EU approves Tremfya in active psoriatic arthritis.- Janssen Pharma

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) has approved Tremfya (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy. Approval for this new indication is based on results from the DISCOVER-1 and DISCOVER-2 Phase III clinical studies, which assessed safety and efficacy of guselkumab 100 mg q4w and q8w in adult patients with active PsA. DISCOVER-1 evaluated 381 participants with active PsA who had an inadequate response to standard therapies, including participants (~30 percent) previously treated with anti-tumour necrosis factor (TNF) alpha biologics. DISCOVER-2 included 739 patients who were biologic-naïve only and had an inadequate response to standard therapies.9 Data from these studies was published earlier this year in The Lancet (24-weeks; DISCOVER-1, DISCOVER 2). The published results show that in both studies, at week 24, adult patients with active PsA achieved statistical significance in the primary endpoint of American College of Rheumatology (ACR) 20 percent improvement (ACR20) response (DISCOVER-1: p<0.001; discover-2: p><0.001) in both q4w and q8w guselkumab groups (discover-1: n="255;" discover-2: n="493)" vs the placebo groups (discover-1: n="126;" discover-2: n="246)." in addition, significant improvements in quality of life scores (36-item short-form [sf36] physical component summary) were observed in the guselkumab groups vs the placebo groups in discover-1 (p><0.001 for both doses); in discover-2, significant improvements were observed in the q4w guselkumab group vs placebo group (p="0.0056" [q8w, p="0.068])." in discover 2, inhibition of structural damage progression was measured radiographically and expressed as the mean change from baseline in the total modified van der heijde-sharp (vdh-s) score. at week 24, the guselkumab q4w group demonstrated statistically significantly less radiographic progression (p="0.006)" and the guselkumab q8w group showed numerically less progression than placebo (p="0.068)." at week 52, the mean change from baseline in total modified vdh-s score was similar in the guselkumab q8w and q4w groups (mean scores of 0.97 and 1.07 respectively). in addition, higher psoriasis area and severity index 75 percent improvement (pasi 75), pasi 90 and pasi 100 response rates were observed in the q4w and q8w guselkumab groups vs the placebo groups (in discover-1, all unadjusted p><0.001 with pasi 100 being p="0.0005" and in discover-2, all unadjusted p><0.001). in both studies, guselkumab was well-tolerated, and observed adverse events (aes) were generally consistent with previous studies of guselkumab and current prescribing information.>