Malignancies occur infrequently with tofacitinib

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 [4]. A dose-dependent increased risk of NMSC could not be derived from the data.

Lichtenstein et al. [5] 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 overall cohort (incidence rate 0.48; 95% CI 0.21-0.95); all had received tofacitinib 10 mg BID. No clustering of malignancies (excl. NMSC) was noted. NMSC occurred in two tofacitinib-treated patients in the induction cohort and in three in the maintenance cohort (all 10 mg BID). In the overall cohort, 11 patients were recorded (see Table).

Table: Demographics and summary of incidence of malignancies [5]



NMSC incidence rates in the maintenance cohort for tofacitinib 5 mg BID were not higher than for placebo. Of the 11 overall cohort patients with NMSC, ten had been exposed to azathioprine or 6-mercaptopurine and ten had failed treatment with TNF inhibitors [5].