J ALLERGY CLIN IMMUNOL

FEBRUARY 2011

AB160 Abstracts

MONDAY

607 Severe Geriatric Asthma: Efficacy of Omalizumab in a VApopulation

P. Verma1, I. Randhawa2, W. B. Klaustermeyer1; 1VA Greater Los An-

geles Healthcare System/UCLA Allergy-Immunology Division, Los An-

geles, CA, 2UCLA Allergy-Immunology Division, Los Angeles, CA.

RATIONALE: To compare clinical outcomes of omalizumab therapy in a

severe asthma geriatric veteran population.

METHODS: A retrospective, observational data analysis was performed

over two years. Cohort outcome measures one year prior to omalizumab

therapy were compared to one year of active treatment. Statistical analysis

included two sample t-tests.

RESULTS: The total number of patients enrolled was 17 with mean age of

61 years. Omalizumab therapy was associated with a significant reduction

in acute asthma exacerbations requiring prednisone treatment (p<0.01), a

significant improvement in forced expiratory volume in 1 second (FEV1)

of 0.28 liters (p<0.01), and significantly higher Asthma Control Test

(ACT) scores at 3 months of therapy (p50.043), 6 months of therapy

(p50.039), and 12 months of therapy (p<0.01). Two out of 5 patients on

daily prednisone for over 6 months were able to discontinue systemic ste-

roid use within 3 months of omalizumab treatment.

CONCLUSIONS:Our study suggests elderly patients with severe asthma

demonstrate a significant positive clinical response to omalizumab.

608 Comparative Effectiveness Of Extrafine HydrofluoroalkaneBeclomethasone And Fluticasone In Asthma Management: AReal-world Observational Study From The United States

D. B. Price1,2, P. Dorinsky3, P. Polos4, A. Burden2, J. von Ziegenweidt2,

A. Chisholm2; 1University of Aberdeen, Foresterhill Health Centre, Aber-

deen, UNITED KINGDOM, 2Research in Real Life Ltd, Norfolk,

UNITED KINGDOM, 3Teva Pharmaceuticals, Horsham, PA, 4i3 Re-

search, Cary, NC.

RATIONALE: Relative effectiveness studies of inhaled corticosteroids

(ICS) in real-life asthma populations are lacking.

OBJECTIVE: To compare relative effectiveness of fluticasone propionate

(FP) metered-dose inhaler (MDI) and extrafine hydrofluoroalkane beclo-

methasone dipropionate (EF HFA-BDP) (Qvar�) MDI in real-life patients

with asthma initiating ICS therapy.

METHODS:Retrospective study using the Ingenix Normative Healthcare

InformationDatabase to assess asthma control over 1 year in patients (5-80

years) initiating ICS therapy as EF HFA-BDP or FP. Outcomes were

asthma control (composite measure: no unplanned asthma hospitalization

or emergency room [ER] attendance; no oral corticosteroids; no antibiotics

for lower respiratory infection, average daily SABA usage <_180mcg) and

number of exacerbations (no unplanned asthma hospitalization / ER atten-

dance and no oral corticosteroids). Patients were matched on baseline de-

mography and disease severity (age, gender, oral steroid prescriptions,

asthma consultations not resulting in oral steroids, daily reliever medica-

tion usage).

RESULTS: EFHFA-BDPwas prescribed at significantly lower mean dose

than FP (p<0.001). Patients initiating ICS as EF HFA-BDP had signifi-

cantly greater odds of achieving asthma control (OR [95%CI]: 1.00 vs

0.79 [0.73,0.85]), a reflection of higher SABA usage among FP patients

(p<0.001). Respiratory-related hospitalizations were significantly lower

for EF HFA-BDP patients (OR [95%CI]: 1.00 vs 1.22 [1.10,1.34]).

Exacerbation rates were comparable between treatments.

CONCLUSIONS: Patients initiating ICS therapywith EFHFA-BDPwere

at least as likely to achieve successful asthma control as patients initiating

therapy with FP despite EF HFA-BDP being prescribed a significantly

lower dose. These data suggest ICS action site is important in achieving ef-

fective asthma management in real life.

609 Response to Budesonide/Formoterol Pressurized Metered-Dose Inhaler (BUD/FM pMDI) by Patient's Sex in Non-Blackand Black Populations With Asthma

S. M. Meltzer1, S. L. Spector2, T. Uryniak3, U. J. Martin3; 1Allergy and

Asthma Care Center of Southern California, Long Beach, CA, 2California

Allergy & Asthma Medical Group, Los Angeles, CA, 3AstraZeneca LP,

Wilmington, DE.

RATIONALE:Differential effects of BUD/FMpMDI on absolute, but not

percent, changes from baseline in pulmonary function variables have been

described for males versus females in predominately white asthma popula-

tions. We tested these findings in a black population with moderate to se-

vere persistent asthma.

METHODS: Data from 2 double-blind, 12-week, randomized studies in

non-black (white, Asian, or other; study I[n5190]:NCT00652002;Drugs.

2006;66:2235) or self-reported black (study II[n5308]:NCT00702325) ado-

lescents and adults with asthma taking twice daily BUD/FM pMDI 320/9 mgor BUD (I:pMDI 320 mg; II:dry powder inhaler 360 mg) were assessed.RESULTS: Baseline percent predicted FEV1 values were similar in males

(I,II:68.0%-69.8%) and females (I,II:67.4%-71.0%). Similarly, meanpercent

changes from baseline to treatment average in predose FEV1 were consistent

inmales and females (I:9.3%vs 9.5%; II:12.5%vs 8.2%).However, absolute

improvements in pulmonary function variables were greater in males versus

females: predose FEV1 (I:0.25 vs 0.15; II:0.23 vs 0.13 L), morning PEF

(I:50.5 vs 25.9; II:31.4 vs 22.5 L/min), evening PEF (I:47.1 vs 25.5;

II:26.0 vs 19.2 L/min). Reductions in total daily rescue medication use

were similar between males and females receiving BUD/FM, respectively

(I:0.9 vs 1.0; II:1.1 vs 1.3 inhalations/day). Improvements in pulmonary

function and reductions in rescue medication in males and females were

greater with BUD/FM versus BUD (both studies).

CONCLUSIONS: In both black and non-black males and females with

asthma of similar severity receiving BUD/FM treatment, percentage im-

provements in pulmonary function and reductions in rescue medication

use were similar, while absolute improvements in pulmonary function

were greater in males versus females.

610 Alcohol-Based Mouthwashes Following Inhaled Corticoste-roids: To Use or Not To Use

T. M. Nsouli1,2, E. J. McSorley-Gerard2, C. D. Schluckebier2, C. Davis2,

M. Fakhriyazdi2, S. T. Nsouli2; 1Georgetown University School of Medi-

cine, Washington, DC, 2Burke and Watergate Allergy and Asthma Re-

search Centers, Washington, DC.

RATIONALE: Alcohol-based mouthwashes (ABMW) are often recom-

mended to asthmatic patients using inhaled corticosteroids (ICS) to prevent

oral candidiasis and hoarseness. A large body of evidence from epidemio-

logical studies conducted in different populations has supported the fact

that regular alcohol consumption is strongly associated with an increased

risk of oral cancers. Neoplasm of the oral cavity is the sixth leading cause

ofmalignancyworldwide and is a cause of significant morbidity (Boyle JO,

Strong EW. Oral Cavity Cancer in: Shah JP, eds. Cancer of the Head and

Neck, BC Decker, London; 2001). However, the safety of long-term use

of ABMW is still open to debate.

METHODS: We reviewed the medical literature evaluating the potential

risk of oral cancers due to regular use of ABMW. Some studies (Werner

CW, Br Dent J. 2009; 2007: 488; McCullough MJ, Aust Dent J. 2008;

53:302) have suggested that regular and prolonged use of ABMWmay in-

crease the risk of oral cancer.

RESULTS:Asthmatic patients treated with ICS frequently use ABMW to

prevent oral adverse effects. The alcohol component of the mouthwash

may contribute to an increased risk of developing oral malignancy.

CONCLUSION: Considering the evidence that rinsing with water is as ef-

fective as ABMW to clear ICS particles from the oral cavity (Kelloway JS

et al. Allergy Asthma Proc. 2001; 22:367), it would be prudent for aller-

gists/immunologists prescribing ICS to advise their patients to utilize a

non-ABMWor water as a safe effective mouth rinse, thus avoiding poten-

tial unnecessary increased risk of oral cancer.