agger; N=109 N=111 (95% CI)‡
*
CIMZIA administered every 2 weeks preceded by a loading dose of 400 mg at Weeks 0, 2 and 4
†
CIMZIA administered every 4 weeks not preceded by a loading dose regimen
‡
95% Confidence Intervals constructed using the large sample approximation to the Normal Distribution.
§
Major clinical response is defined as achieving ACR70 response over a continuous 6-month period
ACR20
Week 24 14% 59% 45% (38%, 52%) 9% 46% 36% (25%, 47%)
Week 52 13% 53% 40% (33%, 47%) N/A N/A
ACR50
Week 24 8% 37% 30% (24%, 36%) 4% 23% 19% (10%, 28%)
Week 52 8% 38% 30% (24%, 37%) N/A N/A
ACR70
Week 24 3% 21% 18% (14%, 23%) 0% 6% 6% (1%, 10%)
Week 52 4% 21% 18% (13%, 22%) N/A N/A
Major Clinical Response§ 1% 13% 12% (8%, 15%)
Table 5: Components of ACR Response in Studies RA-I and RA-IV Study RA-I Study RA-IV
Parameter* Placebo +
MTX
N=199 CIMZIA† 200 mg + MTX q 2 weeks
N=393 Placebo +
MTX
N=109 CIMZIA‡ 400 mg q 4 weeks
Monotherapy
N=111
Baseline Week 24 Baseline Week 24 Baseline Week 24 Baseline Week 24
*
For Study RA-I, median is presented. For Study RA-IV, mean (SD) is presented except for CRP which presents geometric mean
†
CIMZIA administered every 2 weeks preceded by a loading dose of 400 mg at Weeks 0, 2 and 4
‡
CIMZIA administered every 4 weeks not preceded by a loading dose regimen
§
Study RA-I - Visual Analog Scale: 0 = best, 100 = worst. Study RA-IV - Five Point Scale: 1 = best, 5 = worst
¶
Patient Assessment of Arthritis Pain. Visual Analog Scale: 0=best, 100=worst
#
Health Assessment Questionnaire Disability Index; 0 = best, 3 = worst, measures the patient's ability to perform the following: dress/groom, arise, eat, walk, reach, grip, maintain hygiene, and maintain daily activity
All values are last observation carried forward.
Number of tender joints (0-68) 28 27 29 9 28 (12.5) 24 (15.4) 30 (13.7) 16 (15.8)
Number of swollen joints (0-66) 20 19 20 4 20 (9.3) 16 (12.5) 21 (10.1) 12 (11.2)
Physician global assessment§ 66 56 65 25 4 (0.6) 3 (1.0) 4 (0.7) 3 (1.1)
Patient global assessment§ 67 60 64 32 3 (0.8) 3 (1.0) 3 (0.8) 3 (1.0)
Pain§¶ 65 60 65 32 55 (20.8) 60 (26.7) 58 (21.9) 39 (29.6)
Disability index (HAQ)# 1.75 1.63 1.75 1.00 1.55 (0.65) 1.62 (0.68) 1.43 (0.63) 1.04 (0.74)
CRP (mg/L)
16.0 14.0 16.0 4.0 11.3 13.5 11.6 6.4
The percent of patients achieving ACR20 responses by visit for Study RA-I is shown in Figure 1. Among patients receiving CIMZIA, clinical responses were seen in some patients within one to two weeks after initiation of therapy.
*
The same patients may not have responded at each time point
Figure 1 Study RA-I ACR20 Response Over 52 Weeks*
Radiographic Response
In Study RA-I, inhibition of progression of structural damage was assessed radiographically and expressed as the change in modified Total Sharp Score (mTSS) and its components, the Erosion Score (ES) and Joint Space Narrowing (JSN) score, at Week 52, compared to baseline. CIMZIA inhibited the progression of structural damage compared to placebo plus MTX after 12 months of treatment as shown in Table 6. In the placebo group, 52% of patients experienced no radiographic progression (mTSS ≤0 |
