Table 3. Summary of Additional Efficacy endpoints, reported as Mean Change (SE) at Week 12, ITT.
| Mean (SE) change | Control, 4 mL (n = 83) | Control, 10 mL (n = 81) | LMWF-5A, 4 mL (n = 83) | LMWF-5A, 10 mL (n = 82) | Control (n = 164) | LMWF-5A (n = 165) | p value† |
| Secondary efficacy endpoint | |||||||
| Stiffness* | −0.55 (0.10) | −0.80 (0.11) | −0.66 (0.10) | −0.79 (0.10) | −0.67 (0.08) | −0.72 (0.07) | .41 |
| Physical function* | −0.58 (0.08) | −0.69 (0.11) | −0.72 (0.09) | −0.83 (0.09) | −0.64 (0.07) | −0.78 (0.06) | .04 |
| Resting pain* | −0.71 (0.09) | −0.68 (0.11) | −0.90 (0.09) | −0.91 (0.09) | −0.70 (0.07) | −0.91 (0.06) | .004 |
| Moving Pain* | −0.69 (0.09) | −0.81 (0.11) | −0.98 (0.09) | −0.94 (0.10) | −0.75 (0.07) | −0.96 (0.07) | .01 |
| PGA subscale | −0.55 (0.12) | −0.74 (0.13) | −0.96 (0.11) | −0.77 (0.13) | −0.65 (0.09) | −0.87 (0.08) | .01 |
| Subgroup population, WOMAC A Pain | |||||||
| Prior injection | −0.66 (0.10) | −0.71 (0.12) | −0.81 (0.12) | −0.87 (0.11) | −0.68 (0.08) | −0.84 (0.08) | .04 |
| No prior injection | −0.82 (0.15) | −0.77 (0.22) | −1.11 (0.11) | −1.05 (0.13) | −0.80 (0.13) | −1.09 (0.08) | .051 |
| K-L Grade II | −0.83 (0.15) | −1.01 (0.22) | −0.94 (0.12) | −1.07 (0.14) | −0.92 (0.13) | −1.01 (0.09) | .70 |
| K-L Grade III | −0.62 (0.11) | −0.76 (0.14) | −0.95 (0.13) | −0.82 (0.15) | −0.69 (0.09) | −0.89 (0.10) | .04 |
| K-L Grade IV | −0.67 (0.19) | −0.34 (0.21) | −0.88 (0.22) | −0.83 (0.16) | −0.51 (0.14) | −0.86 (0.14) | .02 |
*
WOMAC, Western Ontario and McMaster Universities Osteoarthritis.
Control: Saline vehicle control; Index. PGA, Patient Global Assessment of disease severity; K-L, Kellgren-Lawrence.
†
P values were calculated using mixed-effects repeated measures ANCOVA, with adjustment for baseline score.