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

Abstract

Background: OBSERVE-5 was a 5-year Food and Drug Administration-mandated surveillance registry of patients with psoriasis.

Objective: We sought to assess long-term etanercept safety and effectiveness.

Methods: 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.

Results: 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.

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.

Keywords: adverse events; etanercept; infections; malignancy; plaque psoriasis; registry; safety; surveillance.

Copyright © 2014 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Figures

Figure 1

Plaque psoriasis. Etanercept status by visit. The number of patients remaining in the study (black bars) and those who remained on etanercept therapy (white bars) throughout the 5-year study is shown. BL, baseline.

Figure 2

Plaque psoriasis. Effectiveness outcomes. (A) The percentage of psoriasis-affected BSA, (B) percentage of patients with PGA status of clear/almost clear (score 0/1), and (C) mean DLQI total score for all patients (squares), patients on continuous etanercept (circles), patients on etanercept who had a 0- to 30-day gap in therapy (open triangles), and patients on etanercept who had a 0- to 60-day gap in therapy (closed triangles) are shown. Data are presented as observed without imputation for missing data. BSA, body surface area; PGA, physician global assessment; DLQI, Dermatology Life Quality Index.