Abstract

Corticosteroid (CS)-related infection risk in immune thrombocytopenia (ITP) is unknown. The aim of this study was to assess the adjusted CS risk function of severe infection in persistent or chronic primary ITP adults. We designed a nested case-control study in the FAITH cohort. This cohort is built through the French national health insurance database named SNIIRAM and includes all treated incident persistent or chronic primary ITP adults in France (ENCePP n°4574). Patients who entered the FAITH cohort between 2009 and 2012 were eligible (n = 1805). Cases were patients with infection as primary diagnosis code during hospitalization. Index date was the date of first hospitalization for infection. A 2:1 matching was performed on age and entry date in the cohort. Various CS exposure time-windows were defined: current user, exposure during the 1/3/6 months preceding index date and from the entry date. CS doses were converted in prednisone equivalent (PEQ). The cumulative CS doses were averaged in each time-window to obtain daily PEQ dosages. Each CS exposure definition was assessed using multivariate conditional regression models. During the study period, 161 cases (9 opportunistic) occurred. The model with the best goodness of fit was CS exposure during the month before the index date (OR: 2.48, 95% CI: 1.61–3.83). The dose-effect relation showed that the risk existed from averaged daily doses ≥5 mg PEQ (vs. <5 mg: 2.09, 95% CI: 1.17–3.71). The risk of infection was mainly supported by current or recent exposure to CS, even with low doses.

Highlights

  • Immune thrombocytopenia (ITP) is a bleeding disorder due to an autoimmune reaction directed against platelets and megakaryocytes [1,2]

  • We identified a statistically significant association from an average daily dose 5 mg prednisone equivalent (PEQ)/day during the month before the index date

  • This study demonstrated that corticosteroid exposure was a leading factor associated with the occurrence of severe infection in incident primary ITP adults persistently treated

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Summary

Introduction

Immune thrombocytopenia (ITP) is a bleeding disorder due to an autoimmune reaction directed against platelets and megakaryocytes [1,2]. It is referred to as “primary” when not associated to another disease (about 80% of ITPs) [1]. First-line treatment is based on PLOS ONE | DOI:10.1371/journal.pone.0142217. First-line treatment is based on PLOS ONE | DOI:10.1371/journal.pone.0142217 November 11, 2015

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