title: Adalimumab is effective and well tolerated in treating patients with ankylosing spondylitis who have advanced spinal fusion.
abstract: OBJECTIVE
  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) > or =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 (> or =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 > or =80% of the vertebrae, achieved improvements in signs and symptoms similar to those attained by patients whose AS was not advanced.
authors.affiliation: Medical Department I, Rheumatology, Charité, Campus Benjamin Franklin Hospital, Berlin, Germany. martin.rudwaleit@charite.de
authors.forename: Martin
authors.initials: M
authors.lastname: Rudwaleit
authors.forename: Ignazio
authors.initials: I
authors.lastname: Olivieri
authors.forename: Kyriaki A
authors.initials: KA
authors.lastname: Boki
authors.forename: Eduard N
authors.initials: EN
authors.lastname: Griep
authors.forename: Pentti
authors.initials: P
authors.lastname: Järvinen
authors.forename: Robert L
authors.initials: RL
authors.lastname: Wong
authors.forename: Martina
authors.initials: M
authors.lastname: Kron
authors.forename: Sonja
authors.initials: S
authors.lastname: Kary
authors.forename: Hartmut
authors.initials: H
authors.lastname: Kupper
mesh_terms: D000068879:Adalimumab; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011859:Radiography; D012720:Severity of Illness Index; D013167:Spondylitis, Ankylosing / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D014409:Tumor Necrosis Factor-alpha; D000068879:Adalimumab