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Secukinumab Provides Sustained Reduction in Fatigue in Patients with Ankylosing Spondylitis: Long-term Results of Two Phase III Randomized Controlled Trials

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Kvien, Tore K ; Conaghan, Philip G ; Gossec, Laure ; Strand, Vibeke ; Østergaard, Mikkel ; Poddubnyy, Denis ; Williams, Nicole ; Porter, Brian ; Shete, Abhijit ; Gilloteau, Isabelle ; Deodhar, Atul. / Secukinumab Provides Sustained Reduction in Fatigue in Patients with Ankylosing Spondylitis : Long-term Results of Two Phase III Randomized Controlled Trials. In: Arthritis Care & Research. 2021.

Bibtex

@article{f9576e73c5644f15a95c664494eda1d1,
title = "Secukinumab Provides Sustained Reduction in Fatigue in Patients with Ankylosing Spondylitis: Long-term Results of Two Phase III Randomized Controlled Trials",
abstract = "OBJECTIVE: To investigate the longer-term effects of secukinumab 150 mg on fatigue in patients with ankylosing spondylitis (AS) in MEASURE 1 (up to 3 years) and MEASURE 2 (up to 2 years).METHODS: Patients with active AS were randomized to secukinumab or placebo in MEASURE 1 (10 mg/kg intravenous [IV] followed by 150 mg subcutaneous [SC]) and MEASURE 2 (150 mg SC). Patients were naive to or had an inadequate response/intolerance to tumor necrosis factor inhibitors (anti-TNF-naive/ anti-TNF-IR). Fatigue was measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale. Relationships between fatigue response and baseline characteristics and clinical/laboratory variables were explored.RESULTS: Significant improvements in FACIT-F scores from baseline were observed with secukinumab across both studies versus placebo at week 16 (P < 0.05). Improvements were sustained through week 156 (MEASURE 1)/week 104 (MEASURE 2). Significantly more patients reported fatigue responses (FACIT-F increase ≥4; observed data) with secukinumab 150 mg than placebo at week 16 in both MEASURE 1 (P < 0.05) and MEASURE 2 (P < 0.01). Fatigue responses were achieved by 75.6% of patients receiving secukinumab at week 156 (MEASURE 1) and 81.4% at week 104 (MEASURE 2); these results were consistent in both anti-TNF-naive (74.3% and 84.6%) and anti-TNF-IR (81.3% and 75.0%) patients. Baseline characteristics did not predict improvement in fatigue consistently. Fatigue responses were moderately to strongly correlated with responses in several clinical measures, including Assessment of SpondyloArthritis international Society (ASAS)20/40, ASAS5/6 responses, Ankylosing Spondylitis Disease Activity Score-C reactive protein (ASDAS-CRP), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Short-form (SF)-36 scores.CONCLUSION: Secukinumab provided rapid and sustained improvements in fatigue for up to 3 years, regardless of prior anti-TNF exposure.",
author = "Kvien, {Tore K} and Conaghan, {Philip G} and Laure Gossec and Vibeke Strand and Mikkel {\O}stergaard and Denis Poddubnyy and Nicole Williams and Brian Porter and Abhijit Shete and Isabelle Gilloteau and Atul Deodhar",
note = "COPECARE",
year = "2021",
doi = "10.1002/acr.24517",
language = "English",
journal = "Arthritis Care & Research",
issn = "2151-464X",
publisher = "JohnWiley & Sons, Inc",

}

RIS

TY - JOUR

T1 - Secukinumab Provides Sustained Reduction in Fatigue in Patients with Ankylosing Spondylitis

T2 - Long-term Results of Two Phase III Randomized Controlled Trials

AU - Kvien, Tore K

AU - Conaghan, Philip G

AU - Gossec, Laure

AU - Strand, Vibeke

AU - Østergaard, Mikkel

AU - Poddubnyy, Denis

AU - Williams, Nicole

AU - Porter, Brian

AU - Shete, Abhijit

AU - Gilloteau, Isabelle

AU - Deodhar, Atul

N1 - COPECARE

PY - 2021

Y1 - 2021

N2 - OBJECTIVE: To investigate the longer-term effects of secukinumab 150 mg on fatigue in patients with ankylosing spondylitis (AS) in MEASURE 1 (up to 3 years) and MEASURE 2 (up to 2 years).METHODS: Patients with active AS were randomized to secukinumab or placebo in MEASURE 1 (10 mg/kg intravenous [IV] followed by 150 mg subcutaneous [SC]) and MEASURE 2 (150 mg SC). Patients were naive to or had an inadequate response/intolerance to tumor necrosis factor inhibitors (anti-TNF-naive/ anti-TNF-IR). Fatigue was measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale. Relationships between fatigue response and baseline characteristics and clinical/laboratory variables were explored.RESULTS: Significant improvements in FACIT-F scores from baseline were observed with secukinumab across both studies versus placebo at week 16 (P < 0.05). Improvements were sustained through week 156 (MEASURE 1)/week 104 (MEASURE 2). Significantly more patients reported fatigue responses (FACIT-F increase ≥4; observed data) with secukinumab 150 mg than placebo at week 16 in both MEASURE 1 (P < 0.05) and MEASURE 2 (P < 0.01). Fatigue responses were achieved by 75.6% of patients receiving secukinumab at week 156 (MEASURE 1) and 81.4% at week 104 (MEASURE 2); these results were consistent in both anti-TNF-naive (74.3% and 84.6%) and anti-TNF-IR (81.3% and 75.0%) patients. Baseline characteristics did not predict improvement in fatigue consistently. Fatigue responses were moderately to strongly correlated with responses in several clinical measures, including Assessment of SpondyloArthritis international Society (ASAS)20/40, ASAS5/6 responses, Ankylosing Spondylitis Disease Activity Score-C reactive protein (ASDAS-CRP), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Short-form (SF)-36 scores.CONCLUSION: Secukinumab provided rapid and sustained improvements in fatigue for up to 3 years, regardless of prior anti-TNF exposure.

AB - OBJECTIVE: To investigate the longer-term effects of secukinumab 150 mg on fatigue in patients with ankylosing spondylitis (AS) in MEASURE 1 (up to 3 years) and MEASURE 2 (up to 2 years).METHODS: Patients with active AS were randomized to secukinumab or placebo in MEASURE 1 (10 mg/kg intravenous [IV] followed by 150 mg subcutaneous [SC]) and MEASURE 2 (150 mg SC). Patients were naive to or had an inadequate response/intolerance to tumor necrosis factor inhibitors (anti-TNF-naive/ anti-TNF-IR). Fatigue was measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale. Relationships between fatigue response and baseline characteristics and clinical/laboratory variables were explored.RESULTS: Significant improvements in FACIT-F scores from baseline were observed with secukinumab across both studies versus placebo at week 16 (P < 0.05). Improvements were sustained through week 156 (MEASURE 1)/week 104 (MEASURE 2). Significantly more patients reported fatigue responses (FACIT-F increase ≥4; observed data) with secukinumab 150 mg than placebo at week 16 in both MEASURE 1 (P < 0.05) and MEASURE 2 (P < 0.01). Fatigue responses were achieved by 75.6% of patients receiving secukinumab at week 156 (MEASURE 1) and 81.4% at week 104 (MEASURE 2); these results were consistent in both anti-TNF-naive (74.3% and 84.6%) and anti-TNF-IR (81.3% and 75.0%) patients. Baseline characteristics did not predict improvement in fatigue consistently. Fatigue responses were moderately to strongly correlated with responses in several clinical measures, including Assessment of SpondyloArthritis international Society (ASAS)20/40, ASAS5/6 responses, Ankylosing Spondylitis Disease Activity Score-C reactive protein (ASDAS-CRP), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Short-form (SF)-36 scores.CONCLUSION: Secukinumab provided rapid and sustained improvements in fatigue for up to 3 years, regardless of prior anti-TNF exposure.

U2 - 10.1002/acr.24517

DO - 10.1002/acr.24517

M3 - Journal article

C2 - 33227175

JO - Arthritis Care & Research

JF - Arthritis Care & Research

SN - 2151-464X

ER -

ID: 61762575