Rates of serious infection and malignancy in the TRUE NORTH study^1,2

You are advised to read the study design information before these safety outcomes

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• Herpes zoster was reported in 2.2% of patients receiving ZEPOSIA vs 0.4% receiving placebo in the maintenance phase¹
    — No cases were serious or disseminated
• All malignancies in ZEPOSIA patients were found by investigators to be unrelated to the study drug²

Please refer to the ZEPOSIA Summary of Product Characteristics for further safety information

ZEPOSIA has an immunosuppressive effect that predisposes patients to a risk of infection, and may increase the risk of developing malignancies. Physicians should carefully monitor patients, especially those with concurrent conditions or known factors.

Direct comparison can not be made between ZEPOSIA and placebo as no statistical test of comparisons have been made.

*1 patient had basal cell carcinoma.^2
†1 patient had basal cell carcinoma; 1 patient had rectal adenocarcinoma.^2
‡1 patient had breast cancer; 1 patient had adenocarcinoma of the colon.²
OLE, open-label extension; PT, preferred term; SOC, standard of care; UC, ulcerative colitis.