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

JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

卷:72

Article

Kimball, Alexa B.¹  Rothman, Kenneth J.²  Kricorian, Gregory³  Pariser, David^4,5  Yamauchi, Paul S.^6,7  Menter, Alan⁸  Aras, Girish³  Accortt, Neil A.³  Hooper, Michele³  Rice, Kara Creamer³  Gelfand, Joel M.⁹ 

[1] Massachusetts Gen Hosp, Boston, MA 02114 USA

[2] RTI Int, RTI Hlth Solut, Res Triangle Pk, NC USA

[3] Amgen Inc, Thousand Oaks, CA 91320 USA

[4] Eastern Virginia Med Sch, Norfolk, VA USA

[5] Virginia Clin Res Inc, Norfolk, VA USA

[6] Inst Dermatol, Santa Monica, CA USA

[7] Skin Care Ctr, Santa Monica, CA USA

[8] Baylor Res Inst, Dallas, TX USA

[9] Univ Penn, Perelman Sch Med, Philadelphia, PA 19104 USA

关键词: adverse events;    etanercept;    infections;    malignancy;    plaque psoriasis;    registry;    safety;    surveillance;   

DOI  :  10.1016/j.jaad.2014.08.050

来源: Elsevier

【 摘 要 】

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.

【 授权许可】

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