OBSERVE-5, an Observational Post-Marketing Safety Surveillance Registry of Etanercept for the Treatment of Psoriasis: A Model for Studying New Psoriasis Therapies

Background OBSERVE-5 is collecting safety data from real-world use of etanercept in the treatment of psoriasis per a post-marketing commitment of the U.S. Food and Drug Administration. Methods This phase IV prospective, multicenter, 5-year observational registry was designed to enroll patients with plaque psoriasis for whom etanercept is indicated. Patients receive etanercept per standard medical care and can discontinue etanercept therapy at any time following receipt of the baseline dose. Visits occur at least twice yearly; follow-up will be up to 5 years. Conclusions Data from the OBSERVE-5 registry will complement safety data from clinical trials of etanercept.