PMID- 30198588
OWN - NLM
STAT- MEDLINE
DCOM- 20190606
LR  - 20191210
IS  - 1468-3083 (Electronic)
IS  - 0926-9959 (Linking)
VI  - 33
IP  - 2
DP  - 2019 Feb
TI  - Long-term safety profile of ixekizumab in patients with moderate-to-severe plaque 
      psoriasis: an integrated analysis from 11 clinical trials.
PG  - 333-339
LID - 10.1111/jdv.15242 [doi]
AB  - BACKGROUND: Psoriasis in many patients is a chronic and recalcitrant disease that 
      requires long-term treatment, reinforcing the importance of long-term safety 
      data. Ixekizumab, a high-affinity monoclonal antibody that selectively targets 
      interleukin (IL)-17A, is approved for treating patients with moderate-to-severe 
      plaque psoriasis. OBJECTIVE: To determine long-term safety of ixekizumab in 
      psoriasis. METHODS: Integrated safety data are presented from 12-week induction 
      period, 12-60-week maintenance period, and from all ixekizumab-treated patients 
      from 11 clinical studies. Exposure-adjusted incidence rates (IRs) per 100 
      patient-years are reported. RESULTS: Overall, 5689 patients accounted for 
      12 061.5 patient-years of ixekizumab exposure from 11 studies. Over 156 weeks, a 
      total of 83.9% (n = 4775) of patients reported treatment-emergent adverse events 
      (AEs). Most opportunistic infections (IR [95% confidence interval; CI] 1.8 [1.6, 
      2.1]) reported were mucocutaneous candidiasis. The IR (95% CI) for oral Candida 
      infection was 0.9 (0.8, 1.1). There was no trend of increase in IR of AEs of 
      special interest. Serious AEs were reported in 11.8% of patients; death occurred 
      in 0.4% (n = 23) of patients. CONCLUSION: The 3-year, long-term maintenance 
      treatment with ixekizumab did not show any new safety signals in patients with 
      moderate-to-severe plaque psoriasis.
CI  - (c) 2018 European Academy of Dermatology and Venereology.
FAU - Langley, R G
AU  - Langley RG
AD  - Dalhousie University Faculty of Medicine, Halifax, NS, Canada.
FAU - Kimball, A B
AU  - Kimball AB
AD  - Massachusetts General Hospital, Boston, MA, USA.
FAU - Nak, H
AU  - Nak H
AD  - The Jikei University, School of Medicine, Tokyo, Japan.
FAU - Xu, W
AU  - Xu W
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Pangallo, B
AU  - Pangallo B
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Osuntokun, O O
AU  - Osuntokun OO
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Agada, N
AU  - Agada N
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Reich, K
AU  - Reich K
AD  - Dermatologikum Berlin and SCIderm Research Institute, Hamburg, Germany.
LA  - eng
GR  - Eli Lilly and Company/
PT  - Evaluation Study
PT  - Journal Article
DEP - 20181122
PL  - England
TA  - J Eur Acad Dermatol Venereol
JT  - Journal of the European Academy of Dermatology and Venereology : JEADV
JID - 9216037
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - BTY153760O (ixekizumab)
SB  - IM
MH  - Adult
MH  - Antibodies, Monoclonal, Humanized/*administration & dosage/adverse effects
MH  - Clinical Trials as Topic
MH  - Controlled Clinical Trials as Topic
MH  - Dose-Response Relationship, Drug
MH  - Drug Administration Schedule
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Injections, Subcutaneous
MH  - Japan
MH  - Male
MH  - Middle Aged
MH  - Patient Safety
MH  - Psoriasis/*drug therapy/*pathology
MH  - Risk Assessment
MH  - Severity of Illness Index
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2018/09/11 06:00
MHDA- 2019/06/07 06:00
CRDT- 2018/09/11 06:00
PHST- 2018/05/14 00:00 [received]
PHST- 2018/07/26 00:00 [accepted]
PHST- 2018/09/11 06:00 [pubmed]
PHST- 2019/06/07 06:00 [medline]
PHST- 2018/09/11 06:00 [entrez]
AID - 10.1111/jdv.15242 [doi]
PST - ppublish
SO  - J Eur Acad Dermatol Venereol. 2019 Feb;33(2):333-339. doi: 10.1111/jdv.15242. 
      Epub 2018 Nov 22.