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.
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|
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 June 4, 2020.
« Back to 2015 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/effectiveness-and-safety-of-golimumab-in-the-treatment-of-psoriatic-arthritis-over-a-12-month-period/