Figure 4.

Risk of malignancies (excluding NMSC), MACE, MI, VTE and all-cause death in low-risk populations in ORAL Surveillance and tofacitinib clinical development programmes. Low-risk patients were <65 years of age and never smoker. Horizontal dotted line represents IR in low-risk patients treated with tofacitinib in ORAL Surveillance. IRs express the number of patients with first events per 100 PY. All data are for combined tofacitinib doses. *Excluding ORAL Surveillance. Data from ORAL Surveillance overall populations have previously been published and are included for reference; malignancies (excluding NMSC) and MACE (Ytterberg et al ¹), MI (Charles-Schoeman et al ⁵). Also, previously published are data from the tofacitinib RA and PsA development programmes on MACE (Burmester et al ²⁵) and VTE (Mease et al ²⁶). IR, incidence rate; MACE, major adverse cardiovascular events; MI, myocardial infarction; N, number of evaluable patients; n, number of patients with events; NMSC, non-melanoma skin cancer; PsA, psoriatic arthritis; PY, patient-years; RA, rheumatoid arthritis; TNFi, tumour necrosis factor inhibitor; UC, ulcerative colitis; VTE, venous thromboembolism.