PMID- 32669450
OWN - NLM
STAT- MEDLINE
DCOM- 20210831
LR  - 20210831
IS  - 1499-2752 (Electronic)
IS  - 0315-162X (Linking)
VI  - 48
IP  - 2
DP  - 2021 Feb
TI  - Ixekizumab Improves Functioning and Health in the Treatment of Radiographic Axial 
      Spondyloarthritis: Week 52 Results from 2 Pivotal Studies.
PG  - 188-197
LID - 10.3899/jrheum.200093 [doi]
AB  - OBJECTIVE: This study evaluated the effect of ixekizumab (IXE) on self-reported 
      functioning and health in patients with radiographic axial spondyloarthritis 
      (r-axSpA) who were either biological disease-modifying antirheumatic drug 
      (bDMARD)-naive or failed at least 1 tumor necrosis factor inhibitor (TNFi). 
      METHODS: In 2 multicenter, randomized, double-blind, placebo-controlled, and 
      active-controlled (bDMARD-naive only) trials, patients with r-axSpA were randomly 
      assigned to receive 80 mg of IXE [every 2 weeks (Q2W) or every 4 weeks (Q4W)], 
      placebo (PBO), or adalimumab (ADA; bDMARD-naive only). After 16 weeks, patients 
      who received PBO or ADA were rerandomized to receive IXE (Q2W or Q4W) up to Week 
      52. Functioning and health were measured by the generic 36-item Short Form Health 
      Survey (SF-36) and the disease-specific Assessment of Spondyloarthritis 
      international Society Health Index (ASAS HI). Societal health utility was 
      assessed by the 5-level EuroQol-5 Dimension (EQ-5D-5L). RESULTS: At Week 16, both 
      doses of IXE in bDMARD-naive and TNFi-experienced patients resulted in larger 
      improvement in SF-36, ASAS HI, and EQ-5D-5L versus placebo. For SF-36, the 
      largest improvements were seen for the domains of bodily pain, physical function, 
      and role physical. A larger proportion of patients reaching improvement in ASAS 
      HI >/= 3 as well as an achievement of ASAS HI good health status was reported in 
      patients treated with IXE. Improvements were maintained through Week 52. 
      CONCLUSION: IXE significantly improved functioning and health as assessed by both 
      generic and disease-specific measures, as well as societal health utility values 
      in patients with r-axSpA, as measured by SF-36, ASAS HI, and EQ-5D-5L at Week 16, 
      and improvements were sustained through 52 weeks.
CI  - Copyright (c) 2021 by the Journal of Rheumatology.
FAU - Kiltz, Uta
AU  - Kiltz U
AUID- ORCID: 0000-0001-5668-4497
AD  - U. Kiltz, MD, J. Braun, MD, PhD, Rheumazentrum Ruhrgebiet, Herne, and 
      Ruhr-Universitat Bochum, Bochum, Germany; uta.kiltz@elisabethgruppe.de.
FAU - Wei, James Cheng-Chung
AU  - Wei JC
AUID- ORCID: 0000-0001-9328-0336
AD  - J. Cheng-Chung Wei, MD, PhD, Institute of Medicine, Chung Shan Medical 
      University, Graduate Institute of Integrated Medicine, China Medical University, 
      Taichung, Taiwan.
FAU - van der Heijde, Desiree
AU  - van der Heijde D
AUID- ORCID: 0000-0002-5781-158X
AD  - D. van der Heijde, MD, PhD, Leiden University Medical Center, Leiden, the 
      Netherlands.
FAU - van den Bosch, Filip
AU  - van den Bosch F
AUID- ORCID: 0000-0002-3561-5932
AD  - F. van den Bosch, MD, PhD, Department of Internal Medicine and Pediatrics, Ghent 
      University, VIB Center for Inflammation Research, Ghent, Belgium.
FAU - Walsh, Jessica A
AU  - Walsh JA
AD  - J.A. Walsh, MD, University of Utah School of Medicine and Salt Lake City Veterans 
      Affairs Medical Center, Salt Lake City, Utah, USA.
FAU - Boonen, Annelies
AU  - Boonen A
AD  - A. Boonen, MD, PhD, Rheumatology, Maastricht University Medical Center, and Care 
      and Public Health Research Institute, Maastricht University, Maastricht, the 
      Netherlands.
FAU - Gensler, Lianne S
AU  - Gensler LS
AUID- ORCID: 0000-0001-6314-5336
AD  - L.S. Gensler, MD, University of California San Francisco, San Francisco, 
      California, USA.
FAU - Hunter, Theresa
AU  - Hunter T
AD  - T. Hunter, PhD, H. Carlier, MD, Y. Dong, PhD, X. Li, PhD, R. Bolce, MSN, Eli 
      Lilly and Company, Indianapolis, Indiana, USA.
FAU - Carlier, Hilde
AU  - Carlier H
AD  - T. Hunter, PhD, H. Carlier, MD, Y. Dong, PhD, X. Li, PhD, R. Bolce, MSN, Eli 
      Lilly and Company, Indianapolis, Indiana, USA.
FAU - Dong, Yan
AU  - Dong Y
AD  - T. Hunter, PhD, H. Carlier, MD, Y. Dong, PhD, X. Li, PhD, R. Bolce, MSN, Eli 
      Lilly and Company, Indianapolis, Indiana, USA.
FAU - Li, Xiaoqi
AU  - Li X
AD  - T. Hunter, PhD, H. Carlier, MD, Y. Dong, PhD, X. Li, PhD, R. Bolce, MSN, Eli 
      Lilly and Company, Indianapolis, Indiana, USA.
FAU - Bolce, Rebecca
AU  - Bolce R
AD  - T. Hunter, PhD, H. Carlier, MD, Y. Dong, PhD, X. Li, PhD, R. Bolce, MSN, Eli 
      Lilly and Company, Indianapolis, Indiana, USA.
FAU - Strand, Vibeke
AU  - Strand V
AUID- ORCID: 0000-0003-4978-4072
AD  - V. Strand, MD, Stanford University School of Medicine, Palo Alto, California, 
      USA.
FAU - Braun, Juergen
AU  - Braun J
AUID- ORCID: 0000-0002-9156-5095
AD  - U. Kiltz, MD, J. Braun, MD, PhD, Rheumazentrum Ruhrgebiet, Herne, and 
      Ruhr-Universitat Bochum, Bochum, Germany.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20200715
PL  - Canada
TA  - J Rheumatol
JT  - The Journal of rheumatology
JID - 7501984
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antirheumatic Agents)
RN  - BTY153760O (ixekizumab)
SB  - IM
MH  - Antibodies, Monoclonal, Humanized/therapeutic use
MH  - *Antirheumatic Agents/therapeutic use
MH  - Double-Blind Method
MH  - Humans
MH  - *Spondylarthritis/diagnostic imaging/drug therapy
MH  - Treatment Outcome
OTO - NOTNLM
OT  - ASAS Health Index
OT  - EQ-5D
OT  - SF-36
OT  - ankylosing spondylitis
OT  - ixekizumab
OT  - radiographic axial spondyloarthritis
EDAT- 2020/07/17 06:00
MHDA- 2021/09/01 06:00
CRDT- 2020/07/17 06:00
PHST- 2020/07/06 00:00 [accepted]
PHST- 2020/07/17 06:00 [pubmed]
PHST- 2021/09/01 06:00 [medline]
PHST- 2020/07/17 06:00 [entrez]
AID - jrheum.200093 [pii]
AID - 10.3899/jrheum.200093 [doi]
PST - ppublish
SO  - J Rheumatol. 2021 Feb;48(2):188-197. doi: 10.3899/jrheum.200093. Epub 2020 Jul 
      15.