BACKGROUND: OBSERVE-5 was a 5-year Food and Drug Administration-mandated surveillance registry of @entity1 with @entity1569 . OBJECTIVE: We sought to assess long-term etanercept safety and effectiveness. METHODS: @entity1 with moderate to severe @entity1569 enrolled; a single baseline dose of etanercept was required. Key outcome measures included serious adverse events, serious infectious events, events of medical interest, @entity1569 -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. RESULTS: For 2510 @entity1 , 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 @entity5 excluding @entity1489 ; 3.6% (95% CI 2.7%-4.5%) for @entity1489 ; 2.8% (95% CI 2.0%-3.6%) for @entity453 ; 0.7% (95% CI 0.3%-1.2%) for @entity1569 worsening; 0.2% (95% CI 0.0%-0.4%) for @entity6220 ; 0.1% (95% CI 0.0%-0.3%) for @entity706 and for @entity378 ; and 0.1% (95% CI 0.0%-0.2%) for @entity1292 and for lupus; 55 fatal events were reported. Rates of @entity5 , @entity706 , @entity1489 , and hospitalization-associated infections were not higher than expected relative to administrative claims data. The percentage of @entity1 rated as clear/almost clear was 12% at baseline, which increased to 51% at month 6 and remained relatively stable throughout 5 years. LIMITATIONS: No internal comparator group was included; rare events may not have been detected. CONCLUSION: No new safety signals were observed with long-term, real-world etanercept use.

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

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity6220 :: ('MESH:D020279', 'Disease') :: ['central nervous system demyelinating disorder'] @entity1569 :: ('MESH:D011565', 'Disease') :: ['psoriasis'] @entity706 :: ('MESH:D008223', 'Disease') :: ['lymphomas', 'lymphoma'] @entity5 :: ('MESH:D009369', 'Disease') :: ['malignancies'] @entity1489 :: ('MESH:D012878', 'Disease') :: ['nonmelanoma skin cancer'] @entity453 :: ('MESH:D003324', 'Disease') :: ['coronary artery disease'] @entity378 :: ('MESH:D014376', 'Disease') :: ['tuberculosis'] @entity1292 :: ('MESH:D009894', 'Disease') :: ['opportunistic infection']
@entity1569 :: (MESH:D011565,Disease) :: ['psoriasis']
