OBSERVE-5: Observational postmarketing safety surveillance registry of etanercept for the treatment of psoriasis final 5-year results - 13/12/14
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.
Le texte complet de cet article est disponible en PDF.Key words : adverse events, etanercept, infections, malignancy, plaque psoriasis, registry, safety, surveillance
Abbreviations used : BSA, CI, EMI, NMSC, PGA, SAE, SIE, SIR, TNF
Plan
Funded by Immunex, a wholly owned subsidiary of Amgen Inc, and by Wyeth, which was acquired by Pfizer Inc in October 2009. |
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Disclosures: Dr Kimball is a consultant for AbbVie Inc, Amgen Inc, Merck & Co Inc, Janssen-Ortho Inc, and Pfizer Inc; is an investigator for Janssen-Ortho Inc; and serves on an advisory board for Vascular Biogenics. Dr Rothman is an employee of RTI International, an independent nonprofit research organization that does work for government agencies and pharmaceutical companies. Drs Kricorian, Aras, Accortt, and Hooper, and Ms Rice are employees and shareholders of Amgen Inc. Dr Pariser is a consultant for Abbott Laboratories, Amgen Inc, Astellas Pharma US Inc, Bickel Biotechnology, Celgene Corp, Dermira, DUSA Pharmaceuticals Inc, LEO Pharma Inc, MelaSciences, Novartis Pharmaceuticals Corp, Procter & Gamble Co, and Valeant Pharmaceuticals International; is an investigator for Abbott Laboratories, Amgen Inc, Astellas Pharma US Inc, Asubio Pharmaceuticals Inc, Basliea, Celgene Corp, Eli Lilly and Co, Galderma Laboratories LP, Graceway Pharmaceuticals LLC, Intendis Inc, Johnson & Johnson Consumer Products Co, LEO Pharma Inc, Novartis Pharmaceuticals Corp, Novo Nordisk A/S, Ortho Dermatologics, Peplin Inc, Pfizer Inc, Photocure ASA, Stiefel a GSK Company, and Valeant Pharmaceuticals International; and serves on advisory boards for Galderma Laboratories LP, Genentech Inc, Janssen-Ortho Inc, Medicis Pharmaceutical Corp, Ortho Dermatologics, Pfizer Inc, and Stiefel a GSK Company. Dr Yamauchi is a consultant for AbbVie Inc, Amgen Inc, Baxter Healthcare Corp, Janssen-Ortho Inc, Novartis Pharmaceuticals Corp, and Pfizer Inc; is an investigator for Amgen Inc, Celgene Corp, Galderma USA, Janssen-Ortho Inc, LEO Pharma Inc, Lilly ICOS LLC, and Pfizer Inc; serves on speakers bureaus for AbbVie Inc, Amgen Inc, Galderma USA, Janssen-Ortho Inc, LEO Pharma Inc, and Novartis Pharmaceuticals Corp; and serves on an advisory board for Lilly ICOS LLC. Dr Menter serves on advisory boards for AbbVie Inc, Allergan Inc, Amgen Inc, Boehringer Ingelheim GmbH, Genentech Inc, Janssen Pharmaceuticals Inc, LEO Pharma Inc, and Pfizer Inc; is a consultant for AbbVie Inc, Allergan Inc, Amgen Inc, Convoy Therapeutics Inc, Eli Lilly and Co, Janssen Pharmaceuticals Inc, LEO Pharma Inc, Novartis AG, Pfizer Inc, Syntrix Biosystems Inc, Wyeth, and XenoPort Inc; is an investigator for AbbVie Inc, Allergan Inc, Amgen Inc, ApoPharma Inc, Boehringer Ingelheim GmbH, Celgene Corp, Convoy Therapeutics Inc, Eli Lilly and Co, Genentech Inc, Janssen Pharmaceuticals Inc, LEO Pharma Inc, Merck & Co Inc, Novartis AG, Pfizer Inc, SymBio Pharmaceuticals/Maruho Co Ltd, Syntrix Biosystems Inc, and Wyeth; and serves on speakers bureaus for AbbVie Inc, Amgen Inc, Janssen Pharmaceuticals Inc, LEO Pharma Inc, and Wyeth. Dr Teller is a consultant for Amgen Inc, AbbVie Inc, Janssen Pharmaceuticals Inc, and Celgene, and is an investigator for Amgen Inc. Dr Gelfand is a consultant for Pfizer Inc, Janssen Pharmaceuticals Inc, and Merck & Co Inc, and a consultant and investigator for Amgen Inc, Eli Lilly and Co, and AbbVie Inc. |
Vol 72 - N° 1
P. 115-122 - janvier 2015 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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