Fumio Kamiyama5, Takao Fujisawa4, Naoki Okada6,7. 1. Project for Vaccine and Immune Regulation, Laboratory of Vaccine and Immune Regulation (BIKEN), Graduate School of Pharmaceutical Sciences, Osaka University, 1-6 Yamadaoka, Suita, Osaka, 565-0871, Japan. 2. Advanced Research of Medical and Pharmaceutical Sciences, Graduate School of Pharmaceutical Sciences, Osaka University, 1-6 Yamadaoka Suita, Osaka, 565-0871, Japan. 3. Project of Clinical Pharmacology and Therapeutics, Center for Advanced Education and Research in Pharmaceutical Sciences, Graduate School of Pharmaceutical Sciences, Osaka University, 1-6 Yamadaoka, Suita, Osaka, 565-0871, Japan. 4. Allergy Center and Department of Clinical Research, Mie National Hospital, 357 Osato-kubota, Tsu, Mie, 514-0125, Japan. 5. CosMED Pharmaceutical Co. Ltd, 32 Higashikujokawanishi-cho Minami-ku, Kyoto, 601-8014, Japan. 6. Project for Vaccine and Immune Regulation, Laboratory of Vaccine and Immune Regulation (BIKEN), Graduate School of Pharmaceutical Sciences, Osaka University, 1-6 Yamadaoka, Suita, Osaka, 565-0871, Japan. okada@phs.osaka-u.ac.jp. 7. Laboratory of Vaccine and Immune Regulation (BIKEN), Graduate School of Pharmaceutical Sciences, Osaka University, 1-6 Yamadaoka, Suita, Osaka, 565-0871, Japan. okada@phs.osaka-u.ac.jp.
Abstract
PURPOSE: Epicutaneous immunotherapy (EPIT) involving the skin's immune system is easy to use, painless and has a low risk of systemic side effects; it can be applied to food allergies that have a high morbidity rate in children. In this study, we evaluated the safety and efficacy of hydrophilic gel patch (HG) for EPIT. METHODS: Milk protein concentrate (MPC)-containing HG was applied to the skin that maintained a barrier function or formed puncture holes with microneedle, and MPC-specific antibodies were measured. The clinical study was conducted involving patients with severe milk allergy. RESULTS: No specific immune response was induced when immunizing to intact skin, and antibody production was observed by forming puncture holes. It was suggested that MPC contained in HG has immunogenicity and a very small amount of MPC was delivered to intact skin. In the clinical study, the symptom induction threshold increased in four of eight subjects, allowing them to consume milk and switch to oral immunotherapy. Although local skin reactions and temporary elevation of specific IgE antibodies were observed, no systemic side effects appeared throughout the study. CONCLUSIONS: EPIT using HG is a safe method to enable oral administration even in patients with severe milk allergies.
PURPOSE: Epicutaneous immunotherapy (EPIT) involving the skin's immune system is easy to use, painless and has a low risk of systemic side effects; it can be applied to food allergies that have a high morbidity rate in children. In this study, we evaluated the safety and efficacy of hydrophilic gel patch (HG) for EPIT. METHODS: Milk protein concentrate (MPC)-containing HG was applied to the skin that maintained a barrier function or formed puncture holes with microneedle, and MPC-specific antibodies were measured. The clinical study was conducted involving patients with severe milk allergy. RESULTS: No specific immune response was induced when immunizing to intact skin, and antibody production was observed by forming puncture holes. It was suggested that MPC contained in HG has immunogenicity and a very small amount of MPC was delivered to intact skin. In the clinical study, the symptom induction threshold increased in four of eight subjects, allowing them to consume milk and switch to oral immunotherapy. Although local skin reactions and temporary elevation of specific IgE antibodies were observed, no systemic side effects appeared throughout the study. CONCLUSIONS: EPIT using HG is a safe method to enable oral administration even in patients with severe milk allergies.
Entities:
Keywords:
cow milk allergy; epicutaneous immunotherapy; exploratory clinical pilot study; hydrophilic gel patch
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