THE JOURNAL OF
`AllergymClinical
`Immunology Mal
`
`American Academy of
`VOLUME 129 . NUMBER 2
`Allergy Asthma
`— & Immunolog
`
`AMERICAN ACADEMY or ALLERGY,
`ASTHMA & IMMUNOLOGY
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`1
`?
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`ii
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`%
`1
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`2012 AAAAI Annual Meeting
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`Orlando, FL
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`March 2-March 6, 2012
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`Program and abstracts of papers to be presented
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`during scientific sessions
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`Abstract sessions programmed by the AAAAI
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`J ALLERGY CLIN IMMUNOL
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`February 2012
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`1A
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`Page 1 of 5
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`CSL EXHIBIT 1091
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`CSL EXHIBIT 1091
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`THE JOURNAL or
`Allergym Clinical
`Immunology
`
`AMA"
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`VOLUME 129 0 NUMBER 2
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`OFFICIAL JOURNAL or THE AMERICAN ACADEMY or ALLERGY, ASTHMA & IMMUNOLOGY
`
`American Academy of
`Allergy Asthm
`& lmmunolog_
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`
`
`Meeting Information
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`Abstracts
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`Saturday, March 3
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`Sunday, March 4
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`Monday, March 5
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`Tuesday, March 6
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`Scientific Program
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`Alphabetic Index by Abstract Authors
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`Keyword Index
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`Author Disclosures
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`Late—Breaking Abstracts
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`Author Disclosures for Late—Breaking Abstracts
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`3A
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`ABl
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`AB72
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`AB 147
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`ABZl l
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`A3251
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`AB305
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`AB326
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`AB331
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`AB364
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`AB372
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`© 20/2 American Academy of Allergy, Asthma & [Immunology
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`Statements and opinions expressed in the articles and communications herein are those of the author(s) and not necessarily those of the Editor(s), the pub—
`lisher, or the AAAAI. The Editor(s) and publisher disclaim any responsibility or liability for such material and do not guarantee, warrant, or endorse any
`product or service advertised in this publication, nor do they guarantee any claim made by the manufacturer of such product or service.
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`2A February 2012
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`J ALLERGY CLIN IMMUNOL
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`J ALLERGY CLIN IMMUNOL
`VOLUME 129, NUMBER 2
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`Abstracts A3369
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`measured at different times. Also, no change was seen in skin test,
`intradermal test and specific antibodies.
`CONCLUSIONS: This preliminary study suggests that the micro-syringe
`challenge with honeybee venom is feasible, and produces results undis—
`tinguishable from those of the traditional sting challenge. An application
`also to vespid venom is under evaluation.
`
`L2 Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD)
`of Subcutaneous (SC) Cinryze® ((21 inhibitor (C1 INH) with
`Recombinant Human Hyaluronidase (rHuPHle)
`in Subjects
`with Hereditary Angioedema (HAE)
`J. Scllranzl, R. Levyz, W. Lumry3, M. Manning“, J. Jacobss, S. S.
`Dyehters, M. J. LaBarreG, A. Phillipsl, S. Gelonel, C. Broomlg lVire-
`Pharma Incorporated, Exton, PA, 2Family Allergy and Asthma Center, At-
`lanta, GA, 3AARA Research Center, Dallas, TX, 4Allergy and
`Immunology Associates, Scottsdale, AZ, 5Allergy and Asthma Clinical
`Research, Inc., Walnut Creek, CA, 6I-[alozyme Therapeutics, San Diego,
`CA.
`RATIONALE: HAE manifests as recurrent painful, disabling, and
`sometimes fatal swelling attacks. CINRYZE administered by the 1V route
`replaces deficient and/or dysfunctional C1 INH and has proven efficacy
`and safety for both acute treatment and prevention. In order to provide
`broader options for patients to control disease, the potential enhancement
`of CINRYZE SC dispersion and absorption when co»administered with
`rHuPH20 was assessed in HAE patients.
`METHODS: This open~label, multiple-dose study was conducted in 12
`HAE patients who received twice-weekly 1000 or 2000 U SC doses of
`CINRYZE co—administered as a single injection with rHuPHZO for 2
`weeks. Comparisons were made to data from the same subjects who had
`prior exposure to ClNRYZE without rHuPHZO. Safety, tolerability, PK/
`PD, and inununogenicity were assessed.
`RESULTS: SC CINRYZE co-administered with rHuPI-IZO was well
`tolerated, with no AEs leading to discontinuation or SAEs. Mild/moderate
`injection site reactions were noted in the majority of subjects, with severe
`erythema reported in 2 subjects. Co—administration with rHuPH20 resulted
`in increased CINRYZE systemic exposure relative to SC administration of
`CINRYZE alone. Preliminary mean values attained were: functional C1
`INH exposure of 36—61 hr-U/mL‘, Cmax of 0.43—0.72 U/mL; antigenic C1
`INTI level of 0.13—0.24 g/L and C4 was 174-210 mg/mL. No subjects had
`detectable Cl INH antibodies in plasma 30 days after the last dose.
`CONCLUSIONS: CINRYZE co—adrninistered as a single SC injection
`with rHuPHZO was well tolerated and resulted in physiologically relevant
`functional Cl INH levels. Evaluation of the efficacy and safety of this
`innovative combination therapy is planned.
`
`L1
`
`Hypoallergenicity. Growth and Tolerance of an Amino Acid
`Based Formula (AAF) with Synbiotics in Allergic and Healthy
`Infants and Children
`B. M. Harvey‘, s. M. Gillman2, J. E, Langfords, T, D. Green“, R. H.
`Schwartzs, A. W. Burks"; lChildren’s Investigational Research Program,
`LLC (CHIRP), Bentonvillc, AR, 2Children’s Hospital of Orange County,
`Orange Country, CA, 3Nutricia Advanced Medical Nutrition, Dancne Re—
`search Centre for Specialised Nunition, Liverpool, UNITED KINGDOM,
`AChildren’s Hospital of Pittsburgh, Pittsburgh, PA, 5Iuova Fairfax Hospital
`for Children, Virginia, VA, 6Duke University Medical Center, Durham,
`NC.
`RATIONALE: Cow’s milk allergy (CMA) affects 25% of infants and
`children in Western counuies. Study 1 evaluated the effects of an AAF
`containing synbiotics (a specific mixture of short & long chain fructo-
`oligosaccharidcs and pectin derived acidic oligosaccharides [0.8g/ 100ml]
`+ Bifidobacterium Breve M»16V [1.3x109CFU/100ml]) on overall growth
`and tolerance in healthy, term infants. In study 2 the hypoallergenicity of
`the AAF containing synbiotics was evaluated in infants and children
`with documented CMA according to AAP guidelines.
`METHODS: In study 1, a total of 115 healthy, full—term formula fed
`infants (10 :4 days) randomly received the AAF with synbiotics or a
`commercially available control AAF without synbiotics (Neocate Infant
`DHA & ARA®, Nutricia Liverpool, UK) for 16 weeks as sole source of
`nutrition. Anthropometric measurements, tolerance, and adverse events
`were recorded throughout the study. In study 2, the hypoallergenicity of the
`AAF with synbiotics was evaluated in 30 infants and children (aged 0—3
`years) with lgE mediated CMA using a doubleeblind placebo—controlled
`food challenge (DBPCFC) and a 7 day feeding period.
`RESULTS: In study 1 overall growth as measured by weight, length and
`head circumference, tolerance and safety outcomes were similar in both
`groups at week 16. In study 2, all 30 subjects completed the DBPCFC with
`no reported allergic reactions.
`CONCLUSION: The results of these studies demonstrate that an AAF
`with synbiotics is safe, well tolerated and promotes normal growth when
`fed to healthy term infants as a sole source of nutrition and is hypoaller-
`genic in CMA infants and children.
`
`L2 Bee Venom Challenge By A Micro-syringe: Validation
`Procedure
`G. Corteluni‘, M. cherinoz, E. Froncescatoa, s. runuazzi", I. Spadolinis,
`G. Passalacquas; 1Rimini Hospital - Internal medicine and Rheumatolngy,
`Rimini, ITALY, 2Ospedale San Giovanni di Dio , Allergy clinic, Florence,
`ITALY, 3Entomon sas, Florence, ITALY, 4University of Florence - Dipar—
`timento di Biologia Evoluzionistica, Florence, ITALY, 5Anallergo, Flor-
`ence, ITALY, 6University of Genoa - Allergy and Respiratory Diseases,
`Geneva, ITALY.
`BACKGROUND: The honeybee sting challenge is considered a reliable
`diagnostic procedure, expecially for experimental purpose, but difficult to
`perform in clinical practice. Objective: we assessed the feasibility and
`reliability of a challenge test using a micro siryuge and compared to the
`standard procedure.
`METHODS: Patients enrolled on bee venom immunotherapy underwent a
`sting challenge (according to Golden 2006), and were kept under 1 hour
`observation. Large local reactions, were followed—up up to 48 hours.
`Immunological parameters were assessed one month after challenge.
`Those patients displaying systemic reactions at the sting challenge were
`excluded from the syringe challenge for ethical reasons. The syringe
`challenge was done by injecting SO IncL of fresh unfiltered bee venom at 2
`mm depth (the length of the sting left by a bee). The same follow-up as at
`the first challenge was performed.
`RESULTS: l9 patients on bee venom immunotherapy underwent the sting
`challenge with live bees. Four of them had immediate systemic reactions
`(generalized urticaria and/or asthma), and were excluded from the second
`challenge. Thelii patients with large local reaction and 2 patients with no
`reaction underwent the syringe challenge. There was no significant change,
`versus the sting challenge, in the diameters of the large local reactions,
`
`Page 3 of 5
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`9/25/2018
`
`Safety, Phannacoklnetlcs (PK), and Pharmaoodynamics (PD) of Subcutaneous (SC) Cinryze® (C1 Inhibitor (C1 INH) with Recombinant
`
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`Journal of Allergy and Clinical Immunology
`
`Volume 129, Issue 2, Supplement, February 2012, Page A3369
`
`Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of
`
`Subcutaneous (SC) Cinryze® (C1 inhibitor (C1 INH) with
`
`Recombinant Human Hyaluronidase (rHuPH20) in Subjects with
`
`Hereditary Angioedema (HAE)
`
`J. Schranz 1, R. Levy 2, W. Lumry 3, M. Manning 4, J. Jacobs 5, S.S. Dychter 6, M.J. LaBarre 6, A. Phillips 1, S. Gelone
`
`1, C. Broom 1
`
`\firoPharma Incorporated, Exton, PA
`
`Family Allergy and Asthma Center, Atlanta, GA
`
`AARA Research Center, Dallas, TX
`
`Allergy and Immunology Associates, Scottsdale, AZ
`
`Allergy and Asthma Clinical Research, Inc., Walnut Creek, CA
`
`Halozyme Therapeutics, San Diego, CA
`
`mm&w~
`
`Available online 9 February 2012.
`
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`https:/Idoi.org/10.1016/j.jaci.2012.01.022
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