Prior TNFi Failure Increases Adverse Events in Tofacitinib Treatment of UC

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Prior tumor necrosis factor inhibitor (TNFi) failure is a significant risk factor for herpes zoster and adjudicated non-melanoma skin cancer in patients taking tofacitinib for the treatment of ulcerative colitis (UC), according to a new study.

However, prior TNFi and/or immunosuppressant failure may not stop the benefit from tofacitinib induction or maintenance therapy among patients with UC.

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The study, authored by Dr Gary Lichtenstein and colleagues, was presented at the Advances in Inflammatory Bowel Diseases this week.

After determining the efficacy of tofacitinib through their program’s OCTAVE Induction 1, 2, and Sustain studies, the researchers evaluated the week 8 remission rates among participants who had prior TNFi failure and prior immunosuppressant failure.

Remission rates were lower among participants who had had TNFi or immunosuppressant failure.

Where there were sufficient adverse events to analyze, the researchers then evaluated both the effects of prior TNFi failure and the prior immunosuppressant exposure on adverse events of special interest, including herpes zoster and adjudicated non-melanoma skin cancer.

According to the researchers, prior immunosuppressant exposure was not identified as a significant risk factor for adverse events of special interest.

However, among all participants treated with tofacitinib in the UC program who experienced prior TNFi failure, 86.6% had adverse events and 15.8% had serious adverse events. Both are higher than the rates of adverse events and serious adverse events (79.7% and 13.9%, respectively) among those who had not experienced prior TNFi failure.

“Herpes zoster cases in the UC program were typically non-complicated and manageable with standard antiviral therapy,” the researchers concluded.

—Colleen Murphy

Reference:

Lichtenstein G, Cohen B, Peyrin-Biroulet L, et al. Impact of prior immunosuppressant and tumor necrosis factor inhibitor therapies on tofacitinib efficacy and safety in patients with ulcerative colitis. Paper presented at: Advances in Inflammatory Bowel Diseases; December 13-15, 2018; Orlando, FL. https://www.consultant360.com/meeting-materials/impact-prior-immunosuppressant-and-tumor-necrosis-factor-inhibitor-therapies. Accessed November 28, 2018.