Tocilizumab Subcutáneo en Artritis Reumatoide: Resultados del Programa de Marco Común del Estudio Fase 4 TOZURA Conducido en 22 Países
This multi-national TOZURA study programme confirmed the efficacy and safety profile of subcutaneous tocilizumab (TC-SC) when administered as either monotherapy or in combination with csDMARDs.
TOZURA was a Phase 4 study programme that evaluated open-label, TCZ-SC in patients with moderate-to-severe RA. A total of 1804 patients with active RA were enrolled in the study programme. Patients had inadequate responses to csDMARDs, anti-TNF therapies, or they were MTX-naïve. TCZ-SC was administered weekly for 6 months, as either monotherapy (n=353) or combination therapy (n=1451). Clinical efficacy, safety and immunogenicity outcomes were measured throughout the study, and results were compared between therapy groups.
At 6 months, efficacy significantly improved in both therapy groups for all clinical outcomes, including DAS28-ESR and CDAI scores. Efficacy data were similar between TCZ-SC monotherapy and combination therapy patients.
The incidence of adverse and serious adverse events was similar between therapy groups, and consistent with previously published data¹. Immunogenicity was low for both therapy groups – data which have not been previously published for TCZ-SC monotherapy patients.
The authors concluded that TCZ-SC therapy is an efficacious treatment for patients with RA. TCZ-SC monotherapy and combination therapy were similarly effective and safety outcomes were consistent with the known safety profile of TCZ-SC.
¹ Ogata A, et al. Long-term safety and efficacy of subcutaneous tocilizumab monotherapy: results from the 2-year open-label extension of the MUSASHI study. J Rheumatol 2015; 42:799-809.