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Abstract Number: 2866

Effectiveness and Safety of Golimumab in the Treatment of Psoriatic Arthritis over a 12 Month Period

Proton Rahman1, Michel Zummer2, William G Bensen3, Isabelle Fortin4, Dalton Sholter5, Milton F. Baker6, Regan Arendse7, Eliofotisti Psaradellis8, Emmanouil Rampakakis9, Francois Nantel10, Allen J Lehman10, Cathy Tkaczyk11, Karina Maslova10 and Brendan Osborne11, 1Medicine, Memorial University, St John's, NF, Canada, 2Rheumatology, Hôpital Maisonneuve-Rosemont and University of Montreal, Montreal, QC, Canada, 3St Joseph's Healthcare Hamilton, Hamilton, ON, Canada, 4Centre de Rhumatologie de l'Est du Québec, Rimouski, QC, Canada, 5Rheumatology Associates, Edmonton, AB, Canada, 6VIHA, Victoria, BC, Canada, 7University of Saskatchewan, Saskatoon, SK, Canada, 8JSS Medical Research, Montreal, QC, Canada, 9JSS Medical Research, St-Laurent, QC, Canada, 10Janssen Inc., Toronto, ON, Canada, 11Medical Affairs, Janssen Inc., Toronto, ON, Canada

Meeting: ACR/ARHP Annual Meeting 2015

Date of first publication: September 29, 2015

Keywords: ,

Session Information

Date: Tuesday, November 10, 2015

Title: Spondylarthropathies and Psoriatic Arthritis - Clinical Aspects and Treatment Poster III: Therapy

Session Type: ACR Poster Session C

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

Background/Purpose: The efficacy and tolerability of golimumab (GLM) in patients with psoriatic arthritis (PsA) has been demonstrated in several controlled clinical trials. Longitudinal observational studies assessing the real-life effectiveness of anti-TNF agents are essential to demonstrate true population-based benefits. The objective of this analysis was to assess the 12-month outcomes in PsA patients treated with GLM in Canadian routine clinical practice.

Methods: BioTRAC is an ongoing, prospective registry of patients initiating treatment for rheumatoid arthritis, ankylosing spondylitis, or PsA with infliximab or GLM. Eligible participants for this analysis included PsA patients treated with GLM enrolled since 2010.  Descriptive statistics were produced for clinical outcome measures and patient reported outcomes over 12 months. Within-group changes were assessed for statistical significance with the paired-samples Student’s t-test and the McNemar test. Safety was assessed with the incidence of adverse events (AEs)/100 patient-years. 

Results:

There were 151 patients included in this analysis with a mean (SD) age of 51.3 (13.4) years and a disease duration since diagnosis of 4.3 (5.0) years. The proportion of males and females was even (50%). Six-month and 12-month follow-up was available for 109 (72.2%) and 69 (45.7%) patients, respectively. Upon six months of treatment, statistically significant and clinically meaningful improvements were observed for all disease parameters and were sustained over 12 months of treatment. Mean (SD) disease parameters at baseline and 12 months of treatment are shown in Table 1. 

The proportion of patients with minimal disease activity (MDA) was 9.8% at baseline, 52.1% at 6 months, and 50.0% at 12 months. The prevalence of enthesitis decreased from baseline to 12 months from 27.8% to 18.8% (P=0.791), while a considerable decrease was observed for dactylitis from 27.8% to 2.9% (P<0.001), respectively. The incidence of new enthesitis cases and new dactylitis cases at 12 months was 11.1% and 1.9%, respectively.  

A total of 216 AEs (172.6 events/100 patient-years) were reported by 78 (51.7%) patients and 22 serious AEs (SAEs) (17.6 events/100 patient-years) by 12 (7.9%) patients.  The incidence of serious infections and malignancies were 4 (3.2 events/100 patient-years) and 5 (4.0 events/100 patient-years), respectively. There was one death reported during the course of the study judged as not related to GLM by the treating physician.  

Conclusion: The results of this Canadian longitudinal observational study have shown that a significant burden of illness is observed at GLM initiation in PsA patients. Treatment with GLM was well tolerated and effective in reducing symptom severity and improving disease outcomes in PsA patients over 12 months.

Table 1: Disease Parameters Over 12 Months of Treatment with GLM

Disease Parameter, mean (SD) Baseline 12 Months  P-Value
Enthesitis count 1.5 (3.1) 0.8 (2.2) 0.738
Enthesitis count among patients with enthesitis 5.4 (3.8) 4.6 (3.2) 0.093
Dactylitis count 1.3 (3.1) 0.03 (0.17) 0.003
Dactylitis count among patients with dactylitis 4.7 (4.5) 1.0 (1.0) NC
Morning Stiffness, Minutes 34.4 (39.5) 14.3 (21.2) 0.012
SJC28 4.9 (4.2) 0.9 (2.0) <0.001
TJC28 6.9 (6.8) 2.6 (5.0) <0.001
Pain, mm VAS 49.2 (26.3) 26.3 (25.1) <0.001
PtGA, mm VAS 49.3 (26.5) 25.7 (23.0) <0.001
MDGA, 0-10 NRS 4.9 (2.2) 1.7 (1.7) <0.001
HAQ 1.0 (0.7) 0.7 (0.7) 0.003
PASI 2.3 (3.9) 0.6 (1.0) 0.008
DAS28-CRP 4.1 (1.4) 2.5 (1.0) <0.001
NC=not computable
Disclosure: P. Rahman, None; M. Zummer, Janssen Inc, 5; W. G. Bensen, Janssen Inc., 5; I. Fortin, Janssen Inc., 5; D. Sholter, Janssen Inc., 5; M. F. Baker, Janssen Inc., 5; R. Arendse, Janssen Inc., 5; E. Psaradellis, employee of JSS Medical Research, 3; E. Rampakakis, JSS, 3; F. Nantel, Janssen Inc., 3; A. J. Lehman, employee of Janssen Inc., 3; C. Tkaczyk, Janssen Inc., 3; K. Maslova, Employee of Janssen Inc., 3; B. Osborne, Janssen Inc., 3.

To cite this abstract in AMA style:

Rahman P, Zummer M, Bensen WG, Fortin I, Sholter D, Baker MF, Arendse R, Psaradellis E, Rampakakis E, Nantel F, Lehman AJ, Tkaczyk C, Maslova K, Osborne B. Effectiveness and Safety of Golimumab in the Treatment of Psoriatic Arthritis over a 12 Month Period [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/effectiveness-and-safety-of-golimumab-in-the-treatment-of-psoriatic-arthritis-over-a-12-month-period/. Accessed .

ACR Meeting Abstracts - https://acrabstracts.org/abstract/effectiveness-and-safety-of-golimumab-in-the-treatment-of-psoriatic-arthritis-over-a-12-month-period/