Table 3: Analysis of safety profile of Tofacitinib.

Outcome Number of studiesNumber of participantsOdds ratio [Confidence Interval] -value

Serious adverse events with Tofacitinib 5 mg versus placebo at month 0–35 [1519]18910.80 [0.47, 1.35]0.39
Serious adverse events with Tofacitinib 10 mg versus placebo at month 0–35 [1519]18960.77 [0.45, 1.31]0.33
Serious infections with Tofacitinib 5 mg versus placebo at month 0–34 [15, 16, 18, 19]14231.91 [0.31, 11.70]0.49
Serious infections with Tofacitinib 10 mg versus placebo at month 0–34 [15, 16, 18, 19]14182.10 [0.44, 9.94]0.35
Serious adverse events with Tofacitinib 5 mg versus 10 mg at month 3–65 [1519]24271.28 [0.80, 2.03]0.30
Serious adverse events with Tofacitinib 5 mg versus 10 mg at month 6–122 [18, 19]10421.53 [0.79, 2.97]0.21
Serious infections with Tofacitinib 5 mg versus 10 mg at month 3–64 [15, 16, 18, 19]17971.62 [0.67, 3.94]0.28
Serious infections with Tofacitinib 5 mg versus 10 mg at month 6–122 [18, 19]10420.74 [0.16, 3.31]0.69
Mild neutropenia (1500–1999 cells/mm3) with Tofacitinib 5 mg versus placebo at month 0–34 [15, 16, 18, 19]13081.55 [0.64, 3.77]0.33
Mild neutropenia (1500–1999 cells/mm3) with Tofacitinib 10 mg versus placebo at month 0–34 [15, 16, 18, 19]13121.97 [0.83, 4.67]0.12
Moderate to severe neutropenia (500–1499 cells/mm3) with Tofacitinib 5 mg versus placebo at month 0–34 [15, 16, 18, 19]13083.26 [0.71, 14.95]0.13
Moderate to severe neutropenia (500–1499 cells/mm3) with Tofacitinib 10 mg versus placebo at month 0–34 [15, 16, 18, 19]13122.99 [0.52, 17.02]0.22
Anaemia (decreased haemoglobin −1 to −3 g/dL) with Tofacitinib 5 mg versus placebo at month 0–34 [15, 16, 18, 19]13390.56 [0.38, 0.83]0.004*
Anaemia (decreased haemoglobin −1 to −3 g/dL) with Tofacitinib 10 mg versus placebo at month 0–34 [15, 16, 18, 19]13371.05 [0.74, 1.48]0.80

Significant.