PMID- 31685553
OWN - NLM
STAT- MEDLINE
DCOM- 20200424
LR  - 20200424
IS  - 1468-2060 (Electronic)
IS  - 0003-4967 (Print)
IS  - 0003-4967 (Linking)
VI  - 79
IP  - 2
DP  - 2020 Feb
TI  - Efficacy and safety of ixekizumab through 52 weeks in two phase 3, randomised, 
      controlled clinical trials in patients with active radiographic axial 
      spondyloarthritis (COAST-V and COAST-W).
PG  - 176-185
LID - 10.1136/annrheumdis-2019-216118 [doi]
AB  - OBJECTIVES: To investigate the efficacy and safety of ixekizumab for up to 52 
      weeks in two phase 3 studies of patients with active radiographic axial 
      spondyloarthritis (r-axSpA) who were biological disease-modifying antirheumatic 
      drug (bDMARD)-naive (COAST-V) or tumour necrosis factor inhibitor 
      (TNFi)-experienced (COAST-W). METHODS: Adults with active r-axSpA were randomised 
      1:1:1:1 (n=341) to 80 mg ixekizumab every 2 (IXE Q2W) or 4 weeks (IXE Q4W), 
      placebo (PBO) or 40 mg adalimumab Q2W (ADA) in COAST-V and 1:1:1 (n=316) to IXE 
      Q2W, IXE Q4W or PBO in COAST-W. At week 16, patients receiving ixekizumab 
      continued their assigned treatment; patients receiving PBO or ADA were 
      rerandomised 1:1 to IXE Q2W or IXE Q4W (PBO/IXE, ADA/IXE) through week 52. 
      RESULTS: In COAST-V, Assessment of SpondyloArthritis international Society 40 
      (ASAS40) responses rates (intent-to-treat population, non-responder imputation) 
      at weeks 16 and 52 were 48% and 53% (IXE Q4W); 52% and 51% (IXE Q2W); 36% and 51% 
      (ADA/IXE); 19% and 47% (PBO/IXE). Corresponding ASAS40 response rates in COAST-W 
      were 25% and 34% (IXE Q4W); 31% and 31% (IXE Q2W); 14% and 39% (PBO/IXE). Both 
      ixekizumab regimens sustained improvements in disease activity, physical 
      function, objective markers of inflammation, QoL, health status and overall 
      function up to 52 weeks. Safety through 52 weeks of ixekizumab was consistent 
      with safety through 16 weeks. CONCLUSION: The significant efficacy demonstrated 
      with ixekizumab at week 16 was sustained for up to 52 weeks in bDMARD-naive and 
      TNFi-experienced patients. bDMARD-naive patients initially treated with ADA 
      demonstrated further numerical improvements after switching to ixekizumab. Safety 
      findings were consistent with the known safety profile of ixekizumab. TRIAL 
      REGISTRATION NUMBER: NCT02696785/NCT02696798.
CI  - (c) Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No 
      commercial re-use. See rights and permissions. Published by BMJ.
FAU - Dougados, Maxime
AU  - Dougados M
AD  - Paris Descartes University; Department of Rheumatology, Hopital Cochin; 
      Assistance Publique - Hopitaux de Paris; INSERM (U1153), Clinical Epidemiology 
      and Biostatistics, PRES Sorbonne Paris-Cite, Paris, France 
      maxime.dougados@aphp.fr.
FAU - Wei, James Cheng-Chung
AU  - Wei JC
AD  - Institute of Medicine, Chung Shan Medical University; Department of Internal 
      Medicine, Chung Shan Medical University Hospital; Graduate Institute of 
      Integrated Medicine, China Medical University, Taichung, Taiwan.
FAU - Landewe, Robert
AU  - Landewe R
AD  - Amsterdam Rheumatology and Clinical Immunology Center, Amsterdam, The 
      Netherlands.
FAU - Sieper, Joachim
AU  - Sieper J
AD  - Charite Universitatsmedizin Berlin, Berlin, Germany.
FAU - Baraliakos, Xenofon
AU  - Baraliakos X
AD  - Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Bochum, Germany.
FAU - Van den Bosch, Filip
AU  - Van den Bosch F
AD  - Ghent University Hospital, Gent, Belgium.
FAU - Maksymowych, Walter P
AU  - Maksymowych WP
AUID- ORCID: 0000-0002-1291-1755
AD  - University of Alberta, Edmonton, Alberta, Canada.
FAU - Ermann, Joerg
AU  - Ermann J
AD  - Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, 
      USA.
FAU - Walsh, Jessica A
AU  - Walsh JA
AD  - Division of Rheumatology, University of Utah and Salt Lake City Veterans Affairs 
      Medical Centers, Salt Lake City, Utah, USA.
FAU - Tomita, Tetsuya
AU  - Tomita T
AD  - Department of Orthopaedic Biomaterial Science, Osaka University Graduate School 
      of Medicine, Suita, Osaka, Japan.
FAU - Deodhar, Atul
AU  - Deodhar A
AD  - Oregon Health and Science University, Portland, Oregon, USA.
FAU - van der Heijde, Desiree
AU  - van der Heijde D
AUID- ORCID: 0000-0002-5781-158X
AD  - Department of Rheumatology, Leiden University Medical Center, Leiden, The 
      Netherlands.
FAU - Li, Xiaoqi
AU  - Li X
AD  - Eli Lilly and Company, Indianapolis, Indiana, USA.
FAU - Zhao, Fangyi
AU  - Zhao F
AD  - Eli Lilly and Company, Indianapolis, Indiana, USA.
FAU - Bertram, Clinton C
AU  - Bertram CC
AD  - Eli Lilly and Company, Indianapolis, Indiana, USA.
FAU - Gallo, Gaia
AU  - Gallo G
AD  - Eli Lilly and Company, Indianapolis, Indiana, USA.
FAU - Carlier, Hilde
AU  - Carlier H
AD  - Eli Lilly and Company, Indianapolis, Indiana, USA.
FAU - Gensler, Lianne S
AU  - Gensler LS
AD  - University of California, San Francisco, California, USA.
CN  - COAST-V and COAST-W Study Groups
LA  - eng
SI  - ClinicalTrials.gov/NCT02696798
SI  - ClinicalTrials.gov/NCT02696785
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20191104
PL  - England
TA  - Ann Rheum Dis
JT  - Annals of the rheumatic diseases
JID - 0372355
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Tumor Necrosis Factor Inhibitors)
RN  - BTY153760O (ixekizumab)
RN  - FYS6T7F842 (Adalimumab)
SB  - IM
EIN - Ann Rheum Dis. 2020 Jun;79(6):e75. PMID: 32434813
MH  - Adalimumab/administration & dosage
MH  - Antibodies, Monoclonal, Humanized/*administration & dosage
MH  - Antirheumatic Agents/*administration & dosage
MH  - Double-Blind Method
MH  - Drug Substitution
MH  - Female
MH  - Humans
MH  - Male
MH  - Radiography
MH  - Severity of Illness Index
MH  - Spondylarthritis/diagnostic imaging/*drug therapy
MH  - Time Factors
MH  - Treatment Outcome
MH  - Tumor Necrosis Factor Inhibitors/*administration & dosage
PMC - PMC7025731
OTO - NOTNLM
OT  - DMARDs (biologic)
OT  - ankylosing spondylitis
OT  - spondyloarthritis
COIS- Competing interests: MD has served as a consultant and received research grants 
      from AbbVie, Eli Lilly and Company, Pfizer and UCB Pharma. JC-CW has served as a 
      consultant and/or speaker and/or has received research grants from Abbott, 
      Bristol-Myers Squibb, Celgene, Chugai, Eisai, Eli Lilly and Company, Janssen, 
      Novartis, Pfizer, Sanofi-Aventis, TSH Taiwan and UCB Pharma. RL has served as a 
      consultant and/or advisor and/or has received research grants from AbbVie, 
      Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Janssen, Galapagos, Merck, 
      Novartis, Pfizer and UCB Pharma. RL is the director of Rheumatology Consultancy 
      BV, a company that was indirectly contracted by Eli Lilly and Company to perform 
      read services for the COAST program. JS has served as a consultant and/or speaker 
      for AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, 
      Novartis, Pfizer, Roche and UCB Pharma. XB has served as a consultant and/or has 
      received research grants from AbbVie, Bristol-Myers Squibb, Celgene, Janssen, 
      MSD, Novartis, Pfizer, Roche and UCB Pharma. FVdB has served as a consultant 
      and/or speaker and/or has received research grants from AbbVie, Bristol-Myers 
      Squibb, Celgene, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Sanofi 
      and UCB Pharma. WPM has served as a consultant and/or received honoraria and/or 
      research/educational grants from AbbVie, Boehringer Ingelheim, Celgene, Eli Lilly 
      and Company, Galapagos, Janssen, Novartis, Pfizer and UCB Pharma, and is Chief 
      Medical Officer of CARE Arthritis Limited. JE has served as a consultant and/or 
      received research grants from AbbVie, Boehringer Ingelheim, Eli Lilly and 
      Company, Janssen, Novartis, Pfizer, Takeda and UCB Pharma. JAW has been a 
      consultant and/or received research grants from AbbVie, Amgen, Celgene, Eli Lilly 
      and Company, Novartis, Pfizer and UCB Pharma. AD has been a consultant and/or 
      received research support from AbbVie, Bristol-Myers Squibb, Eli Lilly and 
      Company, Glaxo Smith & Klein, Janssen, Novartis, Pfizer and UCB Pharma. DvdH has 
      been a consultant for AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, 
      Boehringer Ingelheim, Celgene, Daiichi, Eli Lilly and Company, Galapagos, Gilead, 
      Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda and UCB Pharma 
      and is a Director of Imaging Rheumatology BV. TT has been a consultant and 
      speaker for AbbVie, Astellas, Bristol-Myers Squibb, Eisai, Eli Lilly and Company, 
      Janssen, Mitsubishi Tanabe, Novartis, Pfizer and Takeda. XL, FZ, CCB, GG and HC 
      are current employees and shareholders of Eli Lilly and Company. LSG has been a 
      consultant and/or received research grants/support from AbbVie, Amgen, Eli Lilly 
      and Company, Galapagos, Janssen, Novartis, Pfizer and UCB Pharma.
EDAT- 2019/11/07 06:00
MHDA- 2020/04/25 06:00
PMCR- 2020/02/17
CRDT- 2019/11/06 06:00
PHST- 2019/08/01 00:00 [received]
PHST- 2019/10/03 00:00 [revised]
PHST- 2019/10/05 00:00 [accepted]
PHST- 2019/11/07 06:00 [pubmed]
PHST- 2020/04/25 06:00 [medline]
PHST- 2019/11/06 06:00 [entrez]
PHST- 2020/02/17 00:00 [pmc-release]
AID - annrheumdis-2019-216118 [pii]
AID - 10.1136/annrheumdis-2019-216118 [doi]
PST - ppublish
SO  - Ann Rheum Dis. 2020 Feb;79(2):176-185. doi: 10.1136/annrheumdis-2019-216118. Epub 
      2019 Nov 4.