;40% (17)
The results of the components of the ACR response criteria for Study IV are shown in Table 7. Similar results were observed for XELJANZ in Studies I, II, III, V, and VI.
Table 7: Components of ACR Response at Month 3
Study IV
XELJANZ
5 mg
Twice Daily + MTX XELJANZ
10 mg*
Twice Daily + MTX Placebo + MTX
N=321 N=316 N=160
Component (mean)† Baseline Month 3† Baseline Month 3† Baseline Month 3†
* The recommended dose of XELJANZ is 5 mg twice daily. † Data shown is mean (Standard Deviation) at Month 3. ‡ Visual analog scale: 0 = best, 100 = worst. § Health Assessment Questionnaire Disability Index: 0 = best, 3 = worst; 20 questions; categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities.
Number of tender joints
(0–68) 24
(14) 13
(14) 23
(15) 10
(12) 23
(13) 18
(14)
Number of swollen joints
(0–66) 14
(8) 6
(8) 14
(8) 6
(7) 14
(9) 10
(9)
Pain‡ 58
(23) 34
(23) 58
(24) 29
(22) 55
(24) 47
(24)
Patient global assessment‡ 58
(24) 35
(23) 57
(23) 29
(20) 54
(23) 47
(24)
Disability index
(HAQ-DI)§ 1.41
(0.68) 0.99
(0.65) 1.40
(0.66) 0.84
(0.64) 1.32
(0.67) 1.19
(0.68)
Physician global assessment‡ 59
(16) 30
(19) 58
(17) 24
(17) 56
(18) 43
(22)
CRP (mg/L) 15.3
(19.0) 7.1
(19.1) 17.1
(26.9) 4.4
(8.6) 13.7
(14.9) 14.6
(18.7)
The percent of ACR20 responders by visit for Study IV is shown in Figure 5. Similar responses were observed for XELJANZ in Studies I, II, III, V, and VI.
Figure 5: Percentage of ACR20 Responders by Visit for Study IV
Figure 5
Radiographic Response
Two studies were conducted to eva luate the effect of XELJANZ on structural joint damage. In Study IV and Study VI, progression of structural joint damage was assessed radiographically and expressed as change from baseline in mTSS and its components, the erosion score and joint space narrowing score, at Months 6 and 12. The proportion of patients with no radiographic progression (mTSS change less than or equal to 0) was also assessed.
In Study IV, XELJANZ 10 mg twice daily plus background MTX reduced the progression of structural damage compared to placebo plus MTX at Month 6. When given at a dose of 5 mg twice daily, XELJANZ exhibited similar effects on mean progression of structural damage (not statistically significant). These results are shown in Table 8. Analyses of erosion and joint space narrowing scores were consistent with the overall results.
In the placebo plus MTX group, 74% of patients experienced no radiographic progression at Month 6 compared to 84% and 79% of patients treated with XELJANZ plus MTX 5 or 10 mg twice daily.
In Study VI, XELJANZ monotherapy inhibited the progression of structural damage compared to MTX at Months 6 and 12 as shown in Table 8. Analyses of erosion and joint space narrowing scores were consistent with the overall results.
In the MTX group, 55% of patients experienced no radiographic progression at Month 6 compared to 73% and 77% of patients treated with XELJANZ 5 or 10 mg twice daily.
Tabl |
