Table 2.
Results of major and other key secondary endpoints
| Endpoint | Placebo (n=556) |
Sirukumab | |
| 50 mg q4w (n=557) |
100 mg q2w (n=557) |
||
| HAQ-DI change from baseline at week 24, mean (SD)* | –0.22 (0.53) | –0.43 (0.58)† | –0.46 (0.57)† |
| ACR50 at week 16, n (%)‡ | 60 (10.8) | 167 (30.0)§ | 146 (26.2)§ |
| ACR50 at week 24, n (%)¶ | 69 (12.4) | 168 (30.2)§ | 185 (33.2)§ |
| ACR50 at week 52, n (%)** | 77 (13.8) | 169 (30.3)§ | 198 (35.5)§ |
| ACR70 at week 16, n (%)‡ | 22 (4.0%) | 75 (13.5%)§ | 75 (13.5%)§ |
| ACR70 at week 24, n (%)¶ | 19 (3.4%) | 83 (14.9%)§ | 91 (16.3%)§ |
| ACR70 at week 52, n (%)** | 30 (5.4%) | 92 (16.5%)§ | 103 (18.5%)§ |
| DAS28 (CRP) <2.6 at week 24, n (%)¶ | 31 (5.6) | 145 (26.0)§ | 142 (25.5)§ |
| Major clinical response by week 52, n (%)** | 10 (1.8) | 30 (5.4)§ | 50 (9.0)§ |
| SF-36 PCS change from baseline at week 52, mean (SD)†† | 2.42 (6.81) | 5.66 (7.74)‡‡ | 6.16 (7.23)‡‡ |
| SF-36 MCS change from baseline at week 52, mean (SD)†† | 2.69 (9.57) | 5.35 (9.64)‡‡ | 4.77 (9.80)‡‡ |
*Based on imputed values by missing data (LOCF)/EE(LOCF).
†p≤0.001 versus placebo based on analysis of covariance.
‡Based on imputed values by missing data (NR)/TF(NR).
§p≤0.01 versus placebo based on Cochran-Mantel-Haenszel test.
¶Based on imputed values by missing data (NR)/TF(NR)/EE(NR).
**Based on imputed values by missing data (NR)/TF(NR)/EE(NR)/LE(NR).
††Based on imputed values by missing data (LOCF)/EE(LOCF)/LE(LOCF).
‡‡p≤0.001 versus placebo based on analysis of variance.
ACR50/70, American College of Rheumatology 50%/70%; DAS28 (CRP), 28-joint Disease Activity Score based on C reactive protein; EE, early escape; HAQ-DI, Health Assessment Questionnaire–Disability Index; LE, late escape; LOCF, last observation carried forward; MCS, mental component summary; NR, non-responder; PCS, physical component summary; q2w, every 2 weeks; q4w, every 4 weeks; SF-36, Short Form-36; TF, treatment failure.