Agnès Sola-Gazagnes1, Catherine Pecquet2, Stefano Berré3, Peter Achenbach4,5, Laure-Anne Pierson6, Isabelle Virmoux-Buisson7, Jocelyne M'Bemba7, Fabienne Elgrably7, Philippe Moguelet8, Christian Boitard7,3, Sophie Caillat-Zucman9,10, Moussa Laanani11, Joel Coste11, Etienne Larger7,3, Roberto Mallone7,3. 1. Assistance Publique-Hôpitaux de Paris, Hôpitaux Universitaires de Paris Centre-Université Paris Cité, Cochin Hospital, Service de Diabétologie et Immunologie Clinique, Paris, France. agnes.sola@aphp.fr. 2. Assistance Publique-Hôpitaux de Paris, Hôpital Tenon, Service d'Allergologie Dermatologie, Paris, France. 3. Université Paris Cité, CNRS, Inserm, Institut Cochin, Paris, France. 4. Helmholtz Zentrum München, German Research Center for Environmental Health, Institute of Diabetes Research, Munich-Neuherberg, Germany. 5. Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Forschergruppe Diabetes, Munich, Germany. 6. Assistance Publique-Hôpitaux de Paris, Hôtel-Dieu, Service de Pharmacie, Pharmacologie, Toxicologie, Paris, France. 7. Assistance Publique-Hôpitaux de Paris, Hôpitaux Universitaires de Paris Centre-Université Paris Cité, Cochin Hospital, Service de Diabétologie et Immunologie Clinique, Paris, France. 8. Assistance Publique-Hôpitaux de Paris, Hôpital Tenon, Service d'Anatomo-Pathologie, Sorbonne Université, Faculté de Médecine, Paris, France. 9. Assistance Publique-Hôpitaux de Paris, Hôpital Saint-Louis, Laboratoire d'Immunologie, Paris, France. 10. Université Paris Cité, Inserm UMR976, Institut de Recherche Saint-Louis, Paris, France. 11. Université Paris Cité, Assistance Publique-Hôpitaux de Paris, Cochin Hospital, Biostatistics and Epidemiology Unit, Paris, France.
Abstract
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.
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.
Authors: Anders Lindholm; Lisbeth B Jensen; Philip D Home; Philip Raskin; Bernhard O Boehm; Jacob Råstam Journal: Diabetes Care Date: 2002-05 Impact factor: 19.112
Authors: S Edwin Fineberg; Thomas T Kawabata; Deborah Finco-Kent; Robert J Fountaine; Gregory L Finch; Alan S Krasner Journal: Endocr Rev Date: 2007-09-04 Impact factor: 19.871