ZEPOSIA®Black medical triangle (ozanimod) safety & tolerability profile

ZEPOSIA®Black medical triangle (ozanimod) safety & tolerability profile

The safety profile of ZEPOSIA has been well-studied across Multiple Sclerosis and Ulcerative Colitis1–3

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

Up to ~8 years of ZEPOSIA experience in UC and MS1,2*†

5

phase 3
clinical trials

across UC and MS3–6†

>13,000

patients

in UC and MS clinical trials and post-marketing setting7,8‡#

>20,000

patient years

of total exposure in UC and MS clinical trials and post-marketing setting7,8‡#

*From the start of the TOUCHSTONE phase 2 clinical trial (December 26, 2012) through OLE study data cutoff (September 30, 2020). Only includes patients receiving the 0.92 mg dose of ZEPOSIA.1,2
†UC=TRUE NORTH, TRUE NORTH OLE study; MS=SUNBEAM, RADIANCE, and DAYBREAK.3-6
‡MS trials include phase 1, phase 2, SUNBEAM, RADIANCE, and DAYBREAK. UC trials include TOUCHSTONE, TRUE NORTH, and the TRUE NORTH OLE study. The post-marketing setting data cutoff was November 19, 2021.7,8
#Exposure for patients with MS in clinical trials: 2630 patients and 11,935 patient years. Exposure for patients with UC in clinical trials: 1140 patients and 2325 patient years. Exposure for patients in the post-marketing setting across indications: 9738 patients and 6455 patient years.7,8

MS, multiple sclerosis; UC, ulcerative colitis.

ZEPOSIA safety profile in the TRUE NORTH clinical studies4,9

Adapted from Sandborn WJ et al. 2021.

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  • ZEPOSIA’s safety profile is consistent with its known safety findings9
  • In the TRUE NORTH study maintenance phase, over twice as many patients taking placebo discontinued treatment vs. those taking ZEPOSIA (45.4% vs. 20.0%, respectively)9
Please refer to the ZEPOSIA Summary of Product Characteristics for full safety information

*The final safety follow-up visit was scheduled to occur 90 days (within a window of ±10 days) after the final dose of ozanimod or placebo. ULN denotes upper limit of the normal range.4
**The group names indicate whether the patients received ozanimod or placebo during the maintenance period only; all the patients in the maintenance period had received ozanimod during the induction period.4
†The most frequent events were defined as those that occurred in at least 3% of the patients who received ozanimod during the induction or maintenance period.4
‡Laboratory values were flagged by the central laboratory if they fell outside the standard reference range. The investigator decided whether the laboratory value qualified as an adverse event.4
§All the patients had documented presence of varicella–zoster virus IgG antibody or complete varicella–zoster vaccination at screening.4

AE, adverse event; IgG, immunoglobulin G; ITT, intention to treat; TNFi, tumour necrosis factor inhibitor; ULN, upper limit of normal.

In TRUE NORTH, cardiovascular serious AEs in the ZEPOSIA arm were uncommon compared to placebo10

  1. Induction phase, ZEPOSIA (n=429) vs. placebo (n=216): Cardiac disorders 1.4% vs 0.9%; vascular disorders 2.3% vs. 0.5%10
  2. Maintenance phase, ZEPOSIA-placebo (n=227) vs. ZEPOSIA-ZEPOSIA (n=230) vs. placebo (n=69): Cardiac disorders 0% vs. 1.3% vs 2.9%; vascular disorders 1.8% vs. 2.6% vs. 1.4%10
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No cases of myocardial infarction, pulmonary embolism, or deep vein thrombosis associated with ZEPOSIA in the induction phase10

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No cases of bradycardia, stroke, myocardial infarction, pulmonary embolism, or deep vein thrombosis associated with continuous ZEPOSIA use in the maintenance phase10

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No deaths related to cardiovascular events10

Prior to treatment initiation with ozanimod, an ECG in all patients should be obtained to determine whether any pre-existing cardiac abnormalities are present. In patients with certain pre-existing conditions, first-dose monitoring is recommended.3

AE, adverse event; ECG, electrocardiogram.

References

  1. ClinicalTrials.gov. Efficacy and safety study of ozanimod in ulcerative colitis (Touchstone). Available at: https://clinicaltrials.gov/ct2/show/record/NCT01647516 (Accessed June 2023).
  2. Danese S et al. Long-term use of ozanimod in patients with moderately to severely active ulcerative colitis. Poster presented at: European Crohn’s and Colitis Organisation (ECCO) Virtual, February 16-19, 2022. Poster DOP44.
  3. Zeposia (ozanimod) Summary of Product Characteristics, 2022.
  4. Sandborn WJ et al. N Engl J Med. 2021;385(14):1280-1291.
  5. ClinicalTrials.gov. An extension study of RPC1063 as therapy for moderate to severe ulcerative colitis. Available at: https://clinicaltrials.gov/ct2/show/reord/NCT02531126 (Accessed June 2023).
  6. ClinicalTrials.gov. A multi-site, open-label extension trial of oral RPC1063 in relapsing multiple sclerosis. Available at: https://clinicaltrials.gov/ct2/show/record/NCT02576717 (Accessed June 2023).
  7. Data on File. OZA 0016. Princeton, NJ: Bristol-Myers Squibb Company.
  8. Data on File. OZA 0017. Princeton, NJ: Bristol-Myers Squibb Company.
  9. Danese S et al. Presented at: United European Gastroenterology Week Virtual Meeting; October 10–14, 2020. Presentation: LB10.
  10. Long M et al. Long-term cardiac safety of ozanimod in phase 3 clinical program of ulcerative colitis and relapsing multiple sclerosis. Presented at: Digestive Disease Week (DDW); San Diego, CA, and Virtual, May 21–24, 2022. Presentation 15.

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

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Job: 2084-GB-2300276 Date of Preparation: June 2023