Ixekizumab improves spinal pain, function, fatigue, stiffness, and sleep in radiographic axial Spondyloarthritis: COAST-V/W 52-week results
Abstract Background This analysis assessed improvements in patients with radiographic axial spondyloarthritis (r-axSpA) treated with ixekizumab in the Assessment of Spondyloarthritis International Society (ASAS) treatment response domains and additional patient-reported outcomes at 1 year of treatme...
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doaj-697f0166133e48e2b2b361b5bee91e842021-09-26T11:34:41ZengBMCBMC Rheumatology2520-10262021-09-015111110.1186/s41927-021-00205-3Ixekizumab improves spinal pain, function, fatigue, stiffness, and sleep in radiographic axial Spondyloarthritis: COAST-V/W 52-week resultsAtul A. Deodhar0Philip J. Mease1Proton Rahman2Victoria Navarro-Compán3Vibeke Strand4Theresa Hunter5Rebecca Bolce6Luis Leon7Steve Lauzon8Helena Marzo-Ortega9Division of Arthritis and Rheumatic Diseases, Oregon Health & Science UniversitySwedish Medical Center/ Providence St. Joseph Health and University of WashingtonMemorial University of NewfoundlandDepartment of Rheumatology, Hospital Universitario La Paz, IdiPAZDivision of Immunology/Rheumatology, Stanford University School of MedicineEli Lilly and CompanyEli Lilly and CompanyEli Lilly and CompanyEli Lilly and CompanyNational Institute for Health Research (NIHR) Leeds Biomedical Research Centre, Leeds Teaching Hospitals Trust and LIRMM, University of LeedsAbstract Background This analysis assessed improvements in patients with radiographic axial spondyloarthritis (r-axSpA) treated with ixekizumab in the Assessment of Spondyloarthritis International Society (ASAS) treatment response domains and additional patient-reported outcomes at 1 year of treatment. Methods COAST-V and COAST-W were 52-week, phase 3, randomized controlled trials evaluating the efficacy and safety of ixekizumab in biologic disease-modifying antirheumatic drug (bDMARD)-naïve and tumor necrosis factor inhibitor (TNFi)-experienced patients with radiographic spondyloarthritis, respectively. Patients were treated with 80-mg ixekizumab either every 2 weeks or every 4 weeks. Patient-reported outcomes included Patient Global Disease Activity, Spinal Pain, stiffness as measured by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Questions 5 and 6, function as measured by the Bath Ankylosing Spondylitis Functional Index, fatigue as measured by the Fatigue Numeric Rating Scale and BASDAI question 1, Spinal Pain at Night, and sleep quality as measured by the Jenkins Sleep Evaluation Questionnaire. Mixed-effects models for repeated measures were used to analyze changes from baseline in patient-reported outcomes from weeks 1 to 16, and descriptive statistics were reported from weeks 20 to 52. Analysis of covariance with Scheffé’s method was used for the ASAS response association analyses. Results This study assessed 341 bDMARD-naïve and 316 TNFi-experienced patients in the placebo-controlled blinded treatment dosing period (weeks 1–16) as well as 329 bDMARD-naïve and 281 TNFi-experienced patients in the dose double-blind extended treatment period (weeks 20–52). bDMARD-naïve or TNFi-experienced patients treated with ixekizumab every 2 weeks and every 4 weeks reported improvements in patient global disease activity, spinal pain, function, stiffness, fatigue, spinal pain at night, and sleep quality through week 52. Greater correlations with improvements in all response domains were seen when comparing ASAS40 responders to ASAS20 non-responders (p < 0.001), with up to 10.5-fold greater improvements observed in ASAS40 responses compared with ASAS20 non-responders. Function and fatigue demonstrated the highest values. Conclusions Ixekizumab-treated bDMARD-naïve and TNFi-experienced patients with radiographic axial spondyloarthritis achieving ASAS40 reported sustained and consistent improvement in all ASAS response domains and other patient-reported outcomes though week 52, with spinal pain, function, and stiffness as major drivers of the response. Trial registration NCT02696785 and NCT02696798 , March 2, 2016.https://doi.org/10.1186/s41927-021-00205-3ASASPROsSpinal painStiffnessFatigueRadiographic axial spondyloarthritis |
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DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Atul A. Deodhar Philip J. Mease Proton Rahman Victoria Navarro-Compán Vibeke Strand Theresa Hunter Rebecca Bolce Luis Leon Steve Lauzon Helena Marzo-Ortega |
spellingShingle |
Atul A. Deodhar Philip J. Mease Proton Rahman Victoria Navarro-Compán Vibeke Strand Theresa Hunter Rebecca Bolce Luis Leon Steve Lauzon Helena Marzo-Ortega Ixekizumab improves spinal pain, function, fatigue, stiffness, and sleep in radiographic axial Spondyloarthritis: COAST-V/W 52-week results BMC Rheumatology ASAS PROs Spinal pain Stiffness Fatigue Radiographic axial spondyloarthritis |
author_facet |
Atul A. Deodhar Philip J. Mease Proton Rahman Victoria Navarro-Compán Vibeke Strand Theresa Hunter Rebecca Bolce Luis Leon Steve Lauzon Helena Marzo-Ortega |
author_sort |
Atul A. Deodhar |
title |
Ixekizumab improves spinal pain, function, fatigue, stiffness, and sleep in radiographic axial Spondyloarthritis: COAST-V/W 52-week results |
title_short |
Ixekizumab improves spinal pain, function, fatigue, stiffness, and sleep in radiographic axial Spondyloarthritis: COAST-V/W 52-week results |
title_full |
Ixekizumab improves spinal pain, function, fatigue, stiffness, and sleep in radiographic axial Spondyloarthritis: COAST-V/W 52-week results |
title_fullStr |
Ixekizumab improves spinal pain, function, fatigue, stiffness, and sleep in radiographic axial Spondyloarthritis: COAST-V/W 52-week results |
title_full_unstemmed |
Ixekizumab improves spinal pain, function, fatigue, stiffness, and sleep in radiographic axial Spondyloarthritis: COAST-V/W 52-week results |
title_sort |
ixekizumab improves spinal pain, function, fatigue, stiffness, and sleep in radiographic axial spondyloarthritis: coast-v/w 52-week results |
publisher |
BMC |
series |
BMC Rheumatology |
issn |
2520-1026 |
publishDate |
2021-09-01 |
description |
Abstract Background This analysis assessed improvements in patients with radiographic axial spondyloarthritis (r-axSpA) treated with ixekizumab in the Assessment of Spondyloarthritis International Society (ASAS) treatment response domains and additional patient-reported outcomes at 1 year of treatment. Methods COAST-V and COAST-W were 52-week, phase 3, randomized controlled trials evaluating the efficacy and safety of ixekizumab in biologic disease-modifying antirheumatic drug (bDMARD)-naïve and tumor necrosis factor inhibitor (TNFi)-experienced patients with radiographic spondyloarthritis, respectively. Patients were treated with 80-mg ixekizumab either every 2 weeks or every 4 weeks. Patient-reported outcomes included Patient Global Disease Activity, Spinal Pain, stiffness as measured by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Questions 5 and 6, function as measured by the Bath Ankylosing Spondylitis Functional Index, fatigue as measured by the Fatigue Numeric Rating Scale and BASDAI question 1, Spinal Pain at Night, and sleep quality as measured by the Jenkins Sleep Evaluation Questionnaire. Mixed-effects models for repeated measures were used to analyze changes from baseline in patient-reported outcomes from weeks 1 to 16, and descriptive statistics were reported from weeks 20 to 52. Analysis of covariance with Scheffé’s method was used for the ASAS response association analyses. Results This study assessed 341 bDMARD-naïve and 316 TNFi-experienced patients in the placebo-controlled blinded treatment dosing period (weeks 1–16) as well as 329 bDMARD-naïve and 281 TNFi-experienced patients in the dose double-blind extended treatment period (weeks 20–52). bDMARD-naïve or TNFi-experienced patients treated with ixekizumab every 2 weeks and every 4 weeks reported improvements in patient global disease activity, spinal pain, function, stiffness, fatigue, spinal pain at night, and sleep quality through week 52. Greater correlations with improvements in all response domains were seen when comparing ASAS40 responders to ASAS20 non-responders (p < 0.001), with up to 10.5-fold greater improvements observed in ASAS40 responses compared with ASAS20 non-responders. Function and fatigue demonstrated the highest values. Conclusions Ixekizumab-treated bDMARD-naïve and TNFi-experienced patients with radiographic axial spondyloarthritis achieving ASAS40 reported sustained and consistent improvement in all ASAS response domains and other patient-reported outcomes though week 52, with spinal pain, function, and stiffness as major drivers of the response. Trial registration NCT02696785 and NCT02696798 , March 2, 2016. |
topic |
ASAS PROs Spinal pain Stiffness Fatigue Radiographic axial spondyloarthritis |
url |
https://doi.org/10.1186/s41927-021-00205-3 |
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