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Table 4 Summary of tofacitinib exposure and incidence rates for safety events of special interest

From: Tofacitinib, an oral Janus kinase inhibitor, as monotherapy or with background methotrexate, in Japanese patients with rheumatoid arthritis: an open-label, long-term extension study

  Tofacitinib Tofacitinib All tofacitinib
5 mg BID 10 mg BID
(N = 381) (N = 105) (N = 486)
Exposure, patient-years 1111.7 328.2 1439.9
Patients with events per 100 patient-years (95 % CI)
 Adverse events 307.5 (277.0, 340.4) 311.8 (255.0, 377.5) 308.4 (281.3, 337.4)
 Serious adverse events 11.2 (9.2, 13.5) 9.2 (6.1, 13.3) 10.7 (9.0, 12.6)
 Serious infections 3.2 (2.2, 4.5) 3.7 (1.9, 6.4) 3.3 (2.4, 4.4)
 Herpes zoster (serious and non-serious) 7.1 (5.5, 8.9) 8.6 (5.6, 12.7) 7.4 (6.0, 9.1)
 Serious herpes zoster 1.0 (0.5, 1.8) 0.9 (0.2, 2.7) 1.0 (0.5, 1.6)
 Composite MACEa 0.4 (0.1, 1.0) 0.3 (0.0, 1.7) 0.4 (0.1, 0.9)
 Gastrointestinal perforations 0 (0.0, 0.3) 0 (0.0, 1.1) 0 (0.0, 0.3)
 All malignancy excluding NMSC 1.4 (0.8, 2.3) 0.3 (0.0, 1.7) 1.2 (0.7, 1.9)
 Mortality 0.6 (0.3, 1.3) 0.0 (0.0, 1.1) 0.5 (0.2, 1.0)
  1. aTotal exposure per group is less than for other safety events as composite major adverse cardiovascular event (MACE) adjudication applies only to data collected after 25 February 2009. Exposure was 1056.1, 325.0, and 1381.1 patient-years for tofacitinib 5 mg twice daily (BID), tofacitinib 10 mg BID and all tofacitinib, respectively
  2. NMSC non-melanoma skin cancer