Study of active controlled monotherapy used for rheumatoid arthritis, an IL-6 inhibitor (SAMURAI): evidence of clinical and radiographic benefit from an x ray reader-blinded randomised controlled trial of tocilizumab.
OBJECTIVE
To evaluate the ability of tocilizumab (a humanised anti-IL-6 receptor antibody) monotherapy to inhibit progression of structural joint damage in patients with RA.


METHODS
In a multi-centre, x ray reader-blinded, randomised, controlled trial, 306 patients with active RA of <5 years' duration were allocated to receive either tocilizumab monotherapy at 8 mg/kg intravenously every 4 weeks or conventional disease-modifying antirheumatic drugs (DMARDs) for 52 weeks. Radiographs of hands and forefeet were scored by the van der Heijde modified Sharp method.


RESULTS
Patients had a mean disease duration of 2.3 years and a disease activity score in 28 joints of 6.5 at baseline. Mean total modified Sharp score (TSS) was 29.4, which was very high despite the relatively short disease duration. At week 52, the tocilizumab group showed statistically significantly less radiographic change in TSS (mean 2.3; 95% CI 1.5 to 3.2) than the DMARD group (mean 6.1; 95% CI 4.2 to 8.0; p<0.01). Tocilizumab monotherapy also improved signs and symptoms. The overall incidences of AEs were 89% and 82% (serious AEs: 18% and 13%; serious infections: 7.6% and 4.1%) in the tocilizumab and DMARD groups, respectively.


CONCLUSIONS
Tocilizumab monotherapy was generally well tolerated and provided radiographic benefit in patients with RA.
Nishimoto
Norihiro
N
Laboratory of Immune Regulation, Graduate School of Frontier Biosciences, Osaka University 1-3, Yamada-oka, Suita, Osaka, 565-0871, Japan. norihiro@fbs.osaka-u.ac.jp
Hashimoto
Jun
J
Miyasaka
Nobuyuki
N
Yamamoto
Kazuhiko
K
Kawai
Shinichi
S
Takeuchi
Tsutomu
T
Murata
Norikazu
N
van der Heijde
Désirée
D
Kishimoto
Tadamitsu
T
D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000276:immunology; D001424:Bacterial Infections / Q000150:complications; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D033023:Foot Joints / Q000000981:diagnostic imaging; D050823:Hand Joints / Q000000981:diagnostic imaging; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000009:adverse effects / Q000627:therapeutic use; D008875:Middle Aged; D011859:Radiography; D012720:Severity of Illness Index; D016896:Treatment Outcome; D000093242:Interleukin-6 Inhibitors
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D008727:Methotrexate; D000093242:Interleukin-6 Inhibitors; C502936:tocilizumab