Review article: guide to tofacitinib dosing in patients with ulcerative colitis

Background: Tofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). The induction dose is 10 mg twice daily (b.d.), whilst for maintenance therapy, the lowest effective dose should be used. Aim: To examine published evidence on the two tofacitinib dosing strategies used in UC treatment, including expert interpretation of the data and how they could inform clinical practice. Methods: The use of tofacitinib 5 or 10 mg b.d. was assessed using data from the tofacitinib UC clinical programme in the context of different clinical scenarios. We include experts' opinions on the clinical implications of dose adjustment to inform the benefit/risk of using tofacitinib 5 or 10 mg b.d., based on clinical scenarios and real-world data. Results: Factors to consider when adjusting the tofacitinib dose include disease severity, comorbidities and previous biological exposure. The endoscopic subscore can determine whether a patient is a good candidate for dose reduction. Following disease relapse, the response can be recaptured in a substantial number of patients with a dose increase. Furthermore, data are now published showing real-world use of tofacitinib and, so far, these are consistent with data from the clinical trials. Conclusion: Clinicians must consider the benefit/risk balance of tofacitinib 10 versus 5 mg b.d. in terms of dose-related side effects, as well as the safety implications of undertreating active disease. All patients should be closely monitored for disease relapse following dose reduction or interruption for early recapture of response.