ABSTRACT: INTRODUCTION: To evaluate the safety and efficacy of tocilizumab in patients having failed anti-TNFalpha therapy for spondyloarthritis, under real-life conditions. METHODS: French rheumatologists and internal-medicine practitioners registered on the Club Rhumatismes et Inflammations website were asked to report on patients given tocilizumab (4 or 8 mg/Kg) to treat active disease meeting ASAS criteria for axial or peripheral spondyloarthritis, after anti-TNFalpha treatment failure. Safety and efficacy after 3 and 6 months were assessed retrospectively using standardized questionnaires. RESULTS: Data were obtained for 21 patients, 13 with axial spondyloarthritis (46% men; median age, 42 years; disease duration, 11 years; HLA B27-positive, 92.3%) and 8 with peripheral spondyloarthritis (25% men; median age, 40 years; disease duration, 10 years; HLA B27-positive, 62.5%). No patients with axial disease had at least 20 mm decrease in BASDAI neither a BASDAI50 response or major ASDAS improvements after 3 or 6 months; an ASDAS clinically important improvement was noted at month-3 in 5 of 13 patients and at month-6 in 1 of 4 patients. A good DAS28 response was achieved in 4 patients with peripheral disease, including 1 in EULAR remission at month-3. At month-6, 4 patients were still taking tocilizumab including 1 in EULAR remission and 1 with a good DAS28 response. Tocilizumab was well tolerated, with no serious adverse events. Initially elevated acute-phase reactants declined during tocilizumab therapy. CONCLUSION: In patients having failed anti-TNFtherapy, tocilizumab decreased acute-phase reactants but failed to substantially improve axial spondyloarthritis and was inconsistently effective in peripheral spondyloarthritis.
