Phase III study of Tremfya meets endpoints in psoriatic arthritis.- Janssen Pharma

The Janssen Pharmaceutical Companies of Johnson & Johnson announced 24-week Phase III data showing a significantly greater proportion of patients with active psoriatic arthritis (PsA) treated with Tremfya (guselkumab) achieved at least a 20 percent improvement in disease signs and symptoms (American College of Rheumatology ACR20 response) compared to placebo. These findings represent the primary endpoints of the DISCOVER-1 and DISCOVER-2 Phase III studies, which were designed to evaluate the efficacy and safety of investigational use of Tremfya for the treatment of adult patients with active PsA. Results from DISCOVER-1 show that at week 24, 59 percent of adult patients with active PsA receiving Tremfya every four weeks (q4w) and 52 percent of patients receiving Tremfya at weeks 0, 4 and every eight weeks thereafter (q8w) achieved an ACR20 response compared to 22 percent of patients receiving placebo (both p<0.001). among patients who had a minimum 3 percent body surface area (bsa) affected with psoriasis, and an investigator global assessment (iga) score of at least 2 at baseline, 75 percent of patients receiving tremfya q4w and 57 percent of patients receiving tremfya q8w achieved an iga score of 0 (cleared) or 1 (minimal) and a>2 grade reduction, compared to 15 percent of patients receiving placebo (both p<0.001).>

Results from DISCOVER-2 show that at week 24, 64 percent of adult, biologic-naive patients with active PsA receiving Tremfya q4w or q8w respectively, achieved an ACR20 response, compared to 33 percent of patients receiving placebo (both p<0.001). among patients who had an at least 3 percent bsa affected with psoriasis, and an iga score of at least 2 at baseline, 69 percent receiving tremfya q4w and 71 percent receiving tremfya q8w achieved an iga score of 0 or 1, and an at least 2 grade reduction from baseline, compared to 19 percent of patients receiving placebo (both p><0.001). patients with active psa receiving tremfya q4w showed significantly reduced radiographic damage progression vs. placebo at week 24.>

In DISCOVER-1 and DISCOVER-2, observed adverse events (AEs) were generally consistent with previous studies of Tremfya and current prescribing information.These data were presented as part of an oral plenary session (abstract 0807) and a late-breaking poster session (abstract L13), respectively, at the American College of Rheumatology and Association of Rheumatology Professionals (ACR/ARP) 2019 Annual Meeting.