SAN FRANCISCO, CA—Golimumab was well tolerated and effective in reducing symptom severity and improving disease outcomes in patients with ankylosing spondylitis over 12 months, a Canadian longitudinal study reported at the 2015 ACR/ARHP Annual Meeting.
The efficacy and tolerability of golimumab for patients with ankylosing spondylitis has been established in controlled clinical trials but “it is essential to assess the real-life effectiveness of therapeutic interventions in order to demonstrate true population-based benefits,” explained Denis Choquette, MD, from University of Montreal, Montreal, Quebec, Canada, and colleagues.
To describe the real-life efficacy of golimumab in a clinical practice setting, the investigators analyzed 206 patients with ankylosing spondylitis treated since 2010 who were enrolled in the ongoing, prospective Biologic Treatment Registry Across Canada (BioTRAC). The registry contains data on patients initiating treatment for rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis with infliximab or golimumab.
They obtained clinical outcome measures and patient reported outcomes over 12 months of treatment. Safety was calculated by incidence of adverse events per 100 patient-years.
Mean age of the patients was 45.6 years; 61.2% were male. Disease duration since diagnosis was 5.7 years and 93.2% were biologic naïve.
“After 6 months of treatment, statistically significant (P<0.001) and clinically meaningful improvements were observed for all disease parameters and were sustained over 12 months of treatment (P<0.001),” the investigators reported.
Clinically important improvement in Ankylosing Spondylitis Disease Activity Score (ASDAS; change ≥1.1) by 6 and 12 months was 46.6% and 40.0%, respectively. Major improvement (change ≥2.0) was achieved by 13.8% and 25.0%, respectively.
The proportion of patients who achieved ASDAS inactive disease (ASDAS <1.3) increased from 2.6% at baseline to 21.2% at 12 months; very high disease activity (ASDAS >3.5) decreased from 44.4% to 21.2%.
A total of 282 adverse events (215.8 events per 100 patient-years) was reported by 51% of patients, and 23 serious adverse events (17.6 events per 100 patient-years) by 9.7% of patients.
“The incidence of serious infections and malignancies were 2 (1.5 events per 100 patients-years) and 1 (0.8 events per 100 patient-years), respectively,” they concluded, adding, “there were no deaths reported during the course of the study.”