3.5 55.8
Month 3 35.4 29.5 23.6 36.4 27.0 25.6
CRP (mg/L)
Baseline 10.4 10.5 8.1 12.1 13.8 15.0
Month 3 8.6 4.0 2.7 11.4 7.7 7.3
The percentage of ACR20 responders by visit for Study PsA-I is shown in Figure 6. Similar responses were observed in Study PsA-II. In both studies, improvement in ACR20 response on XELJANZ was observed at the first visit after baseline (Week 2).
Figure 6: Percentage of ACR20 Responders by Visit Through Month 3 in Study PsA-I1
Figure 6
BID=twice daily; SE=standard error.
Subjects with missing data were treated as non-responders.
In patients with active psoriatic arthritis evidence of benefit in enthesitis and dactylitis was observed with XELJANZ treatment.
1 Subjects received one concomitant nonbiologic DMARD.
The recommended dose of XELJANZ is 5 mg twice daily.
Physical Function
Improvement in physical functioning was measured by the HAQ-DI. Patients receiving XELJANZ 5 mg or 10 mg twice daily demonstrated significantly greater improvement (p≤0.05) from baseline in physical functioning compared to placebo at Month 3 (Table 12).
Table 12: Change from Baseline in HAQ-DI in Studies PsA-I and PsA-II
Least Squares Mean Change from Baseline In HAQ-DI at Month 3
Nonbiologic DMARD Inadequate Responders* (TNFi-Naïve) TNFi Inadequate Responders†
Study PsA-I‡ Study PsA-II‡
Treatment Group Placebo XELJANZ 5 mg
Twice Daily XELJANZ 10 mg§
Twice Daily Placebo XELJANZ 5 mg
Twice Daily XELJANZ 10 mg §
Twice Daily
N¶ 104 107 104 131 129 132
* Inadequate response to at least one nonbiologic DMARD due to lack of efficacy and/or intolerability. † Inadequate response to at least one TNF inhibitor (TNFi) due to lack of efficacy and/or intolerability. ‡ Subjects received one concomitant nonbiologic DMARD. § The recommended dose of XELJANZ is 5 mg twice daily. ¶ N is the total number of subjects in the statistical analysis.
LSM Change from Baseline -0.18 -0.35 -0.40 -0.14 -0.39 -0.35
Difference from Placebo (95% CI) - -0.17
(-0.29, -0.05) -0.22
(-0.34, -0.10) - -0.25
(-0.38, -0.13) -0.22
(-0.34, -0.09)
In Study PsA-I, the HAQ-DI responder rate (response defined as having improvement from baseline of ≥0.35) at Month 3 was 53% in patients receiving XELJANZ 5 mg twice daily, 55% in patients receiving XELJANZ 10 mg twice daily, and 31% in patients receiving placebo. Similar responses were observed in Study PsA-II.
Other Health-Related Outcomes
General health status was assessed by the Short Form health survey (SF-36). In Studies PsA-I and PsA-II, patients receiving XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily had greater improvement from baseline compared to placebo in Physical Component Summary (PCS) score, but not in Mental Component Summary (MCS) score at Month 3. Patients receiving XELJANZ 5 mg twice daily reported consistently greater improvement relative to placebo in the domains of Physical Functioning, Bodily Pain, Vitality, and Social Functioning, but not in Role Physical, General Health, Role Emotional, or Mental Health.
Radiographic Respons |
