Tofacitinib use in ulcerative colitis reports infrequent malignant events, finds study

Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). . The safety of tofacitinib in adults with moderate to severe active UC has been evaluated in clinical studies .Researchers performed an integrated analysis of malignancy events from the tofacitinib phase 3 UC clinical development program (excluding nonmelanoma skin cancer [NMSC]).

For the study design, Data (up to May 2019) were pooled from two phase 3 induction studies, a phase 3 maintenance study, and an ongoing, open-label, long-term extension (OLE) study, and analyzed as 3 cohorts: induction (N = 1139), maintenance (N = 592), and overall (induction, maintenance, and ongoing OLE study; N = 1124). Proportions and incidence rates (IRs; unique patients with events per 100 patient-years [PY] of exposure) for malignancies confirmed by adjudication were calculated.

Results highlighted some key facts.

• The overall cohort consisted of patients who received at least 1 dose of tofacitinib at 5 or 10 mg twice daily, for up to 6.8 years, with an exposure of 2576.4 PY.
• Of the 1124 overall cohort tofacitinib-treated patients, 20 developed a malignancy (excluding NMSC; IR, 0.75; 95% confidence interval, 0.46–1.16), of which 17 occurred in patients treated with tofacitinib 10 mg twice daily; importantly, more than 80% of patients predominantly received this dose.
• Furthermore, there was no apparent clustering of malignancy types, and IRs were stable over time.

"Continued monitoring of risk for malignancies over time is needed to fully assess the risk of malignancies including NMSC in patients treated with tofacitinib; larger studies with longer exposure, including analysis of registry data, will enable further understanding of the long-term safety profile of tofacitinib for patients with UC. Before initiation of tofacitinib treatment, the risks and benefits of tofacitinib should be considered in patients with known malignancies other than successfully treated NMSC, or when considering continuation of tofacitinib treatment in those patients who develop a malignancy."the team concluded.

For full article follow the link: https://doi.org/10.1093/ibd/izaa199

Source: Inflammatory Bowel Diseases