her ACR20 response rates were observed within 2 weeks compared to placebo. In the 12-month trials, ACR response rates in XELJANZ-treated patients were consistent at 6 and 12 months.
Table 5: Proportion of Patients with an ACR Response
Percent of Patients
Monotherapy in Nonbiologic or Biologic DMARD Inadequate Responders*
MTX Inadequate Responders†
TNF Inhibitor Inadequate Responders‡
Study I
Study IV
Study V
N§
PBO
XELJANZ
5 mg Twice Daily
XELJANZ 10 mg Twice Daily
PBO
+ MTX
XELJANZ
5 mg Twice Daily + MTX
XELJANZ
10 mg Twice Daily + MTX
PBO + MTX
XELJANZ
5 mg Twice Daily + MTX
XELJANZ
10 mg Twice Daily + MTX
122
243
245
160
321
316
132
133
134
* Inadequate response to at least one DMARD (biologic or nonbiologic) due to lack of efficacy or toxicity. † Inadequate response to MTX defined as the presence of sufficient residual disease activity to meet the entry criteria. ‡ Inadequate response to a least one TNF inhibitor due to lack of efficacy and/or intolerance. § N is number of randomized and treated patients. ¶ NA Not applicable, as data for placebo treatment is not available beyond 3 months in Studies I and V due to placebo advancement.
ACR20
Month 3
26%
59%
65%
27%
55%
67%
24%
41%
48%
Month 6
NA¶
69%
70%
25%
50%
62%
NA
51%
54%
ACR50
Month 3
12%
31%
36%
8%
29%
37%
8%
26%
28%
Month 6
NA
42%
46%
9%
32%
44%
NA
37%
30%
ACR70
Month 3
6%
15%
20%
3%
11%
17%
2%
14%
10%
Month 6
NA
22%
29%
1%
14%
23%
NA
16%
16%
In Study IV, a greater proportion of patients treated with XELJANZ 5 mg or 10 mg twice daily plus MTX achieved a low level of disease activity as measured by a DAS28-4(ESR) less than 2.6 at 6 months compared to those treated with MTX alone (Table 6).
Table 6: Proportion of Patients with DAS28-4(ESR) Less Than 2.6 with Number of Residual Active Joints
Study IV
DAS28-4(ESR) Less Than 2.6
Placebo + MTX
XELJANZ 5 mg Twice Daily + MTX
XELJANZ 10 mg Twice Daily + MTX
160
321
316
Proportion of responders at Month 6 (n)
1% (2)
6% (19)
13% (42)
Of responders, proportion with 0 active joints (n)
50% (1)
42% (8)
36% (15)
Of responders, proportion with 1 active joint (n)
0
5% (1)
17% (7)
Of responders, proportion with 2 active joints (n)
0
32% (6)
7% (3)
Of responders, proportion with 3 or more active joints (n)
50% (1)
21% (4)
40% (17)
The results of the components of the ACR response criteria for Study IV are shown in Table 7. Similar results were observed in Studies I, II, III, and V.
Table 7: Components of ACR Response at 3 Months
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*
* Data shown is mean (Standard Deviation) at Month 3. † Visual analog scale: 0 = best, 100 = worst. ‡ Health Assessment Questionnaire Disability Inde
