Table 4.
Change from baseline in PROMIS SD SF 8b total score
| 12-Week double-blind period (FAS)a | ||||
|---|---|---|---|---|
| Analysis visit | Statistics | Placebo (n = 167) | Fezolinetant 30 mg (n = 166) | Fezolinetant 45 mg (n = 167) |
| Baseline | No. | 166 | 165 | 167 |
| Mean (SD) | 27.4 (7.0) | 27.3 (6.6) | 26.2 (6.6) | |
| Week 4 | No. | 151 | 155b | 158 |
| Mean (SD) | 24.5 (7.6) | 23.4 (7.3) | 21.3 (6.8) | |
| LS mean change from baseline, mean (SE) | −2.6 (0.5) | −3.9 (0.5) | −5.3 (0.5) | |
| LS mean difference vs placebo (SE) | — | –1.30 (0.7) | –2.7 (0.7) | |
| P value vs placeboc | — | .082 | <.001 | |
| Week 12 | No. | 144d | 139 | 145 |
| Mean (SD) | 23.8 (7.0) | 23.0 (7.7) | 21.2 (5.7) | |
| LS mean change from baseline, mean (SE) | −3.4 (0.5) | −4.1 (0.5) | −5.5 (0.5) | |
| LS mean difference vs placebo (SE) | — | −0.7 (0.7) | –2.0 (0.7) | |
| P value vs placeboc | — | .381 | .007 | |
| Start of fezolinetant treatment (SAF-fezolinetant exposure)e | |||||
|---|---|---|---|---|---|
| Analysis visit (duration of fezolinetant exposure) | Statistic | Fezolinetant 30 mg (n = 166) | Fezolinetant 45 mg (n = 167) | Placebo/Fezolinetant 30 mg (n = 76) | Placebo/fezolinetant 45 mg (n = 75) |
| Baseline | No. | 166 | 167 | 76 | 74 |
| Mean (SD) | 27.4 (6.7) | 26.2 (6.6) | 27.2 (7.4) | 27.6 (6.5) | |
| Week 12 (0 weeks exposure for placebo switchers) | No. | 145 | 149 | f | f |
| Mean (SD) | 23.3 (7.7) | 21.2 (5.7) | |||
| Change from baseline, mean (SD) | –4.4 (8.1) | –4.7 (6.8) | |||
| Week 24 (12 weeks exposure for placebo switchers) | No. | 134 | 138 | 67 | 69 |
| Mean (SD) | 21.9 (7.0) | 21.3 (7.3) | 20.8 (6.7) | 22.5 (7.0) | |
| Change from baseline, mean (SD) | –5.6 (7.3) | –4.7 (7.6) | –6.7 (7.4) | –4.8 (7.9) | |
| Week 52 (40 weeks exposure for placebo switchers) | No. | 107 | 116 | 55 | 54 |
| Mean (SD) | 21.2 (6.9) | 20.2 (7.1) | 20.5 (7.1) | 22.1 (7.1) | |
| Change from baseline, mean (SD) | –6.3 (7.3) | –5.7 (7.9) | –7.6 (8.4) | –4.8 (7.1) | |
Abbreviations: FAS, full analysis set; LS, least squares; PROMIS SD SF 8b, Patient-Reported Outcomes Measurement Information System Sleep Disturbance—Short Form 8b; SAF, safety analysis set.
For the double-blind period, data were collected from the first dose of study drug until week 12.
n = 154 for LS change from baseline.
Two-sided unadjusted P value.
n = 143 for LS change from baseline.
For the extension period, data were collected from the first dose of study drug until week 52 for the fezolinetant groups and from week 13 to week 52 for the placebo/fezolinetant groups.
Exposure to fezolinetant began at week 12.