Descriptive Analysis of Reports of Drug Reaction with Eosinophilia and Systemic Symptoms from EudraVigilance and from the RegiSCAR Project.

Abstract

Introduction: Drug reaction with eosinophilia and systemic symptoms (DRESS) is a T-cell-mediated severe cutaneous adverse reaction (SCAR) to drugs. Due to its rarity, there are currently only a few studies which include a larger number of cases. We sought to analyze a larger number of DRESS cases to increase knowledge of clinical symptoms, causative agents, and potentially associated factors.

Methods: This is a non-interventional, retrospective, pharmacoepidemiological study analyzing descriptively DRESS reports in the EudraVigilance ADR database (EV) and DRESS cases in the registry of dZh/RegiSCAR. The two databases were analyzed separately, and the results were compared thereafter to identify both similarities and differences.

Results: 48 cases from EV and 84 RegiSCAR cases were included for the in-depth analysis. The liver was the most frequently involved inner organ. Most of the reactions occurred within 6 weeks after initiating the suspected inducing agent. The percentage of cases with fatal outcome was similar in both datasets (EV: 4.2%, RegiSCAR: 3.6%). Antiseizure drugs - especially carbamazepine - were most frequently involved in both datasets. In 4 reports from EV and 5 cases from RegiSCAR, sulfasalazine was identified as causative agent. Remarkably, all patients with sulfasalazine-induced DRESS were females with arthritic disease who were clearly younger compared to patients of the whole dataset.

Conclusion: Our study confirms results obtained from other studies regarding the frequent involvement of the liver, the time to onset, and DRESS-inducing drugs. Further studies are needed to investigate whether younger female with arthritic disease may carry a higher risk to develop DRESS or whether other factors might be responsible for this observation.