PMID- 23904473
OWN - NLM
STAT- MEDLINE
DCOM- 20140211
LR  - 20220419
IS  - 1468-2060 (Electronic)
IS  - 0003-4967 (Print)
IS  - 0003-4967 (Linking)
VI  - 73
IP  - 1
DP  - 2014 Jan
TI  - 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).
PG  - 69-74
LID - 10.1136/annrheumdis-2013-203523 [doi]
AB  - 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.
FAU - Burmester, Gerd R
AU  - Burmester GR
AD  - Charite-Universitatsmedizin Berlin, Free University and Humboldt University of 
      Berlin, , Berlin, Germany.
FAU - Rubbert-Roth, Andrea
AU  - Rubbert-Roth A
FAU - Cantagrel, Alain
AU  - Cantagrel A
FAU - Hall, Stephen
AU  - Hall S
FAU - Leszczynski, Piotr
AU  - Leszczynski P
FAU - Feldman, Daniel
AU  - Feldman D
FAU - Rangaraj, Madura J
AU  - Rangaraj MJ
FAU - Roane, Georgia
AU  - Roane G
FAU - Ludivico, Charles
AU  - Ludivico C
FAU - Lu, Peng
AU  - Lu P
FAU - Rowell, Lucy
AU  - Rowell L
FAU - Bao, Min
AU  - Bao M
FAU - Mysler, Eduardo F
AU  - Mysler EF
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130731
PL  - England
TA  - Ann Rheum Dis
JT  - Annals of the rheumatic diseases
JID - 0372355
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Immunosuppressive Agents)
RN  - I031V2H011 (tocilizumab)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antibodies, Monoclonal, Humanized/*administration & dosage/adverse 
      effects/pharmacokinetics
MH  - Antirheumatic Agents/*administration & dosage/adverse effects/pharmacokinetics
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Immunosuppressive Agents/*administration & dosage/adverse 
      effects/pharmacokinetics
MH  - Injections, Intravenous
MH  - Injections, Subcutaneous
MH  - Male
MH  - Middle Aged
MH  - Severity of Illness Index
MH  - Treatment Outcome
PMC - PMC3888614
OTO - NOTNLM
OT  - DMARDs (biologic)
OT  - Disease Activity
OT  - Rheumatoid Arthritis
EDAT- 2013/08/02 06:00
MHDA- 2014/02/12 06:00
CRDT- 2013/08/02 06:00
PHST- 2013/08/02 06:00 [entrez]
PHST- 2013/08/02 06:00 [pubmed]
PHST- 2014/02/12 06:00 [medline]
AID - annrheumdis-2013-203523 [pii]
AID - 10.1136/annrheumdis-2013-203523 [doi]
PST - ppublish
SO  - Ann Rheum Dis. 2014 Jan;73(1):69-74. doi: 10.1136/annrheumdis-2013-203523. Epub 
      2013 Jul 31.