Secukinumab provides 'significant, sustained' fatigue reduction in ankylosing spondylitis
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Secukinumab demonstrated rapid, stained improvements in fatigue for up to 3 years among patients with ankylosing spondylitis, according to data published in Arthritis Care & Research.
“Fatigue is reported in up to 66% of patients with AS and has been identified as a key patient priority in the treatment of AS,” Tore K. Kvien, MD, PhD, of Diakonhjemmet Hospital and the University of Oslo, in Norway, and colleagues wrote. “Many patients report that fatigue negatively impacts HRQoL and social functioning; thus, reducing this symptom remains an important unmet need in AS.”
“Interleukin-17A (IL-17A) is one of the key cytokines driving the pathogenesis of AS,” they added. “Secukinumab, a fully human monoclonal antibody that selectively binds to and inhibits IL-17A, is approved for the treatment of AS based on the results of two randomized, double-blind, placebo-controlled, phase 3 trials, MEASURE 1 and MEASURE 2 that demonstrated significant improvements in the signs and symptoms of AS with secukinumab versus placebo. Secukinumab has previously been shown to provide rapid improvements in fatigue.”
To examine the long-term impact of secukinumab (Cosentyx, Novartis) on fatigue among patients with AS, Kvien and colleagues analyzed data from MEASURE 1 and MEASURE 2. According to the researchers, patients with active AS were randomized to receive secukinumab — 10 mg per kg intravenous, followed by 150 mg subcutaneous — or placebo for up to 3 years in MEASURE 1. In MEASURE 2 patients were randomly selected to receive 150 mg of subcutaneous secukinumab or a placebo for up to 2 years. All participants were naïve, or had an inadequate response or intolerance, to TNF inhibitors.
Among the 125 participants randomized to receive 150 mg of secukinumab at baseline in MEASURE 1, 97 completed the 2-year core trial. Later, 87 of these participants entered the extension study, of whom 83 completed week 156. In MEASURE 2, among the 72 patients randomized to secukinumab at baseline, 60 completed week 104. The researchers analyzed fatigue using the Functional Assessment of Chronic Illness Therapy‐Fatigue (FACIT‐F) scale.
According to the researchers, there were significant improvements in FACIT‐F scores from baseline with secukinumab, compared with placebo, across both studies at week 16 (P < .05. These improvements were sustained through week 156 in MEASURE 1 and week 104 in MEASURE 2.
Significantly more patients reported fatigue responses — defined as an FACIT‐F increase of at least 4 — with secukinumab, compared with placebo, at week 16 in both MEASURE 1 (P < .05) and MEASURE 2 (P < .01). In addition, 75.6% of patients receiving secukinumab at week 156 in MEASURE 1 achieved fatigue responses, as did 81.4% of secukinumab 150 mg recipients at week 104 in MEASURE 2. These results were consistent across participants who were naïve, or had an inadequate response or intolerance, to TNF inhibitors.
Baseline characteristics failed consistently predict fatigue reduction. Fatigue responses were moderately to strongly correlated with responses in several clinical measures, including the Assessment of SpondyloArthritis international Society (ASAS) 20/40 and ASAS5/6 responses, as well as the Ankylosing Spondylitis Disease Activity Score‐C reactive protein (ASDAS‐CRP), the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and the Short‐form (SF)‐36 scores.
“Previously, secukinumab has been shown to rapidly improve signs and symptoms, physical function, HRQoL, and fatigue in patients with AS, with a low long-term rate of structural progression measured by modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS),” Kvien and colleagues wrote. “Results presented here build upon these findings, demonstrating significant and sustained improvements in fatigue, as measured using the FACIT-F score, compared with placebo in the overall population and particularly in the anti-TNF-naive population for up to 3 years.”
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