Table 3.
Response rates at Week 12 in physical function, fatigue and pain in the pooled RAPID trials (ITT population)
| Response | PBO + MTX (n = 326) | CZP 200 mg + MTX (n = 639) | CZP 400 mg + MTX (n = 636) |
|---|---|---|---|
| HAQ responsea | |||
| n (%) | 125 (43.7) | 395 (68.1) | 416 (71.2) |
| OR vs PBOb | 2.93* | 3.41* | |
| FAS responsea | |||
| n (%) | 148 (51.8) | 439 (75.7) | 435 (74.5) |
| OR vs PBOb | 3.54* | 3.35* | |
| Pain VAS responsea | |||
| n (%) | 117 (40.9) | 430 (74.0) | 445 (76.1) |
| OR vs PBOb | 5.08* | 5.54* |
aResponse is defined as an improvement from baseline to Week 12 ≥MCID (in absolute value); MCID equals 0.22 (HAQ-DI); 10 (pain VAS); 1 (FAS). Response rates are computed on available data at Week 12; bOR and P-value from logistic regression with treatment as factor and baseline HAQ-DI, pain VAS or FAS score as covariates, respectively; *P≤0.001. PBO: placebo.