Subcutaneous tocilizumab in rheumatoid arthritis : findings from the common-framework phase 4 study programme TOZURA conducted in 22 countries

• Autor(a) principal: Choy, Ernest
• Data de Publicação: 2018
• Outros Autores: Caporali, Roberto, Xavier, Ricardo Machado, Fautrel, Bruno, Sanmarti, Raimon, Bao, Min, Bernasconi, Corrado, Pethö-Schramm, Attila
• Tipo de documento: Artigo
• Idioma: eng
• Título da fonte: Repositório Institucional da UFRGS
• Texto Completo: http://hdl.handle.net/10183/200337
• topic: Artrite reumatóide; Antirreumáticos; Resultado do tratamento; Injeções subcutâneas; Estudo multicêntrico; Ensaio clínico; Rheumatoid arthritis; Biologic therapies; csDMARDs; Tocilizumab

Objectives. The aim of this pooled analysis of the TOZURA study programme was to evaluate the efficacy and safety of subcutaneous tocilizumab (TCZ-SC) as monotherapy or in combination with conventional synthetic DMARDs (csDMARDs) in patients with moderate to severe RA who had an inadequate response to csDMARD or anti-TNF agent therapy or who were MTX naı¨ve. Methods. TOZURA is a multinational, open-label, single-arm, common-framework, phase 4 study programme (11 protocols, 22 countries). Patients received TCZ-SC 162 mg each week for 524 weeks, administered at the investigator’s discretion, as monotherapy or in combination with a csDMARD. Efficacy, safety and immunogenicity were evaluated; propensity scorebased matching was used for between-group comparisons. Results. Of 1804 patients, 353 (19.6%) received monotherapy and 1451 (80.4%) received combination therapy. The 28-joint DAS using ESR (DAS28-ESR) in both groups decreased significantly from baseline to week 24 (mean change: monotherapy 3.40, combination therapy 3.46), with no significant difference between groups (P = 0.46). The proportion of patients who achieved DAS28-ESR or Clinical Disease Activity Index remission or ACR 20/50/70/90 responses was similar between groups. Overall, 13.9% of patients withdrew—6.2% for safety reasons and 1.6% for insufficient therapeutic response; 5.8% of patients experienced one or more serious adverse events [14.6/100 patient-years (PY)]; six deaths occurred (0.64/100 PY). Conclusion. In a common framework of 11 studies in 22 countries, this phase 4 study programme confirmed TCZ-SC’s known efficacy and safety profile with comparable effects as monotherapy and in combination with csDMARDs.