In a recent study published in Inflammatory Bowel Diseases, researchers have highlighted that Lipid levels and ratios generally unchanged from baseline after tofacitinib treatment, and major adverse cardiovascular events were infrequent. Patients with inflammatory bowel disease (IBD), which includes ulcerative colitis (UC) and Crohn's disease (CD), have an elevated risk of cardiovascular morbidity relative to the general population, despite a lower prevalence of classic cardiovascular risk factors (eg, high body mass index, diabetes, hyperlipidemia, and hypertension).
Tofacitinib is an oral, small-molecule Janus kinase inhibitor for the treatment of UC. In clinical studies, tofacitinib treatment has been associated with generally reversible increases in serum lipids during the first few months of therapy. The present study was undertaken with the aim to review data on lipid levels and cardiovascular events, alongside recommendations for managing lipid levels during tofacitinib treatment in patients with UC, based on up-to-date expert guidelines.
For the study design, Data were identified from a phase 3/open-label, long-term extension (OLE) tofacitinib UC clinical program (cutoff May 27, 2019). Data were available from 4 phase 3 clinical trials of 1124 patients with moderately to severely active UC who received ≥1 dose of tofacitinib 5 or 10 mg twice daily in induction (two identical trials), maintenance, and OLE studies (treatment duration ≤6.8 years; 2576.4 patient-years of drug exposure). The trial was termed as a phase 3/OLE tofacitinib UC clinical program.
On analysis, the following results emerged. In the OLE study, tofacitinib treatment was not associated with major changes from baseline in total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, total cholesterol/high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol/high-density lipoprotein cholesterol, with lipid levels and ratios generally remaining stable over time.
The major adverse cardiovascular events incidence rate was 0.26/100 patient-years (95% confidence interval, 0.11-0.54). "As per the approved label, patients commencing tofacitinib therapy should have lipid levels monitored after approximately 4 to 8 weeks, and up-to-date expert guidelines for hyperlipidemia management should be followed. Physicians should follow general clinical guidance on stratification of patients according to cardiovascular risk prior to initiating any therapy, to identify those patients who may benefit from counseling and regular lipid monitoring, and to identify those requiring lipid-lowering intervention during tofacitinib therapy." Recommended the team.