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Title: 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)
Authors: Burmester, Gerd R.
Rubbert-Roth, Andrea
Cantagrel, Alain
Hall, Stephen
Leszczynski, Piotr
Pollak, Daniel Feldman [UNIFESP]
Rangaraj, Madura J.
Roane, Georgia
Ludivico, Charles
Lu, Peng
Rowell, Lucy
Bao, Min
Mysler, Eduardo F.
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
Keywords: Rheumatoid Arthritis
DMARDs (biologic)
Disease Activity
Issue Date: 1-Jan-2014
Publisher: Bmj Publishing Group
Citation: Annals of the Rheumatic Diseases. London: Bmj Publishing Group, v. 73, n. 1, p. 69-74, 2014.
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.
ISSN: 0003-4967
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