Universität zu Köln

Burmester, Gerd R., Rubbert-Roth, Andrea, Cantagrel, Alain, Hall, Stephen, Leszczynski, Piotr, Feldman, Daniel, Rangaraj, Madura J., Roane, Georgia, Ludivico, Charles, Lu, Peng, Rowell, Lucy, Bao, Min and Mysler, Eduardo F. (2014). 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). Ann. Rheum. Dis., 73 (1). S. 69 - 75. LONDON: BMJ PUBLISHING GROUP. ISSN 1468-2060

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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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Burmester, Gerd R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Rubbert-Roth, Andrea UNSPECIFIED UNSPECIFIED UNSPECIFIED Cantagrel, Alain UNSPECIFIED UNSPECIFIED UNSPECIFIED Hall, Stephen UNSPECIFIED UNSPECIFIED UNSPECIFIED Leszczynski, Piotr UNSPECIFIED UNSPECIFIED UNSPECIFIED Feldman, Daniel UNSPECIFIED UNSPECIFIED UNSPECIFIED Rangaraj, Madura J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Roane, Georgia UNSPECIFIED UNSPECIFIED UNSPECIFIED Ludivico, Charles UNSPECIFIED UNSPECIFIED UNSPECIFIED Lu, Peng UNSPECIFIED UNSPECIFIED UNSPECIFIED Rowell, Lucy UNSPECIFIED UNSPECIFIED UNSPECIFIED Bao, Min UNSPECIFIED UNSPECIFIED UNSPECIFIED Mysler, Eduardo F. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-451728
DOI:	10.1136/annrheumdis-2013-203523
Journal or Publication Title:	Ann. Rheum. Dis.
Volume:	73
Number:	1
Page Range:	S. 69 - 75
Date:	2014
Publisher:	BMJ PUBLISHING GROUP
Place of Publication:	LONDON
ISSN:	1468-2060
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language INTERLEUKIN-6 RECEPTOR INHIBITION; THERAPY; TRIAL; METHOTREXATE; ANTIBODY Multiple languages Rheumatology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/45172