PMID- 31734937
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210110
IS  - 2193-8210 (Print)
IS  - 2190-9172 (Electronic)
VI  - 10
IP  - 1
DP  - 2020 Feb
TI  - Injection Site Reactions in the Federal Adverse Event Reporting System (FAERS) 
      Post-Marketing Database Vary Among Biologics Approved to Treat Moderate-To-Severe 
      Psoriasis.
PG  - 99-106
LID - 10.1007/s13555-019-00341-2 [doi]
AB  - INTRODUCTION: Biologics used to treat moderate-to-severe plaque psoriasis may 
      cause injection site reactions (ISRs) characterized by erythema, edema, itch, and 
      sometimes pain. The Federal Adverse Event Reporting System (FAERS) is a 
      repository of spontaneous post-marketing reports of adverse events (AEs) that are 
      reported to the US Food and Drug Administration (FDA). Our objective was to 
      perform a pharmacovigilance analysis of FAERS reports of ISRs associated with the 
      use of subcutaneously administered biologic products approved to treat 
      moderate-to-severe plaque psoriasis. METHODS: The products included in our 
      assessment were adalimumab, etanercept, ixekizumab, secukinumab, and ustekinumab. 
      Reports from the date of US approval for each biologic as treatment for plaque 
      psoriasis through 2 years were included using the search term "injection site." 
      RESULTS: The results show that the FAERS database contained reports of ISRs for 
      all of the included biologics during the 2 years following FDA approval. The most 
      common reports on ISRs were on pain, irritation, and erythema for adalimumab; 
      reaction, pain, and erythema for etanercept; erythema, pain, and reaction for 
      ixekizumab; bruising, pain, hemorrhage for secukinumab; and pain, induration, and 
      swelling for ustekinumab. FAERS does not include data on total patient exposure; 
      therefore, ISR rates could not be calculated. CONCLUSIONS: Specific ISRs varied 
      among the biologic therapies assessed. The findings presented could be helpful 
      when patients consider switching therapies due to ISRs. FUNDING: Eli Lilly and 
      Company.
FAU - Grace, Elsie
AU  - Grace E
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Goldblum, Orin
AU  - Goldblum O
AUID- ORCID: 0000-0003-1827-2031
AD  - Eli Lilly and Company, Indianapolis, IN, USA. goldblum_orin_m@lilly.com.
FAU - Renda, Lisa
AU  - Renda L
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Agada, Noah
AU  - Agada N
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - See, Kyoungah
AU  - See K
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Leonardi, Craig
AU  - Leonardi C
AD  - Central Dermatology, St. Louis, MO, USA.
FAU - Menter, Alan
AU  - Menter A
AD  - Baylor Scott and White Medical Center, Dallas, TX, USA.
LA  - eng
PT  - Journal Article
DEP - 20191116
PL  - Switzerland
TA  - Dermatol Ther (Heidelb)
JT  - Dermatology and therapy
JID - 101590450
PMC - PMC6994575
OTO - NOTNLM
OT  - Adalimumab
OT  - Biologics
OT  - Etanercept
OT  - FAERS
OT  - Injection site reactions
OT  - Ixekizumab
OT  - Psoriasis
OT  - Secukinumab
OT  - Ustekinumab
COIS- Elsie Grace is a full-time employee and minor stock holder of Eli Lilly and 
      Company. Orin Goldblum is a full-time employee and minor stock holder of Eli 
      Lilly and Company. Noah Agada is a full-time employee and minor stock holder of 
      Eli Lilly and Company. Kyoungah See is a full-time employee and minor stock 
      holder of Eli Lilly and Company. Lisa Renda is a full-time employee and minor 
      stock holder of Eli Lilly and Company. Craig Leonardi reports receiving honoraria 
      from AbbVie, Amgen, Boehringer Ingelheim, Dermira, Eli Lilly and Company, 
      Janssen, LEO Pharma, Pfizer, Sandoz, UCB, and Vitae for serving on the advisory 
      board/consultancies; he reports receiving honoraria from AbbVie, Celgene, 
      Novartis, Eli Lilly and Company, UCB, and Sun Pharmaceuticals for speaking 
      engagements; he reports receiving fee-for-service for acting as an investigator 
      for AbbVie, Actavis, Allergan, Amgen, Boehringer Ingelheim, Celgene, Cellceutix, 
      Coherus, Corrona, Dermira, Eli Lilly and Company, Galderma, Glenmark, Janssen, 
      LEO Pharma, Merck, Novartis, Novella, Pfizer, Sandoz, Sienna, Stiefel, and UCB. 
      Alan Menter reports receiving grants and honoraria from Abbott Labs, Amgen, 
      Janssen Biotech, and Sienna (advisory boards, speaker serving investigator, and 
      consulting); he reports receiving grants and honoraria from Boehringer Ingelheim 
      (advisory boards and investigator); he reports receiving grants from Celgene and 
      Merck (investigator); he reports receiving honoraria from Eli Lilly and Company 
      and Novartis (consulting and investigator); and he reports receiving honoraria 
      from UCB (consulting, investigator, and speaker); he is the Editor-in-Chief of 
      this journal.
EDAT- 2019/11/18 06:00
MHDA- 2019/11/18 06:01
PMCR- 2019/11/16
CRDT- 2019/11/18 06:00
PHST- 2019/06/11 00:00 [received]
PHST- 2019/11/18 06:00 [pubmed]
PHST- 2019/11/18 06:01 [medline]
PHST- 2019/11/18 06:00 [entrez]
PHST- 2019/11/16 00:00 [pmc-release]
AID - 10.1007/s13555-019-00341-2 [pii]
AID - 341 [pii]
AID - 10.1007/s13555-019-00341-2 [doi]
PST - ppublish
SO  - Dermatol Ther (Heidelb). 2020 Feb;10(1):99-106. doi: 10.1007/s13555-019-00341-2. 
      Epub 2019 Nov 16.