Adalimumab is effective and well tolerated in treating patients with ankylosing spondylitis who have advanced spinal fusion

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 IIII), 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 IIII, 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 IIII, IV and V disease, respectively. Serious infections occurred in three (1) patients with AS Stages IIII 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.