e 8: Radiographic Changes at Months 6 and 12
* The recommended dose of XELJANZ is 5 mg twice daily. † SD = Standard Deviation ‡ Difference between least squares means XELJANZ minus placebo or MTX (95% CI = 95% confidence interval) § Month 6 and Month 12 data are mean change from baseline.
Study IV
Placebo XELJANZ 5 mg Twice Daily XELJANZ 5 mg Twice Daily XELJANZ 10 mg Twice Daily* XELJANZ 10 mg Twice Daily
N=139
Mean (SD)† N=277
Mean (SD) † Mean Difference from Placebo‡ (CI) N=290
Mean (SD) † Mean Difference from Placebo‡ (CI)
mTSS§
Baseline 33 (42) 31 (48) - 37 (54) -
Month 6 0.5 (2.0) 0.1 (1.7) -0.3 (-0.7, 0.0) 0.1 (2.0) -0.4 (-0.8, 0.0)
Study VI
MTX XELJANZ 5 mg Twice Daily XELJANZ 5 mg Twice Daily XELJANZ 10 mg Twice Daily* XELJANZ 10 mg Twice Daily
N=166
Mean (SD)† N=346
Mean (SD) † Mean Difference from MTX‡ (CI) N=369
Mean (SD) † Mean Difference from MTX‡ (CI)
mTSS§
Baseline 17 (29) 20 (40) - 19 (39) -
Month 6 0.8 (2.7) 0.2 (2.3) -0.7 (-1.0, -0.3) 0.0 (1.2) -0.8 (-1.2, -0.4)
Month 12 1.3 (3.7) 0.4 (3.0) -0.9 (-1.4, -0.4) 0.0 (1.5) -1.3 (-1.8, -0.8)
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.
Other Health-Related Outcomes
General health status was assessed by the Short Form health survey (SF-36). In studies I, IV, and V, patients receiving XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily demonstrated greater improvement from baseline compared to placebo in physical component summary (PCS), mental component summary (MCS) scores and in all 8 domains of the SF-36 at Month 3.
14.2 Psoriatic Arthritis
The XELJANZ clinical development program to assess efficacy and safety included 2 multicenter, randomized, double-blind, placebo-controlled confirmatory trials in 816 patients 18 years of age and older (PsA-I and PsA-II). Although other doses have been studied, the recommended dose of XELJANZ is 5 mg twice daily. All patients had active psoriatic arthritis for at least 6 months based upon the Classification Criteria for Psoriatic Arthritis (CASPAR), at least 3 tender/painful joints and at least 3 swollen joints, and active plaque psoriasis. Patients randomized and treated across the 2 clinical trials represented different psoriatic arthritis subtypes at screening, including <5 joints or asymmetric involvement (21%), ≥5 joints involved (90%), distal interphalangeal (DIP) joint involvement (61%), arthritis mutilans (8%), and spondylitis (19%). Patients in these clinical trials had a |
