Etanercept Shows Sustained Clinical Response Over 10 Years in Early Axial Spondyloarthritis

This study was conducted to assess the long-term clinical efficacy of etanercept in patients with early axial spondyloarthritis, who participated in the ESTHER trial.

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ATLANTA — Over the course of 10 years, a sustained clinical response was seen in patients with early active axial spondyloarthritis (axSpA), including both nonradiographic axial SpA (nr-axSpA) and radiographic axial SpA (r-axSpA), who received etanercept, according to research results presented at the 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting, held November 8 to 13, 2019, in Atlanta, Georgia. Etanercept was seen to be well-tolerated and had a good safety profile in patients with early active axSpA.

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This analysis of the long-term extension of the Etanercept vs Sulfasalazine in Early Axial Spondyloarthritis Trial (ESTHER; Identifier: NCT00844142) was designed to assess the 10-year clinical efficacy of the tumor necrosis factor (TNF) inhibitor etanercept in patients with both nr-axSpA and r-axSpA/ankylosing spondylitis (AS).

At baseline, study patients had a symptom duration of <5 years and a positive magnetic resonance imaging of the spine and/or the sacroiliac joints. In the first year, 40 patients received etanercept and 36 received sulfasalazine; at 12 months, any patient who was not in remission either switched to or continued etanercept for up to 10 years in total. Patients in remission discontinued therapy and were followed-up until the end of year 2, and etanercept was reintroduced and continued until year 10 in cases of remission loss.

Of the 76 initial patients, 25% (n=19, 12 r-axSpA and 7 nr-axSpA) completed the study through year 10. Compared with noncompleters, completers at baseline were significantly more often men and showed lower values of Ankylosing Spondylitis Disease Activity Score (ASDAS), patient and physician global assessments of disease activity, Bath Ankylosing Spondylitis Metrology Index, and Ankylosing Spondylitis Quality of Life Questionnaire.

On analyzing clinical data of completers, researchers found that mean ASDAS, BASDAI, and Bath Ankylosing Spondylitis Functional Index values were constantly <2 during follow-up with no statistically significant differences between patient groups with r-axSpA and nr-axSpA. Sustained clinical response was observed in both groups over 10-year follow-up period.

A total of 39 serious adverse events were observed over the 10 years, with 6 possibly being etanercept-related. These events resulted in 5 patients (1 with lymphoma, 1 with sarcoidosis, 1 with demyelinating neurologic disease, 1 with elevated liver enzymes, and 1 with recurrent minor infections) to discontinue therapy.  

“A sustained clinical response was shown over the 10 years of the study for the completers with comparable rates between r-axSpA and nr-axSpA. [Etanercept] was well-tolerated across the entire treatment period and showed a good safety profile with no new safety signals,” the researchers concluded.

Disclosure: The ESTHER trial was supported by an unrestricted research grant from Pfizer. Please see the original reference for a full list of authors’ disclosures.

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Proft F, Torgutalp M, Weiß A, et al. Long-term clinical outcome of anti-tnf treatment in patients with early axial spondyloarthritis: 10-year data of the etanercept vs. sulfasalazin in early axial spondyloarthritis trial. Presented at: 2019 ACR/ARP Annual Meeting; November 8-13, 2019; Atlanta, GA. Abstract 1491.