Modeling of Treatment Outcomes with Tofacitinib Maintenance Therapy in Patients with Ulcerative Colitis: A Post Hoc Analysis of Data from the OCTAVE Clinical Program.

Doctors use tofacitinib (Xeljanz^®) to treat people with moderate to severe ulcerative colitis. Patients who respond to (have improved symptoms following) treatment with tofacitinib 10 mg twice a day for 8 weeks, or up to 16 weeks if they do not respond initially (known as induction treatment), can receive tofacitinib treatment at the lowest effective dose to sustain their response (called maintenance treatment). Predicting how patients respond to tofacitinib maintenance treatment may help clinicians work out the lowest effective dose for each patient. In this study, data from the tofacitinib clinical trials were used to assess the ability to predict maintenance therapy response or failure in patients with ulcerative colitis. Differences between patients who received tofacitinib 5 or 10 mg twice a day and who either stopped responding to treatment or stopped taking treatment were looked at. The study could not accurately predict which patients would experience disease worsening, steroid-free remission (very mild or no symptoms, and not taking steroids), or take longer to respond following tofacitinib maintenance treatment. Patterns of patients who had stopped responding to treatment, or stopped taking treatment, were similar between patients who received tofacitinib 5 or 10 mg twice daily. When reviewed using doctor- and patient-reported scores that measure ulcerative colitis disease activity, different factors were important in patients with disease worsening compared with disease improvement. The results suggest that further research is needed to more accurately predict how patients with ulcerative colitis will respond to tofacitinib maintenance treatment.