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STELARA® Delivers Consistent Safety Profile In UC

The Confidence Of Up To 11 Years’ Heritage In 5 Immune-mediated Inflammatory Disease Indications[2],[3]

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Combined data from 12 registrational trials in patients with psoriasis, psoriatic arthritis, and Crohn’s disease showed discontinuations due to adverse events (AEs) and incidences of AEs, serious AEs, and infections were consistent between STELARA® - and placebo-treated patients up to 1 year of follow-up.

In UC, STELARA® Has A Consistent Long-term Safety Profile[4]

Key Safety Findings†‡§¶††​

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No New Safety Signals Were Observed Through 2 Years In The Unifi-lte Study[4]

† Number of treatment‐emergent adverse events per 100 patient‐years of follow‐up and 95% confidence interval (rates by each year of follow‐up) in the pooled STELARA® safety cohort. Confidence intervals based on an exact method assuming that the observed number of events follows a Poisson distribution.
‡ Infection as assessed by the investigator.
§ Placebo (First Year) includes 1) Patients who were in clinical response to STELARA® IV induction dosing and were randomised to placebo SC on entry into this maintenance study and were followed after Week 8; and 2) Patients who were in clinical response to placebo IV induction dosing and received placebo SC on entry into this maintenance study. Only includes data from Week 8 onward for patients who were in clinical response to STELARA® IV induction dosing and were randomised to placebo SC on entry into this maintenance study.
¶ All STELARA® (First Year) includes 1) patients who received STELARA® SC (q8w or q12w) in this maintenance study; and 2) patients who were in clinical response to STELARA® IV induction dosing and received placebo SC on entry into this maintenance study; 2) data from Week 0 to Week 8 for patients who were in clinical response to STELARA® IV induction dosing and were randomised to placebo SC on entry into this maintenance study.
†† All STELARA® treated in the LTE (Second Year) includes: 1) Patients who were in clinical response to STELARA® IV induction dosing and were randomised to receive STELARA® 90 mg SC q12w or q8w on entry into the maintenance study, with data from Week 44 through Week 96; 2) Patients who were in clinical response to STELARA® IV induction dosing, randomised to receive placebo SC on entry into the maintenance study, and had a dose adjustment to STELARA® 90 mg SC q8w, with data from the time of dose adjustment onward; 3) Patients who were not in clinical response to STELARA® at I‐8 but were in clinical response at I‐16 after a SC administration of STELARA® at I‐8 and received STELARA® 90 mg SC q8w on entry into the maintenance study with data from Week 44 through Week 96.

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* Long-term remission is considered a target of ideal treatment in the clinical management of ulcerative colitis (UC).[1]

AE: Adverse event; IV: Intravenous; NMSC: Non-melanoma skin cancer; UC: Ulcerative colitis; SC: Subcutaneous.

Prescribing Information

Adverse Events Reporting

References

Danese S et al. Dig Dis 2019;37:266-283.
STELARA® 130 mg concentrate solution for infusion. 90 mg / 45 mg solution for injection. Summary of Product Characteristics. February 2020.
Ghosh S, et al. Drug Saf 2019;42(6):751-768.
Panaccione R et al. Aliment Pharmacol Ther. 2020;52:1658-1675.