Tratamiento de la Artritis Reumatoide con Antagonista del Factor de Necrosis Tumoral o Tocilizumab como el Primer Biológico en un Estudio Comparativo Observacional
To date, the comparative efficacy of tocilizumab and TNFi for patients with RA has only been investigated in a single head-to-head trial and network meta-analyses. This study, ACT-iON, is the first prospective, large-scale, global, multicentre, comparative effectiveness study comparing initiation of intravenous tocilizumab with initiation of a TNFi in patients with RA as the first-line biologic treatment after inadequate response to csDMARDs. Patients were observed in a real-world, clinical practice setting.
In this study, tocilizumab-treated patients had greater improvement in DAS28-ESR at Weeks 24 and 52; change from baseline in CDAI and improvement in HAQ-DI were also greater in tocilizumab-treated patients. Patients who initiated tocilizumab had higher drug survival, which may be related to differences observed in clinical effectiveness. The safety profiles were comparable to the safety profiles reported in clinical trials and clinical practice.
ACT-iON was conducted at 158 sites in 26 countries. Clinical effectiveness and safety outcomes of TNFi and tocilizumab were observed for 52 weeks of routine clinical practice after the initiation of first biologic therapy for the treatment of patients with RA. The study included adult patients with moderate to severe RA, of at least 24 weeks’ duration who were csDMARD intolerant or nonresponders. Patients were initiated with TNFi or with tocilizumab treatment according to the local label.
Results of this study should be interpreted with an understanding of the limitation of potential biases associated with observational studies.