Retrospective evaluation of non-steroidal anti-inflammatory drug-induced hypersensitivity reactions reported in a tertiary hospital allergy unit in Greece

[Speaker] Maria Kakolyri:1
[Co-author] Flora Strikou:1, Caterina Chliva:2, Michael Makris:2, Ekaterini Tiligada:1
1:Department of Pharmacology, Medical School, National and Kapodistrian University of Athens, Greece, 2:Allergy Unit ‘D. Kalogeromitros’, 2nd Department of Dermatology and Venereology, Medical School, National and Kapodistrian University of Athens, University Hospital ‘Attikon’, Athens, Greece

Background: Drug hypersensitivity reactions (DHRs; drug allergy) affect >7% of the population and comprise 15% of adverse drug reactions. Being potentially life threatening and a frequent cause of post-marketing drug withdrawal, DHRs represent important public health and medical concerns. Non-steroidal anti-inflammatory drugs (NSAIDs) are only second to antibiotics as the most frequent DHR-inducing agents. However, solid knowledge on the underlying mechanisms is virtually lacking. Non-standardized studies and DHR misdiagnosis repeatedly lead to misconceptions and to the use of more-expensive and potentially less-effective drugs. This study aimed at critically evaluating a DHR database in an effort to dissect reliable and useful information on NSAID-induced DHRs.
Methods: A proprietary database of DHRs reported in the Outpatient Allergy Unit of 'Attikon' University Hospital, Greece, between 2010-2017 was used. Data on 1183 cases were stored in one IBM SPSS spreadsheet containing 35 variables, including patient history, culprit drug(s) and diagnostic procedures. Normalized NSAID-induced DHR cases, including paracetamol were identified based on the patient history and assessed by descriptive statistics and statistical analyses using the chi-square and Mann-Whitney U tests.
Results: The major limitations identified in the database were the lack of or inconsistently defined variables, including entry date, patient identification number, name of the doctor referred to, DHR type, patient medication record and co-morbidities, as well as multiple entries for a number of patients. Therefore, normalized data on 91 patients reporting DHRs to a NSAID (acetylsalicylic acid 26.4%; mefenamic acid 20.9%; diclofenac 11.0%) were selected for further evaluation. DHRs to the culprit drug were identified in 35 cases (38.5%), whereas 23 (25.3%), 3 (3.3%) and 30 (33.0%) cases were classified as not DHRs, probably or probably not DHRs, respectively. Statistical analysis revealed a significant correlation between performing in vivo skin testing and the diagnostic clinical history of the NSAID-induced DHR.
Conclusions: In conclusion, the structural errors in a patient registry design hampered the value of the stored data. Based on the limited normalized data extracted, the clinical history rather than in vivo skin testing was routinely used for the diagnosis of the NSAID-induced DHRs.

Supported by COST Action BM0806. MK and FS contributed equally.

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