TY - JOUR
T1 - Secukinumab and 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 - Funding Information:
Supported by Novartis Pharma AG, Basel, Switzerland. Dr. Conaghan's work was supported by the UK NIHR Leeds Biomedical Research Centre.
Funding Information:
We thank Aurore Yocolly (Health Economics and Outcomes Research Manager), Steffen Jugl (Health Economics and Outcomes Research Director), and Kunal Gandhi (Medical Director) of Novartis. Medical writing support for the development of this manuscript, under the direction of the authors, was provided by Ashfield MedComms, an Ashfield Health company, and funded by Novartis. This publication was written in accordance with Good Publications Practice (GPP3) guidelines (http://www.ismpp.org/gpp3).
Funding Information:
The study was sponsored by Novartis Pharma AG and was designed by the scientific steering committee and Novartis personnel. Funding for medical writing support was provided by Novartis Pharma AG. Publication of this article was not contingent upon approval by Novartis Pharma AG.
Publisher Copyright:
© 2020 The Authors. Arthritis Care & Research published by Wiley Periodicals LLC on behalf of American College of Rheumatology.
PY - 2022/5
Y1 - 2022/5
N2 - Objective: To investigate the longer-term effects of secukinumab 150 mg on fatigue in patients with ankylosing spondylitis (AS) in the MEASURE 1 study (up to 3 years) and the MEASURE 2 study (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) and MEASURE 2 (150 mg subcutaneous). Patients were naive to treatment with anti–tumor necrosis factor (anti-TNF-naive) therapy or had an inadequate response/intolerance to anti-TNF therapy (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) and week 104 (MEASURE 2). Significantly more patients reported fatigue responses (FACIT-F improvement ≥4; observed data) with secukinumab 150 mg than with 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 patients who were anti-TNF-naive (74.3% and 84.6%, respectively) and anti-TNF-IR (81.3% and 75.0%, respectively). Baseline characteristics did not predict improvement in fatigue consistently. Fatigue responses were moderately to strongly correlated with responses in several clinical measures, including the Assessment of SpondyloArthritis international Society (ASAS) 20%/40% improvement, ASAS5/6 responses, the Ankylosing Spondylitis Disease Activity Score with C-reactive protein level, the Bath Ankylosing Spondylitis Disease Activity Index, and the Short Form 36 health questionnaire 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 the MEASURE 1 study (up to 3 years) and the MEASURE 2 study (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) and MEASURE 2 (150 mg subcutaneous). Patients were naive to treatment with anti–tumor necrosis factor (anti-TNF-naive) therapy or had an inadequate response/intolerance to anti-TNF therapy (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) and week 104 (MEASURE 2). Significantly more patients reported fatigue responses (FACIT-F improvement ≥4; observed data) with secukinumab 150 mg than with 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 patients who were anti-TNF-naive (74.3% and 84.6%, respectively) and anti-TNF-IR (81.3% and 75.0%, respectively). Baseline characteristics did not predict improvement in fatigue consistently. Fatigue responses were moderately to strongly correlated with responses in several clinical measures, including the Assessment of SpondyloArthritis international Society (ASAS) 20%/40% improvement, ASAS5/6 responses, the Ankylosing Spondylitis Disease Activity Score with C-reactive protein level, the Bath Ankylosing Spondylitis Disease Activity Index, and the Short Form 36 health questionnaire scores. Conclusion: Secukinumab provided rapid and sustained improvements in fatigue for up to 3 years, regardless of prior anti-TNF exposure.
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U2 - 10.1002/acr.24517
DO - 10.1002/acr.24517
M3 - Article
C2 - 33227175
AN - SCOPUS:85097001175
SN - 2151-464X
VL - 74
SP - 759
EP - 767
JO - Arthritis Care and Research
JF - Arthritis Care and Research
IS - 5
ER -