CHMP recommends approval of Tremfya in active psoriatic arthritis.- Janssen Pharma

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the expanded use of Tremfya (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA) in the European Union. Guselkumab is currently approved in the EU for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. The CHMP positive opinion is based on data from DISCOVER-1 and DISCOVER-2, two first-in-class Phase III clinical studies, that demonstrated the efficacy and safety of guselkumab 100 mg q4w and q8w for the treatment of active PsA in adult patients. Data from these studies were published in The Lancet in March 2020. Results showed that in both studies, at week 24, the primary endpoints of American College of Rheumatology (ACR) 20 percent improvement (ACR20) achieved statistical significance (DISCOVER-1: p<0.0001; discover-2: p><0.0001) 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)." significant improvements in quality of life scores (36-item short-form [sf36] physical component summary) were also observed in the guselkumab groups vs the placebo groups in discover-1 (p><0.0001 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 addition, higher psoriasis area and severity index 75 percent improvement (pasi 75), pasi 90, and pasi 100 response rates were observed in the guselkumab groups vs the placebo groups (in discover-1, all unadjusted p><0.0001 with pasi 100 being p="0.0005" and in discover-2, all unadjusted p><0.0001).>