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Sola-Gazagnes, A.* ; Pecquet, C.* ; Bèrre, S.* ; Achenbach, P. ; Pierson, L.A.* ; Virmoux-Buisson, I.* ; M’Bemba, J.* ; Elgrably, F.* ; Moguelet, P.* ; Boitard, C.* ; Caillat-Zucman, S.* ; Laanani, M.* ; Coste, J.* ; Larger, E.* ; Mallone, R.*

Insulin allergy: A diagnostic and therapeutic strategy based on a retrospective cohort and a case–control study.

Diabetologia 65, 1278-1290 (2022)

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Open Access Green möglich sobald Postprint bei der ZB eingereicht worden ist.

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Aims/hypothesis: Insulin allergy is a rare but significant clinical challenge. We aimed to develop a management workflow by (1) validating clinical criteria to guide diagnosis, based on a retrospective cohort, and (2) assessing the diagnostic performance of confirmatory tests, based on a case–control study. Methods: In the retrospective cohort, patients with suspected insulin allergy were classified into three likelihood categories according to the presence of all (likely insulin allergy; 26/52, 50%), some (possible insulin allergy; 9/52, 17%) or none (unlikely insulin allergy; 17/52, 33%) of four clinical criteria: (1) recurrent local or systemic immediate or delayed hypersensitivity reactions; (2) reactions elicited by each injection; (3) reactions centred on the injection sites; and (4) reactions observed by the investigator (i.e. in response to an insulin challenge test). All underwent intradermal reaction (IDR) tests. A subsequent case–control study assessed the diagnostic performance of IDR, skin prick and serum anti-insulin IgE tests in ten clinically diagnosed insulin allergy patients, 24 insulin-treated non-allergic patients and 21 insulin-naive patients. Results: In the retrospective cohort, an IDR test validated the clinical diagnosis in 24/26 (92%), 3/9 (33%) and 0/14 (0%) likely, possible and unlikely insulin allergy patients, respectively. In the case–control study, an IDR test was 80% sensitive and 100% specific and identified the index insulin(s). The skin prick and IgE tests had a marginal diagnostic value. Patients with IDR-confirmed insulin allergy were treated using a stepwise strategy. Conclusions/interpretation: Subject to validation, clinical likelihood criteria can effectively guide diabetologists towards an insulin allergy diagnosis before undertaking allergology tests. An IDR test shows the best diagnostic performance. A progressive management strategy can subsequently be implemented. Continuous subcutaneous insulin infusion is ultimately required in most patients. ClinicalTrials.gov: NCT01407640. Graphical abstract: [Figure not available: see fulltext.]

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