Title: Long-Term Safety and Efficacy of Fulranumab in Patients With Moderate-to-Severe Osteoarthritis Pain: A Phase II Randomized, Double-Blind, Placebo-Controlled Extension Study

Sanga, Panna MD et al.


What You Need to Know:

Long-term fulranumab therapy was generally well-tolerated and effective for patients with knee or hip pain caused by moderate-to-severe chronic osteoarthritis.

Trial Design:

  • Phase 2, double-blind, placebo-controlled extension study
  • Patients were randomized to SC placebo or SC fulranumab 1mg every 4 weeks, 3mg every 8 weeks, 3mg every 4 weeks, 6mg every 8 weeks, or 10 mg every 8 weeks
  • 401 of 423 patients who completed the 12-week double-blind efficacy phase entered a 92-week double-blind extension phase plus a 24-week post-treatment follow-up period
  • Safety outcomes included evaluation of treatment-emergent adverse events (TEAEs), pre-identified AEs of interest, and joint replacements
  • Efficacy outcomes included changes from baseline to the end of the double-blind extension phase in scores on the patient’s global assessment and the pain and physical function subscales of the Western Ontario and McMaster Universities Osteoarthritis Index

Key Outcomes:

  • Sustained improvements were seen in all efficacy parameters with fulranumab treatment 1mg every 4 weeks, 3mg every 4 weeks, and 10mg every 8 weeks vs. placebo
  • Similar percentage of patients in both groups had TEAEs (88% [placebo] vs. 91% [fulranumab])
  • The most common TEAEs were arthralgia (21%) and osteoarthritis (18%); neurologic-related TEAEs (28%) were generally mild-to-moderate
  • The most common serious TEAEs were requirement for knee and hip arthroplasty with 80% occurring during the post-treatment follow-up period
  • 81 joint replacements were done in 71 patients (8 [placebo] and 63 [fulranumab]); 15 patients had rapid progression of osteoarthritis (RPOA)
  • All RPOA cases occurred in fulranumab-treated patients taking concomitant NSAIDs and occurred in joints with pre-existing osteoarthritis