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dc.contributor.authorChoy, Ernestpt_BR
dc.contributor.authorCaporali, Robertopt_BR
dc.contributor.authorXavier, Ricardo Machadopt_BR
dc.contributor.authorFautrel, Brunopt_BR
dc.contributor.authorSanmarti, Raimonpt_BR
dc.contributor.authorBao, Minpt_BR
dc.contributor.authorBernasconi, Corradopt_BR
dc.contributor.authorPethö-Schramm, Attilapt_BR
dc.date.accessioned2019-10-10T03:49:26Zpt_BR
dc.date.issued2018pt_BR
dc.identifier.issn1462-0324pt_BR
dc.identifier.urihttp://hdl.handle.net/10183/200337pt_BR
dc.description.abstractObjectives. 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.mimetypeapplication/pdfpt_BR
dc.language.isoengpt_BR
dc.relation.ispartofRheumatology (Oxford). Vol. 57, no. 3 (2018), p. 499-507pt_BR
dc.rightsOpen Accessen
dc.subjectRheumatoid arthritisen
dc.subjectArtrite reumatóidept_BR
dc.subjectBiologic therapiesen
dc.subjectAntirreumáticospt_BR
dc.subjectcsDMARDsen
dc.subjectResultado do tratamentopt_BR
dc.subjectTocilizumaben
dc.subjectInjeções subcutâneaspt_BR
dc.subjectEstudo multicêntricopt_BR
dc.subjectEnsaio clínicopt_BR
dc.titleSubcutaneous tocilizumab in rheumatoid arthritis : findings from the common-framework phase 4 study programme TOZURA conducted in 22 countriespt_BR
dc.typeArtigo de periódicopt_BR
dc.identifier.nrb001102407pt_BR
dc.type.originEstrangeiropt_BR


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