Shots:

• The CHMP’s positive opinion is based on P-III DISCOVER-1 & -2 studies assessing guselkumab (100 mg- q4w/q8w) vs PBO in 381 & 739 patients with active PsA & patients who were biologic-naïve only & who had an inadequate response to standard therapies respectively
• Combined results: @24wks. improvement in ACR (20%); improvements in quality of life scores SF36; higher PASI 75- PASI 90- and PASI 100 response rate were observed. In both studies- Tremfya was generally well tolerated through study completion
• Guselkumab is the first approved mAb that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. If approved- guselkumab will be the first selective (IL)-23 p19 subunit inhibitor licensed for both PsA and moderate to severe PsO

 ­ Ref: Janssen | Image: Janssen