OBSERVE-5 interim analysis: an observational postmarketing safety registry of etanercept for the treatment of psoriasis.
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.


CONCLUSIONS
The registry lacks a control group, and the study is too small to measure the frequency of rare events.


CONCLUSIONS
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.
Massachusetts General Hospital, Boston, Massachusetts 02114, USA. harvardskinstudies@partners.org
Alexa B
AB
Kimball
David
D
Pariser
Paul S
PS
Yamauchi
Alan
A
Menter
Craig F
CF
Teller
Yifei
Y
Shi
Mellissa
M
Yong
Kara
K
Creamer
Michele
M
Hooper
Girish
G
Aras
Gregory
G
Kricorian
Joel M
JM
Gelfand
D000328:Adult; D000368:Aged; D002170:Canada; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage* / Q000009:adverse effects; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D015994:Incidence; D007239:Infections / Q000453:epidemiology; D053208:Kaplan-Meier Estimate; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000453:epidemiology; D011358:Product Surveillance, Postmarketing; D011565:Psoriasis / Q000188:drug therapy* / Q000453:epidemiology; D018124:Receptors, Tumor Necrosis Factor / Q000008:administration & dosage*; D012042:Registries; D014481:United States
D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept