Table 3.
Mean change from baseline to study end in SF-36 PCS, SF-36 MCS, FAS, pain VAS and HAQ-DI scores in RAPID 1, 2 and FAST4WARD (ITT population) [4–6, 18, 21, 22]
| RAPID 1,a,b,c adjusted mean change (s.e.m.) | Placebo + MTX Q2 W (n = 199) | CZP 200 mg + MTX Q2 W (n = 393) | CZP 400 mg + MTX Q2 W (n = 390) |
|---|---|---|---|
| Week 52 | |||
| SF-36 PCS | 1.7 (0.6) | 7.8 (0.4), P < 0.001 | 8.6 (0.4), P < 0.001 |
| SF-36 MCS | 2.1 (0.8) | 6.4 (0.6), P < 0.001 | 6.4 (0.6), P < 0.001 |
| Fatigue (FAS) | −0.8 (0.2) | −2.6 (0.1), P < 0.001 | −2.5 (0.1), P < 0.001 |
| Arthritis pain (VAS) | −8.8 (1.6) | −31.0 (1.2), P < 0.001 | −33.5 (1.2), P < 0.001 |
| Physical function (HAQ-DI) | −0.18 (0.04) | −0.60 (0.03), P < 0.001 | −0.63 (0.03), P < 0.001 |
| RAPID 2,a,b,c adjusted mean change (s.e.m.) | Placebo + MTX Q2 W (n = 127) | CZP 200 mg + MTX Q2 W (n = 246) | CZP 400 mg + MTX Q2 W (n = 246) |
|---|---|---|---|
| Week 24 | |||
| SF-36 PCS | 0.9 (0.7) | 5.2 (0.5), P < 0.001 | 5.5 (0.5), P < 0.001 |
| SF-36 MCS | 1.6 (0.9) | 6.1 (0.7), P < 0.001 | 6.3 (0.7), P < 0.001 |
| Fatigue (FAS) | −0.5 (0.2) | −2.0 (0.1), P < 0.001 | −2.2 (0.1), P < 0.001 |
| Arthritis pain (VAS) | −4.7 (1.9) | −23.7 (1.4), P < 0.001 | −26.1 (1.4), P < 0.001 |
| Physical function (HAQ-DI) | −0.14 (0.04) | −0.50 (0.03), P < 0.001 | −0.50 (0.03), P < 0.001 |
| FAST4WARD,d,e,f least square mean change | Placebo Q4 W (n = 109) | CZP 400 mg Q4 W (n = 111) | |
|---|---|---|---|
| Week 24 | |||
| SF-36 PCS | NA | NA | NA |
| SF-36 MCS | NA | NA | NA |
| Fatigue (FAS)e | −0.3 | NA | −1.7, P < 0.001 |
| Arthritis pain (VAS)b | 1.7 | NA | −20.6, P < 0.001 |
| Physical function (HAQ-DI)b | 0.13 | NA | −0.36, P < 0.001 |
aITT population. bAnalyses performed using last observation carried forward approach. cDosing every 2 weeks. dModified ITT population. eAnalyses based on observed data. fDosing every 4 weeks. P-values vs placebo plus MTX or placebo alone. Analyses were performed using analysis of covariance, with treatment and geographical region as factors and baseline value as covariate. ITT: intention-to-treat; NA: not available.