Rheumatology Advance Access originally published online on March 1, 2009
Rheumatology 2009 48(5):551-557; doi:10.1093/rheumatology/kep022
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Adalimumab is effective and well tolerated in treating patients with ankylosing spondylitis who have advanced spinal fusion
1Medical Department I, Rheumatology, Charité, Campus Benjamin Franklin Hospital, Berlin, Germany, 2Ospedale San Carlo di Potenza, Potenza, Italy, 3Sismanoglio Hospital, Athens, Greece, 4Medisch Centrum Leeuwarden, Leeuwarden, The Netherlands, 5Kiljava Medical Research, Hyvinkää, Finland, 6Abbott Laboratories, Parsippany, NJ, USA and 7Abbott GmbH & Co KG, Ludwigshafen, Germany.
Correspondence to: Martin Rudwaleit, Medical Department I, Rheumatology, Charité, Campus Benjamin Franklin Hospital, Hindenburgdamm 30, 12200 Berlin, Germany. E-mail: martin.rudwaleit{at}charite.de
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Abstract |
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Objectives. To evaluate the effectiveness and safety of adalimumab in treating patients with AS and advanced structural damage.
Methods. Patients with active AS [Bath AS Disease Activity Index (BASDAI) 
4] received 40 mg of adalimumab every other week plus their standard anti-rheumatic therapies in this 12-week, open-label study. Investigators documented the presence or absence of advanced ankylosis based on previous radiographs. Stages IV (from 50 to <80% involvement in more than two spinal segments) and V (80% spinal involvement, including bamboo spine) disease were considered as advanced AS. Effectiveness parameters included Assessment of SpondyloArthritis international Society (ASAS) criteria, BASDAI response and achievement of optimal sleep. Adverse events were reported throughout therapy and at a 70-day follow-up.
Results. The analysis population included 897 patients whose AS was not advanced (i.e. Stages I–III), 31 with Stage IV disease and 41 with Stage V disease. At Week 12, ASAS40/BASDAI 50 responses were achieved by 54%/57% of patients with AS Stages I–III, 48%/58% with AS Stage IV and 54%/66% with AS Stage V, respectively. ASAS partial remission rates were 30, 26 and 7% for patients with Stages I–III, IV and V disease, respectively. Serious infections occurred in three (<1%) patients with AS Stages I–III and in one (1%) patient with AS Stage V.
Conclusions. After 12 weeks of adalimumab therapy, patients with advanced but active AS, including those with structural damage of 80% of the vertebrae, achieved improvements in signs and symptoms similar to those attained by patients whose AS was not advanced.
KEY WORDS: Adalimumab, Ankylosing spondylitis, TNF antagonist, Advanced ankylosis, Total spinal ankylosis
Submitted 9 September 2008;
revised version accepted 19 January 2009.
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