Summary of efficacy results at week 104—ITT population
| Week 104 | |||
|---|---|---|---|
| Add-on (N=277) | Switch (N=276) | p Value* | |
| DAS28-ESR remission rate, % | 38.3 | 35.1 | 0.452 |
| Change in DAS28-ESR, mean (SD) | −3.60 (1.47) | −3.61 (1.43) | 0.934 |
| EULAR good/moderate responders, % | 75.8 | 66.7 | 0.056 |
| ACR/EULAR Boolean remission rate, % | 14.8 | 9.4 | 0.048 |
| SDAI remission rate (≤3.3), % | 22.0 | 19.9 | 0.627 |
| CDAI remission rate (≤2.8), % | 22.7 | 18.1 | 0.203 |
| Change in TJC (68), mean (SD) | −20.3 (13.7) | −20.4 (15.1) | 0.672 |
| Change in SJC (66), mean (SD) | −12.7 (9.0) | −12.6 (10.3) | 0.583 |
| Change in patients' global assessment of disease activity, mean (SD) | −42.1 (25.2) | −41.6 (25.0) | 0.743 |
| Change in physicians' global assessment of disease activity, mean (SD) | −46.5 (20.6) | −46.5 (21.2) | 0.970 |
| Change in patients' global assessment of pain, mean (SD) | −36.3 (27.2) | −38.1 (24.9) | 0.745 |
| Change in RAQoL, mean (SD) | −6.89 (8.69) | −5.24 (8.90) | 0.167 |
| Change in HAQ-DI, mean (SD) | −0.67 (0.71) | −0.69 (0.59) | 0.833 |
| Change in ESR, mean (SD) | −28.0 (25.0) | −27.2 (26.0) | 0.684 |
| Change in CRP, mean (SD) | −1.16 (2.03) | −1.24 (2.34) | 0.597 |
| Change in total GSS, adjusted mean (SEM) | 0.35 (0.35) | 0.95 (0.32) | 0.034 |
| Change in JSN score, adjusted mean (SEM) | 0.38 (0.22) | 0.70 (0.20) | 0.078 |
| Change in erosion score, adjusted mean (SEM) | −0.03 (0.17) | 0.26 (0.16) | 0.037 |
| Patients with no progression in GSS (≤2.1), % | 94.4 | 91.1 | 0.098 |
*Between group p values.
ACR, American College of Rheumatology; CDAI, Clinical Disease Activity Index; CRP, C-reactive protein; DAS28-ESR, Disease Activity Score in 28 joints using erythrocyte sedimentation rate; EULAR, European League Against Rheumatism; GSS, Genant-modified Sharp Score; HAQ-DI, Health Assessment Questionnaire Disability Index; JSN, joint space narrowing; RAQoL, Rheumatoid Arthritis Quality of Life Questionnaire; SDAI, Simplified Disease Activity Index; SEM, SE of the mean; SJC (66), swollen joint count using 66 joints; TJC (68), tender joint count using 68 joints; ITT, intent-to-treat.