Ustekinumab in patients with active psoriatic arthritis: Results of the phase 3, multicenter, double-blind, placebo-controlled psummit I study

Objectives To assess efficacy and safety of UST in reducing signs and symptoms of active PsA in a large, multicenter, double-blind, placebo (PBO)-controlled, Ph3 trial. Methods Adult PsA pts (n=615) w/ active disease (≥5 SJC and ≥5 TJC; CRP≥0.3mg/dL) despite DMARD and/or NSAIDs were randomized to UST45mg, 90mg, or PBO at wks 0, 4, and q12wks, thereafter. At wk16, pts w/ <5% improvement in TJC & SJC entered blinded early escape (PBO$→ $UST45mg; UST45mg→90mg; 90mg→90mg). Stable concomitant MTX use was permitted but not mandated. Pts treated w/ prior anti-TNF agents were excluded. Primary endpoint was ACR20 response at wk24. Secondary endpoints at wk24 included: ACR 50/70, DAS28-CRP response, change from baseline (BL) in HAQ-DI, PASI75 response (in pts w/ ≥3% BSA involvement), and percent change from BL in enthesitis and dactylitis scores (in pts affected at BL). AEs are reported through the PBO-controlled period (wk16) and through wk24. Results Sig greater proportions of UST-than PBO-treated pts had ACR20 response at wk24 (Table). Sig improvements were also observed w/ UST45mg and 90mg for ACR50/70 responses and DAS28-CRP responses at wk24 vs PBO. The changes from BL in HAQ-DI at wk24 were sig greater in the UST than PBO grp, and sig greater proportions of UST-treated pts had a clinically meaningful change from BL in HAQ-DI (≥0.3). Nearly half used concomitant MTX at BL; this did not alter the likelihood of benefit of UST vs PBO. While ACR responses were greater w/ UST than PBO regardless of MTX use, differences were numerically larger among pts not taking MTX. Of 440pts w/ ≥3% BSA involvement at BL, sig larger proportion of UST pts achieved PASI 75 at wk24. Among pts affected w/ enthesitis (n=425) or dactylitis (n=286) at BL, sig greater improvements in enthesitis and dactylitis were observed at wk24 in the UST grp than PBO. Through wk16, the proportion of pts w/ ≥1 AE was similar between pts receiving UST (41.8%) and PBO (42.0%), w/ infections being the most common AE; 1.7% (UST) and 2.0% (PBO) had ≥1 serious AE. No malignancies, serious infections, TB, opportunistic infections, or deaths occurred through wk24. Conclusions In pts w/ active PsA,UST sig reduced the signs and symptoms of arthritis, improved physical function, enthesitis and dactylitis and improved plaque psoriasis vs PBO-treated pts at wk24. Safety profiles were similar between UST-and PBO-treated pts. (Table Presented).