Risankizumab was the first p19 IL-23 blocker licensed for Crohn's, nearly three years ahead of guselkumab. But guselkumab arrived with subcutaneous induction from day one. That matters. Infusion suites are full, and in the US an iv start followed by subcut maintenance can mean two separate insurance approvals, where an all-subcut route needs one. AFFIRM is the sc induction data for risa. First shown by press release in March, the first congress presentation was last night - Millie Long at ACG in Nashville (along with updated press release). Silvio Danese presents the data at UEG on Monday at 16:00. The regimen is 720 mg subcutaneously at weeks 0, 2, 4 and 8, then 360 mg every eight weeks from week 12. Guselkumab's subcutaneous induction is 400 mg at weeks 0, 4 and 8 (then 100mg q8w or 200mg q4w maintenance). In 289 people with Crohn's disease, two-thirds of whom had already failed an advanced therapy, week 12 clinical remission was 55% v 30% and endoscopic response 44% v 14%, roughly where intravenous induction landed in ADVANCE. Endoscopic remission was 28% v 10%. The benefit was largest in patients new to advanced therapy, with endoscopic response of 61% v 15%, against 35% v 14% after advanced therapy failure. AbbVie expects FDA approval later this year, and the EMA has been reviewing it since August, so Europe will probably follow in 2027.