1
464 The Association Between Two SNPs GATA3 (rs1269486, rs2229360) Gene and Allergic Rhinitis Prof. Reza Farid, MD, FAAAAI 1 , Prof. Mohammad Raza Abbaszadegan 2 , Prof. Farahzad Jabbari 3 , Prof. Mehran Gholamin 4 , Dr. Afshin Shirkani, MD 5 , Mrs. Hadis Yousefzadeh 6 , Ms. Atena Mansouri 7 ; 1 Allergy Research Center, Mashhad University of Medical Sciences, Iran, 2 Genetic Research Center,- Mashhsd University of Medical Science, mashhad, Iran, 3 Allergy research center, Mashhsd University of Medical Science, Mashhad, Iran, 4 Immu- nology Research Center, Mashhsd University of Medical Science, mashhad, Iran, 5 Bushehr University of Medical Science, Mashhad, Iran, 6 Allergy Research Center. Mashhsd University of Medical Science, mashhad, Iran, 7 Buoshar university, Iran. RATIONALE: Allergic rhinitis is caused by the interaction of genetics and environment factors. TH2 has crucial role in atopic disease and GATA3 is known to be a contributing factor to increased TH2. Few studies showed Single Nucleotide Polymorphism (SNP) GATA3 was associated with allergic rhinitis, asthma, increased total IgE, and atopic dermatitis. METHODS: This research is a case-control study, using two SNPs: GATA3 (rs1269486, rs2229360). These genes have been assessed in patients with allergic rhinitis as well as normal controls (86 patients and 86 normal). Moreover, blood samples of these participants have been genotyped by PCR. RESULTS: A significant association was found between allergic rhinitis and polymorphisms of alleles, as well as genotypes and hallotype of GATA3 rs1269486 gene. The frequency of A allele and GA genotype were significantly higher in healthy subjects compared to G allele and GG genotype in patients (P <0.001). Furthermore, Haplotypes of AC and GC were found to be significantly higher in normal subjects and patients respectively (p< 0.001). CONCLUSIONS: This study was conducted in the Northeastern parts of Iran. Polymorphisms of GATA3 rs1269486 gene was found to be associated with allergic rhinitis and sensitivity to aeroallergens, however, further research is required to determine polymorphisms in more SNPs, as well as the other regions of the country. 465 Impacts Of Adolescents' Allergic Rhinitis On School Achievement and Quality Of Life Prof. Sun-Hee Choi, MD, PhD 1 , Dr. Kyung Suk Lee, MD, PhD 2 , Prof. Yeong-Ho Rha, MD, PhD 2 ; 1 Gangdong Kyung Hee University Hos- pital, Seoul, South Korea, 2 Kyung Hee University Hospital. RATIONALE: Allergic rhinitis is known to negatively affect one with sleep disorder, attention disorder, anxiety, and other mental disorders that may eventually influence one’s academic achievement. METHODS: Raw data of their academic achievements, ISAAC and QOL questionnaires were collected from 662 students from 4 middle and high schools. Depending on academic achievements, which were categorized into high, middle, and low, cross analysis was performed. The correlation between the rating of students’ quality of life and the percentile of their academic achievements were analyzed. RESULTS: There was no significant difference between the allergic rhinitis group and the normal group in terms of total score, sum of math and science, and English; however, high school rhinitis students who had received treatments over the last 12 months had significantly high Korean language scores. Female rhinitis students showed the highest prevalence, especially those who scored high on Korean language. In addition, high school students who had been given treatment over the past 12 months showed a significantly high prevalence, especially those with high Korean language scores. There are significant positive correlations between quality of life represented by physical fitness index and the percentiles for the following subjects: math and science. CONCLUSIONS: This result contradicts the other research results that support the correlation between allergic rhinitis and low academic achievement. However, considering other research results on how one’s academic achievement can represent social status, it is possible to conclude that allergic rhinitis is seen more often among people with high social status. 466 Allergic Rhinitis (AR) Is Sub-Optimally Controlled: The Need For a More Effective Treatment Option Dr. Phillip L. Lieberman, MD, FAAAAI 1 , Prof. David Price, FRCGP, MRCGP, DRCOG 2 ; 1 Allergy and Asthma Associates, Germantown, TN, 2 Research In Real Life, Cambridge, United Kingdom. RATIONALE: AR remains sub-optimally controlled. Our aim was to (i) use patient survey data to explore the unmet need in AR, and (ii) show how a new treatment option (MP29-02; Dymista), a novel intranasal formula- tion of azelastine hydrochloride (AZE) and fluticasone propionate (FP) in an advanced delivery system can fill this need. METHODS: AR symptomatology and medication usage data were collected from 746 moderate/severe seasonal AR (SAR) patients who completed a healthcare utilization survey in the UK. The patient characteristics mimicked those of patients in the MP29-02 clinical trials. The clinical efficacy of MP29- 02 was compared to commercially available AZE or FP nasal sprays and placebo in a 14-day randomized controlled trial including 610 SAR patients. Time to response was assessed post-hoc. A > _30% to > _90% change from baseline in reflective total nasal symptom score (rTNSS) defined response. RESULTS: 96.2% of patients surveyed were on AR medication; 70.5% taking > _2 medications. These patients remained symptomatic with a mean rTNSS of 12.8 (range 0-24) and a mean rTOSS of 8.6 (range 0-18). Clinical trial data in a matched population showed that more MP29-02-patients achieved > _30%, > _50%, > _60%, > _75% and > _90% rTNSS-reduction, and days faster than either active comparator. FP did not differ from placebo in providing a > _60% rTNSS reduction. CONCLUSIONS: AR is often poorly controlled with current therapies (even multiple therapies). Intranasal corticosteroids fail to provide suffi- cient symptom control in many patients. Treatment with MP29-02 addresses this unmet medical need as it provides faster and more complete symptom control than FP. 467 Short and Long-Term Safety Of MP29-02 In The Treatment Of Allergic Rhinitis Dr. William Berger, MD 1 , Dr. Jonathan A. Bernstein, MD, FAAAAI 2 , Dr. Nancy Ruiz, MD 3 , Dr. Warner W. Carr, MD, FAAAAI 4 ; 1 Allergy & Asthma Associates of Southern California, Mission Viejo, CA, 2 Division of Immunology Allergy & Rheumatology, University of Cincinnati Med- ical Center, Cincinnati, OH, 3 MEDA Pharmaceuticals, Somerset, NJ, 4 Al- lergy and Asthma Associates of SCs, Mission Viejo, CA. RATIONALE: MP29-02 (DymistaÒ), a novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP) in an advanced delivery system, provides better nasal symptom improvement than firstline treatment in SAR and chronic rhinitis patients. Short- and long-term safety from these clinical trials are presented. METHODS: 4022 patients were randomized into 4, 14-day double-blind, placebo-controlled SAR trials to MP29-02, AZE, FP or placebo nasal sprays. 612 chronic rhinitis patients were randomized to a 1-year, open- label, parallel-group trial to MP29-02 or FP nasal sprays. For all studies the total daily dose of AZE and FP was 548mcg and 200mcg, respectively. Safety was assessed by incidence, type, and severity of adverse events, vital signs and nasal examinations. Fasting morning serum cortisol concentra- tions were measured in a sub-group of chronic patients. RESULTS: In all studies the incidence of treatment-related adverse events (TRAEs) for active groups was low, not exceeding placebo in many instances. The most commonly reported TRAEs for MP29-02 were dysgeusia (2.1-7.2%), headache (0.5-2.6%) and epistaxis (1.0-3.9%). Long-term, there was no evidence of TRAE accumulation over time. A SAE was reported by 3 MP29-02-subjects and 1 FP-subject. None were considered treatment-related. There was no appreciable reduction in serum cortisol from baseline following 12 month’s continuous treatment with MP29-02 (-0.08 (SD 5.5) mcg/dL) or FP (-1.04 (SD 5.0) mcg/dL). For all studies, changes in vital signs and nasal examinations were similar in all groups. CONCLUSIONS: MP29-02 was well tolerated in 14-day studies in SAR patients. MP29-02 was safe in a long-term study with no evidence of late- occurring TRAEs. J ALLERGY CLIN IMMUNOL FEBRUARY 2014 AB132 Abstracts SUNDAY

Impacts Of Adolescents' Allergic Rhinitis On School Achievement and Quality Of Life

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J ALLERGY CLIN IMMUNOL

FEBRUARY 2014

AB132 Abstracts

SUNDAY

464 The Association Between Two SNPs GATA3 (rs1269486,rs2229360) Gene and Allergic Rhinitis

Prof. Reza Farid, MD, FAAAAI1, Prof.MohammadRaza Abbaszadegan2,

Prof. Farahzad Jabbari3, Prof. Mehran Gholamin4, Dr. Afshin Shirkani, MD5,

Mrs. Hadis Yousefzadeh6, Ms. Atena Mansouri7; 1Allergy Research Center,

Mashhad University of Medical Sciences, Iran, 2Genetic Research Center,-

Mashhsd University of Medical Science, mashhad, Iran, 3Allergy research

center, Mashhsd University of Medical Science, Mashhad, Iran, 4Immu-

nology Research Center, Mashhsd University of Medical Science, mashhad,

Iran, 5Bushehr University of Medical Science, Mashhad, Iran, 6Allergy

Research Center. Mashhsd University of Medical Science, mashhad, Iran,7Buoshar university, Iran.

RATIONALE: Allergic rhinitis is caused by the interaction of genetics

and environment factors. TH2 has crucial role in atopic disease andGATA3

is known to be a contributing factor to increased TH2. Few studies showed

Single Nucleotide Polymorphism (SNP) GATA3 was associated with

allergic rhinitis, asthma, increased total IgE, and atopic dermatitis.

METHODS: This research is a case-control study, using two SNPs:

GATA3 (rs1269486, rs2229360). These genes have been assessed in

patients with allergic rhinitis as well as normal controls (86 patients and 86

normal). Moreover, blood samples of these participants have been

genotyped by PCR.

RESULTS: A significant association was found between allergic rhinitis

and polymorphisms of alleles, as well as genotypes and hallotype of

GATA3 rs1269486 gene. The frequency of A allele and GA genotype were

significantly higher in healthy subjects compared to G allele and GG

genotype in patients (P <0.001). Furthermore, Haplotypes of AC and GC

were found to be significantly higher in normal subjects and patients

respectively (p< 0.001).

CONCLUSIONS: This study was conducted in the Northeastern parts of

Iran. Polymorphisms of GATA3 rs1269486 gene was found to be

associated with allergic rhinitis and sensitivity to aeroallergens, however,

further research is required to determine polymorphisms in more SNPs, as

well as the other regions of the country.

465 Impacts Of Adolescents' Allergic Rhinitis On SchoolAchievement and Quality Of Life

Prof. Sun-Hee Choi, MD, PhD1, Dr. Kyung Suk Lee, MD, PhD2,

Prof. Yeong-Ho Rha, MD, PhD2; 1Gangdong Kyung Hee University Hos-

pital, Seoul, South Korea, 2Kyung Hee University Hospital.

RATIONALE: Allergic rhinitis is known to negatively affect one with

sleep disorder, attention disorder, anxiety, and other mental disorders that

may eventually influence one’s academic achievement.

METHODS: Raw data of their academic achievements, ISAAC and QOL

questionnaires were collected from 662 students from 4 middle and high

schools. Depending on academic achievements, which were categorized

into high, middle, and low, cross analysis was performed. The correlation

between the rating of students’ quality of life and the percentile of their

academic achievements were analyzed.

RESULTS: There was no significant difference between the allergic

rhinitis group and the normal group in terms of total score, sum ofmath and

science, and English; however, high school rhinitis students who had

received treatments over the last 12 months had significantly high Korean

language scores. Female rhinitis students showed the highest prevalence,

especially those who scored high on Korean language. In addition, high

school students who had been given treatment over the past 12 months

showed a significantly high prevalence, especially those with high Korean

language scores. There are significant positive correlations between quality

of life represented by physical fitness index and the percentiles for the

following subjects: math and science.

CONCLUSIONS: This result contradicts the other research results that

support the correlation between allergic rhinitis and low academic

achievement. However, considering other research results on how one’s

academic achievement can represent social status, it is possible to conclude

that allergic rhinitis is seen more often among people with high social

status.

466 Allergic Rhinitis (AR) Is Sub-Optimally Controlled: The NeedFor a More Effective Treatment Option

Dr. Phillip L. Lieberman, MD, FAAAAI1, Prof. David Price, FRCGP,

MRCGP, DRCOG2; 1Allergy and Asthma Associates, Germantown, TN,2Research In Real Life, Cambridge, United Kingdom.

RATIONALE: AR remains sub-optimally controlled. Our aim was to (i)

use patient survey data to explore the unmet need in AR, and (ii) show how

a new treatment option (MP29-02; Dymista), a novel intranasal formula-

tion of azelastine hydrochloride (AZE) and fluticasone propionate (FP) in

an advanced delivery system can fill this need.

METHODS: ARsymptomatology andmedicationusagedatawere collected

from 746 moderate/severe seasonal AR (SAR) patients who completed a

healthcare utilization survey in the UK. The patient characteristics mimicked

those of patients in theMP29-02 clinical trials. The clinical efficacy ofMP29-

02 was compared to commercially available AZE or FP nasal sprays and

placebo in a 14-day randomized controlled trial including 610 SAR patients.

Time to response was assessed post-hoc. A >_30% to >_90% change from

baseline in reflective total nasal symptom score (rTNSS) defined response.

RESULTS: 96.2% of patients surveyed were on AR medication; 70.5%

taking >_2 medications. These patients remained symptomatic with a mean

rTNSS of 12.8 (range 0-24) and amean rTOSS of 8.6 (range 0-18). Clinical

trial data in a matched population showed that more MP29-02-patients

achieved >_30%, >_50%, >_60%, >_75% and >_90% rTNSS-reduction, and days

faster than either active comparator. FP did not differ from placebo in

providing a >_60% rTNSS reduction.

CONCLUSIONS: AR is often poorly controlled with current therapies

(even multiple therapies). Intranasal corticosteroids fail to provide suffi-

cient symptom control in many patients. Treatment with MP29-02

addresses this unmet medical need as it provides faster and more complete

symptom control than FP.

467 Short and Long-Term Safety Of MP29-02 In The Treatment OfAllergic Rhinitis

Dr. William Berger, MD1, Dr. Jonathan A. Bernstein, MD, FAAAAI2,

Dr. Nancy Ruiz, MD3, Dr. Warner W. Carr, MD, FAAAAI4; 1Allergy &

Asthma Associates of Southern California, Mission Viejo, CA, 2Division

of Immunology Allergy & Rheumatology, University of Cincinnati Med-

ical Center, Cincinnati, OH, 3MEDA Pharmaceuticals, Somerset, NJ, 4Al-

lergy and Asthma Associates of SCs, Mission Viejo, CA.

RATIONALE: MP29-02 (Dymista�), a novel intranasal formulation of

azelastine hydrochloride (AZE) and fluticasone propionate (FP) in an

advanced delivery system, provides better nasal symptom improvement

than firstline treatment in SAR and chronic rhinitis patients. Short- and

long-term safety from these clinical trials are presented.

METHODS: 4022 patients were randomized into 4, 14-day double-blind,

placebo-controlled SAR trials to MP29-02, AZE, FP or placebo nasal

sprays. 612 chronic rhinitis patients were randomized to a 1-year, open-

label, parallel-group trial toMP29-02 or FP nasal sprays. For all studies the

total daily dose of AZE and FP was 548mcg and 200mcg, respectively.

Safetywas assessed by incidence, type, and severity of adverse events, vital

signs and nasal examinations. Fasting morning serum cortisol concentra-

tions were measured in a sub-group of chronic patients.

RESULTS: In all studies the incidence of treatment-related adverse events

(TRAEs) for active groups was low, not exceeding placebo in many

instances. The most commonly reported TRAEs for MP29-02 were

dysgeusia (2.1-7.2%), headache (0.5-2.6%) and epistaxis (1.0-3.9%).

Long-term, there was no evidence of TRAE accumulation over time. A

SAE was reported by 3 MP29-02-subjects and 1 FP-subject. None were

considered treatment-related. Therewas no appreciable reduction in serum

cortisol from baseline following 12 month’s continuous treatment with

MP29-02 (-0.08 (SD 5.5) mcg/dL) or FP (-1.04 (SD 5.0) mcg/dL). For all

studies, changes in vital signs and nasal examinations were similar in all

groups.

CONCLUSIONS: MP29-02 was well tolerated in 14-day studies in SAR

patients. MP29-02 was safe in a long-term study with no evidence of late-

occurring TRAEs.