PMID- 26026334
OWN - NLM
STAT- MEDLINE
DCOM- 20151007
LR  - 20191210
IS  - 1097-6787 (Electronic)
IS  - 0190-9622 (Linking)
VI  - 73
IP  - 2
DP  - 2015 Aug
TI  - Adverse events resulting in withdrawal of biologic therapy for psoriasis in 
      real-world clinical practice: A Canadian multicenter retrospective study.
PG  - 237-41
LID - S0190-9622(15)01591-1 [pii]
LID - 10.1016/j.jaad.2015.04.023 [doi]
AB  - BACKGROUND: Safety profiles of biologics for treatment of psoriasis are limited 
      to data from randomized controlled trials. There is a need for comparative safety 
      reports of biologics based on data from clinical practice. OBJECTIVE: We sought 
      to estimate and compare the incidence of adverse events (AEs) leading to 
      withdrawal of biologics (etanercept, infliximab, adalimumab, and ustekinumab) in 
      the treatment of psoriasis. METHODS: We conducted a multicenter retrospective 
      chart review from September 2005 to September 2014. Incidence proportion and rate 
      of AEs leading to withdrawal by biologic agent and AE were calculated. RESULTS: 
      For 545 treatments administered in 398 patients, 22 (4.04%) AEs were associated 
      with withdrawal, for a rate of 1.97/100 patient-years (95% confidence interval 
      [CI] 1.32-2.94). Common AEs were injection-/infusion-site reactions (0.55%, 
      0.92%, 0%, and 0% for etanercept, infliximab, adalimumab, and ustekinumab, 
      respectively); infections (0%, 0.18%, 0.55%, 0.18%); and malignancies (0.18%, 
      0.18%, 0%, 0.37%). LIMITATIONS: Possible incompleteness of chart details and 
      small study population limit the conclusiveness of findings. CONCLUSION: Biologic 
      agents for treatment of psoriasis are safe; AEs associated with withdrawal 
      occurred in 4% of all administered biologic therapies. It does not appear that 
      real-world patients encounter more AEs with biologics than patients in clinical 
      trials.
CI  - Copyright (c) 2015 American Academy of Dermatology, Inc. Published by Elsevier Inc. 
      All rights reserved.
FAU - Kim, Whan B
AU  - Kim WB
AD  - Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, 
      Canada.
FAU - Marinas, Joseph E C
AU  - Marinas JE
AD  - Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, 
      Canada.
FAU - Qiang, Judy
AU  - Qiang J
AD  - School of Medicine, University of Toronto, Toronto, Ontario, Canada.
FAU - Shahbaz, Ali
AU  - Shahbaz A
AD  - School of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
FAU - Greaves, Simon
AU  - Greaves S
AD  - Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, 
      Canada.
FAU - Yeung, Jensen
AU  - Yeung J
AD  - Division of Dermatology, Department of Medicine, University of Toronto, Toronto, 
      Ontario, Canada; Sunnybrook Health Sciences Center, Toronto, Ontario, Canada; 
      Women's College Hospital, Toronto, Ontario, Canada. Electronic address: 
      jensen.yeung@utoronto.ca.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
DEP - 20150528
PL  - United States
TA  - J Am Acad Dermatol
JT  - Journal of the American Academy of Dermatology
JID - 7907132
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Immunoglobulin G)
RN  - 0 (Receptors, Tumor Necrosis Factor)
RN  - B72HH48FLU (Infliximab)
RN  - FU77B4U5Z0 (Ustekinumab)
RN  - FYS6T7F842 (Adalimumab)
RN  - OP401G7OJC (Etanercept)
SB  - IM
MH  - Adalimumab
MH  - Adult
MH  - Antibodies, Monoclonal/administration & dosage/adverse effects
MH  - Antibodies, Monoclonal, Humanized/administration & dosage/*adverse effects
MH  - Biological Therapy/*adverse effects/methods
MH  - Canada
MH  - Cohort Studies
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology/etiology
MH  - Etanercept
MH  - Female
MH  - Humans
MH  - Immunoglobulin G/administration & dosage/adverse effects
MH  - Incidence
MH  - Infections/chemically induced/epidemiology
MH  - Infliximab
MH  - Injections, Subcutaneous
MH  - Male
MH  - Middle Aged
MH  - Neoplasms/chemically induced/epidemiology
MH  - Psoriasis/*diagnosis/*drug therapy
MH  - Receptors, Tumor Necrosis Factor/administration & dosage
MH  - Retrospective Studies
MH  - Risk Assessment
MH  - Severity of Illness Index
MH  - Ustekinumab
MH  - Withholding Treatment/*statistics & numerical data
OTO - NOTNLM
OT  - adverse event
OT  - biologic
OT  - clinical practice
OT  - psoriasis
OT  - real world
OT  - safety
OT  - tumor necrosis factor inhibitor
EDAT- 2015/06/01 06:00
MHDA- 2015/10/08 06:00
CRDT- 2015/06/01 06:00
PHST- 2015/01/06 00:00 [received]
PHST- 2015/04/08 00:00 [revised]
PHST- 2015/04/09 00:00 [accepted]
PHST- 2015/06/01 06:00 [entrez]
PHST- 2015/06/01 06:00 [pubmed]
PHST- 2015/10/08 06:00 [medline]
AID - S0190-9622(15)01591-1 [pii]
AID - 10.1016/j.jaad.2015.04.023 [doi]
PST - ppublish
SO  - J Am Acad Dermatol. 2015 Aug;73(2):237-41. doi: 10.1016/j.jaad.2015.04.023. Epub 
      2015 May 28.