Table 3.
Categorical efficacy responses at week 24 for patients with moderate-to-severe rheumatoid arthritis randomised to MSB11456 or EU-approved tocilizumab, core period ITT analysis set
| Parameter | MSB11456 (N=302) | EU-approved tocilizumab (N=302) |
| DAS28-ESR* | n=277 | n=285 |
| Remission | 139 (50.2) | 149 (52.3) |
| Low | 43 (15.5) | 42 (14.7) |
| Moderate | 83 (30.0) | 82 (28.8) |
| High | 12 (4.3) | 12 (4.2) |
| DAS28-CRP | n=276 | n=285 |
| Responder† | 46 (16.7) | 55 (19.3) |
| CDAI‡ | n=278 | n=286 |
| Remission | 53 (19.1) | 62 (21.7) |
| Low | 119 (42.8) | 115 (40.2) |
| Moderate | 84 (30.2) | 90 (31.5) |
| High | 22 (7.9) | 19 (6.6) |
| SDAI§ | n=276 | n=285 |
| Remission | 62 (22.5) | 68 (23.9) |
| Low | 112 (40.6) | 113 (39.6) |
| Moderate | 85 (30.8) | 92 (32.3) |
| High | 17 (6.2) | 12 (4.2) |
Data are shown as number (percentage), with percentages calculated based on number of subjects with available data.
*DAS28-ESR: remission <2.6; low ≤2.6 to <3.2; moderate ≤3.2 to ≤5.1; high >5.1.
†DAS28-CRP responder: TJC28 ≤1 and SJC28 ≤1 and PGA ≤10 mm and CRP ≤10 mg/L.
‡CDAI: remission ≤2.8; low <2.8 to ≤10; moderate <10 to ≤22; high >22.
§SDAI: remission ≤3.3; low <3.3 to ≤11; moderate <11 to ≤26; high >26.
CDAI, Clinical Disease Activity Index; DAS28-CRP, Disease Activity Score-28 C reactive protein; ESR, erythrocyte sedimentation rate; EU, European Union; ITT, intention to treat; PGA, Physician’s Global Assessment; SDAI, Simplified Disease Activity Index; SJC28, 28 Joint Count for Swelling; TJC28, 28 Joint Count for Tenderness.