Linear time MMRM analysis of JSW for all randomised patients and analysis of JSN progressors† for all randomised patients, and KLG2 and KLG3 patients
| Cindunistat | |||
|---|---|---|---|
| 50 mg/day | 200 mg/day | Placebo | |
| Linear time MMRM analysis JSN (primary analysis) | |||
| All randomised patients* | N=485 | N=486 | N=486 |
| LS-mean slope (mm/year)±SE | −0.103±0.013 | −0.109±0.012 | −0.115±0.012 |
| (95% CI) | (−0.128 to −0.078) | (−0.134 to −0.085) | (−0.139 to –0.091) |
| LS-mean difference in slopes (mm/year) | |||
| Cindunistat versus placebo±SE | 0.012±0.018 | 0.005±0.017 | |
| (95% CI) | (−0.023 to 0.046) | (−0.029 to 0.040) | – |
| p Value | 0.509 | 0.754 | – |
| JSN progressors† | |||
| All randomised patients‡ | N=485 | N=486 | N=486 |
| Model-adjusted percent (95% CI) | 33.7% (28.5% to 39.5%) | 37.1% (31.8% to 42.8%) | 40.6% (35.1% to 46.3%) |
| Cindunistat versus placebo | |||
| Adjusted OR (95% CI) | 0.745 (0.557 to 0.997) | 0.864 (0.650 to 1.150) | – |
| p Value | 0.047 | 0.317 | – |
| KLG2 patients§ | n=216 | n=203 | n=222 |
| Model-adjusted percent (95% CI) | 22.8% (16.3% to 31.0%) | 27.4% (20.1% to 36.2%) | 34.8% (26.8% to 43.8%) |
| Cindunistat versus placebo | |||
| Adjusted OR (95% CI) | 0.553 (0.341 to 0.896) | 0.708 (0.441 to 1.135) | – |
| p Value | 0.016 | 0.152 | – |
| KLG3 patients¶ | n=269 | n=283 | n=264 |
| Model-adjusted percent (95% CI) | 43.3% (36.0% to 50.8%) | 46.7% (39.7% to 53.8%) | 47.6% (40.5% to 54.8%) |
| Cindunistat versus placebo | |||
| Adjusted OR (95% CI) | 0.841 (0.581 to 1.219) | 0.965 (0.672 to 1.384) | – |
| p Value | 0.360 | 0.845 | – |
Bolded p values are significant at two-sided 0.05 α level.
*n=485 (cindunistat 50 mg/day), 483 (cindunistat 200 mg/day), and 486 (placebo) patients had ≥1 JSW measurement and contributed to the primary analysis.
†Progressors are those patients with a decrease in JSN from baseline greater than the SDD (0.199 mm) at last post-randomisation measurement.
‡n=419 (cindunistat 50 mg/day), 423 (cindunistat 200 mg/day), and 429 (placebo) patients had both baseline and ≥1 post-baseline JSN measurement and contributed to the all randomised patients progressor analyses.
§n=182 (cindunistat 50 mg/day), 169 (cindunistat 200 mg/day), and 190 (placebo) patients had both baseline and ≥1 post-baseline JSN measurement and contributed to the KLG2 patient progressor analyses.
¶n=237 (cindunistat 50 mg/day), 254 (cindunistat 200 mg/day), and 239 (placebo) patients had both baseline and ≥1 post-baseline JSN measurement and contributed to the KLG3 patient progressor analyses.
JSN, joint space narrowing; JSW, joint space width; KLG, Kellgren and Lawrence Grade; LS, least squares; MMRM, mixed model for repeated measures.