Efficacy and Safety of Intravenous Secukinumab for the Treatment of Active Psoriatic Arthritis: Results From the Randomized, Placebo-Controlled Phase III INVIGORATE-2 Study.

Abstract

OBJECTIVE To evaluate the efficacy and safety of intravenous (IV) secukinumab in patients with active psoriatic arthritis (PsA). METHODS INVIGORATE-2 (NCT04209205) is a randomized, placebo-controlled, phase III trial. Patients with active PsA were randomized 1:1 to receive IV secukinumab (6 mg/kg at baseline followed by 3 mg/kg every 4 weeks [q4w]) or placebo. At Week 16, patients randomized to placebo were switched to IV secukinumab (3 mg/kg q4w), and patients receiving IV secukinumab continued treatment through Week 52. The primary efficacy endpoint was achievement of American College of Rheumatology (ACR) 50 response at Week 16. Efficacy and safety were evaluated through Weeks 52 and 60, respectively. RESULTS Among 191 patients randomized to IV secukinumab and 190 to placebo/IV secukinumab, 177 (92.7%) and 170 (89.5%) completed the entire study period, respectively. A significantly higher proportion of patients receiving IV secukinumab vs placebo achieved ACR50 at Week 16 (31.4% vs 6.3%; adjusted P<.0001). All secondary efficacy endpoints were met at Week 16 (all adjusted P<.05 using the predefined hypothesis-testing hierarchy). Patients who switched from placebo to secukinumab at Week 16 showed rapid improvements in ACR50 response rates; by Week 52, both treatment arms experienced similar improvements in efficacy outcomes. No new or unexpected safety signals were observed with IV secukinumab. One death was reported in the placebo group prior to Week 16. CONCLUSION IV secukinumab led to rapid and sustained improvements in clinical measures of PsA, and the safety profile was consistent with that of secukinumab administered subcutaneously.