Integrated analysis of malignancies observed in the UC clinical development programme of tofacitinib showed they occurred infrequently. The incidence rates for malignancies were similar to those reported for tofacitinib in RA patients and for UC patients treated with biologics . A dose-dependent increased risk of NMSC could not be derived from the data.
Lichtenstein et al.  analysed patients who received placebo or tofacitinib 5 or 10 mg BID as three cohorts. These were induction (P2/P3 induction studies, n=1,220), maintenance (P3 maintenance study, n=592) and overall (patients receiving tofacitinib 5 or 10 mg BID in P2, P3 or ongoing long-term extension studies, n=1,157).
Altogether, 1,613 patient-years of tofacitinib exposure and ≤4.4 years of treatment were included. The induction cohort had no patients with malignancy (excl. NMSC), while the maintenance cohort had one (placebo, breast cancer). There were eight such patients in the overal...
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