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Tofacitinib Upped Herpes Zoster Risk in Ulcerative Colitis

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.

Citation:

Sandborn WJ et al. Clin Gastroenterol Hepatol. 2018 Nov 23. doi: 10.1016/j.cgh.2018.11.035.