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`N UmeiOQ
`VEmber 2012
`Ann
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`Supplement]
`NumberS
`annallergyorg
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`Annals of Allergy, Asthma
`& Immunology
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`CSL EXHIBIT 1094
`
`als of allerQY, asthma 8. immunology
`v.109 no 55
`‘
`‘
`uPpl.1 N
`.
`General Collection
`( W 2012)
`W1 AN56
`2012-12-04 08:09:56
`
`2012 Annual Meeting of the American College of
`Allergy, Asthma and Immunology
`
`Oral and Poster Abstracts
`
`November 8—13, 2012
`Anaheim, California
`
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`CSL EXHIBIT 1094
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`Annals of Allergy, Asthma
`2012 & Immunology
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`

`ABSTRACTS
`PRESENTED AT THE INTERNATIONAL
`FOOD ALLERGY CONFERENCE (IFAC)
`ORAL ABSTRACT & POSTER SESSIONS
`
`NOVEMBER 8, 2012
`Anaheim Convention Center
`
`TABLE OF CONTENTS
`
`TOPIC
`
`Oral Abstracts
`Poster Sessions
`
`ABSTRACT NUMBERS
`
`PAGES
`
`F1-F5
`FP1-FP25
`
`A3-A4
`A5-A11
`
`VOLUME 109, NOVEMBER, 2012
`
`A1
`
`Page 3 of 5
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`

`

`ORAL ABSTRACTS
`
`A2
`
`ANNALS OF ALLERGY, ASTHMA & IMMUNOLOGY
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`Page 4 of 5
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`

`ing face, hands, feet, larynx and abdomen. International guidelines recommend
`that patients with HAE should have the on-demand medicine to treat attacks
`at home and should be trained to self-administer this medication. We assessed
`the results from international survey of physicians who treat HAE, conducted
`by World Allergy Organization to determine the acceptance of home treatment
`for acute attacks of HAE. Methods: Physicians (N = 201) predominantly from
`Asia, Europe, and South America voluntarily completed the internet survey
`developed by physician-investigators with HAE expertise between November
`2010 and February 2011. Data were analyzed using descriptive statistics.
`Results: The majority of physicians (84%) treating HAE were allergy and
`immunology specialists, practicing in an academic medical center. Most physi-
`cians (64%) reported treating 1-5 HAE patients in the past year. Only 36%
`physicians reported treating ≥ 2 new HAE cases per year. The first onset of
`HAE symptoms was reported at the age of 11-17 years (39%). The patient’s
`most problematic symptom during the acute attack was throat swelling (48%)
`followed by facial swelling (23%) and abdominal pain (15%). In untreated
`patients, 58% had ≥ 1 acute attack per month and majority of these patients
`needed frequent hospitalizations. The most frequent setting for patients to
`receive emergency treatment included the hospital emergency department (63%)
`followed by hospital wards (21%). Very few patients received treatment for
`acute attacks at home (4% self-treating in their own home and 1% by home
`health care). Though C1-estrase inhibitor was the most used therapy for acute
`HAE attack, many physicians (33%) reported not prescribing it at all. Con-
`clusion: Though most physicians treating HAE internationally are allergy and
`immunology specialists in academic centers, majority of them follow very
`few patients on an annual basis. Despite recommendations, on-demand in home
`treatment for acute HAE attack is still minimally utilized at international level.
`Awareness of self/home therapy should be enhanced among international
`providers treating HAE to improve patient’s quality of life and disease out-
`comes.
`
`34
`SAFETY AND EFFICACY OF ESCALATING DOSES OF C1
`ESTERASE INHIBITOR [HUMAN] AS PROPHYLAXIS IN
`PATIENTS WITH HEREDITARY ANGIOEDEMA (HAE).
`J. Bernstein*1, M. Manning2, H. Li3, M.V. White4, J. Baker5, W.R. Lumry6,
`M. Davis-Lorton7, K. Jacobson8, R.G. Gower9, C. Broom10, D. Fitts10,
`J. Schranz10, 1. Cincinnati, OH; 2. Scottsdale, AZ; 3. Chevy Chase, MD;
`4. Wheaton, MD; 5. Lake Oswego, OR; 6. Dallas, TX; 7. Mineola, NY; 8.
`Eugene, OR; 9. Spokane, WA; 10. Exton, PA.
`Background: C1-esterase replacement therapy (Cinryze®) is used in the US
`for routine prophylaxis of HAE attacks. This open-label study, performed as a
`postmarketing requirement, assessed the safety and efficacy of escalating doses
`of C1INH in patients with HAE who were not adequately controlled on the
`approved dose (1000U every 3 or 4 days). Methods: Eligible patients had >1
`HAE attack/month while taking C1INH 1000U every 3 or 4 days over the 3
`months prior to the trial. IRB approval was obtained; all patients gave informed
`consent. Doses were escalated to 1500U, every 3 or 4 days for 12 weeks, at
`which point patients were evaluated. If treatment was successful (defined as
`an average of ≤1 HAE attack/month) or at the investigator’s discretion, patients
`continued on drug for a 12-week safety follow-up period. Patients who con-
`tinued to have an average of >1 HAE attack/month were eligible for further
`dose escalation to 2000U and then 2500U over sequential 12-week periods with
`evaluation and follow-up at their final study dosage as described above. Patients
`documented HAE attacks. Adverse events (AEs) and changes in physical exams,
`vital signs, and laboratory values were monitored. Results: All patients (N=20)
`started at 1500U; 13 were escalated to 2000U, and 12 were escalated to 2500U.
`Three patients discontinued from the study for non-safety-related reasons. Based
`on preliminary data, 55% of patients were treated successfully or continued on
`their final dose during follow-up at the investigator’s discretion (5 and 6 patients
`in the 1500 and 2500U groups, respectively). Eighteen patients reported 91
`AEs (85% mild or moderate in severity and 95% unrelated to C1INH). The
`most common AEs were URTI (25% of patients) and nasopharyngitis (15%).
`Two patients reported 4 serious AEs (cerebral hygroma, laryngeal HAE attack,
`and worsening of anemia and choledocholithasis) that were considered by inves-
`tigators to be unrelated to C1INH. Notably, there were no systemic thrombotic
`events, discontinuations due to AEs, or deaths. Conclusions: Dose escalation
`of C1INH up to 2500U was well tolerated and reduced HAE attack frequency
`in the majority of patients. There were no systemic thrombotic events. These
`results suggest that dose escalation of C1INH could be considered for patients
`who are not adequately controlled with 1000U every 3 or 4 days.
`
`ABSTRACTS: CONCURRENT SESSIONS
`
`35
`THE ROLE OF THE IMMUNE SYSTEM IN CYSTIC FIBROSIS:
`BENEFITS OF IVIG.
`I. Melamed*, A. Testori, A. McDonald, Centennial, CO.
`Introduction: Chronic sinusitis causes significant morbidity. Atopy and
`immunodeficiency are known predisposing risk factors to chronic sinusitis.
`Recently, multiple studies have shown a linkage between patients with chronic
`sinusitis who do not meet diagnostic criteria with cystic fibrosis (CF) and a sin-
`gle cystic fibrosis gene mutation. The CF gene was discovered years ago, its
`role in CF syndrome is still unclear. In these patients, intravenous immunoglob-
`ulin (IVIg) has been used for immune replacement and immunomodulation.
`We describe our experience using IVIg in 2 patients with a full CF mutation
`and 6 patients with a single mutation. Clinical Data: Our 8 patients ranged in
`age from 3 to 56 years with various CF mutations. The gene mutations included
`F508CF in 2 patients; single copy of F505CF in 4 patients; W1282X in 1 patient;
`and R117H in 1 patient. All patients were diagnosed with chronic sinus dis-
`ease and had received repeated courses of antibiotic therapy. All had positive
`CT scans of the sinuses. An immune work-up was performed: all patients had
`low borderline IgG levels (450±56); 4 patients had an IgG3 subclass deficiency;
`2 patients had low IgA; and 1 patient had low IgM. All patients had low iso-
`hemagglutinin levels. All patients had no response to pneumococcal vaccine,
`and 4 had a low response to tetanus, polio and Haemophilus influenzae type B
`vaccines. Results: All patients were treated with IVIg (600-800mg/Kg body
`weight) and recorded major improvement in the incidence of acute sinusitis
`with no further sinus surgeries recorded. A decreased use of antibiotic therapy
`was noted. Patients and caregivers reported that quality of life of energy lev-
`els had increased an average of 4 steps on a scale of 1 – 10. The full CF muta-
`tion patients were able to preserve their lung function and no hospitalizations
`were recorded after therapy was instituted. Discussion: The CF mutation com-
`bined with an aberrant immune system can lead to chronic sinus infections in
`single mutations, as well as lung destruction in full CF mutation, from various
`infectious and inflammatory pathways. IVIg therapy can benefit these patients
`by reducing the number of infections. IVIg can benefit patients with CF muta-
`tion: - In single mutation as immune replacement in preventing chronic sinus
`infection. - In full CF mutation as an immunomodulatory agent and to reduce
`post-infectious inflammatory changes.
`
`36
`B CELL DEPLETION IN AN INFANT EXPOSED TO R-CHOP IN
`UTERO: REPORT OF A CASE.
`R. Mittel*, J.J. Kulik, Chicago, IL.
`INTRODUCTION: Neonatal B cell immunodeficiency following in utero
`exposure to the B cell-depleting chemotherapy regimens CHOP (cyclophos-
`phamide/doxorubicin/vincristine/prednisone) or R-CHOP (in combination
`with rituximab), is an uncommon complication of pregnancy; consequently,
`there are only anecdotal reports and recommendations for management. We
`report an otherwise healthy infant born without circulating B lymphocytes fol-
`lowing administration of R-CHOP to his mother while he was in utero and a
`review of the literature. CASE REPORT: Thirty-day-old male EO was referred
`for initial immunologic evaluation after term delivery to a 28-yr-old G1P1
`diagnosed with non-Hodgkin’s lymphoma (NHL) in the 2nd trimester and
`given R-CHOP at 8, 5 and 2 wks prior to delivery. At birth and at Day 30, EO
`was normal by history and physical examination. He received Hep B vaccine
`at birth. Laboratory testing at birth showed that EO had lymphopenia but
`normal serum IgG for age. Measurement of peripheral blood lymphocyte mark-
`ers and serum IgG, IgA and IgM on Days 30 and 62 (Table 1) showed nor-
`mal quantities of T and NK cells and low IgG consistent with physiologic
`hypogammaglobulinemia, but persistently absent B cells and serum IgM and
`IgA. On Day 62 pre-immunization analysis of EO’s humoral immunity showed
`protective levels of IgG against tetanus and diphtheria and low levels of IgG
`antibodies to S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F and
`to H. influenzae b. Genetic analysis for X-linked agammaglobulinemia was
`not performed. EO was advised to receive the routine childhood vaccinations
`except rotavirus. A review of published full text articles identified by PubMed
`indicated that maternal outcomes of NHL in pregnancy are best when R-CHOP
`therapy is administered without delay until post-partum. Although transpla-
`cental transport of rituximab and gestational exposure to CHOP are associ-
`ated with transient leukopenia and B cell deficiency of the newborn, the neona-
`tal infection risk does not appear to be significantly increased (Cohen JB,
`Blum KA. Clin Obstet Gynecol 2011). CONCLUSION: B cell lymphopenia
`of the newborn resulting from in utero exposure to B cell-depleting chemother-
`
`VOLUME 109, NOVEMBER, 2012
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`A29
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