Response in Study PsA-II* (TNFi Inadequate Responders)
Treatment Group Placebo XELJANZ
5 mg
Twice Daily XELJANZ
10 mg†
Twice Daily
N‡ 131 131 132
Response Rate Response Rate Difference (%)
95% CI from Placebo Response Rate Difference (%)
95% CI from Placebo
Subjects with missing data were treated as non-responders.
* Subjects received one concomitant nonbiologic DMARD. † The recommended dose of XELJANZ is 5 mg twice daily. ‡ N is number of randomized and treated patients.
Month 3
ACR20 24% 50% 26.0 (14.7, 37.2) 47% 23.3 (12.1, 34.5)
ACR50 15% 30% 15.3 (5.4, 25.2) 28% 13.5 (3.8, 23.3)
ACR70 10% 17% 6.9 (-1.3, 15.1) 14% 4.5 (-3.4, 12.4)
Improvements from baseline in the ACR response criteria components for both studies are shown in Table11.
Table 11: Components of ACR Response at Baseline and Month 3 in Studies PsA-I and PsA-II
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 at Baseline 105 107 104 131 131 132
* Subjects received one concomitant nonbiologic DMARD. † The recommended dose of XELJANZ is 5 mg twice daily. ‡ Data shown are mean value at baseline and at Month 3. § Visual analog scale (VAS): 0 = best, 100 = worst. ¶ HAQ-DI = Health Assessment Questionnaire – Disability Index: 0 = best, 3 = worst; 20 questions; categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities.
ACR Component‡
Number of tender/painful joints (0–68)
Baseline 20.6 20.5 20.3 19.8 20.5 25.5
Month 3 14.6 12.2 9.9 15.1 11.5 14.5
Number of swollen joints (0–66)
Baseline 11.5 12.9 11.7 10.5 12.1 12.8
Month 3 7.1 6.3 4.3 7.7 4.8 6.1
Patient assessment of arthritis pain§
Baseline 53.2 55.7 54.4 54.9 56.4 59.5
Month 3 44.7 34.7 28.5 48.0 36.1 38.1
Patient global assessment of arthritis §
Baseline 53.9 54.7 53.6 55.8 57.4 58.5
Month 3 44.4 35.5 29.8 49.2 36.9 38.8
HAQ-DI¶
Baseline 1.11 1.16 1.08 1.25 1.26 1.37
Month 3 0.95 0.81 0.71 1.09 0.88 1.03
Physician's Global Assessment of Arthritis§
Baseline 53.8 54.6 55.2 53.7 5 |
