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Psoriasis, observational postmarketing safety surveillance registry of Etanercept: 5-year results


OBSERVE-5 was a 5-year FDA-mandated surveillance registry of patients with psoriasis. Researchers have assessed long-term Etanercept ( Enbrel ) safety and effectiveness.

Patients with moderate to severe psoriasis enrolled; a single baseline dose of Etanercept was required.

Key outcome measures included serious adverse events, serious infectious events, events of medical interest, psoriasis-affected body surface area, physician global assessment score, and Dermatology Life Quality Index ( DLQI ) score.
Safety outcomes were assessed relative to data from the MarketScan database.

For 2510 patients, 5-year cumulative incidence was 22.2% for serious adverse events; 6.5% for serious infectious events; 3.2% for malignancies excluding non-melanoma skin cancer; 3.6% for non-melanoma skin cancer; 2.8% for coronary artery disease; 0.7% for psoriasis worsening; 0.2% for central nervous system demyelinating disorder; 0.1% for lymphoma and for tuberculosis; and 0.1% for opportunistic infection and for lupus; 55 fatal events were reported.

Rates of malignancies, lymphomas, non-melanoma skin cancer, and hospitalization-associated infections were not higher than expected relative to administrative claims data.

The percentage of patients rated as clear/almost clear was 12% at baseline, which increased to 51% at month 6 and remained relatively stable throughout 5 years.

In conclusion, no new safety signals were observed with long-term, real-world Etanercept use. ( Xagena )

Kimball AB et al, J Am Acad Dermatol 2014; Epub ahead of print

XagenaMedicine_2014



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