Table 3

Tofacitinib treatment exposure in high-risk and low-risk populations in ORAL Surveillance and RA, PsA, UC development programmes

ORAL Surveillance (RA)Tofacitinib development programme
RA*PsAUC
Overall population
 N291179647831157
 Exposure (PY)10 92223 49720382814
 Follow-up; mean, max (years)3.8, 6.13.0, 10.52.6, 4.82.4, 7.8
High-risk: ≥65 years or ever smoked
 N18953577341444
 %65.1%44.9%43.6%38.4%
 Exposure (PY)698699618371113
Low-risk: <65 years and never smoked
 N10164198442713
 %34.9%52.7%56.4%61.6%
 Exposure (PY)393713 16812011702
  • PY was calculated from the first dose of tofacitinib to the last contact date in ORAL Surveillance, and from the first dose of tofacitinib to the last dose of tofacitinib for all other development programmes.

  • *Excluding ORAL Surveillance.

  • N, number of patients treated with tofacitinib; PsA, psoriatic arthritis; PY, patient-years; RA, rheumatoid arthritis; UC, ulcerative colitis.