All patients fulfilled the 1984 modified New York criteria and were treated continuously with etanercept (2 × 25 mg s.c./week) for a total of seven years.
#INTACEPT INJECTION 25 MG TRIAL#
After the placebo-controlled phase of this trial and treatment discontinuation, all patients ( n = 26) entered the open-label phase of the study if they had experienced a clinical relapse defined as a Bath AS disease activity index (BASDAI, ) ≥4 and a score of ≥4 on a 0 to 10 numeric rating scale (NRS) for spinal pain. The local ethics committees of the universities of Berlin and Muenster approved the initial study and the present extension, and patients gave written informed consent before participation. This is the first report on clinical efficacy and safety of continuous treatment with etanercept over seven years in patients with established AS. Similar data were reported also from other authors after two or five years of follow-up. Īfter our first report from a placebo-controlled study of over three months with successful etanercept treatment in patients with initially active AS, and also successful and safe re-administration after treatment discontinuation (due to lack of medication at that time), we reported the clinical experience of the efficacy and safety of continuous therapy with etanercept over two years. In parallel, a significant decrease of inflammatory lesions in the sacroiliac joints and the spine as detected by magnetic resonance imaging (MRI) was detected as early as six weeks after the start of treatment. The efficacy of the recombinant 75 kD-TNF receptor IgG1 fusion protein etanercept has been demonstrated in clinical studies with patients with active AS, showing a significant decrease of disease activity already after the first two weeks of treatment. Non-steroidal anti-inflammatory drugs (NSAIDs) are considered first-line therapy in AS, while for patients with no response to NSAIDs treatment with anti-tumor necrosis factor (TNF)-α is the only alternative. There is no evidence that disease modifying anti-rheumatic drugs (DMARDs) work in axial manifestations of AS with the exception of sulfasalazine, which has some efficacy in AS patients with peripheral symptoms. Therapeutic options for patients suffering from AS have been limited over the last decades. The socioeconomic burden of AS patients is substantial since absence from work and work disability are increased by three-fold. AS affects young patients and frequently starts in the third decade of life, being initially characterized by inflammation of the axial skeleton but also by new bone formation in later stages. Trial RegistrationĪnkylosing spondylitis (AS), the prototype and the most severe form of the spondyloarthritides (SpA), is a frequent chronic inflammatory rheumatic disease with a prevalence of 0.1% to 1.1%. After seven years, more than half of the initially treated patients remained on anti-TNF therapy, and one-third were in partial remission. This study confirms the clinical efficacy and safety of etanercept in patients with active AS over seven years of continuous treatment. No other clinical parameter at baseline could predict any long-term outcome. Patients who completed the study had lower baseline Bath AS function index (BASFI) scores vs.
From the 10 dropouts, only 5 patients discontinued treatment due to adverse events.
Mean Bath AS activity index (BASDAI) scores, which were elevated at baseline (6.3 ± 0.9), showed constant improvement and remained low: 3.1 ± 2.5 at two years and 2.5 ± 2.2 at seven years, while ASDAS also improved (3.9 ± 0.7 at baseline, 1.8 ± 0.9 at two years, 1.6 ± 0.8 at seven years), all P <0.001. In the completer analysis, 31% patients were in ASAS partial remission at seven years, while 44% patients showed an ASDAS inactive disease status. Overall, 21/26 patients (81%) completed two years of treatment and 16/26 patients (62%) completed seven years. AS disease activity scores (ASDAS) for status and improvement were compared to conventional outcome measures. The primary outcome was the proportion of patients in the Spondyloarthritis International Society (ASAS) partial remission at seven years. The clinical response was assessed by standardized parameters. Overall, 26 patients with active AS were initially treated with etanercept 2 × 25 mg s.c./week with no concomitant disease modifying anti-rheumatic drugs (DMARDs) or steroids. This is the first report on continuous treatment with the TNFα fusion protein etanercept over seven years (y).
Data from clinical studies on the long-term efficacy and safety of anti-tumor necrosis factor (TNF)-α therapy in patients with ankylosing spondylitis (AS) are scarce.
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