Key clinical point: Tofacitinib therapy shows a dose-related increase in risk of herpes zoster in patients with ulcerative colitis.
Major finding: Compared with placebo, a 5-mg twice-daily maintenance dose of tofacitinib produced a 2.1-fold greater risk of herpes zoster infection (95% CI, 0.4-6.0), while a 10-mg twice-daily dose produced a statistically significant 6.6-fold increase in incidence (95% CI, 3.2–12.2).
Study details: Integrated safety analysis of five clinical trials (four randomized, double-blinded, and placebo-controlled) with 1,612.8 total years of exposure (median treatment duration, 1.4 years).
Disclosures: Pfizer makes tofacitinib, funded the individual trials, and paid for medical writing. Dr. Sandborn disclosed grants, personal fees, and nonfinancial support from Pfizer and many other pharmaceutical companies.
Sandborn WJ et al. Clin Gastroenterol Hepatol. 2018 Nov 23. doi: 10.1016/j.cgh.2018.11.035.