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OP0158 Ustekinumab in patients with active psoriatic arthritis: Results of the phase 3, multicenter, double-blind, placebo-controlled psummit I study
  1. I.B. McInnes1,
  2. A. Kavanaugh2,
  3. A.B. Gottlieb3,
  4. L. Puig4,
  5. P. Rahman5,
  6. C. Ritchlin6,
  7. S. Li7,
  8. Y. Wang7,
  9. A.M. Mendelsohn7,
  10. M.K. Doyle7,8
  11. on behalf of the PSUMMIT I Study Group
  1. 1U Glasgow, Scotland, United Kingdom
  2. 2U California, San Diego, CA
  3. 3Tufts Med Cntr, Boston, MA, United States
  4. 4Universitat Autònoma de Barcelona, Barcelona, Spain
  5. 5Memorial U, NL, Canada
  6. 6U Rochester, Rochester, NY
  7. 7Janssen R&D, Spring House, PA
  8. 8U Penn, Philadelphia, PA, United States

Abstract

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.

Disclosure of Interest I. McInnes Grant/Research support from: Investigators for Janssen Research & Development, LLC sponsored clinical study, A. Kavanaugh Grant/Research support from: Investigators for Janssen Research & Development, LLC sponsored clinical study, A. Gottlieb Grant/Research support from: Investigators for Janssen Research & Development, LLC sponsored clinical study, L. Puig Grant/Research support from: Investigators for Janssen Research & Development, LLC sponsored clinical study, P. Rahman Grant/Research support from: Investigators for Janssen Research & Development, LLC sponsored clinical study, C. Ritchlin Grant/Research support from: Investigators for Janssen Research & Development, LLC sponsored clinical study, S. Li Employee of: Janssen Research & Development, LLC, Y. Wang Employee of: Janssen Research & Development, LLC, A. Mendelsohn Employee of: Janssen Research & Development, LLC, M. Doyle Employee of: Janssen Research & Development, LLC

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