Table 4.
EPS rating scales total scores: pooled LAI studies versus pooled oral studies (safety analysis set)
| Paliperidone LAI at 13 weeks | Oral paliperidone at 6 weeks | LAI-PBO | Oral-PBO | |
|---|---|---|---|---|
| AIMS score,a mean (SD) | n = 1269 | n = 946 | n = 497 | n = 341 |
| Baseline | 0.75 (1.916) | 0.55 (1.578) | 0.71 (1.815) | 0.84 (1.937) |
| Change from baseline | −0.10 (1.27) | −0.08 (1.316) | −0.08 (1.365) | −0.08 (1.615) |
| Difference of LSMb (95% CI) | −0.04 (−0.133, 0.064) | |||
| BARS score,a mean (SD) | n = 1269 | n = 948 | n = 497 | n = 343 |
| Baseline | 0.45 (1.104) | 0.52 (1.239) | 0.71 (1.815) | 0.56 (1.160) |
| Change from baseline | −0.09 (1.056) | −0.03 (1.237) | −0.01 (1.091) | 0.02 (1.516) |
| Difference of LSMb (95% CI) | 0.09 (0.013, 0.174)* | |||
| SAS scorea, mean (SD) | n = 1260 | n = 939 | n = 494 | n = 337 |
| Baseline | 0.13 (0.250) | 0.12 (0.250) | 0.13 (0.251) | 0.14 (0.267) |
| Change from baseline | −0.04 (0.200) | 0.0 (0.229) | −0.05 (0.186) | −0.04 (0.186) |
| Difference of LSMb (95% CI) | 0.04 (0.026, 0.056)** |
Notes: Endpoint was defined as the last visit in double-blind phase of LAI studies (day 92) and oral studies (day 43), thus length of exposure differs for the two treatments.
Negative change in score indicates improvement.
Difference of LSM represents oral paliperidone minus paliperidone LAI at endpoint
P = 0.023
P < 0.0001.
Abbreviations: AIMS, Abnormal Involuntary Movement Scale; BARS, Barnes Akathisia Rating Scale; CI, confidence interval; EPS, extrapyramidal symptoms; LAI, long-acting injectable; LSM, least squares mean; PBO, placebo; SAS, Simpson Angus Rating Scale; SD, standard deviation; Oral-PBO, placebo group in oral paliperidone studies; LAI-PBO, placebo group in LAI studies.