Table 2.
Overall response rate at week 26a (central review assessment)
| Endpoint | PF-05280586 | Rituximab-EU | Difference (PF-05280586 minus rituximab-EU) |
|---|---|---|---|
| ITT population | |||
| Number of subjects | 196 | 198 | |
| Overall response rate, n (%)b,c,d | 148 (75.5) | 140 (70.7) | 4.66 |
| (95% CI) | (68.9–81.4) | (63.8–76.9) | (− 4.16 to 13.47) |
| PP population | |||
| Number of subjects | 166 | 176 | |
| Overall response rate, n (%)b,c,e | 143 (86.1) | 138 (78.4) | 7.49 |
| (95% CI) | (79.9–91.0) | (71.6–84.2) | (− 0.67 to 15.80) |
CI confidence interval, CR complete response, ITT intent-to-treat, PP per-protocol, PR partial response, rituximab-EU rituximab reference product from the European Union
aBased on the central review assessments as of the final database lock on May 18, 2018
bSubjects missing their week 26 radiology assessments were imputed as nonresponders
cDefined as the percentage of subjects achieving CR or PR, based on central review
dITT population
ePP population