Table 1.
Characteristics of studies of subcutaneous tocilizumab in rheumatoid arthritis patients
| Phase | Type of study | Number of patients | Treatment arms | DMARD | Primary endpoint | Study duration | Extension | |
|---|---|---|---|---|---|---|---|---|
| MATSURI (Japan)12 | I/II dose escalation | Open trial | 8, 12, 12 | 81 mg q2w SC 162 mg q2w SC 162 mg qw SC |
None | Serum TCZ concentration | 24 w | None |
| BREVACTA (worldwide)13,14 | III db | RCT | 437 vs 219 | TCZ 162 mg q2w SC vs placebo | With | ACR20 | 24 w | Open label during 72 w |
| SUMMACTA (worldwide)15 | III db, dd | Non-inferiority RCT | 558 vs 537 | TCZ 162 mg qw SC vs TCZ 8 mg/kg q4w IV | With | ACR20 | 24 w | Open label during 72 w |
| MUSASHI (Japan)16 | III db, dd | Non-inferiority RCT | 159 vs 156 | TCZ 162 mg q2w SC vs TCZ 8 mg/kg q4w IV | None | ACR20 | 24 w | NA |
Abbreviations: ACR, American College of Rheumatology response rate 20; db, double-blind; dd, double dummy; DMARD, disease-modifying antirheumatic drugs; IV, intravenous; NA, not available; qw, every week; q2w, every two weeks; q4w, every 4 weeks; RCT, randomized controlled study; SC, subcutaneous; TCZ, tocilizumab; vs, versus; w, weeks.