Janssen Reports Results of Tremfya (guselkumab) in P-III DISCOVER Studies for Active Psoriatic Arthritis

Janssen’s Stelara (ustekinumab) Receives the US FDA’s Approval for Moderately to Severely Active Ulcerative Colitis

Shots:

  • The P-III DISCOVER 1 & 2 studies involves assessing of Tremfya (q4w/q8w, SC) vs PBO in 381 & 739 patients with active psoriatic arthritis including those previously treated with biologic anti-TNF alpha agent respectively
  • Collective Results: @24wks. met its 1EPs of ACR20 (59%/52% & 64% vs 22% & 33%); patients with ≥3BSA affected with psoriasis and IGA score of ≥2 at baseline (75%/57% & 69%/71% vs 15% & 19%); showed reduction in radiographic damage progression
  • Tremfya is a mAb targeting p19 subunit of IL-23 and is an approved therapy in the US, Canada, Japan & EU for moderate to severe plaque psoriasis. The sBLA submission to the US FDA on Sept 13, 2019 & EMA’s validation on Oct 11, 2019 is based on the results of P-III DISCOVERY program

Click here to­ read full press release/ article | Ref: PRNewswire | Image: The Boston Globe