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It past 3 years in 2017 after the first purchase of the drug for sublingual immunotherapy (SLIT) for Japanese Cedar pollinosis (JCP). We reported the clinical efficacy of SLIT in the first and the second treated year., Purpose: The purpose of this study is to clear the clinical efficacy of SLIT in the third treated year by comparing with other therapies, such as subcutaneous immunotherapy (SCIT), or other pharmacotherapy., Methods: We compared the clinical efficacy in 2017, of 112 SLIT in the third treated year with 38 SCIT, 364 primary pharmacotherapy that started therapies before pollen dispersal, 254 pharmacotherapy that started therapies after pollen disposal, or 333 non-treatment. The clinical efficacy was evaluated with symptom scores, total nasal symptom scores and combined total nasal symptom-medication scores (TNSMS), symptoms of nose and eye by visual analog scale (VAS), quality of life (QOL) scores by Japanese rhino-conjunctivitis QOL questionnaire (JRQLQ No1)., Results: Both SCIT and SLIT showed good clinical efficacy without significant difference in every assessment. Both SCIT and SLIT were significantly better than other pharmacotherapy in most assessment. Patients, whose symptom scores of nose and eye were 0 and 1 point without any rescue drugs, accounted for 9 and 24% of total SLIT, respectively., Conclusion: SLIT in the third treated year showed good clinical efficacy in reducing symptoms and TNSMS of JCP, and in improving QOL. SLIT was significantly effective compared with other pharmacotherapies.

Sublingual immunotherapy (SLIT) is thought to have enhanced efficacy in the second year of treatment. We studied treatment efficacy in both the first and the second years of treatment (2015 and 2016, respectively) in patients who began SLIT in 2014. Methods: We compared 132 patients who underwent SLIT (age, 41.8 ± 17.5 years; male-to-female ratio, 75: 57) and a control group of 56 patients who underwent primary pharmacotherapy (age, 44.9 ± 13.5 years; male-to-female ratio, 25: 31). The study was performed during the peak pollen seasons of 2015 and 2016. Pollen dispersal was similar in 2015 and 2016 (2,509 grains/cm2 and 3,505 grains/cm2, respectively). The clinical efficacy of SLIT was evaluated by assessing nasal and eye symptoms and total symptoms with symptom scores and combined symptom-medication scores, visual analog scale scores, and quality of life (QOL) scores according to the Japanese rhino-conjunctivitis QOL questionnaire (JRQLQ No. 1). QOL was also evaluated with JRQLQ No. 1. The first endpoint was enhanced efficacy of SLIT in the second year compared with that in the first year. Results: With respect to nasal and eye symptoms, the assessments in the primary pharmacotherapy group were unchanged in the second year; however, most of these assessments in the SLIT group demonstrated significantly enhanced efficacy of SLIT in the second year. In QOL of SLIT, only 2 of 17 showed significantly enhanced efficacy of SLIT in the second year. Conclusion: SLIT shows enhanced efficacy in the second year.

Sublingual immunotherapy (SLIT) for Japanese cedar pollinosis is known to be effective. However, better SLIT adherence is needed to improve its safety and efficacy. 　Purpose: The purpose of this study was to evaluate SLIT adherence and its influence on clinical outcome. 　Methods: We conducted a detailed survey of 132 patients who have been receiving SLIT for 2 years on adherence at each visit using both questionnaires and direct calculation from prescription. Questionnaires on total symptoms using the visual analog scale (VAS), face scale, and total nasal symptom medication score (TNSMS) were obtained at the peak season for Japanese cedar pollinosis. 　Results: Good adherence by prescription for 2 years was observed in 83.1% ± 11.7% of patients. The adherence in the second year (80.8% ± 13.6%) was lower than that in the first year (88.5% ± 9.8%). However, adherence by questionnaire was 13.5% higher than that by prescription. VAS of total symptoms and adherence did not correlate; however, evaluations by VAS, face scale, and TNSMS were significantly improved if the adherence cut-off value was set to 70% or 75%. 　Conclusion: Our results suggest that SLIT adherence for Japanese cedar pollinosis is high and adequate adherence is required for better efficacy.

It past 2 years in 2016 after the first purchase of the drug for sublingual immunotherapy (SLIT) for Japanese Cedar pollinosis (JCP)., Purpose: The purpose of this study is to clear the clinical efficacy of SLIT in the second treated year by comparing with other therapies, such as subcutaneous immunotherapy (SCIT), or other pharmacotherapy., Methods: We started SLIT at our clinic in October-December, 2014. We compared the clinical efficacy in 2016, of 133 SLIT with 46 SCIT, 351 primary pharmacotherapy that started therapies before pollen dispersal, 221 pharmacotherapy that started therapies after pollen disposal, or 337 non-treatment. The clinical efficacy was evaluated with symptom scores and combined symptom-medication scores (SMS), symptoms of nose and eye by visual analog scale (VAS), quality of life (QOL) scores by Japanese rhino-conjunctivitis QOL questionnaire (JRQLQ No1)., Results: Fourteen cases by unknown reasons and 3 cases by inevitable reasons were dropped out for 2 years. Both SCIT and SLIT showed good clinical efficacy without significant difference in every assessment. Both SCIT and SLIT were significantly better than other pharmacotherapy in most assessment. Patients, whose symptom scores of nose and eye were 0 or 1 point without any rescue drugs, accounted for 26.3% of total SLIT., Conclusion: SLIT in the second treated year showed good clinical efficacy in reducing symptoms and SMS of JCP, and in improving QOL. SLIT was significantly effective compaired with other pharmacotherapies.

Unlabelled: Sublingual immunotherapy (SLIT) for Japanese cedar pollinosis is effective, however, caution must be exercised against allergen-specific adverse events (AEs) during SLIT., Purpose: The purpose of this study was to clarify the AEs of SLIT in a large cohort of patients with Japanese cedar pollinosis., Methods: We conducted a detailed survey, by both questionnaires and direct interviews, of 207 patients receiving SLIT at our clinic., Results: Eighty-four of the 207 patients (40.5%) developed AEs, with AEs involving the oral cavity and throat being the most common (56 patients; 27.1%). Sixteen patients (7.9%) had local mucosal swelling, but the swelling resolved in all the cases. Other allergen-induced symptoms such as nasal symptoms (29 events, 14.0%), eye symptoms (14 events, 6.8%) and ear symptoms (20 events, 9.7%) were also recognized. All the AEs were minor, and discontinuation of SLIT was not necessitated in any of the patients because of AEs. There were 52 AEs (25.0%) in the up-dose phase and 61 AEs (29.3%) in the maintenance phase. However, only 4 of the 161 patients (2.5%) developed AEs during the pollen season. Most AEs developing during the maintenance phase occurred in the first few weeks. In 60% of the cases, the AEs disappeared within 2 weeks, and in 6.0% (5 events), they persisted for longer than 2 months. There were no age-or sex-related differences in the prevalence of cedar pollen-specific IgE, or in the adherence to the treatment., Conclusion: AEs in SLIT were shown in many patients, however, the severity of AEs was mild and no events interfered SLIT.

Unlabelled: The first drug of sublingual immunotherapy (SLIT) for Japanese Cedar pollinosis (JCP) was purchased in 2014.  , Purpose: The purpose of this study is to clear the clinical efficacy of SLIT by comparing with other therapies, such as subcutaneous immunotherapy (SCIT), or other pharmacotherapy.  , Methods: We started SLIT at our clinic in October-December, 2014. We compared the clinical efficacy of 191 SLIT with 48 SCIT, 191 primary pharmacotherapy that started therapies before pollen dispersal, 141 pharmacotherapy that started therapies after pollen disposal, or 169 non-treatment in the first follow-up year. The clinical efficacy was evaluated with quality of life (QOL) scores by Japanese rhino-conjunctivitis QOL questionnaire (JRQLQ No1), symptoms of nose and eye by visual analog scale (VAS), symptom scores and combined symptom-medication scores (SMS).  , Results: Mild adverse events (AEs) were observed in many cases, but no patient was discontinued by AEs in SLIT patients. Five cases by unknown reasons and 3 cases by inevitable reasons were dropped out before pollen. Adherence of SLIT was 89±12%. SCIT was better than SLIT in most assessments, but not significant. Both SCIT and SLIT were significantly better than other pharmacotherapy. Patients, whose symptom scores of nose and eye were 0 or 1 point without any rescue drugs, accounted for 16.8% of total SLIT in the first follow-up year.  , Conclusion: SCIT was slightly better than SLIT in reducing symptoms and SMS of JCP, and in improving QOL. However, the differences were not significant. SLIT was significantly effective than other pharmacotherapies.

Background: This study intended to assess the severity of Japanese cedar pollinosis using the Practical Guideline for the Management of Allergic Rhinitis in Japan (PG-MARJ) and the Allergic Rhinitis and its Impact on Asthma (ARIA) Guideline., Methods: An Internet questionnaire survey of patients with pollinosis was conducted in mid-May 2011 and responses were obtained from 3382 individuals who had potential symptoms of Japanese cedar pollinosis from February to early May 2011 and who had experienced such symptoms for at least two pollen seasons., Results: According to PG-MARJ, 23.5% of the respondents had severest rhinitis, 29.4% severe rhinitis, 31.3% moderate rhinitis, 13.8% mild rhinitis and 2.0% asymptomatic rhinitis. According to ARIA, 67.2% of them had moderate/severe persistent rhinitis, 23.8% moderate/severe intermittent rhinitis, 4.4% mild persistent rhinitis and 4.6% mild intermittent rhinitis., Conclusions: Moderate to severe rhinitis was diagnosed in more than 80% of the respondents according to PG-MARJ, while moderate/severe rhinitis was diagnosed in more than 90% of the respondents according to ARIA. Most of the respondents suffered relatively severe pollinosis. More than 80% of the respondents had all the three major symptoms (i.e., sneezing, rhinorrhea and nasal blockage). Disagreement in the severity assessment between the two guidelines was noted in approximately 20% of the respondents.

Background: Bronchial asthma (BA) and allergic rhinitis (AR) are thought to share a common pathogenesis. However, reports concerning the comorbidity of the two diseases in a large-scaled population are rare in Japan. In the present study, we performed an analysis on the two diseases using questionnaires that addressed the diagnosis, symptoms and period of occurrence in more than 10,000 patients with BA or AR., Methods: Patients with BA (adult: n = 2,781, childhood: n = 3,283) and AR (n = 3,945) were enrolled in the present study during the 3 months from August 1, 2006 to October 31, 2006., Results: Sixty one percent of the patients with adult BA showed symptoms of AR. Among them, 68% of the patients were diagnosed with AR. Among the patients with childhood BA, 68% showed AR symptoms and 60% were diagnosed with AR. On the other hand, 49% of AR patients showed BA symptoms and 35% of them were diagnosed with BA. The symptoms of both BA and AR in the BA and AR patients were frequent in two seasons, March and April, and September and October. In addition, BA and AR symptoms often co-occurred in the patients with BA and AR., Conclusions: Comorbidity of BA and AR was high in both populations of BA and AR. The symptoms of both BA and AR co-occurred on both a daily and seasonal basis. These results suggested that BA and AR share a common immuno-pathogenesis in the airway and need to be treated as a single airway disease.

Background: Some patients with Japanese cedar (JC) pollinosis already show pollinosis symptoms before the first day of the pollen season as determined by microscopic pollen counts., Methods: Airborne pollen allergen (Cry j 1) levels were measured by electron spin resonance radical immunoassay, a highly-sensitive method for Cry j 1 with a sensitivity 10-100-fold higher than conventional enzyme-linked immunosorbent assay. The symptom data from patients with JC pollinosis were collected from a mobile phone site, "pollen check sheet", and the onset times of the patients' symptoms were analyzed., Results: The relationship between airborne Cry j 1 levels and the onset time of pollinosis symptoms was investigated. The symptoms of some patients began at the time airborne Cry j 1 levels fluctuated at 1 to 3 pg/m3 and symptom scores increased at the time of sudden increase in Cry j 1 levels. About 40% of patients began to show symptoms until the first day of the pollen season and the time nearly corresponds to the time of sudden increase in Cry j 1 levels., Conclusions: Pollinosis symptoms of some patients began at the time airborne Cry j 1 levels fluctuated at 1 to 3 pg/m3 and symptom scores increased at the time of sudden increase in Cry j 1 levels. The latter time nearly corresponds to the first day of the pollen season.

Immunotherapy using T-cell epitope peptides or CpG DNA conjugated with allergenic protein is useful, although the mechanisms of these therapies differ. However, the combination of CpG DNA and peptide, but not protein, had not been documented. Therefore, we investigated CpG DNA conjugated with peptide to obtain positive synergistic effects. In the first experiment, mice were vaccinated with a conjugate of CpG DNA and Cry j 2 T-cell epitope peptide p246-259 (CpG-peptide); a mixture of CpG DNA and peptide (CpG+peptide); peptide alone, or PBS alone, and immunized with Cry j 2. In the second experiment, mice were immunized with Cry j 2 and injected with CpG-peptide, CpG+peptide, peptide only, or PBS only. In both experiments, Cry j 2-specific IgE, IL-4, and IL-5 were significantly lower in mice given CpG-peptide, versus those given CpG+peptide, peptide alone, or PBS alone. However, IgG2a, IgG2b and IFN-gamma did not increase in mice injected with CpG-peptide. In the third experiment, CpG-peptide significantly attenuated nasal symptoms (sneezing and nasal rubbing) compared to CpG+peptide, peptide alone, or PBS alone. Mice were also injected with a conjugate of CpG DNA and Cry j 2 protein (CpG-Cry j 2) or CpG-peptide to compare prime responses. Mice vaccinated with CpG-Cry j 2 generated Cry j 2-specific IgG1, whereas those vaccinated with CpG-peptide did not produce IgG1. This study demonstrated, for the first time, that immunotherapy with CpG DNA conjugated with a T-cell peptide is useful in preventing and treating allergic conditions.

In Japan, pollen of Cryptomeria japonica and Chamaecyparis obtusa are a yearly source of distress for many people suffering seasonally from allergic rhinitis. To study common epitopes shared by the two species, two monoclonal antibodies (moAbs) were raised against Cry j 1, which is the most predominant allergen in C. japonica. One of the moAbs was found to be reactive even to the major allergen of C. obtusa, demonstrating that the moAb (J1B01) can detect an epitope shared by both species J1B01 strongly inhibited the binding of the major allergens of C. japonica and C. obtusa to IgE of patients who are sensitive to C. japonica and C. obtusa. This finding signifies the importance of the epitope recognized by J1B01.

Clinical characterization of patients with allergy to Chamaecyparis obtusa (Cypress) pollen and their specific IgE antibody was investigated by using AlaSTAT assay, a new method for measurement of antigen-specific IgE antibody. Positive rate of antigen-specific antibody in patients with allergic pollinosis was 83.5% for Japanese cedar pollen and 80.0% for Chamaecyparis obtusa pollen. 76.4% of patients were sensitized both to Japanese cedar and Chamaecyparis obtusa pollen, however, 7.9% were sensitized only to the latter. As for clinical symptoms, duration of attack was short and severity was mild or moderate in the patients sensitized only to Chamaecyparis obtusa pollen. Patients who visited hospital in April, in that Chamaecyparis obtusa pollen disseminated in the air predominantly, showed significant elevation in AlaSTAT scores compared with patients who visited in February and March (p < 0.05).

To evaluate the roles of eosinophils in allergic rhinitis, eosinophil cationic protein (ECP) levels in sera and nasal secretions were measured in 28 patients with allergic rhinitis. In patients, blood eosinophil counts and serum ECP levels were significantly higher than in controls (p < 0.05). However, there was no statistically significant correlation between blood eosinophil count and serum ECP level (r = 0.025). The number of eosinophils and the ECP level in nasal secretion were also measured. In patients, the ECP level increased with the number of eosinophils, and the ECP level in nasal secretion was significantly higher than in controls (p < 0.05). These results suggest that eosinophils and ECP play important roles in allergic rhinitis.