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STELARA® Studies In UC

The UNIFI Trial Included An 8-Week IV Induction Study Followed By A 44-Week Randomised Withdrawal Maintenance Study Of STELARA® In Patients With Moderately-To-Severely Active UC.[2]
All Patients Completing Week 44 Of The Maintenance Study Were Eligible To Enter The Long-Term Extension And Continue Their Same STELARA® Or Placebo Maintenance Regimen If The Investigator Felt They Would Benefit From Continued Treatment.[3]

JMC Updates-2
† Weight range-based STELARA® doses approximating 6 mg/kg; 260 mg (weight ≤55 kg), 390 mg (weight >55 kg and ≤85 kg), 520 mg (weight >85 kg).
‡ Placebo IV induction non-responders received STELARA® IV and were evaluated at Week 16. Responders to the placebo IV non-response W8+STELARA® IV responders W16, did re-randomise. The STELARA® IV partial responders at W8 received STELARA® SC at W8 and retested at W16 were not re-randomised.
§ Patients in clinical response 8 weeks after receiving STELARA® IV.
¶ Not an approved dose for the treatment of UC.

Component not published? componentType is undefined.

Component not published? componentType is undefined.

* Long-term remission is considered a target of ideal treatment in the clinical management of ulcerative colitis (UC).[1]
IV: Intravenous; SC: Subcutaneous; TNF: Tumour necrosis factor; UC: Ulcerative colitis.

Prescribing Information

Adverse Events Reporting


References

Danese S et al. Dig Dis 2019;37:266-283.
Sands BE et al. N Eng J Med 2019;38:1201-1214.
Panaccione R et al. Aliment Pharmacol Ther. 2020;52:1658-1675.
Danese S et al. Poster Tu1739 presented at Digestive Disease Week (DDW) Annual Meeting, 18-21 May 2019, San Diego, CA, USA.