Subcutaneous tocilizumab in rheumatoid arthritis : findings from the common-framework phase 4 study programme TOZURA conducted in 22 countries
dc.contributor.author | Choy, Ernest | pt_BR |
dc.contributor.author | Caporali, Roberto | pt_BR |
dc.contributor.author | Xavier, Ricardo Machado | pt_BR |
dc.contributor.author | Fautrel, Bruno | pt_BR |
dc.contributor.author | Sanmarti, Raimon | pt_BR |
dc.contributor.author | Bao, Min | pt_BR |
dc.contributor.author | Bernasconi, Corrado | pt_BR |
dc.contributor.author | Pethö-Schramm, Attila | pt_BR |
dc.date.accessioned | 2019-10-10T03:49:26Z | pt_BR |
dc.date.issued | 2018 | pt_BR |
dc.identifier.issn | 1462-0324 | pt_BR |
dc.identifier.uri | http://hdl.handle.net/10183/200337 | pt_BR |
dc.description.abstract | 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. | pt_BR |
dc.format.mimetype | application/pdf | pt_BR |
dc.language.iso | eng | pt_BR |
dc.relation.ispartof | Rheumatology (Oxford). Vol. 57, no. 3 (2018), p. 499-507 | pt_BR |
dc.rights | Open Access | en |
dc.subject | Rheumatoid arthritis | en |
dc.subject | Artrite reumatóide | pt_BR |
dc.subject | Biologic therapies | en |
dc.subject | Antirreumáticos | pt_BR |
dc.subject | csDMARDs | en |
dc.subject | Resultado do tratamento | pt_BR |
dc.subject | Tocilizumab | en |
dc.subject | Injeções subcutâneas | pt_BR |
dc.subject | Estudo multicêntrico | pt_BR |
dc.subject | Ensaio clínico | pt_BR |
dc.title | Subcutaneous tocilizumab in rheumatoid arthritis : findings from the common-framework phase 4 study programme TOZURA conducted in 22 countries | pt_BR |
dc.type | Artigo de periódico | pt_BR |
dc.identifier.nrb | 001102407 | pt_BR |
dc.type.origin | Estrangeiro | pt_BR |
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