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THE EFFECTS OF FREEZING ON EPINEPHRINE AUTO-INJECTOR DEVICE FUNCTION
Abstracts: Poster Sessions / Ann Allergy Asthma Immunol 121 (2018) S22−S62
P351 HELMINTH INFECTION AND ALLERGIC SENSITIZATION IN ESWATI CHILDREN N. Ramsey*,1, A. DiNardo2, C. Lupinek3, T. Nishiguci2, R. Kiss3, G. Mtetwa4, B. Mzileni4, A. Kay4, W. Secpr*,5, R. Mejia2, C. Davis2, R. Valenta3, J. Orange1, P. Hotez2, A. Mandalakas2, 1. New York, NY; 2. Houston, TX; 3. Vienna, Austria; 4. Mbabane, Swaziland; 5. Atlanta, GA Introduction: The link between helminth infection and allergic conditions is complex and the two conditions have been noted to be both indirectly and directly related. Here we describe helminth infection, allergic symptoms, environmental exposures, and allergen sensitization among patients at a clinic in Mbabane, Swaziland. Methods: Participants are enrolled in a longitudinal umbrella study which houses the nested case control study presented here. Allergic symptoms are defined by clinician H&P, and interviewer-guided modified International Survey on Allergies and Asthma in Childhood survey in Siswati. Environmental exposures were identified using interviewer-guided survey in Siswati. IgE sensitization to more than 160 allergen molecules was detected using ImmunoCAP ISAC technology. Results: On average patients were 8 years old and 44% were male. Nineteen percent (38/188) of participants have current helminth infection and 8% (15/188) have remote helminth infection. Sixtyeight percent (128/188) of participants surveyed were positive for one or more allergic symptom. Eczema/rash was more prevalent in children with exposure to a miner in the home. Remotely infected patients had less allergy symptoms. House dust mite allergens were the most common allergens recognized in this population 28% (45/ 160). Allergen sensitization was strikingly absent or low in patients with helminth infection. Conclusions: Our evidence suggests that allergic symptoms are common in this population and allergies are less likely among patients with remote helminth infection. There is a dampening of allergen sensitization in patients with helminth infection and allergy symptoms in patients with remote helminth infection. These results support the hygiene hypothesis, in part, and further elucidate its complexities.
P352 SUBCUTANEOUS SELF-ADMINISTRATION OF LANADELUMAB FOR PROPHYLACTIC TREATMENT IN PATIENTS WITH HEREDITARY ANGIOEDEMA (HAE) W. Lumry*,1, P. Busse2, P. Lu3, G. Jain3, C. Nurse3, M. Maurer4, 1. Dallas, TX; 2. New York, NY; 3. Lexington, MA; 4. Berlin, Germany Introduction: Administration of a large C1 inhibitor (C1-INH) volume twice weekly for prophylaxis can be burdensome. Lanadelumab, a monoclonal antibody targeting plasma kallikrein, effectively prevents attacks in patients with HAE type I/II. Patients’ self-administration experience was investigated. Methods: Interim data (May 2016-September 2017) from an ongoing open-label extension study (NCT02741596) on attack rates and injection site reactions (ISRs) in rollover patients from a phase 3 study (after their second dose) and non-rollover patients who received 300 mg (2 mL) subcutaneous (SC) lanadelumab every 2 weeks (Q2W) via self-administration versus administration by study staff were compared. Trained patients (aged ≥ 12 years) self-administered lanadelumab (at home or in-clinic) after two administrations by staff. Patients with intravenous C1-INH experience indicated their preferred administration route in a survey. Results: In 212 patients, 56.4% of 3157 doses were self-administered. Of 209 patients who received ≥ 1 dose, ≥ 80% of doses were administered by staff versus self-administered in 61 versus 97 patients; mean (SD) attack rate reductions were -2.1 (1.98) and -3.3 (2.58) attacks/ month, respectively. The proportion of doses causing ISRs postadministration by staff, self-administration at home and in-clinic
S57
were 19.4%, 21.5%, and 16.9%, respectively. At day 266, 70.9% versus 7.3% of 55 patients preferred SC over intravenous administration and 59.3% and 52.5% of 59 patients reported that SC injections were easier to administer and convenient, respectively. Conclusions: Patients successfully self-administered SC lanadelumab (300 mg Q2W) to prevent HAE attacks effectively with no difference in efficacy or ISRs compared with patients who received doses by inclinic staff.
P353 A SEMI-AUTOMATED APPROACH TO IDENTIFYING CHRONIC COUGH IN ELECTRONIC HEALTH RECORDS M. Weiner1, J. Weaver*,2, P. Dexter1, A. Roberts1, Z. Liu1, S. Hui1, A. Church1, I. DOSHI3, K. Heithoff2, 1. Indianapolis, IN; 2. Kenilworth, NJ; 3. RAHWAY, NJ Introduction: Chronic cough (CC) of eight or more weeks affects up to 10% of adults and may lead to expensive treatments and reduced quality of life. Incomplete diagnostic coding complicates identifying CC in electronic health records (EHRs). Natural language processing (NLP) of EHR text could improve CC detection. Objective: Assess NLP as a method to identify CC in EHRs. Methods: Coded and text-based data from a Midwestern EHR were used to identify patients aged 18-85 during 2005-2015. NLP evaluated all text notes except prescriptions and patient instructions, for mentions of cough or expectoration. Filtering based on output review was performed: after initial cohort identification, two clinicians and a biostatistician reviewed twelve sets of 50 records each, with iterative refinements, until the positive predictive value exceeded 90%. NLP, ICD-10, or cough medication identified cough encounters. Three encounters spanning at least 56 days within 120 days defined CC. Results: Optimization of NLP required identifying and eliminating cough denials, general instructions, and historical references. Of 260,517 cough encounters, 23% had a diagnostic code or medication indicating cough. Encounters identified 25,767 patients (62% women) with CC. NLP alone identified 74%; diagnoses or medications alone identified 14%. The positive predictive value was 97%. Conclusions: Most cohort patients were identified through NLP alone, rather than diagnoses or medications. NLP improved detection of patients nearly seven-fold, addressing the gap in ability to identify and characterize CC disease burden. Identifying these patients is important for characterizing their treatment and unmet needs. Pharmacology and Pharmacotherapeutics
P400 THE EFFECTS OF FREEZING ON EPINEPHRINE AUTO-INJECTOR DEVICE FUNCTION A. Cooper*, J. Brown, P. Qu, Seattle, WA Introduction: Epinephrine auto-injectors (EAIs) typically require storage temperatures between 20-25°C with permitted excursions between 15°-30°C. However, previous studies suggest that freezing does not degrade epinephrine, and in one study 10 frozen and thawed EAIs fired successfully. We aim to further explore the effects of freezing on EAI function. Methods: For 104 paired same-lot post-consumer single-commonbrand expired EAIs (50 0.3 mg and 50 0.15 mg devices), one of the pair was frozen at -25°C for 24 hours while the other was kept at recommended temperatures (control). After thawing the frozen device, both devices were fired into meat. The increase in meat mass and decrease in device mass were measured to estimate the mass of solution fired. Results: There was sufficient power (>95%) to conclude equivalence for both outcomes, defined as equivalent if the average difference in mass for frozen devices was within 10% of the difference for unfrozen devices. Two one-sided t-tests showed equivalence for both
S58
Abstracts: Poster Sessions / Ann Allergy Asthma Immunol 121 (2018) S22−S62
outcomes (p value < 0.0001) indicating frozen and thawed devices fired a similar mass of epinephrine solution compared with unfrozen devices. Testing continued to show equivalence after controlling for device epinephrine dose (0.3 mg vs 0.15 mg) and expiration date, using two one-sided tests in a general linear model. Conclusions: Freezing for 24 hours did not impair EAI device’s function once thawed. While freezing is not recommended, devices accidentally left in freezing temperatures for short periods are at low risk for malfunction.
P401 ATTITUDES AND BELIEFS TOWARD EPINEPHRINE AUTO-INJECTOR PRICE INCREASE E. Wang*, A. Plunk, M. Morales, Norfolk, VA Introduction: A few years ago, the price of an epinephrine autoinjection device increased dramatically. Now with multiple options of epinephrine auto-injectors, we set out to identify what drives patient purchasing trends. Methods: Cross sectional study using an anonymous survey. The target population included parents of both male and female children who have purchased an epinephrine auto-injector within the last 10 years. The patient panel included multiple satellite CHKD allergy and immunology clinics. Results: We found that while 73% of families we surveyed “completely agreed” to feeling financially burdened by the cost of an epinephrine auto-injector (and 97% overall agreed), 68% “completely agreed” (and 93% overall agreed) to the belief in having a new auto-injector every year. 86% of families “completely agreed” in the importance of having an epinephrine auto-injector at school or daycare and only 15% of families generally worried about the side effects or harm of giving the epinephrine auto-injector. 95% of families generally felt comfortable giving the auto-injector if necessary. The number one factor in deciding which epinephrine auto-injector to purchase was physician recommendation and prescription, followed by price/insurance coverage, then pharmacy suggestion, and finally, ease of use and brand name. Conclusions: While a significant majority of our patients feel financially burdened by the cost of epinephrine auto-injectors, they also agree with the importance of purchasing it yearly. Physician recommendation and prescription is the number one deciding factor in their purchasing choice, almost three times more than cost. This study demonstrates the importance of physician awareness of the prices of medications.
P402 A PHASE 1/1B STUDY OF AN INHALED FORMULATION OF ITRACONAZOLE IN HEALTHY VOLUNTEERS AND ASTHMATICS D. Hava*,1, L. Tan2, P. Johnson3, A. Curran1, J. Perry1, S. Kramer1, K. Kane1, P. Bedwell4, D. Henderson5, G. Layton4, K. Singh6, L. Connor6, D. Singh6, J. Roach1, 1. Lexington, MA; 2. Cambridge, United Kingdom; 3. Eichenweg 3, Switzerland; 4. Kent, United Kingdom; 5. Nottingham, United Kingdom; 6. Manchester, United Kingdom Introduction: Oral itraconazole has variable pharmacokinetics and risks of significant adverse events (AEs) associated with high plasma exposure. A dry powder inhalation formulation of itraconazole (ITRA) is being developed to treat Allergic Bronchopulmonary Aspergillosis (ABPA). This study was conducted to evaluate safety, tolerability and pharmacokinetics of ITRA in healthy volunteers and asthmatics. Methods: The study was a 3-part, multi-center, open-label study. Healthy volunteers (n=5-6/cohort) received either single (Part 1 5mg, 10mg, 25mg, 35mg) or multiple doses of ITRA (Part 2 -10mg, 20mg, 35mg) over 14d. In Part 3 stable, adult asthmatics received a single dose of 20mg ITRA or 200mg of oral itraconazole in a 2-period cross-over design. Itraconazole plasma (Parts 1-3) and sputum (Part 3) concentrations were evaluated.
Results: All study drug-related AEs were mild, and no moderate, severe or serious study drug-related AEs were reported. The most common drug-related AE was the infrequent occurrence of mild cough. At steady-state, ITRA resulted in plasma exposure (AUC0-24h) that was 100-400 fold lower across doses tested than reported for oral itraconazole. In asthmatics, ITRA achieved Cmax sputum concentrations 45-fold higher and plasma AUC0-24h concentrations 85-fold lower than oral itraconazole. Conclusions: ITRA was safe and well-tolerated under the study conditions tested, and achieved significantly higher lung and lower plasma exposure compared to oral itraconazole, supporting the potential of ITRA to improve upon both the efficacy and safety profile observed with oral itraconazole in patients with ABPA.
P403 MULTIPHASIC TREATMENT MODALITY FOR PEDIATRIC EOSINOPHILIC GASTROENTERITIS, A SINGLE CENTER EXPERIENCE K. Kennedy*, M. Ruffner, A. Muir, Philadelphia, PA Introduction: Treatment of eosinophilic gastroenteritis (EG) in pediatrics is challenging. Options available include systemic immune modulators as well as targeted dietary restriction. Both regimens are difficult to adhere to given the adverse effects of systemic steroid therapy and compliance difficulties with diet restriction. At our institution we have found that only 25% of patients with EG respond to diet restriction. Here we describe the presentation and outcome of pediatric EG patients placed on a unique multiphasic steroid treatment. This treatment modality has not been previously described and is novel in its delivery pharmacokinetics which enable targeted local steroid delivery to areas beyond the esophagus. Methods: Seven patients with biopsy proven EG treated with a regimen of multiphasic steroids were reviewed. Endoscopy results including visualization and gastric eosinophil count were compared before and several months after treatment. When available, the effect of treatment on serum absolute eosinophil count, albumin and total protein was compared. Results: All patients had improvement on biopsy after initiation of multiphasic therapy with most showing resolution of gastric eosinophils. The most common modality used was at least one capsule crushed and one capsule opened of budesonide 3mg. Most patients were not on concurrent diet restriction unless they had known IgE mediated sensitization or self-restricted. The age range at initiation was 1-17 years with more patients starting treatment in adolescence. Five of the seven patients reviewed had atopic disease. Conclusions: We present our experience and promising outcomes in using a novel, targeted steroid treatment for pediatric patients with EG.
P404 FACTORS ASSOCIATED WITH THE INITIATION OF BIOLOGIC DRUGS IN MEDICAID PATIENTS WITH SEVERE UNCONTROLLED ASTHMA D. Bukstein*, fitchburg, WI Introduction: Severe Uncontrolled asthma is associated with high health care costs, yet guidance is lacking on how early to initiate biologic drugs. Few studies have examined the factors associated with the transition from nonbiologic drugs to biologics. Objective: To examine patient sociodemographics, medication use patterns, and clinical characteristics associated with lack of initiation of biologic drugs in the treatment of severe uncontrolled asthma. Methods: This was a prospective study using the Wisconsin Medicaid patients that were seen in an entirely Medicaid clinic in an underserved area of Milwaukee, Wisconsin. 31 consecutive Medicaid patients with severe uncontrolled asthma were interviewed.
P351 HELMINTH INFECTION AND ALLERGIC SENSITIZATION IN ESWATI CHILDREN N. Ramsey*,1, A. DiNardo2, C. Lupinek3, T. Nishiguci2, R. Kiss3, G. Mtetwa4, B. Mzileni4, A. Kay4, W. Secpr*,5, R. Mejia2, C. Davis2, R. Valenta3, J. Orange1, P. Hotez2, A. Mandalakas2, 1. New York, NY; 2. Houston, TX; 3. Vienna, Austria; 4. Mbabane, Swaziland; 5. Atlanta, GA Introduction: The link between helminth infection and allergic conditions is complex and the two conditions have been noted to be both indirectly and directly related. Here we describe helminth infection, allergic symptoms, environmental exposures, and allergen sensitization among patients at a clinic in Mbabane, Swaziland. Methods: Participants are enrolled in a longitudinal umbrella study which houses the nested case control study presented here. Allergic symptoms are defined by clinician H&P, and interviewer-guided modified International Survey on Allergies and Asthma in Childhood survey in Siswati. Environmental exposures were identified using interviewer-guided survey in Siswati. IgE sensitization to more than 160 allergen molecules was detected using ImmunoCAP ISAC technology. Results: On average patients were 8 years old and 44% were male. Nineteen percent (38/188) of participants have current helminth infection and 8% (15/188) have remote helminth infection. Sixtyeight percent (128/188) of participants surveyed were positive for one or more allergic symptom. Eczema/rash was more prevalent in children with exposure to a miner in the home. Remotely infected patients had less allergy symptoms. House dust mite allergens were the most common allergens recognized in this population 28% (45/ 160). Allergen sensitization was strikingly absent or low in patients with helminth infection. Conclusions: Our evidence suggests that allergic symptoms are common in this population and allergies are less likely among patients with remote helminth infection. There is a dampening of allergen sensitization in patients with helminth infection and allergy symptoms in patients with remote helminth infection. These results support the hygiene hypothesis, in part, and further elucidate its complexities.
P352 SUBCUTANEOUS SELF-ADMINISTRATION OF LANADELUMAB FOR PROPHYLACTIC TREATMENT IN PATIENTS WITH HEREDITARY ANGIOEDEMA (HAE) W. Lumry*,1, P. Busse2, P. Lu3, G. Jain3, C. Nurse3, M. Maurer4, 1. Dallas, TX; 2. New York, NY; 3. Lexington, MA; 4. Berlin, Germany Introduction: Administration of a large C1 inhibitor (C1-INH) volume twice weekly for prophylaxis can be burdensome. Lanadelumab, a monoclonal antibody targeting plasma kallikrein, effectively prevents attacks in patients with HAE type I/II. Patients’ self-administration experience was investigated. Methods: Interim data (May 2016-September 2017) from an ongoing open-label extension study (NCT02741596) on attack rates and injection site reactions (ISRs) in rollover patients from a phase 3 study (after their second dose) and non-rollover patients who received 300 mg (2 mL) subcutaneous (SC) lanadelumab every 2 weeks (Q2W) via self-administration versus administration by study staff were compared. Trained patients (aged ≥ 12 years) self-administered lanadelumab (at home or in-clinic) after two administrations by staff. Patients with intravenous C1-INH experience indicated their preferred administration route in a survey. Results: In 212 patients, 56.4% of 3157 doses were self-administered. Of 209 patients who received ≥ 1 dose, ≥ 80% of doses were administered by staff versus self-administered in 61 versus 97 patients; mean (SD) attack rate reductions were -2.1 (1.98) and -3.3 (2.58) attacks/ month, respectively. The proportion of doses causing ISRs postadministration by staff, self-administration at home and in-clinic
S57
were 19.4%, 21.5%, and 16.9%, respectively. At day 266, 70.9% versus 7.3% of 55 patients preferred SC over intravenous administration and 59.3% and 52.5% of 59 patients reported that SC injections were easier to administer and convenient, respectively. Conclusions: Patients successfully self-administered SC lanadelumab (300 mg Q2W) to prevent HAE attacks effectively with no difference in efficacy or ISRs compared with patients who received doses by inclinic staff.
P353 A SEMI-AUTOMATED APPROACH TO IDENTIFYING CHRONIC COUGH IN ELECTRONIC HEALTH RECORDS M. Weiner1, J. Weaver*,2, P. Dexter1, A. Roberts1, Z. Liu1, S. Hui1, A. Church1, I. DOSHI3, K. Heithoff2, 1. Indianapolis, IN; 2. Kenilworth, NJ; 3. RAHWAY, NJ Introduction: Chronic cough (CC) of eight or more weeks affects up to 10% of adults and may lead to expensive treatments and reduced quality of life. Incomplete diagnostic coding complicates identifying CC in electronic health records (EHRs). Natural language processing (NLP) of EHR text could improve CC detection. Objective: Assess NLP as a method to identify CC in EHRs. Methods: Coded and text-based data from a Midwestern EHR were used to identify patients aged 18-85 during 2005-2015. NLP evaluated all text notes except prescriptions and patient instructions, for mentions of cough or expectoration. Filtering based on output review was performed: after initial cohort identification, two clinicians and a biostatistician reviewed twelve sets of 50 records each, with iterative refinements, until the positive predictive value exceeded 90%. NLP, ICD-10, or cough medication identified cough encounters. Three encounters spanning at least 56 days within 120 days defined CC. Results: Optimization of NLP required identifying and eliminating cough denials, general instructions, and historical references. Of 260,517 cough encounters, 23% had a diagnostic code or medication indicating cough. Encounters identified 25,767 patients (62% women) with CC. NLP alone identified 74%; diagnoses or medications alone identified 14%. The positive predictive value was 97%. Conclusions: Most cohort patients were identified through NLP alone, rather than diagnoses or medications. NLP improved detection of patients nearly seven-fold, addressing the gap in ability to identify and characterize CC disease burden. Identifying these patients is important for characterizing their treatment and unmet needs. Pharmacology and Pharmacotherapeutics
P400 THE EFFECTS OF FREEZING ON EPINEPHRINE AUTO-INJECTOR DEVICE FUNCTION A. Cooper*, J. Brown, P. Qu, Seattle, WA Introduction: Epinephrine auto-injectors (EAIs) typically require storage temperatures between 20-25°C with permitted excursions between 15°-30°C. However, previous studies suggest that freezing does not degrade epinephrine, and in one study 10 frozen and thawed EAIs fired successfully. We aim to further explore the effects of freezing on EAI function. Methods: For 104 paired same-lot post-consumer single-commonbrand expired EAIs (50 0.3 mg and 50 0.15 mg devices), one of the pair was frozen at -25°C for 24 hours while the other was kept at recommended temperatures (control). After thawing the frozen device, both devices were fired into meat. The increase in meat mass and decrease in device mass were measured to estimate the mass of solution fired. Results: There was sufficient power (>95%) to conclude equivalence for both outcomes, defined as equivalent if the average difference in mass for frozen devices was within 10% of the difference for unfrozen devices. Two one-sided t-tests showed equivalence for both
S58
Abstracts: Poster Sessions / Ann Allergy Asthma Immunol 121 (2018) S22−S62
outcomes (p value < 0.0001) indicating frozen and thawed devices fired a similar mass of epinephrine solution compared with unfrozen devices. Testing continued to show equivalence after controlling for device epinephrine dose (0.3 mg vs 0.15 mg) and expiration date, using two one-sided tests in a general linear model. Conclusions: Freezing for 24 hours did not impair EAI device’s function once thawed. While freezing is not recommended, devices accidentally left in freezing temperatures for short periods are at low risk for malfunction.
P401 ATTITUDES AND BELIEFS TOWARD EPINEPHRINE AUTO-INJECTOR PRICE INCREASE E. Wang*, A. Plunk, M. Morales, Norfolk, VA Introduction: A few years ago, the price of an epinephrine autoinjection device increased dramatically. Now with multiple options of epinephrine auto-injectors, we set out to identify what drives patient purchasing trends. Methods: Cross sectional study using an anonymous survey. The target population included parents of both male and female children who have purchased an epinephrine auto-injector within the last 10 years. The patient panel included multiple satellite CHKD allergy and immunology clinics. Results: We found that while 73% of families we surveyed “completely agreed” to feeling financially burdened by the cost of an epinephrine auto-injector (and 97% overall agreed), 68% “completely agreed” (and 93% overall agreed) to the belief in having a new auto-injector every year. 86% of families “completely agreed” in the importance of having an epinephrine auto-injector at school or daycare and only 15% of families generally worried about the side effects or harm of giving the epinephrine auto-injector. 95% of families generally felt comfortable giving the auto-injector if necessary. The number one factor in deciding which epinephrine auto-injector to purchase was physician recommendation and prescription, followed by price/insurance coverage, then pharmacy suggestion, and finally, ease of use and brand name. Conclusions: While a significant majority of our patients feel financially burdened by the cost of epinephrine auto-injectors, they also agree with the importance of purchasing it yearly. Physician recommendation and prescription is the number one deciding factor in their purchasing choice, almost three times more than cost. This study demonstrates the importance of physician awareness of the prices of medications.
P402 A PHASE 1/1B STUDY OF AN INHALED FORMULATION OF ITRACONAZOLE IN HEALTHY VOLUNTEERS AND ASTHMATICS D. Hava*,1, L. Tan2, P. Johnson3, A. Curran1, J. Perry1, S. Kramer1, K. Kane1, P. Bedwell4, D. Henderson5, G. Layton4, K. Singh6, L. Connor6, D. Singh6, J. Roach1, 1. Lexington, MA; 2. Cambridge, United Kingdom; 3. Eichenweg 3, Switzerland; 4. Kent, United Kingdom; 5. Nottingham, United Kingdom; 6. Manchester, United Kingdom Introduction: Oral itraconazole has variable pharmacokinetics and risks of significant adverse events (AEs) associated with high plasma exposure. A dry powder inhalation formulation of itraconazole (ITRA) is being developed to treat Allergic Bronchopulmonary Aspergillosis (ABPA). This study was conducted to evaluate safety, tolerability and pharmacokinetics of ITRA in healthy volunteers and asthmatics. Methods: The study was a 3-part, multi-center, open-label study. Healthy volunteers (n=5-6/cohort) received either single (Part 1 5mg, 10mg, 25mg, 35mg) or multiple doses of ITRA (Part 2 -10mg, 20mg, 35mg) over 14d. In Part 3 stable, adult asthmatics received a single dose of 20mg ITRA or 200mg of oral itraconazole in a 2-period cross-over design. Itraconazole plasma (Parts 1-3) and sputum (Part 3) concentrations were evaluated.
Results: All study drug-related AEs were mild, and no moderate, severe or serious study drug-related AEs were reported. The most common drug-related AE was the infrequent occurrence of mild cough. At steady-state, ITRA resulted in plasma exposure (AUC0-24h) that was 100-400 fold lower across doses tested than reported for oral itraconazole. In asthmatics, ITRA achieved Cmax sputum concentrations 45-fold higher and plasma AUC0-24h concentrations 85-fold lower than oral itraconazole. Conclusions: ITRA was safe and well-tolerated under the study conditions tested, and achieved significantly higher lung and lower plasma exposure compared to oral itraconazole, supporting the potential of ITRA to improve upon both the efficacy and safety profile observed with oral itraconazole in patients with ABPA.
P403 MULTIPHASIC TREATMENT MODALITY FOR PEDIATRIC EOSINOPHILIC GASTROENTERITIS, A SINGLE CENTER EXPERIENCE K. Kennedy*, M. Ruffner, A. Muir, Philadelphia, PA Introduction: Treatment of eosinophilic gastroenteritis (EG) in pediatrics is challenging. Options available include systemic immune modulators as well as targeted dietary restriction. Both regimens are difficult to adhere to given the adverse effects of systemic steroid therapy and compliance difficulties with diet restriction. At our institution we have found that only 25% of patients with EG respond to diet restriction. Here we describe the presentation and outcome of pediatric EG patients placed on a unique multiphasic steroid treatment. This treatment modality has not been previously described and is novel in its delivery pharmacokinetics which enable targeted local steroid delivery to areas beyond the esophagus. Methods: Seven patients with biopsy proven EG treated with a regimen of multiphasic steroids were reviewed. Endoscopy results including visualization and gastric eosinophil count were compared before and several months after treatment. When available, the effect of treatment on serum absolute eosinophil count, albumin and total protein was compared. Results: All patients had improvement on biopsy after initiation of multiphasic therapy with most showing resolution of gastric eosinophils. The most common modality used was at least one capsule crushed and one capsule opened of budesonide 3mg. Most patients were not on concurrent diet restriction unless they had known IgE mediated sensitization or self-restricted. The age range at initiation was 1-17 years with more patients starting treatment in adolescence. Five of the seven patients reviewed had atopic disease. Conclusions: We present our experience and promising outcomes in using a novel, targeted steroid treatment for pediatric patients with EG.
P404 FACTORS ASSOCIATED WITH THE INITIATION OF BIOLOGIC DRUGS IN MEDICAID PATIENTS WITH SEVERE UNCONTROLLED ASTHMA D. Bukstein*, fitchburg, WI Introduction: Severe Uncontrolled asthma is associated with high health care costs, yet guidance is lacking on how early to initiate biologic drugs. Few studies have examined the factors associated with the transition from nonbiologic drugs to biologics. Objective: To examine patient sociodemographics, medication use patterns, and clinical characteristics associated with lack of initiation of biologic drugs in the treatment of severe uncontrolled asthma. Methods: This was a prospective study using the Wisconsin Medicaid patients that were seen in an entirely Medicaid clinic in an underserved area of Milwaukee, Wisconsin. 31 consecutive Medicaid patients with severe uncontrolled asthma were interviewed.