Ankylosing spondylitis: long-term efficacy and safety of secukinumab

  • Baraliakos X & al.
  • RMD Open
  • 3 Sep 2019

  • curated by Sarfaroj Khan
  • UK Clinical Digest
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Takeaway

  • In patients with ankylosing spondylitis (AS), secukinumab 150 mg provided sustained efficacy and a favourable and consistent safety profile through 5 years of treatment
  • In more than 50% of patients, 75 mg dose was found to be suboptimal, dose escalation to 150 mg improved efficacy.

Why this matters

  • Besides tumour necrosis factor (TNF) inhibitors, secukinumab (150 mg) is the only approved biological standard disease-modifying anti-rheumatic drug for AS.
  • Findings support evidence for the use of secukinumab as a long-term treatment option for both biologic-naïve patients and those who experience an inadequate response or intolerance to anti-TNF agents.

Study design

  • Safety and efficacy of secukinumab in AS were evaluated in this phase 3 study (2-year core MEASURE 1 trial, n=371; 3-year extension study, n=230/371).
  • Dose escalation from 75 to 150 mg at or after 156 weeks was allowed after the approval of treating physician.
  • Primary outcome: Assessment of SpondyloArthritis international Society (ASAS) 20/40 criteria and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score at 5 years.
  • Funding: Novartis Pharma.

Key results

  • At 5 years
    • ASAS 20 and 40 responses were 78.6% and 65.2%, respectively.
    • BASDAI 50 response was 63.4%.
  • The mean BASDAI total score at 5 years with secukinumab 150 mg was 2.6.
  • The dose was escalated from 75 to 150 mg in 56.2% patients at week 168; in these patients, ASAS40, ASAS-partial remission, ASAS 5/6 and BASDAI50 responses improved.
  • Secukinumab was well tolerated; most common adverse events (relative frequency >2%) were nasopharyngitis, headache, diarrhoea and upper respiratory tract infection.
  • Treatment-emergent anti-drug antibodies were detected in one patient in the secukinumab 150 mg group 
  • 4 deaths occurred during the 5-year treatment, none of them was treatment related.

Limitations

  • Pharmaceutical company sponsored.