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OBSERVE-5: observational postmarketing safety surveillance registry of etanercept for the treatment of psoriasis final 5-year results.


ABSTRACT: OBSERVE-5 was a 5-year Food and Drug Administration-mandated surveillance registry of patients with psoriasis.We sought to assess long-term etanercept 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 score. Safety outcomes were assessed relative to data from the MarketScan database.For 2510 patients, 5-year cumulative incidence was 22.2% (95% confidence interval [CI] 20.3%-24.2%) for serious adverse events; 6.5% (95% CI 5.4%-7.7%) for serious infectious events; 3.2% (95% CI 2.3%-4.1%) for malignancies excluding nonmelanoma skin cancer; 3.6% (95% CI 2.7%-4.5%) for nonmelanoma skin cancer; 2.8% (95% CI 2.0%-3.6%) for coronary artery disease; 0.7% (95% CI 0.3%-1.2%) for psoriasis worsening; 0.2% (95% CI 0.0%-0.4%) for central nervous system demyelinating disorder; 0.1% (95% CI 0.0%-0.3%) for lymphoma and for tuberculosis; and 0.1% (95% CI 0.0%-0.2%) for opportunistic infection and for lupus; 55 fatal events were reported. Rates of malignancies, lymphomas, nonmelanoma 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.No internal comparator group was included; rare events may not have been detected.No new safety signals were observed with long-term, real-world etanercept use.

SUBMITTER: Kimball AB 

PROVIDER: S-EPMC4758511 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature

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OBSERVE-5: observational postmarketing safety surveillance registry of etanercept for the treatment of psoriasis final 5-year results.

Kimball Alexa B AB   Rothman Kenneth J KJ   Kricorian Gregory G   Pariser David D   Yamauchi Paul S PS   Menter Alan A   Teller Craig F CF   Aras Girish G   Accortt Neil A NA   Hooper Michele M   Rice Kara Creamer KC   Gelfand Joel M JM  

Journal of the American Academy of Dermatology 20140926 1


<h4>Background</h4>OBSERVE-5 was a 5-year Food and Drug Administration-mandated surveillance registry of patients with psoriasis.<h4>Objective</h4>We sought to assess long-term etanercept safety and effectiveness.<h4>Methods</h4>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 ass  ...[more]

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