SAN FRANCISCO, CA—Golimumab ameliorated the significant burden of illness observed in psoriatic arthritis at treatment initiation, reducing symptom severity and improving disease outcomes over 12 months, a study of patients in routine clinical practice in Canada presented at the 2015 ACR/ARHP Annual Meeting has found.
To date, several controlled clinical trials have demonstrated the efficacy and tolerability of golimumab in patients with psoriatic arthritis. However, “longitudinal observational studies assessing the real-life effectiveness of anti-TNF agents are essential to demonstrate true population-based benefits,” noted Proton Rahman, MD, Professor of Medicine, Rheumatology, at Memorial University in St John’s, Newfoundland, Canada, in explaining the rationale for the study.
Dr. Rahman and colleagues interrogated BioTRAC, an ongoing prospective registry of patients initiating treatment for rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis with infliximab or golimumab, and included 151 patients with psoriatic arthritis who were treated with golimumab and enrolled since 2010.
“Descriptive statistics were produced for clinical outcome measures and patient reported outcomes over 12 months,” he noted. Paired-samples Student’s t-test and the McNemar test were used to assess within-group changes for statistical significance, and safety was assessed with the incidence of adverse events per 100 patient-years.
Mean age of the patients was 51.3 years and disease duration since diagnosis, 4.3 years; 50% were male.
Six-month follow-up was available for 109 patients (72.2%), and 12-month follow-up for 69 (45.7%).
At six months of treatment, “statistically significant and clinically meaningful improvements were observed for all disease parameters and were sustained over 12 months of treatment,” Dr. Rahman reported.
This included morning stiffness (minutes) (P=0.012), 28 swollen joint count (SJC28) (P<0.001), 28 tender joint count (TJC28) (P<0.001), pain (P<0.001), Patient Global Assessment of Disease Activity (PtGA) (P<0.001), physician global assessment of disease activity (MDGA) (P<0.001), Health Assessment Questionnaire (HAQ) (P=0.003), Psoriasis Area and Severity Index (PASI) (P=0.008), and Disease Activity Score 28-C-Reactive Protein (DAS28-CRP) (P<0.001).
“The proportion of patients with minimal disease activity was 9.8% at baseline, 52.1% at 6 months, and 50.0% at 12 months,” he stated. In addition, enthesitis prevalence decreased from 27.8% to 18.8% from baseline to 12 months (P=0.791) as well as a notable decrease in prevalence of dactylitis from 27.8% to 2.9% (P<0.001), respectively.
Golimumab was well tolerated and effective in lowering the severity of symptoms and improving disease outcomes in this cohort of patients over 12 months, concluded study authors.