medwireNews: Patients with non-radiographic axial spondyloarthritis (nr-axSpA) who are treated with etanercept continue to experience benefits over 2 years of treatment, follow-up study results suggest.
In the EMBARK trial, patients with early, active nr-axSpA who failed to respond to nonsteroidal anti-inflammatory (NSAID) treatment were randomly assigned to receive either double-blind etanercept 50 mg/week or placebo for 12 weeks, followed by an open-label period during which all patients received etanercept for 92 weeks.
Previous analysis at the 12-week timepoint showed that patients treated with etanercept experienced a significant improvement in clinical symptoms and markers of inflammation compared with placebo-treated patients, explain the study authors in Arthritis Care & Research.
After 104 weeks of follow-up, 75% of 81 patients who received etanercept throughout the double-blind and open-label periods experienced at least a 20% improvement according to the Assessment in Ankylosing Spondylitis Response Criteria (ASAS20) and 61% achieved a 40% improvement. In addition, 60% had inactive disease as indicated by an Ankylosing Spondylitis Disease Activity Score of less than 1.3 points.
From week 12 to week 104, the proportion of patients receiving etanercept throughout the study who experienced these endpoints remained stable or increased, whereas patients originally assigned to the placebo group experienced similar improvements to those in the etanercept group from week 24 onwards.
The team also observed a sustained reduction in inflammation over the study period. The number of patients in the etanercept group with elevated levels of C-reactive protein (>3 mg/L) decreased from 45% at baseline to 21% at week 104, with a corresponding decrease from 41% to 21% among those originally assigned to placebo.
In all, 79% of patients receiving etanercept and 78% of those receiving placebo in the double-blind period experienced a treatment-emergent adverse event over the 104-week follow-up. The three most common adverse events in both groups were nasopharyngitis, diarrhea, and upper respiratory tract infection, experienced by a respective 23%, 10%, and 9% of patients receiving etanercept throughout the study and by 20%, 8%, and 12% of those originally assigned to placebo.
Although Maxime Dougados (Cochin Hospital, Paris, France) and colleagues note that the follow-up study was limited by its open-label design, they conclude that “these findings support the long-term safety and efficacy of etanercept therapy in patients with early, active nr-axSpA who had an inadequate response to NSAIDs.”
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