Table 3 Adverse events with tofacitinib at week 12 and withdrawal from trials
| Â | 5Â mg bid | 10Â mg bid | ||||
|---|---|---|---|---|---|---|
Adverse events | No. of studies | Sample size (tofacitinib, placebo) | Risk ratio [95% CI] | No. of studies | Sample size (tofacitinib, placebo) | Risk ratio [95% CI] |
Infection | Â | Â | Â | Â | Â | Â |
Upper respiratory tract infection | 4 | 901, 522 | 1.12 [0.61, 2.05] | 4 | 896, 522 | 0.77 [0.40, 1.49] |
Urinary tract infection | 4 | 901, 522 | 1.22 [0.58, 2.57] | 4 | 901, 522 | 1.01 [0.45, 2.27] |
Bronchitis | 4 | 901, 522 | 0.80 [0.25, 2.56] | 4 | 896, 522 | 1.01 [0.34, 2.96] |
Nasopharyngitis | 5 | 928, 550 | 1.57 [0.51, 4.83] | 5 | 922,550 | 1.67 [0.82, 3.39] |
Influenza | 3 | 768, 390 | 0.37 [0.08, 1.64] | 3 | 762, 390 | 1.25 [0.25, 6.20] |
Pharyngitis | 2 | 231, 136 | 0.01 [−0.01, 0.03] | 2 | 227, 136 | 0.03 [−0.09, 0.14] |
Immune system | Â | Â | Â | Â | Â | Â |
Neutropeniaa | 4 | 826, 482 | 1.41 [0.55, 3.61] | 4 | 830, 482 | 1.73 [0.68, 4.38] |
Rash | 3 | 552, 296 | 0.32 [0.04, 2.61] | 3 | 543, 296 | 2.51 [0.63, 9.93] |
Withdrawal | No. of studies | Tofacitinib N (%) | Placebo N (%) | Â | Â | Risk ratio [95% CI] |
All causes | 5 | 158 (12.31%) | 59 (16.71%) | Â | Â | 0.60 [0.45, 0.78] |
Adverse events | 5 | 50 (3.89%) | 8 (2.27%) | Â | Â | 1.43 [0.68, 3.03] |
Lack of efficacy | 5 | 16 (1.25%) | 20 (5.67%) | Â | Â | 0.18 [0.09, 0.35] |