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.author Burmester, Gerd R.
dc.contributor.author Rubbert-Roth, Andrea
dc.contributor.author Cantagrel, Alain
dc.contributor.author Hall, Stephen
dc.contributor.author Leszczynski, Piotr
dc.contributor.author Feldman, Daniel [UNIFESP]
dc.contributor.author Rangaraj, Madura J.
dc.contributor.author Roane, Georgia
dc.contributor.author Ludivico, Charles
dc.contributor.author Bao, Min
dc.contributor.author Rowell, Lucy
dc.contributor.author Davies, Claire
dc.contributor.author Mysler, Eduardo F.
dc.date.accessioned 2018-07-26T17:30:30Z
dc.date.available 2018-07-26T17:30:30Z
dc.date.issued 2016
dc.identifier http://dx.doi.org/10.1136/annrheumdis-2015-207281
dc.identifier.citation Annals Of The Rheumatic Diseases. London, v. 75, n. 1, p. 68-74, 2016.
dc.identifier.issn 0003-4967
dc.identifier.uri http://repositorio.unifesp.br/handle/11600/46089
dc.description.abstract Objectives 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.sponsorship Roche
dc.description.sponsorship F. Hoffmann-La Roche, Ltd.
dc.format.extent 68-74
dc.language.iso eng
dc.publisher Bmj Publishing Group
dc.relation.ispartof Annals Of The Rheumatic Diseases
dc.rights Acesso aberto
dc.subject Modifying Antirheumatic Drugs en
dc.subject Interleukin-6 Receptor Inhibition en
dc.subject Rheumatoid-Arthritis en
dc.subject Double-Blind en
dc.subject Biologic Agents en
dc.subject Placebo en
dc.subject Trial en
dc.subject Professionals en
dc.subject Monotherapy en
dc.subject Preferences en
dc.title Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA) en
dc.type Artigo
dc.description.affiliation Free University and Humboldt University of Berlin, Berlin, Germany
dc.description.affiliation Humboldt Univ, D-10099 Berlin, Germany
dc.description.affiliation Klinikum der Universität zu Köln, Köln, Germany
dc.description.affiliation Centre Hospitalier Universitaire de Toulouse, Toulouse, France
dc.description.affiliation Cabrini Medical Centre, Malvern, Australia
dc.description.affiliation Poznan Medical University, Poznan, Poland
dc.description.affiliation Universidade Federal de São Paulo, São Paulo, Brazil
dc.description.affiliation Arthritis & Diabetes Clinic, Inc, Monroe, Louisiana, USA
dc.description.affiliation Rheumatology Associates of South Carolina, Charleston, South Carolina, USA
dc.description.affiliation East Penn Rheumatology Associates, Bethlehem, Pennsylvania, USA
dc.description.affiliation Genentech Inc, South San Francisco, California, USA
dc.description.affiliation Roche Products Limited, Welwyn Garden City, UK AL7 3AY, Herts, England
dc.description.affiliation Organizacion Medica de Investigación, Buenos Aires, Argentina
dc.description.affiliationUnifesp Universidade Federal de São Paulo, São Paulo, Brazil
dc.identifier.doi 10.1136/annrheumdis-2015-207281
dc.description.source Web of Science
dc.identifier.wos WOS:000366402400049



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