ACR Meeting Abstracts

ACR Meeting Abstracts

  • Home
  • Meetings Archive
    • ACR Convergence 2021
    • ACR Convergence 2020
    • 2020 ACR/ARP PRSYM
    • 2019 ACR/ARP Annual Meeting
    • 2018 ACR/ARHP Annual Meeting
    • 2017 ACR/ARHP Annual Meeting
    • 2017 ACR/ARHP PRSYM
    • 2016-2009 Meetings
    • Download Abstracts
  • Keyword Index
  • Advanced Search
  • Your Favorites
    • Favorites
    • Login
    • View and print all favorites
    • Clear all your favorites
  • Meeting Resource Center

Abstract Number: 2562

Ustekinumab in Patients with Active Psoriatic Arthritis: Results of the Phase 3, Multicenter, Double-Blind, Placebo-Controlled Psummit I Study

Arthur Kavanaugh1, Iain B. McInnes2, Alice B. Gottlieb3, Lluis Puig4, Proton Rahman5, Christopher T. Ritchlin6, Shu Li7, Yuhua Wang8, Alan Mendelsohn9 and Mittie K. Doyle7, 1UCSD School of Medicine, La Jolla, CA, 2University of Glasgow, Glasgow, United Kingdom, 3Tufts Medical Center, Boston, MA, 4Universitat Autònoma de Barcelona, 5Faculty of Medicine, Memorial University of Newfoundland, St. John's, NF, Canada, 6Allergy, Immunology and Rheumatology, University of Rochester, Rochester, NY, 7Janssen Research & Development, LLC, Spring House, PA, 8Janssen Research & Development, LLC., Spring House, PA, 9Immunology, Janssen Research & Development, LLC, Spring House, PA

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: Psoriatic arthritis

  • Tweet
  • Email
  • Print
Session Information

Session Title: Spondylarthropathies and Psoriatic Arthritis - Clinical Aspects and Treatment: Psoriatic Arthritis

Session Type: Abstract Submissions (ACR)

Ustekinumab in Patients with Active Psoriatic Arthritis: Results of the Phase 3, Multicenter, Double-blind, Placebo-Controlled PSUMMIT I Study

Background/Purpose: To assess efficacy and safety of ustekinumab (UST) in reducing signs and symptoms of active psoriatic arthritis (PsA) in a large, multicenter, double-blind, placebo (PBO)-controlled, Phase 3 trial.

Methods:   Adult PsA pts (n=615) with active disease (≥5 SJC and ≥5 TJC;CRP≥0.3mg/dL) despite DMARD and/or NSAID therapy were randomized to receive UST45mg, 90mg, or PBO at wks 0, 4, and q12wks, thereafter. At wk16, pts with <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 with 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 baseline in enthesitis and dactylitis scores (in pts affected at baseline). Adverse events (AE) are reported through the PBO-controlled period (wk16) and through wk24.

Results: Significantly greater proportions of UST-treated vs PBO–treated pts had ACR20 response at wk24 (Table). Significant improvements were also observed with UST45mg and 90mg for ACR50/70 responses and DAS28-CRP responses at wk24 vs PBO. The changes from baseline in HAQ-DI at wk24 were significantly greater in the UST than PBO grp, and significantly greater proportions of UST-treated pts had a clinically meaningful change from baseline in HAQ-DI (≥0.3). Nearly half used concomitant MTX at baseline; this did not alter the likelihood of benefit of UST vs PBO. While ACR responses were greater with UST than PBO regardless of MTX use, differences were numerically larger among pts not taking MTX. Of 440pts with ≥3% BSA involvement at baseline, significantly larger proportion of UST pts achieved PASI 75 at wk24. Among pts affected with enthesitis (n=425) or dactylitis (n=286) at baseline, significantly greater improvements in enthesitis and dactylitis were observed at wk24 in the UST grp than PBO. Through wk16, the proportion of pts with ≥1 AE was similar between pts receiving UST(41.8%) and PBO (42.0%), with 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.

 

Conclusion: In pts with active PsA, UST significantly 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:  PSUMMIT efficacy results at Wk 24

 

PBO (n=206)

UST 45mg (n=205)

UST 90mg (n=204)

ACR20, %

ACR50, %

ACR70, %

DAS28-CRP response, %

Median HAQ-DI change from baseline

Pts with ≥0.3 reduction, %

PASI75*, %

Median % change in enthesitis score*

Median % change in dactylitis score*

22.8

8.7

2.4

34.5

-0.0

28.2

11.0

0.0

0.0

42.4

24.9

12.2

 65.9

-0.3

47.8

57.2

-42.9

-75.0

49.5

27.9

14.2

 67.6

-0.3

47.5

62.4

-50.0

-70.8

*Among pts affected at baseline.; p<0.001 for all parameters vs PBO

 


Disclosure:

A. Kavanaugh,

Janssen Research and Development, LLC,

9;

I. B. McInnes,

Janssen Research and Development, LLC,

9;

A. B. Gottlieb,

Janssen Research and Development, LLC,

9;

L. Puig,

Janssen Research and Development, LLC,

9;

P. Rahman,

Janssen Research and Development, LLC,

9;

C. T. Ritchlin,

Janssen Research and Development, LLC,

9;

S. Li,

Janssen Research and Development, LLC,

3;

Y. Wang,

Janssen Research and Development, LLC,

3;

A. Mendelsohn,

Janssen Research & Development, LLC,

3;

M. K. Doyle,

Janssen Research and Development, LLC,

3.

  • Tweet
  • Email
  • Print

« Back to 2012 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/ustekinumab-in-patients-with-active-psoriatic-arthritis-results-of-the-phase-3-multicenter-double-blind-placebo-controlled-psummit-i-study/

Advanced Search

Your Favorites

You can save and print a list of your favorite abstracts during your browser session by clicking the “Favorite” button at the bottom of any abstract. View your favorites »

ACR Pediatric Rheumatology Symposium 2020

© COPYRIGHT 2022 AMERICAN COLLEGE OF RHEUMATOLOGY

Wiley

  • Home
  • Meetings Archive
  • Advanced Search
  • Meeting Resource Center
  • Online Journal
  • Privacy Policy
  • Permissions Policies