in Table 5. Similar results were observed with Studies II and III. In trials I–V, patients treated with either 5 or 10 mg twice daily XELJANZ had higher ACR20, ACR50, and ACR70 response rates versus placebo, with or without background DMARD treatment, at Month 3 and Month 6. Higher 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. ¶ The recommended dose of XELJANZ is 5 mg twice daily. # 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
* The recommended dose of XELJANZ is 5 mg twice daily.
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) |
