Descriptive Analysis of DRESS Reports from EudraVigilance and DRESS Cases from the RegiSCAR-project

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 registry cases were included for the in-depth analysis. The liver was the most frequently involved inner organ. Most of the reactions occurred within six 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.