AS: secukinumab yields sustained benefit in MEASURE-4 study

  • Kivitz AJ & al.
  • Rheumatol Ther
  • 18 Aug 2018

  • curated by Miriam Davis, PhD
  • Clinical Essentials
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Takeaway

  • Secukinumab (Cosentyx) ± loading dose reduced signs and symptoms of ankylosing spondylitis (AS) but failed to achieve the primary efficacy endpoint at 16 weeks because of an unexpectedly high placebo effect.
  • Secukinumab showed sustained responses over the course of a non-placebo-controlled maintenance phase lasting 88 more weeks.

Why this matters

  • Clinicians should consider prescribing secukinumab because of its sustained reduction in signs and symptoms of AS.

Study design

  • Randomized, placebo-controlled, phase 3 MEASURE-4 trial (n=350) of self-administered subcutaneous secukinumab consisting of 3 groups: secukinumab 150 mg with 150 mg loading dose (load group), secukinumab without loading dose (no-load group), or placebo.
  • Patients were dosed weekly until week 4, and thereafter every 4 weeks until 104 weeks.
  • At 16 weeks, placebo group was converted to open-label 150 mg no-load secukinumab.
  • Primary outcome was ≥20% improvement on the Assessment of SpondyloArthritis International Society criteria (ASAS20) at 16 weeks.
  • Funding: Novartis Pharma AG.

Key results

  • No differences in primary outcome at week 16 for secukinumab load group (59.5%), no-load group (61.5%), and placebo group (47%; P=.057 and .054, respectively).
  • Sustained ASAS20 responses observed at week 104 (74% of 150-mg group and 77.5% of no-load group).
  • No new safety signals emerged.

Limitations

  • High placebo effect.

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