Trial summary1

  • ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) was studied in a multicenter, international, randomized, double-blind, parallel-arm, placebo- (saline) and active-controlled (TAcs) trial that evaluated patients with moderate to severe OA pain of the knee (N=484)
    • Patients were treated with a single intra-articular injection of ZILRETTA (32mg, n=161), saline (n=162), or TAcs (40mg, n=161) and followed for up to 24 weeks, with daily pain reported and evaluations at baseline and at Weeks 4, 8, 12, 16, 20, and 24
Key outcomes

Pivotal trial outcome measures:

Average daily pain (ADP): Measures daily pain intensity on a 0 to 10 numeric rating scale (NRS)

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®)2: Evaluates pain, stiffness, and physical functioning of the treated knee

Knee Injury and Osteoarthritis Outcomes Score (KOOS) QoL subscale3: Assesses patients’ perceptions about their treated knee and associated problems related to quality of life (QoL)

*

AUE curve measures change from baseline in weekly mean ADP score.4

Defined as time from intra-articular injection to the first daily pain assessment of >30% improvement from baseline.

ADP=average daily pain; AUE=area under the effect curve; OA=osteoarthritis; TAcs=triamcinolone acetonide crystalline suspension.

Proven relief from osteoarthritis knee pain vs saline control

Rapid, substantial, and persistent reduction in osteoarthritis knee pain intensity vs saline control4,5

Pain relief in patients with moderate to severe knee OA

  • Rapid—4 days median time to onset with ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) and 3 days with TAcs5*
  • Substantial—50% reduction from baseline at Week 124
  • Persistent—reduction in ADP each week from Weeks 1 to 12, extending to Week 164

*Defined as time from intra-articular injection to the first daily pain assessment of >30% improvement from baseline. The median time to onset of pain relief for the saline control group was 11 days.5

ADP=average daily pain; BL=baseline; LS=least squares; NRS=numeric rating scale; OA=osteoarthritis; SE=standard error; TAcs=triamcinolone acetonide crystalline suspension.

Outcome measures in pain, stiffness, function, and quality of life

Primary endpoint with ZILRETTA and saline control

  • Average daily pain (ADP): Change from baseline at Week 12 in the weekly mean of ADP intensity score vs saline control (P<0.0001)5

ZILRETTA, TAcs, and saline control results across multiple endpoints

Secondary endpoints

  • AUE baseline to Week 12 in weekly mean ADP score with ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) vs saline control (P<0.0001)4
  • AUE baseline to Week 12 in weekly mean ADP score with ZILRETTA vs TAcs was not met5

Exploratory endpoints

  • Secondary exploratory: ADP change from baseline at Week 12 with ZILRETTA vs TAcs was not met5
  • Median time to onset of pain relief: ZILRETTA 4 days vs TAcs 3 days5*
  • Change from baseline on WOMAC subscales (pain, stiffness, and function)2
  • Change from baseline in KOOS QoL subscale3

Statistical significance cannot be determined from exploratory endpoints

Secondary and exploratory results4†

Multiple measures chart Multiple measures chart Multiple measures chart Multiple measures chart Multiple measures chart
*

Defined as time from intra-articular injection to the first daily pain assessment of >30% improvement from baseline. The median time to onset of pain relief for the saline control group was 11 days.5

For ADP and WOMAC A, B, and C: ZILRETTA (n=161), TAcs (n=161), and saline control (n=162). For KOOS: ZILRETTA (n=136), TAcs (n=134), and saline control (n=144).4

ADP=average daily pain; AUE=area under the effect curve; BL=baseline; KOOS=Knee Injury and Osteoarthritis Outcome Score; LS=least squares; NRS=numeric rating scale; QoL=quality of life; SE=standard error; TAcs=triamcinolone acetonide crystalline suspension; WOMAC=Western Ontario and McMaster Universities Osteoarthritis Index.