Shots: The approval is based on two pivotal P-III clinical trials (DISCOVER-1 and DISCOVER-2) assessing Tremfya (100 mg, SC, q8w) following two starter doses @0 & 4wks. vs PBO in 1,120 adults with active PsA who had an inadequate response to standard therapies. Tremfya is the 1st and only biologic approved for PsA to improve […]Read More
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 […]Read More
Shots: The sBLA is based on two P-III DISCOVER-1 & 2 studies assessing Tremfya (SC) in 381 & 739 patients with active PsA including prior treated patients with anti-TNF therapy and continued through 52wks. & biologic-naïve patients planning to continue through 100wks. respectively The P-III DISCOVER-1 & 2 studies resulted in meeting their 1EPs i.e, […]Read More
Shots: The P-IIIb/IV SPIRIT-H2H study results involve assessing of Taltz vs Humira (adalimumab) in 566 patients with PsA who are biologic DMARD-naive for 52wks. The P-IIIb/IV SPIRIT-H2H study results: met its 1EPs & 2Eps i.e, @24wks. reduction by 50% in disease activity as defined by ACR50; PASI100 (36% vs 28%) & superior to Humira, ACR50 […]Read More
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