PMID- 26775775
OWN - NLM
STAT- MEDLINE
DCOM- 20160520
LR  - 20160118
IS  - 1097-6787 (Electronic)
IS  - 0190-9622 (Linking)
VI  - 74
IP  - 2
DP  - 2016 Feb
TI  - Long-term safety and efficacy of etanercept in children and adolescents with 
      plaque psoriasis.
PG  - 280-7.e1-3
LID - S0190-9622(15)02270-7 [pii]
LID - 10.1016/j.jaad.2015.09.056 [doi]
AB  - BACKGROUND: There are no systemic therapies approved in the United States to 
      treat pediatric psoriasis. OBJECTIVE: We sought to evaluate long-term safety and 
      efficacy of etanercept in children and adolescents with moderate to severe plaque 
      psoriasis. METHODS: This 5-year, open-label extension study enrolled patients 
      aged 4 to 17 years who had participated in a 48-week parent study. End points 
      included occurrence of adverse events (AEs) and serious AEs including infections, 
      and rates of 75% and 90% improvement in Psoriasis Area and Severity Index score 
      and clear/almost clear on static physician global assessment. RESULTS: Of 182 
      patients enrolled, 181 received etanercept and 69 completed 264 weeks. Through 
      week 264, 161 (89.0%) patients reported an AE, most commonly upper respiratory 
      tract infection (37.6%), nasopharyngitis (26.0%), and headache (21.5%). Seven 
      patients reported 8 serious AEs; only 1 (cellulitis) was considered 
      treatment-related. No cases of opportunistic infections or malignancy were 
      reported. Rates of 75% improvement in Psoriasis Area and Severity Index score ( approximately  
      60%-70%) and 90% improvement in Psoriasis Area and Severity Index score ( approximately  
      30%-40%) and static physician global assessment status clear/almost clear ( approximately  
      40%-50%) were maintained through week 264. LIMITATIONS: The number of patients 
      remaining on study at week 264 was small. CONCLUSION: Etanercept in pediatric 
      patients was generally well tolerated and efficacy was maintained in those who 
      remained in the study for up to 264 weeks.
CI  - Copyright (c) 2015 American Academy of Dermatology, Inc. Published by Elsevier Inc. 
      All rights reserved.
FAU - Paller, Amy S
AU  - Paller AS
AD  - Northwestern University Feinberg School of Medicine and the Ann and Robert H. 
      Lurie Children's Hospital of Chicago, Chicago, Illinois. Electronic address: 
      apaller@northwestern.edu.
FAU - Siegfried, Elaine C
AU  - Siegfried EC
AD  - Cardinal Glennon Children's Hospital and Saint Louis University, St Louis, 
      Missouri.
FAU - Pariser, David M
AU  - Pariser DM
AD  - Eastern Virginia Medical School and Virginia Clinical Research Inc.
FAU - Rice, Kara Creamer
AU  - Rice KC
AD  - Amgen Inc, Thousand Oaks, California.
FAU - Trivedi, Mona
AU  - Trivedi M
AD  - Amgen Inc, Thousand Oaks, California.
FAU - Iles, Jan
AU  - Iles J
AD  - Amgen Inc, Thousand Oaks, California.
FAU - Collier, David H
AU  - Collier DH
AD  - Amgen Inc, Thousand Oaks, California.
FAU - Kricorian, Greg
AU  - Kricorian G
AD  - Amgen Inc, Thousand Oaks, California.
FAU - Langley, Richard G
AU  - Langley RG
AD  - Dalhousie University, Halifax, Nova Scotia, Canada.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Am Acad Dermatol
JT  - Journal of the American Academy of Dermatology
JID - 7907132
RN  - 0 (Immunosuppressive Agents)
RN  - OP401G7OJC (Etanercept)
SB  - IM
MH  - Adolescent
MH  - Cellulitis/chemically induced
MH  - Child
MH  - Child, Preschool
MH  - Etanercept/*adverse effects/therapeutic use
MH  - Female
MH  - Headache/chemically induced
MH  - Humans
MH  - Immunosuppressive Agents/*adverse effects/therapeutic use
MH  - Male
MH  - Nasopharyngitis/chemically induced
MH  - Psoriasis/*drug therapy
MH  - Respiratory Tract Infections/chemically induced
MH  - Severity of Illness Index
MH  - Time Factors
OTO - NOTNLM
OT  - etanercept
OT  - long-term safety
OT  - open-label
OT  - pediatric population
OT  - plaque psoriasis
EDAT- 2016/01/19 06:00
MHDA- 2016/05/21 06:00
CRDT- 2016/01/19 06:00
PHST- 2015/05/20 00:00 [received]
PHST- 2015/09/10 00:00 [revised]
PHST- 2015/09/24 00:00 [accepted]
PHST- 2016/01/19 06:00 [entrez]
PHST- 2016/01/19 06:00 [pubmed]
PHST- 2016/05/21 06:00 [medline]
AID - S0190-9622(15)02270-7 [pii]
AID - 10.1016/j.jaad.2015.09.056 [doi]
PST - ppublish
SO  - J Am Acad Dermatol. 2016 Feb;74(2):280-7.e1-3. doi: 10.1016/j.jaad.2015.09.056.