Table 2.
Primary and secondary outcomes at 12 weeks*
| LSM change from baseline (95% CI) |
Difference (95% CI) |
P | ||
|---|---|---|---|---|
| Placebo | DF‐HA | |||
| Primary outcome | ||||
| WOMAC pain score, mm† | ||||
| Primary analysis | −17.1 (−19.8, −14.4) | −23.2 (−25.9, −20.4) | −6.1 (−9.4, −2.8) | <0.001 |
| Sensitivity analysis | −17.2 (−19.9, −14.4) | −23.2 (−25.9, −20.4) | −6.0 (−9.3, −2.7) | <0.001 |
| Secondary outcomes | ||||
| WOMAC stiffness score, mm† | −13.3 (−16.1, −10.5) | −17.9 (−20.7, −15.1) | −4.6 (−8.0, −1.2) | 0.008 |
| WOMAC physical function score, mm† | −13.2 (−15.8, −10.5) | −18.9 (−21.5, −16.2) | −5.7 (−8.9, −2.5) | <0.001 |
| Total score | −14.0 (−16.6, −11.4) | −19.6 (−22.2, −16.9) | −5.6 (−8.7, −2.4) | <0.001 |
| 50‐foot walking test pain score, mm† | −21.3 (−24.3, −18.2) | −28.1 (−31.1, −25.1) | −6.8 (−10.5, −3.2) | <0.001 |
| Mean daily pain score | −1.20 (−1.41, −0.99) | −1.76 (−1.97, −1.55) | −0.56 (−0.82, −0.31) | <0.001 |
| Patient global assessment score, mm† | −18.1 (−20.7, −15.4) | −24.6 (−27.2, −22.0) | −6.5 (−9.7, −3.3) | <0.001 |
| Physician global assessment score, mm† | −16.4 (−18.6, −14.2) | −20.9 (−23.1, −18.7) | −4.5 (−7.2, −1.9) | <0.001 |
| SF‐36 summary score | ||||
| MCS | −0.1 (−1.0, 0.7) | 0.5 (−0.3, 1.4) | 0.6 (−0.4, 1.7) | 0.209 |
| RCS | 2.5 (1.2, 3.8) | 2.1 (0.8, 3.4) | −0.4 (−2.0, 1.1) | 0.588 |
| PCS | 4.3 (3.0, 5.6) | 5.9 (4.5, 7.2) | 1.6 (0.0, 3.2) | 0.049 |
| OMERACT‐OARSI response | ||||
| Responder‡ | −0.11 (−0.36, 0.14)§ | 0.41 (0.15, 0.67)§ | 1.69 (1.24, 2.30)¶ | <0.001 |
| Strict responder# | −1.26 (−1.56, −0.97)§ | −0.71 (−0.99, −0.43)§ | 1.74 (1.25, 2.43)¶ | 0.001 |
*
OMERACT‐OARSI = Outcome Measures in Rheumatology–Osteoarthritis Research Society International (see Table 1 for other definitions).
†
On a 100‐mm visual analog scale.
‡
Responders were defined as subjects with ≥20% improvement from baseline and an absolute change of ≥10 mm in ≥2 of the following 3 measures: WOMAC pain subscale score, WOMAC physical function subscale score, and/or patient global assessment score.
§
Values are the log odds (95% confidence interval [95% CI]).
¶
Values are the odds ratio (95% CI).
#
Strict responders were defined as subjects with ≥50% improvement from baseline and absolute change of ≥20 mm in the WOMAC pain subscale score or WOMAC physical function subscale score.