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Basophil histamine release to Amoxicilloyl-poly-L-lysine compared to amoxicillin in patients with IgE-mediated allergic reactions to amoxicillin

Arribas F1, Falkencrone S2, Sola J3, Gomez-Serranillos MP4, Laguna JJ5, Montañez MI6,7, Fernandez TD6,7, Rodríguez D1, Pineda F1, Stahl Skov P2, Mayorga C6,7*; Torres MJ6,7*
* Both authors have contributed equally

1Diater Laboratorios. Madrid, Spain
2Department of Dermatology, University Hospital of Odense, Denmark & Charité, Berlin, Germany.
3Allergy Service, Ramon y Cajal Hospital, Madrid, Spain
4Departament of Pharmacology,University Complutense of Madrid. Spain
5Allergy Unit, Cruz Roja Hospital, Madrid, Spain.
6Allergy Unit, IBIMA-Regional University Hospital of Malaga UMA, Málaga, Spain.
7Andalusian Center for Nanomedicine and Biotechnology - BIONAND, Málaga, Spain.

J Investig Allergol Clin Immunol 2017; Vol. 27(6)
doi: 10.18176/jiaci.0180

Background: Amoxicillin (AX) is the betalactam most often involved in IgE-mediated reactions and the diagnosis is mainly based on skin testing (ST) although without optimal sensitivity. We have produced a newly AX derivative, amoxicilloyl-poly-L-lysine (APL), and have analysed its IgE recognition by passive histamine release test (pHRT).
Methods: Patients (N=19) with confirmed AX allergy and with specific IgE positive to AX and controls (N=10) with good tolerance to AX were included. pHRT was done using “IgE-stripped” blood from a unique donor, sensitized in vitro by patient sera, and incubated with AX or APL. Histamine released was determined and expressed as ng of histamine release/mL blood.
Results: Patients clinical symptoms were anaphylaxis (N=9), urticaria (N=7), erythema (N=2) and not defined immediate reactions (N=1). The median time interval between reaction and study was 90 days (IQR: 60-240) and between drug intake and development of symptoms 24 min (IQR: 10-60). The median sIgE level was 3.37 kUA/L (IQR: 0.95-5.89). Sensitivity of pHRT to APL was 79% and the specificity 100% which were higher than data obtained with pHRT to AX (63% sensitivity and 90% specificity). There was a positive correlation between maximal histamine release levels obtained with AX and APL (r=0.63).
Conclusions: In patients with immediate hypersensitivity reactions to AX, APL showed a higher sensitivity and specificity compared to the culprit drug, AX, when tested in vitro by pHRT. This indicates that APL can improve in vitro diagnostic accuracy of AX allergic reactions. Further use for ST needs to be done.

Key words: Allergy, Amoxicillin, Amoxicilloyl-poly-L-lysine, Basophil histamine release, Immediate reactions.