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Rigshospitalet - en del af Københavns Universitetshospital
E-pub ahead of print

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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

DOI

  • Tore K Kvien
  • Philip G Conaghan
  • Laure Gossec
  • Vibeke Strand
  • Mikkel Østergaard
  • Denis Poddubnyy
  • Nicole Williams
  • Brian Porter
  • Abhijit Shete
  • Isabelle Gilloteau
  • Atul Deodhar
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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.

OriginalsprogEngelsk
TidsskriftArthritis Care & Research
ISSN2151-464X
DOI
StatusE-pub ahead of print - 2021

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