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Etanercept Showing Short-Term Efficacy in Undifferentiated Spondyloarthritis

Anti-tumour necrosis factor-alpha (TNF-alpha) etanercept may be useful in patients with active undifferentiated spondyloarthritis (uSpA), according to the results of a recently published study. The researchers also noted that patients with various manifestations of the disease all appeared to respond equally well.

Ten patients in a severe or active stage of uSpA, according to modified European Spondylarthropathy Study Group Criteria, were enrolled into this open label trial undertaken by Jan Brandt, MD, and colleagues from the Free University in Berlin, Germany. The patients received etanercept, 25 mg, twice a week for 12 weeks and were followed for up to 12 additional weeks. Participants were assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the BAS Functional Index (BASFI), pain on a numerical scale, the Funktionsfragebogen Hannover (FFbH) assessment of functional disability and the Medical Outcome Study Short Form- 36 (SF-36). They defined the primary outcome of concern as greater than or equal to 50% improvement in the BASDAI.

Nine of the 10 patients originally enrolled were available for follow up through week 24. Treatment with etanercept resulted in a greater than or equal to 50% regression of disease activity as measured by the BASDAI in 60% of the patients. The mean BASDAI fell from 6.1 at baseline to 3.5 at week 12 (P = .01). The BASDFI improved by at least 20% in all but 2 patients with the mean values decreasing significantly from 5.7 to 3.7 at week 12 (P = .006). Mean pain value and disability as measured by the FFbH improved indicating an improvement in function.

The patients were subdivided into 3 groups related to baseline findings. The groups included those with inflammatory back pain (IBP), those with IBP and peripheral arthritis and those with peripheral arthritis without axial disease. Although the BASDAI declined in those with IBP alone, the response was limited by 2 of 4 patients in this category who did not respond to treatment. Those with IBP and peripheral arthritis showed a decrease in mean BASDAI from 6.4 to 2.8. The lone patient with isolated peripheral polyarthritis also improved markedly.

Eight of the 10 patients improved by at least 20% on the pain scale and their data were used to estimate the time-to-relapse after stopping treatment. Four of the 8 patients relapsed within 3 months and an additional 3 relapsed later. The mean time to relapse was 4.5 weeks.

"Our data from an open-label study suggests that etanercept is effective in a majority of patients with uSpA," wrote Dr. Brandt. "In the present trial, we report that the various disease manifestations of patients with uSpA respond equally well to therapy with etanercept."

J Rheumatol 2004 Mar;31:531-8. "Successful Short Term Treatment of Patients with Severe Undifferentiated Spondyloarthritis with the Anti-Tumor Necrosis Factor-a Fusion Receptor Protein Etanercept"

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