Table 2.
Efficacy of triamcinolone acetonide ER 32 mg as a single IA injection in patients with pain from osteoarthritis of the knee in a randomized, double-blind, phase III trial; data are least square means [28]
| Endpoint | TA-ER (n = 161) |
PL (n = 162) |
BGD TA-ER vs. PL (95% CI) |
TA-CS (n = 161) |
BGD TA-ER vs. TA-CS (95% CI) |
|---|---|---|---|---|---|
| Key endpointsa | |||||
| ADP change from BL at week 12 | − 3.12 | − 2.14 | − 0.98 (− 1.47, − 0.49)*** | − 2.86 | − 0.26 (− 0.74, 0.23) |
| AUEweek1–12 | − 247.3 | − 145.3 | − 102.0 (− 136.8, − 67.3)*** | − 231.9 | − 15.3 (− 49.8, 19.2) |
| AUEweek1–24 | − 432.5 | − 297.0 | − 135.5 (− 205.9, − 65.2)**b | NA | NA |
| Exploratory endpointsc | |||||
| WOMAC-A (pain) | NA | NA | − 0.37 (− 0.55, − 0.20)*** | NA | − 0.17 (− 0.34, − 0.00)* |
| WOMAC-B (stiffness) | − 0.44 (− 0.63, − 0.25)*** | − 0.23 (− 0.42, − 0.04)* | |||
| WOMAC-C (physical function) | − 0.38 (− 0.54, − 0.21)*** | − 0.22 (− 0.38, − 0.05)* | |||
| KOOS-QOL | + 8.97 (+ 4.37, + 13.57)*** | + 5.42 (+ 0.78, + 10.06)* | |||
ADP average daily pain, AUE area under effect, BGD between group difference, BL baseline, CI confidence interval, CS crystalline suspension, ER extended-release, IA intra-articular, KOOS-QOL Knee Injury and Osteoarthritis Outcome Score-Quality of Life, LSM least squares mean, NA not available, PL placebo, TA triamcinolone acetonide, WOMAC Western Ontario and McMaster Universities Osteoarthritis Index
*p < 0.05, **p < 0.001, ***p < 0.0001 vs. PL
aPrimary endpoint: LSM change from BL to week 12 in ADP with TA-ER vs. PL in the full analysis set. Secondary endpoints (in step-down order): AUEweek1–12 TA-ER vs. PL; AUEweek1–12 TA-ER vs. TA-CS; ADP change from BL to week 12 vs. TA-CS; and AUEweek1–24 TA-ER vs. PL
bp-value considered informative only as the previous comparison in step-down testing (AUEweek1–12 for TA-ER vs. TA-CS) was not significant
cData recorded at week 12