Janssen Presents Three-Year Data of Stelara (ustekinumab) in P-lll UNIFI LTE Study for the Treatment of Moderately to Severely Active Ulcerative Colitis at ECCO

July 12, 2021 Auto Bot Clinical Trials, Janssen, P-lll, Stelara, ustekinumab 0

Shots:

  • The P-III UNIFI study involves assessing the safety & efficacy of Stelara (90mg, q8w/q12w) as induction and maintenance therapy vs PBO in 588 patients with UC with inadequate response & were unable to tolerate conventional therapies
  • Results: in IIT population, 55.2% were in symptomatic remission & 96.4% of the patients in symptomatic remission were corticosteroid-free @3yrs., no new safety signals were identified. In LTE study, 91.4% receiving corticosteroids at maintenance baseline were no longer receiving corticosteroids @152wks.
  • Stelara is a fully human mAb & is the first biologic treatment to selectively inhibit the IL-12 and IL-23 pathways

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