Table 3

IRs of infections or malignancies, patients with events/100 patient-years (95% CI)

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  • *Average dosing was based on average daily dose: patients receiving <15 mg/day were assigned to the 5 mg twice daily group; patients receiving ≥15 mg/day were assigned to the 10 mg twice daily group.

  • †Constant dosage without prior exposure to another tofacitinib dose or adalimumab during the study; patients who switched doses were not included in this group.

  • ‡Defined as requiring hospitalisation or parenteral antimicrobial therapy, or otherwise meeting SAE criteria.

  • §IR calculated for female patients only; N [total patient-years' exposure]: N=5125 [16 077] (all tofacitinib); N=1863 [5701] (average tofacitinib 5 mg twice daily); N=3262 [10 377] (average tofacitinib 10 mg twice daily); N=1935 [2984] (constant tofacitinib 5 mg twice daily); N=2335 [5608] (constant tofacitinib 10 mg twice daily).

  • ¶Lymphoproliferative disorders/lymphoma.

  • HZ, herpes zoster; IR, incidence rate; n, unique number of patients with event; NA, not available; NMSC, non-melanoma skin cancer; SAE, serious adverse event; TB, tuberculosis.