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©2014 Baishideng Publishing Group Inc.
World J Orthop. Sep 18, 2014; 5(4): 504-511
Published online Sep 18, 2014. doi: 10.5312/wjo.v5.i4.504
Published online Sep 18, 2014. doi: 10.5312/wjo.v5.i4.504
Table 3 Summary of safety and tolerability data for tofacitinib from phase 3 clinical trials (month 0-3) n (%)
| ORAL solo | ORAL step | ORAL standard | ORAL sync | ORAL scan | ||||||||||||
| Placebo(n = 122) | Tofacitinib5 mg bid(n = 243) | Tofacitinib10 mg bid(n = 245) | Placebo(n = 132) | Tofacitinib5 mg bid(n = 133) | Tofacitinib10 mg bid(n = 134) | Placebo(n = 108) | Tofacitinib5 mg bid(n = 204) | Tofacitinib10 mg bid(n = 201) | Adalimumab 40 mg once Q2W(n = 204) | Placebo(n = 159) | Tofacitinib5 mg bid(n = 315) | Tofacitinib10 mg bid(n = 318) | Placebo(n = 160) | Tofacitinib5 mg bid(n = 321) | Tofacitinib10 mg bid(n = 316) | |
| Patients with AE, | 67 (54.9) | 124 (51) | 139 (56.7) | 75 (56.8) | 71 (53.4) | 76 (56.7) | 51 (47.2) | 106 (52) | 94 (46.8) | 105 (51.5) | 97 (61) | 166 (52.7) | 173 (54.4) | 73 (45.6) | 157 (48.9) | 171 (54.1) |
| Patients with SAE | 6 (4.9) | 1 (0.4) | 5 (2) | 6 (4.5) | 2 (1.5) | 2 (1.5) | 2 (1.9) | 12 (5.9) | 10 (5) | 5 (2.5) | 6 (3.8) | 9 (2.9) | 8 (2.5) | 5 (3.1) | 12 (3.7) | 10 (3.2) |
| Discontinuation due to AE | 5 (4.1) | 2 (0.8) | 6 (2.4) | 7 (5.3) | 8 (6) | 6 (4.5) | 3 (2.8) | 14 (6.9) | 10 (5) | 10 (4.9) | 2 (1.3) | 13 (4.1) | 13 (4.1) | 5 (3.1) | 15 (4.7) | 14 (4.4) |
- Citation: Lundquist LM, Cole SW, Sikes ML. Efficacy and safety of tofacitinib for treatment of rheumatoid arthritis. World J Orthop 2014; 5(4): 504-511
- URL: https://www.wjgnet.com/2218-5836/full/v5/i4/504.htm
- DOI: https://dx.doi.org/10.5312/wjo.v5.i4.504