Shots:

• The submission is based on P-III UNIFI study (had two part one induction and second maintenance) results assessing Stelara vs PBO (130 mg- 6 mg/kg) in 961 patients in ratio (1:1:1) with moderately to severely active UC for a duration of 1 year
•  P-III UNIFI study results: clinical remission (15.6%- 15.5% vs 15.3%); endoscopic healing (26.3%- 27.0% vs 5.3%); clinical response (51.3%- 61.8% vs 31.3%); mucosal healing (20.3%- 18.4% vs 8.9%); IBDQ improvements (31.5-31.0 vs 10)- also presented at ACG & UEGW in 2018
• Stelara (ustekinumab) is a mAb developed for targeting IL-12 and IL-23 cytokines indicated for plaque psoriasis and psoriatic arthritis. Additionally- the submission involves Stelara’s sBLA filling to FDA for moderately to severely active UC in adults on 20 dec- 2018

Ref: J&J | Image: Janssen