OBSERVE-5 interim analysis: An observational postmarketing safety registry of etanercept for the treatment of psoriasis - 18/04/13
, David Pariser, MD b, Paul S. Yamauchi, MD, PhD c, Alan Menter, MD d, Craig F. Teller, MD e, Yifei Shi, MS f, Mellissa Yong, PhD f, Kara Creamer, MS f, Michele Hooper, MD f, Girish Aras, PhD f, Gregory Kricorian, MD f, Joel M. Gelfand, MD, MSCE g
Reprint requests: Alexa B. Kimball, MD, MPH, Massachusetts General Hospital, 50 Staniford St, #240, Boston, MA 02114.Abstract |
Background |
Etanercept is approved for the treatment of chronic moderate to severe plaque psoriasis in adults.
Objective |
We sought to evaluate the long-term safety of etanercept in a real-world clinical setting. Assessment of etanercept efficacy was a secondary objective.
Methods |
OBSERVE-5 is a 5-year observational safety registry initiated in May 2006 at multiple sites in the United States and Canada. Data collection includes the number of serious adverse events, serious infectious events, and prespecified events of medical interest. Efficacy data include body surface area assessments, physician and patient global assessments of psoriasis, and the Dermatology Life Quality Index. This interim analysis presents data from the first 3 years of the follow-up period.
Results |
A total of 2511 patients were enrolled. Of 1890 patients continuing in the registry after 3 years, 113 were inactive for 1 to 2 years, and 115 were inactive for longer than 2 years. The 3-year incidence proportions of serious adverse events and serious infectious events based on Kaplan-Meier methodology were 0.14 and 0.04, respectively. The observed numbers of patients experiencing lymphoma, serious infectious events requiring hospitalization, nonmelanoma skin cancer, and malignancies excluding nonmelanoma skin cancer were not higher than the expected number of cases estimated from a large US administrative health claims database.
Limitations |
The registry lacks a control group, and the study is too small to measure the frequency of rare events.
Conclusion |
Etanercept demonstrated good tolerability in patients with plaque psoriasis in the clinical setting in this interim analysis. No new or unexpected safety concerns were observed.
Le texte complet de cet article est disponible en PDF.Key words : etanercept, infections, lymphoma, nonmelanoma skin cancer, psoriasis, registry, safety
Abbreviations used : BSA, CI, NMSC, TNF
Plan
| Funded by Immunex Corp, a wholly owned subsidiary of Amgen Inc. Dikran Toroser of Amgen Inc and Karen Zimmermann and Rick Davis of Complete Healthcare Communications (funded by Amgen Inc) provided medical writing support. |
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| Disclosure: Dr Kimball is an investigator and consultant for Amgen Inc, Abbott Laboratories, Idera, Janssen Pharmaceuticals Inc, Merck, Pfizer Inc, and VBL Therapeutics. She consults with Novartis and has fellowship funding from Janssen Pharmaceuticals Inc. Dr Pariser is an investigator and consultant for Abbott Laboratories, Amgen Inc, Astellas, Celgene, Novartis, and Valeant Pharmaceuticals International. He is an investigator and serves on an advisory board for Galderma Laboratories LP, Ortho Dermatologics, Pfizer Inc, and Stiefel. He is an investigator for Basilea, Dow Pharmaceutical Sciences Inc, Eli Lilly and Co, Graceway Pharmaceuticals LLC, Intendis Inc, Novo Nordisk, Peplin Inc, and Photocure ASA. He serves on an advisory board for Genentech Inc, Janssen-Ortho Inc, and Medicis Pharmaceuticals Corp. He is a consultant for Mela Sciences and has received honoraria from LEO Pharma US. Dr Yamauchi serves on advisory boards and is a speaker, consultant, and investigator for Abbott Laboratories, Amgen Inc, and Centocor. Dr Menter serves on advisory boards and is a speaker, consultant, and investigator for Abbott Laboratories, Amgen Inc, Centocor, and Wyeth. He serves on the advisory board and is a consultant and speaker for Galderma Laboratories LP. He is a consultant and investigator for Eli Lilly and Co and Stiefel, and an investigator for Allergan, Celgene, Novartis, Novo Nordisk, Pfizer Inc, and Syntrix Biosystems. Dr Teller is a speaker for Amgen Inc, Abbott Laboratories, and Janssen Pharmaceuticals Inc. Mr Shi, Ms Creamer, and Drs Hooper, Aras, and Kricorian are currently employed by and have stock ownership in Amgen Inc. Dr Yong was employed by Amgen Inc at the time the study was conducted and currently has stock ownership in Amgen Inc. Dr Gelfand served as consultant with Abbott Laboratories, Amgen Inc, Celgene, Centocor, Novartis, and Pfizer Inc, receiving honoraria. He had grants or has pending grants from Abbott Laboratories, Amgen Inc, Genentech Inc, Novartis, and Pfizer Inc. He has received payment for CME work related to psoriasis. He also received a donation from Amgen Inc to the University of Pennsylvania to further develop the Dermatology Clinical Effectiveness Research Network. |
Vol 68 - N° 5
P. 756-764 - mai 2013 Retour au numéro
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