Centro Studi GISED

Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Acute Generalized Exanthematous Pustulosis (AGEP) and DRESS-Syndrome (Drug Reaction with Eosinophilia and Systemic Symptoms) are rare but severe, drug-related adverse reactions, of high morbidity and mortality.

Lombardy, a region with nine million inhabitants and a high rate of computerization, offers an ideal setting to control, characterize, and study the risk factors for the above events.

The React-Lombardia project, promoted by the Lombardy region and coordinated by the Centro Studi GISED in the regional programs area of pharmaco vigilance, aimed at:

1. establishing a regional Registry of severe cutaneous drug-related reactions which allow risks due to the marketing of new drugs to be controlled and to inform doctors and the public about severe cutaneous drug-related reactions.
2. establishing a cohort of patients with a history of severe drug-related reactions in order to perform a study on prognosis and related factors and improve the treatment of the reactions.

The project involved 22 hospital centres located in 10 provinces of Lombardy.


Data collected during the first five years of the study were published in two scientific articles:

1. Diphoorn J, Cazzaniga S, Gamba C, et al; REACT-Lombardia study group. Incidence, causative factors and mortality rates of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) in northern Italy: data from the REACT registry. Pharmacoepidemiol Drug Saf. 2015 Dec 21 [Epub ahead of print]
2. Gamba C, Schroeder J, Citterio A, et al; Gruppo REACT-Lombardia. [Surveillance of severe cutaneous drug reactions: experience REACT-Lombardia]. Recenti Prog Med. 2014;105:379-84.

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