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 in Studies I, II, III and V.
Figure 5: Percentage of ACR20 Responders by Visit for Study IV
Physical Function Response
Improvement in physical functioning was measured by the HAQ-DI. Patients receiving XELJANZ 5 and 10 mg twice daily demonstrated greater improvement from baseline in physical functioning compared to placebo at Month 3.
The mean (95% CI) difference from placebo in HAQ-DI improvement from baseline at Month 3 in Study III was -0.22 (-0.35, -0.10) in patients receiving 5 mg XELJANZ twice daily and -0.32 (-0.44, -0.19) in patients receiving 10 mg XELJANZ twice daily. Similar results were obtained in Studies I, II, IV and V. In the 12-month trials, HAQ-DI results in XELJANZ-treated patients were consistent at 6 and 12 months.
16 HOW SUPPLIED/STORAGE AND HANDLING
XELJANZ is provided as 5 mg tofacitinib (equivalent to 8 mg tofacitinib citrate) tablets: White, round, immediate-release film-coated tablets, debossed with "Pfizer" on one side, and "JKI 5" on the other side, and available in:
Bottles of 60:
NDC 0069-1001-01
Bottles of 180:
NDC 0069-1001-02
Storage and Handling
Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature].
Do not repackage.
17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Medication Guide).
Inform patients of the availability of a Medication Guide, and instruct them to read the Medication Guide prior to taking XELJANZ. Instruct patients to take XELJANZ only as prescribed.
This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.
LAB-0445-1.0
MEDICATION GUIDE
XELJANZ (ZEL' JANS')
(tofacitinib)
Read this Medication Guide before you start taking XELJANZ and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is the most important information I should know about XELJANZ?
XELJANZ may cause serious side effects including:
1. Serious infections.
XELJANZ is a medicine that affects your immune system. XELJANZ can lower the ability of your immune system to fight infections. Some people have serious infections while taking XELJANZ, including tuberculosis (TB), and infections caused by bacteria, fu