Objective: To evaluate the effectiveness and safety of tocilizumab (TCZ) in patients with rheumatoid arthritis (RA) in clinical practice, establishing the optimized regimen and switching from intravenous (IV) to subcutaneous (SC) therapy.
Material and methods: Retrospective observational study. We included 53 RA patients treated with TCZ. The main outcome was TCZ effectiveness at week 24. Secondary outcome variables included effectiveness at week 52, therapeutic maintenance, physical function and safety. The effectiveness of optimization and the switch from IV to SC was evaluated at 3 and 6 months. The efficacy was measured with the Disease Activity Score. Paired t-tests or Wilcoxon were used to evaluate effectiveness and survival time using Kaplan-Meier.
Results: The proportion of patients who achieved remission or low disease activity at weeks 24 and 52 was 75.5% and 87.3%, respectively. The mean retention time (95% confidence interval [95% CI] was 81.7 months [76.6-86.7]). Twenty-one of 53 patients (39.6%) optimized the TCZ dose and 35 patients switched from IV TCZ to SC, with no changes in effectiveness. The adverse event rate was 13.6 events/100 patient-years.
Conclusions: Tocilizumab appears to be effective and safe in RA in clinical practice. The optimized regimen appears to be effective in most patients in remission, even when they change from IV to SC.
Keywords: Anti-IL-6 antibody; Anticuerpo anti-IL-6; Anticuerpo monoclonal humanizado; Artritis reumatoide; Cambio de formulación; Disease-modifying antirheumatic drugs; Efectividad; Effectiveness; Fármacos modificadores de la enfermedad biológicos; Humanized monoclonal antibody; Optimización; Optimization; Rheumatoid arthritis; Safety; Seguridad; Switching formulation; Tocilizumab.
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