Optimise: An Austrian Multicentre Study on the Effectiveness and Safety of Tocilizumab in Combination with Methotrexate versus Tocilizumab for Mild/Moderate Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Background: As data on the efficacy of biologics in patients with mild/moderate rheumatoid arthritis are limited, this study was performed to assess the efficacy and safety of tocilizumab plus methotrexate versus tocilizumab monotherapy on disease activity. Methods: Seventy-seven patients with mild/moderate rheumatoid arthritis and an inadequate response (Disease Activity Score 28 > 3.2) to methotrexate were initially enrolled (mean Disease Activity Score 28 3.91 +/0.54) and received three infusions of tocilizumab 8 mg/kg every 4 weeks plus methotrexate. Subjects achieving a good/moderate European League Against Rheumatism response after three months of open-label treatment were randomised to Group A (tocilizumab plus methotrexate) or Group B (tocilizumab plus placebo methotrexate). The primary endpoint was the Disease Activity Score 28 change from week 12 to 24. The secondary endpoints included the proportion of patients achieving remission according to the Disease Activity Score 28 and various disease activity indices at week 24. Results: Sixty-five patients were included in the blinded trial phase. At week 12, the mean Disease Activity Score 28 was 1.51 in Group A (n = 32) and 1.72 in Group B (n = 33). The Disease Activity Score 28 difference between the groups was not statistically significant (p = 0.19). No substantial differences were seen with regard to the secondary endpoints. Conclusions: Additional tocilizumab treatment led to improvement in patients with mild/moderate rheumatoid arthritis. The study results give no indication that the combination of Tocilizumab with Methotrexate induces a better outcome (preserving the level of disease activity achieved at week 12) in comparison with Tocilizumab monotherapy in patients corresponding to those included into the study.