Serious infections and malignancy

Serious infections and malignancy

Rates of serious infection and malignancy in the TRUE NORTH study1,2

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

Graphic showing the rates of serious infection and malignancy for cohorts 1 and 2 in the TRUE NORTH study

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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.


  1. Zeposia (ozanimod) Summary of Product Characteristics, 2022.
  2. Sandborn WJ et al. NEJM 2021; 385(14):1280–1291.

Adverse events should be reported. Reporting forms and information can be found at: UK –, or search for MHRA Yellow Card in the Google Play or Apple App Store. Ireland-via HPRA Pharmacovigilance at Adverse events should also be reported to Bristol-Myers Squibb via or 0800 731 1736 (UK); 1800 749 749 (Ireland).

© 2022 Bristol-Myers Squibb Company. All rights reserved.
Job: 2084-GB-2300276 Date of Preparation: June 2023