Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA)

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dc.contributor.authorBurmester, Gerd R.
dc.contributor.authorRubbert-Roth, Andrea
dc.contributor.authorCantagrel, Alain
dc.contributor.authorHall, Stephen
dc.contributor.authorLeszczynski, Piotr
dc.contributor.authorFeldman, Daniel [UNIFESP]
dc.contributor.authorRangaraj, Madura J.
dc.contributor.authorRoane, Georgia
dc.contributor.authorLudivico, Charles
dc.contributor.authorBao, Min
dc.contributor.authorRowell, Lucy
dc.contributor.authorDavies, Claire
dc.contributor.authorMysler, Eduardo F.
dc.contributor.institutionUniversidade Federal de São Paulo (UNIFESP)
dc.date.accessioned2018-07-26T17:30:30Z
dc.date.available2018-07-26T17:30:30Z
dc.date.issued2016
dc.description.abstractObjectives To evaluate the long-term efficacy and safety of subcutaneous (SC) tocilizumab (TCZ) versus intravenous (IV) TCZ, including switching formulations, in patients with rheumatoid arthritis (RA) and inadequate response to disease-modifying antirheumatic drugs (DMARDs). Methods Patients (n=1262) were randomised 1: 1 to receive TCZ-SC 162 mg weekly (qw)+placebo-IV every four weeks (q4w) or TCZ-IV 8 mg/kg q4w+placebo-SC qw in combination with DMARD(s). After a 24-week double-blind period, patients receiving TCZ-SC were re-randomised 11: 1 to TCZ-SC (n=521) or TCZ-IV (TCZ-SCIV, n=48), and patients receiving TCZ-IV were re-randomised 2: 1 to TCZ-IV (n=372) or TCZ-SC (TCZ-IV-SC n=186). Maintenance of clinical responses and safety through week 97 were assessed. Results The proportions of patients who achieved American College of Rheumatology (ACR) 20/50/70 responses, Disease Activity Score in 28 joints remission and improvement from baseline in Health Assessment Questionnaire Disability Index >= 0.3 were sustained through week 97 and comparable across arms. TCZ-SC had a comparable safety profile to TCZ-IV through week 97, except that injection site reactions (ISRs) were more common with TCZ-SC. Safety profiles in patients who switched were similar to those in patients who received continuous TCZ-SC or TCZ-IV treatment. The proportion of patients who developed anti-TCZ antibodies remained low across treatment arms. No association between anti-TCZ antibody development and clinical response or adverse events was observed. Conclusions The long-term efficacy and safety of TCZ-SC was maintained and comparable to that of TCZ-IV, except for ISRs. Profiles in patients who switched formulations were comparable to those in patients who received TCZ-IV or TCZ-SC. TCZ-SC provides additional treatment options for patients with RA.en
dc.description.affiliationFree University and Humboldt University of Berlin, Berlin, Germany
dc.description.affiliationHumboldt Univ, D-10099 Berlin, Germany
dc.description.affiliationKlinikum der Universität zu Köln, Köln, Germany
dc.description.affiliationCentre Hospitalier Universitaire de Toulouse, Toulouse, France
dc.description.affiliationCabrini Medical Centre, Malvern, Australia
dc.description.affiliationPoznan Medical University, Poznan, Poland
dc.description.affiliationUniversidade Federal de São Paulo, São Paulo, Brazil
dc.description.affiliationArthritis & Diabetes Clinic, Inc, Monroe, Louisiana, USA
dc.description.affiliationRheumatology Associates of South Carolina, Charleston, South Carolina, USA
dc.description.affiliationEast Penn Rheumatology Associates, Bethlehem, Pennsylvania, USA
dc.description.affiliationGenentech Inc, South San Francisco, California, USA
dc.description.affiliationRoche Products Limited, Welwyn Garden City, UK AL7 3AY, Herts, England
dc.description.affiliationOrganizacion Medica de Investigación, Buenos Aires, Argentina
dc.description.affiliationUnifespUniversidade Federal de São Paulo, São Paulo, Brazil
dc.description.sourceWeb of Science
dc.description.sponsorshipRoche
dc.description.sponsorshipF. Hoffmann-La Roche, Ltd.
dc.format.extent68-74
dc.identifierhttps://dx.doi.org/10.1136/annrheumdis-2015-207281
dc.identifier.citationAnnals Of The Rheumatic Diseases. London, v. 75, n. 1, p. 68-74, 2016.
dc.identifier.doi10.1136/annrheumdis-2015-207281
dc.identifier.issn0003-4967
dc.identifier.urihttps://repositorio.unifesp.br/handle/11600/46089
dc.identifier.wosWOS:000366402400049
dc.language.isoeng
dc.publisherBmj Publishing Group
dc.relation.ispartofAnnals Of The Rheumatic Diseases
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectModifying Antirheumatic Drugsen
dc.subjectInterleukin-6 Receptor Inhibitionen
dc.subjectRheumatoid-Arthritisen
dc.subjectDouble-Blinden
dc.subjectBiologic Agentsen
dc.subjectPlaceboen
dc.subjectTrialen
dc.subjectProfessionalsen
dc.subjectMonotherapyen
dc.subjectPreferencesen
dc.titleEfficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA)en
dc.typeinfo:eu-repo/semantics/article
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