Table 2

Summary of efficacy results at week 104—ITT population

 Week 104
Add-on (N=277)Switch (N=276)p Value*
DAS28-ESR remission rate, %38.335.10.452
Change in DAS28-ESR, mean (SD)−3.60 (1.47)−3.61 (1.43)0.934
EULAR good/moderate responders, %75.866.70.056
ACR/EULAR Boolean remission rate, %
SDAI remission rate (≤3.3), %
CDAI remission rate (≤2.8), %22.718.10.203
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), %94.491.10.098
  • *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.