Outcomes of a multicentre randomised clinical trial of etanercept to treat ankylosing spondylitis

Objective: A double blind, randomised, placebo controlled study to evaluate the safety and efficacy of etanercept to treat adult patients with ankylosing spondylitis (AS). Methods: Adult patients with AS at 14 European sites were randomly assigned to 25 mg injections of etanercept or placebo twice w...

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Published in:Annals of the rheumatic diseases 2004-12, Vol.63 (12), p.1594-1600
Main Authors: Calin, A, Dijkmans, B A C, Emery, P, Hakala, M, Kalden, J, Leirisalo-Repo, M, Mola, E M, Salvarani, C, Sanmartí, R, Sany, J, Sibilia, J, Sieper, J, van der Linden, S, Veys, E, Appel, A M, Fatenejad, S
Format: Article
Language:English
Subjects:
Adult
ankylosing spondylitis
Antirheumatic Agents - adverse effects
Antirheumatic Agents - therapeutic use
ASAS
Assessments in Ankylosing Spondylitis
Back pain
BASDAI
BASFI
Bath Ankylosing Spondylitis Disease Activity Index
Bath Ankylosing Spondylitis Functional Index
Biological and medical sciences
biological treatment
C reactive protein
C-Reactive Protein - metabolism
CRP
Disease
disease modifying antirheumatic drugs
Diseases of the osteoarticular system
DMARDs
Double-Blind Method
erythrocyte sedimentation rate
ESR
Etanercept
Extended Report
Female
Humans
Immunoglobulin G - adverse effects
Immunoglobulin G - therapeutic use
Immunoglobulins
Immunologic Factors - adverse effects
Immunologic Factors - therapeutic use
Immunomodulators
Inflammation
Inflammatory joint diseases
Male
Medical sciences
Middle Aged
non-steroidal anti-inflammatory drugs
NSAIDs
Patients
Pharmacology. Drug treatments
PsA
psoriatic arthritis
Receptors, Tumor Necrosis Factor - therapeutic use
Rheumatoid arthritis
Severity of Illness Index
Spine - physiopathology
Spondylitis, Ankylosing - drug therapy
Spondylitis, Ankylosing - physiopathology
TNFα
Treatment Outcome
Tumor necrosis factor-TNF
tumour necrosis factor inhibitors
tumour necrosis factor α
VAS
visual analogue scale
Working groups
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Summary:Objective: A double blind, randomised, placebo controlled study to evaluate the safety and efficacy of etanercept to treat adult patients with ankylosing spondylitis (AS). Methods: Adult patients with AS at 14 European sites were randomly assigned to 25 mg injections of etanercept or placebo twice weekly for 12 weeks. The primary efficacy end point was an improvement of at least 20% in patient reported symptoms, based on the multicomponent Assessments in Ankylosing Spondylitis (ASAS) response criteria (ASAS 20). Secondary end points included ASAS 50 and ASAS 70 responses and improved scores on individual components of ASAS, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), acute phase reactants, and spinal mobility tests. Safety was evaluated during scheduled visits. Results: Of 84 patients enrolled, 45 received etanercept and 39 received placebo. Significantly more etanercept patients than placebo patients responded at the ASAS 20 level as early as week 2, and sustained differences were evident up to week 12. Significantly more etanercept patients reported ASAS 50 responses at all times and ASAS 70 responses at weeks 2, 4, and 8; reported lower composite and fatigue BASDAI scores; had lower acute phase reactant levels; and had improved spinal flexion. Etanercept was well tolerated. Most adverse events were mild to moderate; the only between-group difference was injection site reactions, which occurred significantly more often in etanercept patients. Conclusions: Etanercept is a well tolerated and effective treatment for reducing clinical symptoms and signs of AS.
ISSN:0003-4967
1468-2060
DOI:10.1136/ard.2004.020875