SAN FRANCISCO, CA—Golimumab appears to have similar drug survival at two years in different chronic arthritides regardless of prior biological disease modifying drug (bDMARD) treatment, results of a multicenter prospective observational study reported at the 2015 ACR/ARHP Annual Meeting.
The group with a higher hazard to discontinue golimumab is female patients with spondyloarthritis with extra-articular manifestations, he noted.
Previous studies had shown that survival of anti-TNF drugs was lower in patients with rheumatoid arthritis (RA), reported Leonardo Santo, MD, DSS4 Barletta, ASL BT Andria-Rheumatology Service, Barletta, Italy.
In this study, Dr. Santo and colleagues investigated golimumab drug retention and its effectiveness in patients with axial spondyloarthritis, psoriatic arthritis, and RA who initiated treatment due to active disease despite prior DMARD or bDMARD therapy. The patients received standard care at 10 rheumatologic centers in Apulia, southern Italy. Also evaluated was the impact of possible baseline predictors.
Primary study endpoint was golimumab drug retention at two years; a secondary end point was clinical outcomes based on Disease Activity Score 28 (DAS28) and reduction in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).
“Time to discontinuation was defined as the time between drug initiation and last administration plus one dispensation interval,” he noted. “Kaplan-Meier curve analysis was used to assess drug retention, and a Cox proportional regression model, adjusting for potential confounders, including prior bDMARD exposure, patient demographics, and disease characteristics, for the analysis of predictors.”
A total of 357 patients were enrolled in the study; 154 had psoriatic arthritis, 80 had RA, and 123 had spondyloarthritis. Of these, 151 (42.3%) were biologic-naïve. Disease duration was 6.7±6 years for psoriatic arthritis, 8.1±7 years for RA, and 7.0±6 for spondyloarthritis.
At two years, crude drug survival rate was 74.8% (21.1±0.5 months) for spondyloarthritis, 67.5% (20.2± 0.8 months) for RA, and 63.6% (18.8±0.6 months) for psoriatic arthritis (not statistically significant).
“Analysis of predictors showed that female gender strongly correlated with golimumab discontinuation (hazard ratio [HR] 3.6, 95% CI: 1.4–9.2), while the lack of extra-articular manifestations was a negative predictor (HR 4.8, 95% CI: 1.1–20.9) for spondyloarthritis patients,” they reported. “No predictors of drug survival for RA and psoriatic arthritis were found.”
Golimumab was found to be effective in all patients, with a significant reduction in DAS28 and BASDAI at 12 and 24 months vs. baseline. For RA, DAS28 values were 5.2±1.3, 3.1±1.2, and 2.9±1.5 at baseline, 12 months, and 24 months. For spondyloarthritis, DAS28 values were 4.2±1.3, 2.9±1.2, and 2.9±1.2, respectively; BASDAI values were 6.1±2.6, 2.8±1.6, and 3.2±2.3, respectively. For psoriatic arthritis, DAS28 values were 4.5±1.1, 3.3±1.3, and 3.1±1.3, respectively; BASDAI values were 6.2±3, 4.4±2.5, and 3.2±1.7, respectively.