Shots:

• The approval is based on P-III study results assessing Tremfya (guselkumab- 100mg) vs PBO in 78 patients with moderate-to-severe plaque psoriasis
• P-III ORION study: IGA score of 0/1 or PASI 90 @16wks. (81%- 76% vs 0%-0%); IGA score of 0 @16 wk (56% vs 0%); PASI 100 response @16 wks (50% vs 0%)
• Tremfya (guselkumab-100mg- SC) is a mAb offering one-press patient-controlled injector inhibiting interleukin (IL)-23- evaluated in two P-III trials for active psoriatic arthritis & Crohn’s disease and is approved in the US- EU- Canada & Japan for moderate-to-severe plaque psoriasis in adults

Ref: Janssen | Image: Janssen