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:
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:
Supported by Novartis Pharma AG, Basel, Switzerland. Dr. Conaghan's work was supported by the UK NIHR Leeds Biomedical Research Centre.
Funding Information:
Dr. Kvien has received consulting and/or speaking fees from AbbVie, Biogen, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly and Company, Epirus, Hospira, Merck‐Serono, MSD, Mundipharma, Novartis, Oktal, Orion Pharma, Hospira/Pfizer, Roche, Sandoz, and UCB (less than $10,000 each) and research grants to Diakonhjemmet Hospital from AbbVie, Bristol Myers Squibb, MSD, Pfizer, Roche, and UCB. Dr. Conaghan has received consulting and/or speaking fees from AbbVie, Bristol Myers Squibb, GlaxoSmithKline, Merck, Novartis, Pfizer, and Roche (less than $10,000 each) and research grants from Bristol Myers Squibb. Dr. Gossec has received consulting fees from AbbVie, Amgen, Biogen, Bristol Myers Squibb, Celgene, Janssen, Novartis, Pfizer, Roche, Sandoz, and UCB (less than $10,000 each) and research grants from UCB, Eli Lilly and Company, Pfizer, and Bristol‐Myers Squibb. Dr. Strand has received consulting fees from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, CORRONA, Genentech/Roche, GlaxoSmithKline, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Regeneron, Samsung, Sandoz, Sanofi, and UCB (less than $10,000 each). Dr. Østergaard has received consulting fees, speaking fees, and/or travel expenses from AbbVie, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly and Company, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, and UCB (less than $10,000 each) and research grants from AbbVie, Celgene, Centocor, Merck, and Novartis. Dr. Poddubnyy has received consulting and/or speaking fees from AbbVie, Bristol Myers Squibb, Celgene, Eli Lilly and Company, MSD, Novartis, Pfizer, Roche, and UCB (less than $10,000 each) and research grants from AbbVie, MSD, Novartis, and Pfizer. Drs. Porter and Shete and Ms. Gilloteau are employees of Novartis and own Novartis stock. Dr. Deodhar has received speaking fees, consulting fees, and/or travel expenses from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Janssen, Novartis, Pfizer, and UCB (less than $10,000 each) and research grants from Bristol Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Janssen, Novartis, Pfizer, and UCB. No other disclosures relevant to this article were reported.
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).
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
VL - 74
SP - 759
EP - 767
JO - Arthritis Care and Research
JF - Arthritis Care and Research
SN - 2151-464X
IS - 5
ER -