In patients with early, active non-radiographic axial spondyloarthritis and suboptimal response to at least two NSAIDs, a regimen of etanercept for 104 weeks appeared to yield lasting improvements in clinical and imaging outcomes, according to recently published findings.
Researchers evaluated 215 adult patients with axial SpA according to the Assessment of Spondyloarthritis International Society (ASAS) classification criteria. Patients had been symptomatic for more than 3 years and fewer than 5 years, and failed to respond to at least two NSAIDs. Patients were randomly allocated to receive double-blind etanercept at 50 mg/week (n=106) or placebo (n=109) for a duration of 12 weeks.
Between weeks 12 and 104, these patients were treated with open-label etanercept 50 mg/week. At 104 weeks, researchers assessed clinical, MRI Spondyloarthritis Research Consortium of Canada [SPARCC] scores and safety outcomes.
At the 104th week, 75% of patients who received etanercept throughout the study duration achieved ASAS20 and 61% of patients who received etanercept throughout achieved ASAS40. ASDAS inactive disease was attained by 60% and a BASDAI 50 response was achieved by 70% of patients.
Between weeks 12 and 104, the etanercept/etanercept group retained a stable or increased percentage of patients who achieved these clinical efficacy endpoints. Between weeks 24 and 104, comparable results were achieved between the etanercept/etanercept group and the placebo group. In an analysis in which patients with missing data were omitted, similar trends were observed in both treatment groups. The open-label treatment period revealed sustained improvements in most non-radiographic and axial SpA signs and symptoms in both the etanercept/etanercept group and the etanercept/placebo group.
Between baseline and the 104th week, the researchers observed continued improvements in both the etanercept/etanercept group and the placebo/etanercept group in terms of clinical outcomes and in SPARCC MRI scores.
After the study, 51% of patients treated with etanercept throughout the double-blind and open-label periods achieved sustained ASDAS remission; 44% achieved MRI sacroiliac joint remission; and 78% attained MRI spine remission.
A total of 79% of patients were affected by a treatment-emergent adverse event (etanercept/etanercept, 79%; placebo/etanercept, 78%). Eight percent of patients experienced serious adverse events (etanercept/etanercept, 8%; placebo/etanercept, 7%) and 6% of patients ceased participation in the study due to treatment-emergent adverse events (etanercept/etanercept, 6%; placebo/etanercept, 5%).
Attaining MRI remission of sacroiliac joint or spine inflammation at any time point was generally not linked to ongoing ASDAS remission or low disease activity.
“The standard dose of adalimumab results in a wide variation of serum concentrations. Part of these patients are overexposed, since adalimumab concentrations above 5 mg/dL do not result in a better treatment response,” study author Merel L’Ami, MSc, told Healio Rheumatology. “This study showed that patients with adalimumab concentrations above 8 mg/dL can extend their dose interval by 1 week. Drug costs can be significantly reduced, and the risk of adverse events can possibly be decreased.”– by Jennifer Byrne
: Please see the study for all other authors’ relevant financial disclosures.