Incidence of adverse events similar to saline control1

  • Most commonly reported treatment-emergent adverse events (≥1%) in clinical studies including randomized, double-blind, parallel-group, placebo- and/or active-controlled, and pharmacokinetic/pharmacodynamic studies with follow-up ranging from 6 to 24 weeks
Overall incidence of adverse events
Adverse events
*

Incidence in which the adverse event rate is higher for ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) than saline control.

Radiographic assessments of the knee showed no changes for most patients treated with a repeat dose of ZILRETTA at 52 Weeks2

  • Radiographic outcomes in patients with baseline and end-of-study radiographs (n=165)
Radiographic evaluation
Radiographic evaluation
Radiographic evaluation
Radiographic evaluation
Radiographic evaluation
Radiographic evaluation
Radiographic evaluation
Radiographic evaluation

In a real-world study on repeat administration, the median time to repeat injection was 16.6 weeks2

Single Arm Trial
Single Arm Trial
  • 95.1% (195/208) of patients benefited from the first injection, and of the 195 patients,           8.2% (16/208) discontinued the trial or had no indication for the second injection
    • Timing of subsequent injection based on symptoms is consistent with the clinical management of OA knee pain2
      • – 74% of patients didn’t require a second injection for 16-24 weeks2*

    The efficacy and safety of repeat administration of ZILRETTA have not been demonstrated.

    *Considered to be related to progression of osteoarthritis, rather than a treatment-related change, because appearance was nonspecific and severe joint space narrowing was observed for both the baseline and end-of-study radiographs.
    Timing of the second ZILRETTA injection among patients who received two injections (n=179): Week 12: 25.1% (45/179); Week 16: 33.5% (60/179); Week 20: 20.7% (37/179); Week 24: 20.1% (36/179). Excludes one patient who received the second injection after Week 24.

    ACR=American College of Rheumatology; KOOS QOL=Knee Injury and Osteoarthritis Outcomes Score–Quality of Life; OA=osteoarthritis; TEAEs=treatment-emergent adverse events;=Western Ontario and McMaster Universities Osteoarthritis Index.