PMID- 29969700
OWN - NLM
STAT- MEDLINE
DCOM- 20190219
LR  - 20190320
IS  - 1097-6787 (Electronic)
IS  - 0190-9622 (Linking)
VI  - 80
IP  - 1
DP  - 2019 Jan
TI  - Ixekizumab provides superior efficacy compared with ustekinumab over 52 weeks of 
      treatment: Results from IXORA-S, a phase 3 study.
PG  - 70-79.e3
LID - S0190-9622(18)32195-9 [pii]
LID - 10.1016/j.jaad.2018.06.039 [doi]
AB  - BACKGROUND: Biologics targeting interleukin 17A (IL-17A) allow for rapid 
      clearance of psoriatic plaques, with a clinically favorable safety profile. 
      OBJECTIVES: To compare the safety and efficacy of ixekizumab, an IL-17A 
      antagonist, with the safety and efficacy of the IL-12/23 inhibitor ustekinumab 
      through 52 weeks of treatment in the head-to-head trial IXORA-S. METHODS: 
      Patients were randomized to ixekizumab (n = 136) or ustekinumab (n = 166) and 
      dosed per the approved labels. After 1 year, efficacy was assessed via 
      improvements in Psoriasis Area and Severity Index (PASI) score (with PASI 90 
      indicating a 90% or greater improvement from baseline PASI score) and a static 
      Physician's Global Assessment (sPGA) response of either 0 or 0 or 1, with 
      dropouts counted as nonresponders. Safety analyses included treatment-emergent 
      adverse events (AEs). RESULTS: At week 52, significantly more ixekizumab-treated 
      patients (P < .01) reported PASI 90 (104 [76.5%]), an sPGA response of 0 (72 
      [52.9%]), or an sPGA response of 0 or 1 (110 [82.1%]) responses than did 
      ustekinumab-treated patients (PASI 90, 98 [59.0%]; sPGA response of 0, 60 
      [36.1%]; and sPGA response of 0 or 1, 108 [65.1%]). Treatment-emergent AEs, 
      serious AEs, and discontinuation rates were not different between the treatment 
      groups. Injection site reactions occurred more frequently in the 
      ixekizumab-treated group (ixekizumab, 22 [16.3%]; ustekinumab, 2 [1.2%]) 
      (P < .001). LIMITATIONS: This study was not designed to compare safety end points 
      related to rare events. CONCLUSIONS: Compared with ustekinumab, ixekizumab showed 
      superior efficacy and comparable safety outcomes through 52 weeks of treatment.
CI  - Copyright (c) 2018. Published by Elsevier Inc.
FAU - Paul, Carle
AU  - Paul C
AD  - Dermatology Department, CHU, Paul Sabatier University, Toulouse, France. 
      Electronic address: paul.c@chu-toulouse.fr.
FAU - Griffiths, Christopher E M
AU  - Griffiths CEM
AD  - Dermatology Centre, Salford Royal Hospital, University of Manchester, Manchester 
      Academic Health Science Centre, Manchester, United Kingdom.
FAU - van de Kerkhof, Peter C M
AU  - van de Kerkhof PCM
AD  - Department of Dermatology, Radboud University Nijmegen Medical Centre, Nijmegen, 
      The Netherlands.
FAU - Puig, Lluis
AU  - Puig L
AD  - Hospital de la Santa Creu i Sant Pau, Universitat Autonoma de Barcelona, 
      Barcelona, Spain.
FAU - Dutronc, Yves
AU  - Dutronc Y
AD  - Eli Lilly and Company, Indianapolis, Indiana.
FAU - Henneges, Carsten
AU  - Henneges C
AD  - Eli Lilly and Company, Indianapolis, Indiana.
FAU - Dossenbach, Martin
AU  - Dossenbach M
AD  - Eli Lilly and Company, Indianapolis, Indiana.
FAU - Hollister, Kristin
AU  - Hollister K
AD  - Eli Lilly and Company, Indianapolis, Indiana.
FAU - Reich, Kristian
AU  - Reich K
AD  - Dermatologikum Berlin and Georg-August-University Gottingen, Gottingen, Germany.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20180630
PL  - United States
TA  - J Am Acad Dermatol
JT  - Journal of the American Academy of Dermatology
JID - 7907132
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Dermatologic Agents)
RN  - BTY153760O (ixekizumab)
RN  - FU77B4U5Z0 (Ustekinumab)
SB  - IM
MH  - Adult
MH  - Antibodies, Monoclonal, Humanized/*administration & dosage
MH  - Dermatologic Agents/*administration & dosage
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Psoriasis/*drug therapy
MH  - Time Factors
MH  - Treatment Outcome
MH  - Ustekinumab/*administration & dosage
OTO - NOTNLM
OT  - IXORA-S
OT  - biologic
OT  - clinical trial
OT  - efficacy
OT  - ixekizumab
OT  - psoriasis
OT  - safety
OT  - ustekinumab
EDAT- 2018/07/04 06:00
MHDA- 2019/03/21 06:00
CRDT- 2018/07/04 06:00
PHST- 2017/12/20 00:00 [received]
PHST- 2018/06/10 00:00 [revised]
PHST- 2018/06/26 00:00 [accepted]
PHST- 2018/07/04 06:00 [pubmed]
PHST- 2019/03/21 06:00 [medline]
PHST- 2018/07/04 06:00 [entrez]
AID - S0190-9622(18)32195-9 [pii]
AID - 10.1016/j.jaad.2018.06.039 [doi]
PST - ppublish
SO  - J Am Acad Dermatol. 2019 Jan;80(1):70-79.e3. doi: 10.1016/j.jaad.2018.06.039. 
      Epub 2018 Jun 30.