A LONG-TERM, PROSPECTIVE, OBSERVATIONAL COHORT STUDY OF THE SAFETY AND EFFECTIVENESS OF ETANERCEPT IN THE TREATMENT OF PAEDIATRIC PSORIASIS PATIENTS IN A NATURALISTIC SETTING: A POST-AUTHORISATION SAFETY STUDY (PASS)

Detailed Summary

Psoriasis is a chronic, often severe, autoimmune condition that affects approximately 2% of the world's population. The epidemiology of pediatric psoriasis has not been well documented and no treatment guidelines exist for pediatric psoriasis. Etanercept is a biologic drug and has been licensed for the treatment of chronic severe plaque psoriasis in children and adolescents (6-17 years of age) who are inadequately controlled by or are intolerant to, other systemic therapies or phototherapies. Although the long-term safety and efficacy of etanercept in children with juvenile idiopathic arthritis (JIA) has been studied and the short-term safety profile of etanercept in both JIA and pediatric psoriasis appears similar, there is limited data available about the long-term effects of etanercept in pediatric psoriasis, especially with respect to malignancy. The aim of this study is to assess the safety and effectiveness of etanercept for the treatment of pediatric psoriasis in Europe. Patients aged \<=17 with plaque psoriasis diagnosed by a dermatologist will be invited to participate in the registry only after a clinical decision has been made to prescribe etanercept. The safety of the drug and how well the drug works will be evaluated during the follow-up period. The follow-up period will last 5 years and patients will be followed up every 3 months for the first 2 years and every 6 months for the next 3 years or until the end of study.

Study Details

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Interventions