Shots:

• The P-II GALAXI 1 study involves assessing of Tremfya vs PBO in patients with mod. to severely active CD with intolerance to conventional therapies. In interim analyses- patients were randomized equally into 5 arms- with Tremfya (200/600/1200 mg (IV) @0- 4 & 8wks. respectively or with ustekinumab- dosed at ~6mg/kg (IV) @0wk. and dosed 90 mg (SC) @8wks. or PBO
• @12wks. (Tremfya vs PBO)- reductions in CDAI (154.1- -144.3- -149.5 vs -36.0); patients achieving clinical remission vs PBO (CDAI<150): (54.0%- 56.0%- 50.0% vs 15.7%); clinical remission among conventional therapy failures & among patients who had previously failed biologic therapy- (61.6% vs 18.5% & 45.5% vs 12.5%) respectively
• @12wks- Tremfya induced greater improvement across key clinical and endoscopic outcome measures- with a safety profile consistent with approved indications. Tremfya is a mAb that selectively binds to the p19 subunit of (IL)-23 and inhibits its interaction with the IL-23 recepto

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