rss
Ann Rheum Dis doi:10.1136/annrheumdis-2013-203523
  • Clinical and epidemiological research
  • Extended report

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)

  1. Eduardo F Mysler13
  1. 1Charité-Universitätsmedizin Berlin, Free University and Humboldt University of Berlin, Berlin, Germany
  2. 2Klinikum der Universität zu Köln, Koln, Germany
  3. 3Centre Hospitalier Universitaire de Toulouse, Toulouse, France
  4. 4Cabrini Medical Centre, Malvern, Australia
  5. 5J. Strus Poznan Municipal Hospital, Poznan University of Medical Sciences, Poland
  6. 6Universidade Federal de São Paulo, São Paulo, Brazil
  7. 7Arthritis & Diabetes Clinic, Inc, Monroe, Louisiana, USA
  8. 8Rheumatology Associates, P.A., Charleston, South Carolina, USA
  9. 9East Penn Rheumatology Associates, PC, Bethlehem, Pennsylvania, USA
  10. 10Hoffmann-La Roche Inc, Nutley, New Jersey, USA
  11. 11Roche Products Limited, Welwyn Garden City, UK
  12. 12Genentech, Inc, South San Francisco, California, USA
  13. 13Organizacion Medica de Investigación, Buenos Aires, Argentina
  1. Correspondence to Dr Gerd R Burmester, Department of Rheumatology and ClinicaI Immunology, Charité-Universitätsmedizin Berlin, Charitéplatz 1, Berlin 10117, Germany; gerd.burmester{at}charite.de
  • Received 25 February 2013
  • Revised 13 June 2013
  • Accepted 9 July 2013
  • Published Online First 31 July 2013

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 162 mg weekly+placebo-IV every 4 weeks or tocilizumab-IV 8 mg/kg every 4 weeks+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 24 weeks.

Conclusions Tocilizumab-SC 162 mg weekly demonstrated comparable efficacy to tocilizumab-IV 8 mg/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.