ACR Meeting Abstracts

ACR Meeting Abstracts

  • Home
  • Meetings Archive
    • 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
    • Register
    • View and print all favorites
    • Clear all your favorites
  • Meeting Resource Center

Abstract Number: 612

Safety and Effectiveness of Ustekinumab for the Treatment of Psoriatic Arthritis over a 6 Month Period

Regan Arendse1, Anna Jaroszynska2, Derek Haaland3, Pauline Boulos4, Isabelle Fortin5, Raheem Kherani6, Ariel Masetto7, Jonathan Chan8, Eliofotisti Psaradellis9, Melissa Stutz9, Brendan Osborne10, Francois Nantel10 and Allen J Lehman11, 1University of Saskatchewan, Saskatoon, SK, Canada, 2Private practice, Burlington, ON, Canada, 3Rheumatology, Clinical Immunology & Allergy, McMaster University, Barrie, ON, Canada, 4Rheumatology, McMaster University, Hamilton, ON, Canada, 5Centre de Rhumatologie De l’Est du Quebec, Rimouski, QC, Canada, 6University of British Columbia, Richmond, BC, Canada, 7Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada, 8Rheumatology, University of British Columbia, Vancouver, BC, Canada, 9JSS Medical Research, Montreal, QC, Canada, 10Medical Affairs, Janssen Inc., Toronto, ON, Canada, 11Janssen Inc., Toronto, ON, Canada

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: Biologics, PRO, psoriatic arthritis and registry

  • Tweet
  • Email
  • Print
Save to PDF
Session Information

Date: Sunday, November 5, 2017

Session Title: Spondyloarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment Poster I

Session Type: ACR Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose: Ustekinumab (UST) is a fully human immunoglobin monoclonal antibody against interleukin-12 (IL-12) and interleukin-23 (IL-23) that has been proven safe and efficacious for the treatment of PsA in randomized clinical trials. The aim of the current analysis was to assess the safety and effectiveness of UST among PsA patients treated under Canadian routine clinical care.

Methods: BioTRAC is an ongoing, prospective registry of patients initiating treatment with infliximab or golimumab for rheumatoid arthritis, ankylosing spondylitis, or PsA, or with UST for PsA. Eligible participants for this analysis included UST-treated PsA patients enrolled between 2014-2016. Clinical outcomes assessed at Baseline and the Month 6 visit were: SJC, TJC, pain (100mm visual analogue scale; VAS), PtGA and MDGA (100mm VAS), PASI, HAQ-DI, DAS-28, and joint counts for dactylitis and enthesitis. Safety was ascertained by the incidence of adverse events (AEs), reported per 100 patient years (PY) of follow-up. Descriptive statistics were produced for all variables, and between-visit changes in outcomes were assessed for statistical significance with the paired-samples t-test.

Results: A total of 63 UST-treated PsA patients were identified. Mean (SD) age and disease duration at Baseline was 52.8 (11.2) and 5.5 (8.1) years, respectively. A majority of patients were female (63.5 %), and 100.0% were biologic naïve.  Changes from Baseline to Month 6 were statistically significant for all clinical outcomes (p < 0.05), except for the PtGA (Table 1). With respect to enthesitis and dactylitis, missing data did not permit assessment of improvement from baseline to Month 6.  At baseline, 50.9% of patients had some dactylitis and 34.9% had some enthesitis.

Overall, 36 AEs were reported by 21 patients from Baseline to the Month 6 visit. The majority were mild in nature (n=26/36; 72.2%); “probable” and “very likely” relation to the study drug was determined for 11.1% (n=4/36) and 8.3% (n=3/36) of AEs, respectively. The most common AEs included General Disorders and Administration Site Conditions (n=7/21; 33.3%) and Infections and Infestations (n=8/21; 38.1%). No serious AEs were reported.

Table 1. Clinical outcome parameters over time, and changes from Baseline to Month 6

 

Baseline

Month 6

Change†

p-value§

 

Parameter, mean (SD)

 

 

 

 

 

SJC-28

3.8 (3.8)

1.6 (2.1)

-2.7 (6.0)

0.014

 

TJC-28

6.5 (5.6)

3.4 (5.7)

-2.6 (3.6)

<0.001

 

Pain, mm*

55.1 (22.2)

44.6 (27.7)

-11.3 (22.5)

0.008

 

PtGA, mm*

58.2 (22.4)

49.1 (28.3)

-9.7 (33.0)

0.101

 

MDGA, mm*

51.8 (22.9)

23.4 (19.7)

-28.3 (25.5)

<0.001

 

PASI

4.4 (7.2)

0.7 (1.1)

-3.5 (4.7)

<0.001

 

HAQ-DI

1.1 (0.6)

0.8 (0.6)

-0.3 (0.7)

0.019

 

DAS-28

4.0 (1.2)

3.5 (1.2)

-0.5 (0.9)

0.026

 

* 100 mm VAS;  † Based on patients with available Baseline and Month 6 data; § P-value derived from the paired samples t-test

 

Conclusion: The results of this analysis demonstrate that UST, administered to PsA patients in a routine clinical care setting, is safe and effective in improving clinical outcomes over 6 months of treatment.


Disclosure: R. Arendse, None; A. Jaroszynska, None; D. Haaland, None; P. Boulos, None; I. Fortin, None; R. Kherani, None; A. Masetto, None; J. Chan, None; E. Psaradellis, Janssen Inc., 9; M. Stutz, None; B. Osborne, Janssen Inc., 3; F. Nantel, Janssen Inc., 3; A. J. Lehman, Janssen Inc., 3.

To cite this abstract in AMA style:

Arendse R, Jaroszynska A, Haaland D, Boulos P, Fortin I, Kherani R, Masetto A, Chan J, Psaradellis E, Stutz M, Osborne B, Nantel F, Lehman AJ. Safety and Effectiveness of Ustekinumab for the Treatment of Psoriatic Arthritis over a 6 Month Period [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/safety-and-effectiveness-of-ustekinumab-for-the-treatment-of-psoriatic-arthritis-over-a-6-month-period/. Accessed February 25, 2021.
  • Tweet
  • Email
  • Print
Save to PDF

« Back to 2017 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/safety-and-effectiveness-of-ustekinumab-for-the-treatment-of-psoriatic-arthritis-over-a-6-month-period/

Advanced Search

Your Favorites

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

ACR Convergence: Where Rheumatology Meets. All Virtual. November 5-9.

ACR Pediatric Rheumatology Symposium 2020

© COPYRIGHT 2021 AMERICAN COLLEGE OF RHEUMATOLOGY

Wiley

  • Home
  • Meetings Archive
  • Advanced Search
  • Meeting Resource Center
  • Online Journal
  • Privacy Policy
  • Permissions Policies
loading Cancel
Post was not sent - check your email addresses!
Email check failed, please try again
Sorry, your blog cannot share posts by email.
This site uses cookies: Find out more.