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

Session Information

Date: Sunday, November 5, 2017

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 .

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