Shots:

• The approval is based on two pivotal P-III clinical trials (DISCOVER-1 and DISCOVER-2) assessing Tremfya (100 mg- SC- q8w) following two starter doses @0 & 4wks. vs PBO in 1-120 adults with active PsA who had an inadequate response to standard therapies. Tremfya is the 1st and only biologic approved for PsA to improve fatigue as measured by FACIT-F in the product label
• Results: DISCOVER-1 & 2 study- ACR20 (52% & 64% vs 22% & 33%)- in pooled analysis @24wks.- resolved enthesitis (50% vs 29%)- resolved dactylitis (59% vs 42%) respectively.  Additionally- it improved signs and symptoms in joints- skin- and soft tissue in adults with active PsA
• Tremfya is the 1st approved fully human mAb that targets IL-23. It is approved in the US- Canada- EU- Japan- and other countries globally for moderate to severe PsO & in the US- Japan- and Brazil for PsA

­ Ref: Janssen | Image: Janssen