A randomised, double-blind, parallel-group study of the safety and efficacy of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional disease-modifying antirheumatic drugs in patients with moderate to severe rheumatoid arthritis (SUMMACTA study)

A randomised, double-blind, parallel-group study of the safety and efficacy of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional disease-modifying antirheumatic drugs in patients with moderate to severe rheumatoid arthritis (SUMMACTA study)

Author Burmester, Gerd R. Google Scholar
Rubbert-Roth, Andrea Google Scholar
Cantagrel, Alain Google Scholar
Hall, Stephen Google Scholar
Leszczynski, Piotr Google Scholar
Pollak, Daniel Feldman Autor UNIFESP Google Scholar
Rangaraj, Madura J. Google Scholar
Roane, Georgia Google Scholar
Ludivico, Charles Google Scholar
Lu, Peng Google Scholar
Rowell, Lucy Google Scholar
Bao, Min Google Scholar
Mysler, Eduardo F. Google Scholar
Institution Charite
Free Univ Berlin
Humboldt Univ
Klinikum Univ Koln
Ctr Hosp Univ Toulouse
Cabrini Med Ctr
Poznan Univ Med Sci
Universidade Federal de São Paulo (UNIFESP)
Arthrit & Diabet Clin Inc
Rheumatol Associates PA
East Penn Rheumatol Associates PC
Hoffmann La Roche Inc
Roche Prod Ltd
Genentech Inc
Org Med Invest
Abstract Objectives This study compared the efficacy and safety of subcutaneous (SC) versus intravenous (IV) formulations of tocilizumab in patients with rheumatoid arthritis with an inadequate response to disease-modifying antirheumatic drugs (DMARD).Methods Patients (n=1262) were randomly assigned to receive tocilizumab-SC 162mg weekly+placebo-IV every 4weeks or tocilizumab-IV 8mg/kg every 4weeks+placebo-SC weekly in combination with traditional DMARD. the primary outcome was to demonstrate the non-inferiority of tocilizumab-SC to tocilizumab-IV with regard to the proportion of patients in each group achieving an American College of Rheumatology (ACR) 20 response at week 24 using a 12% non-inferiority margin (NIM). Secondary outcomes were disease activity score using 28 joints (DAS28), ACR responses, health assessment questionnaire scores and safety assessments.Results At week 24, 69.4% (95% CI 65.5 to 73.2) of tocilizumab-SC-treated patients versus 73.4% (95% CI 69.6 to 77.1) of tocilizumab-IV-treated patients achieved an ACR20 response (weighted difference between groups -4.0%, 95% CI -9.2 to 1.2); the 12% NIM was met. ACR50/70 responses, DAS28 and physical function improvements were comparable between the tocilizumab-SC and tocilizumab-IV groups. the safety profiles of tocilizumab-SC and tocilizumab-IV were similar, and the most common adverse event was infection. Injection-site reactions (ISR) occurred more frequently in the tocilizumab-SC group than in the tocilizumab-IV (placebo-SC) group. No anaphylaxis was reported over the 24weeks.Conclusions Tocilizumab-SC 162mg weekly demonstrated comparable efficacy to tocilizumab-IV 8mg/kg. the safety profile of tocilizumab-SC is consistent with the known and well-established safety profile of tocilizumab-IV, with the exception of a higher incidence of ISR, which were more common with tocilizumab-SC administration.
Keywords Rheumatoid Arthritis
DMARDs (biologic)
Disease Activity
Language English
Sponsor Roche. F. Hoffmann-La Roche, Ltd (Roche)
Date 2014-01-01
Published in Annals of the Rheumatic Diseases. London: Bmj Publishing Group, v. 73, n. 1, p. 69-74, 2014.
ISSN 0003-4967 (Sherpa/Romeo, impact factor)
Publisher Bmj Publishing Group
Extent 69-74
Origin http://dx.doi.org/10.1136/annrheumdis-2013-203523
Access rights Open access Open Access
Type Article
Web of Science ID WOS:000327835100016
URI http://repositorio.unifesp.br/handle/11600/37124

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