Osteoarthritis: fasinumab improves pain, function in phase 2b/3

  • Dakin P & al.
  • Arthritis Rheumatol
  • 17 Jun 2019

  • International Clinical Digest
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Takeaway

  • Fasinumab improves pain and function at all dose levels in patients with moderate to severe osteoarthritis and a history of inadequate response or intolerance to analgesics.
  • Arthropathies are a dose-related adverse event.

Why this matters

  • Fasinumab is an investigational antinerve growth factor monoclonal antibody.
  • Results warrant further clinical development with an emphasis on low fasinumab doses.

Study design

  • Phase 2b/3, double-blind, randomized controlled clinical trial (n=421) of placebo or 1 of 4 fasinumab doses (1, 3, 6, or 9 mg) every 4 weeks over the course of a 16-week trial and follow-up at 36 weeks.
  • Primary outcome was pain assessed at 16 weeks by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscale.
  • Funding: Regeneron Pharmaceuticals, Inc.

Key results

  • Fasinumab at all doses (vs placebo) showed statistical and clinically important reductions in pain (least squares mean difference ranged from −0.78 to −1.40, exceeding the minimal clinically important difference (−0.75).
  • Pain reduction was apparent by 2 weeks and was maintained through 16 weeks of treatment, but not thereafter.
  • No dose-response was seen in pain improvement.
  • WOMAC physical function also improved at all 4 doses (vs placebo); Patient Global Assessment improved by >30% at a 1-mg dose (P=.0132) and 9-mg dose (P=.008).
  • Arthropathies were higher in the fasinumab (7%) than placebo (1%) groups, and were dose-related.

Limitations

  • High drop-out rate (approximately 19%).