INVIGORATE-2 Study - IV Secukinumab in Active Psoriatic Arthritis Save

The INVIGORATE-2 trial reports that intravenous (IV) secukinumab (SEC) is both effective and safe in patients with active psoriatic arthritis (PsA), demonstrating improvements on par with subcutaneous SEC.

This SEC trial was a randomized, placebo-controlled, phase III study wherin 381 active PsA patients were were randomized 1:1 to receive IV secukinumab (6 mg/kg at baseline followed by 3 mg/kg every 4 weeks [q4w]) or placebo. The primary endpoint was achievement of an ACR50 response at Week 16. At Week 16, placebo patients were switched to IV secukinumab (3 mg/kg q4w), and SEC patients continued treatment with IV secukinumab through Week 52.

At week 52, 93% and 90%  completed the entire study. The week 16 ACR50 responses were significantly higher in those receiving IV SEC (31%) vs placebo (6.3%; adjusted P<.0001). All secondary efficacy endpoints also favored IV SEC at Week 16 (P<.05). 

Placebo treated patients who crossed over to IV SEC at Week 16, also showed rapid improvements to an ACR50 response. Clinical responses were maintained to week 52 in both treatment arms. There were no new or unexpected safety signals in this trial; there was one death reported in the placebo group prior to Week 16.

These data led to the recent additional FDA approval for IV secukinumab in patients with active PsA.