Discontinuation of TNF-alpha Inhibitors in Patients With Spondyloarthritis
Status:
Terminated
Trial end date:
2012-05-01
Target enrollment:
Participant gender:
Summary
Spondylarthropathy (SpA) comprises a group of rheumatic diseases mainly affecting the spine
and sacroiliac joints. In most of the patients disease activity alternates, and some patients
have symptom free periods. Tumor-Necrosis-Factor-alpha (TNF-alpha) antagonists have
significantly improved the treatment options for patients with spondyloarthritis. TNF-alpha
antagonist therapy is costly, implies an increased risk of infections, including reactivation
of tuberculosis, and the risk of long-term adverse events, as cancer, is fully clarified. It
is highly relevant to explore to which extent anti-TNF-alpha therapy can be discontinued in
SpA patients without immediate relapse of disease activity. Two studies have investigated
discontinuation of a TNF-alpha antagonist (infliximab and etanercept) in ankylosing
spondylitis, reporting flares in the majority of patients within the 1-year follow-up period,
with the longest times to relapse in patients with the lowest disease activity. The effect of
adalimumab discontinuation has never been studied, and, furthermore, the effect of
TNF-alpha-antagonist discontinuation has never been studied in patients with early
spondyloarthritis not fulfilling the New York criteria.