- Intra-articular injection of microsphere formulation of triamcinolone acetonide extended-release (TA-ER) for knee osteoarthritis (KOA) reduces the need for rescue analgesia in a pooled analysis of 3 phase 2/3 randomized controlled trials.
Why this matters
- This pooled analysis adds to the efficacy of TA-ER.
- Efficacy was first established in a phase 3 trial using lower pain intensity (vs saline-placebo and immediate release intra-articular TA [TA crystalline solution or TAcs]) as the primary outcome in one of the trials included in this pooled analysis.
- Pooled analysis (n=798) of patients with symptomatic KOA (American College of Rheumatology criteria; Kellgren-Lawrence grade 2/3) with a baseline average daily pain intensity score of ≥5 to ≤9 on a numeric rating scale of 0-10.
- Primary outcome was rescue medication (acetaminophen/paracetamol tablets 500 mg) on an as-needed basis
- Funding: Flexion Therapeutics, Inc.
- The TA-ER group used fewer rescue tablets per day through week 24:
- TA-ER vs saline-placebo (least-squares mean [LSM] difference, −0.43; P=.0002).
- TA-ER vs TAcs (LSM, −0.24; P=.0433).
- The TA-ER used fewer rescue tabs in area under the effect curves:
- TA-ER vs saline-placebo (LSMweeks1-12, −24.5; P=.0121 and LSMweeks1-24, −51.6; P=.0023).
- TA-ER vs TAcs (LSMweeks1-12, −21.1; P=.0424 and LSMweeks1-24, −32.2; P=.0731).
- None identified by the authors.