Table 2.
Efficacy end points at week 52 in the full analysis seta
| SB5 group (n = 269) | ADA overall group (n = 273) | ADA/SB5 group (n = 125) | ADA/ADA group (n = 129) | |
|---|---|---|---|---|
| ACR response rate, % | ||||
| ACR20 | 77.8 | 76.0 | 78.8 | 73.4 |
| ACR50 | 50.0 | 52.5 | 54.2 | 50.8 |
| ACR70 | 31.9 | 27.3 | 26.3 | 28.2 |
| DAS28‐ESR | ||||
| Mean change from baseline | −3.05 | −2.97 | −3.02 | −2.92 |
| LDA, no./total no. (%)b | 118/247 (47.8) | 112/242 (46.3) | 55/118 (46.6) | 57/124 (46.0) |
| Remission, no./total no. (%)b | 75/247 (30.4) | 70/242 (28.9) | 34/118 (28.8) | 36/124 (29.0) |
| SDAI | ||||
| Mean change from baseline | −29.0 | −28.0 | −28.2 | −27.8 |
| LDA, no./total no. (%)b | 88/247 (35.6) | 95/242 (39.3) | 46/118 (39.0) | 49/124 (39.5) |
| Remission, no./total no. (%)b | 55/247 (22.3) | 46/242 (19.0) | 23/118 (19.5) | 23/124 (18.5) |
| CDAI | ||||
| Mean change from baseline | −28.5 | −27.4 | −27.50 | −27.3 |
| LDA, no./total no. (%)b | 84/248 (33.9) | 91/242 (37.6) | 45/118 (38.1) | 46/124 (37.1) |
| Remission, no./total no. (%)b | 52/248 (21.0) | 47/242 (19.4) | 23/118 (19.5) | 24/124 (19.4) |
| Boolean‐based remission, no./total no. (%)b, c | 35/247 (14.2) | 31/242 (12.8) | 17/118 (14.4) | 14/124 (11.3) |
| Radiographic results | ||||
| Change from baseline in joint erosion score, mean ± SD | 0.1 ± 1.6 | 0.2 ± 1.3 | 0.2 ± 1.4 | 0.2 ± 1.2 |
| Change from baseline in joint space narrowing score, mean ± SD | 0.1 ± 1.3 | 0.2 ± 1.8 | 0.1 ± 1.5 | 0.3 ± 1.9 |
| Change from baseline in SHS, mean ± SD | 0.2 ± 2.5 | 0.4 ± 2.6 | 0.3 ± 2.7 | 0.5 ± 2.4 |
| Proportion of patients with change from baseline in SHS >0, no./total no. (%)b | 48/241 (19.9) | 57/238 (23.9) | 22/114 (19.3) | 35/124 (28.2) |
a
ACR20 = American College of Rheumatology 20% improvement criteria; LDA = low disease activity; SDAI = Simplified Disease Activity Index; CDAI = Clinical Disease Activity Index; SHS = modified Sharp/van der Heijde score (see Table 1 for other definitions).
b
Number of patients with available data at each time point.
c
Determined based on 28–swollen joint count ≤1, 28–tender joint count ≤1, CRP level ≤10 mg/liter, and VAS score ≤10 mm on patient's global assessment.