Table 3.
Phase IIIb, IV and open-label clinical trials of tocilizumab.
| Study | Population studied | Design (country) | Administration duration | N | Treatment arm | Conclusion | Ref. |
|---|---|---|---|---|---|---|---|
| TAMARA (Phase IIIb) | DMARDs-IR | RCT (Germany) | 24 weeks | 286 | TCZ (8) monotherapy TCZ (8) + DMARDs |
TCZ was effective in daily clinical practice | 44,45 |
| DAMBIO (Phase IV) | DMARDs-IR or aTNF-IR | Retrospective cohort (Denmark) | 48 weeks | 178 | TCZ was effective in daily clinical practice | 46 | |
| REACTION | DMARDs-IR or aTNF-IR | Retrospective cohort (Japan) | 2 years | 229 | TCZ was effective in daily clinical practice | 47–49 | |
| ROSE (Phase IIIb) | DMARDs-IR | RCT (USA) | 24 weeks | 619 | TCZ (8) monotherapy PBO |
TCZ monotherapy was effective | 52 |
| Japanese PMS (Phase IV) | DMARDs-IR or aTNF-IR | Retrospective cohort (Japan) | 28 weeks | 7901 | TCZ was effective in daily clinical practice | 66,67 | |
| Post hoc analysis of clinical data | Patients of LITHE, OPTION, RADIATE study | Observational open-label (International) | Start at week 16 end at week 24 | 714 | TCZ (4) IR→TCZ (8) TCZ (8) IR→continues TCZ (8)→continues |
Dose escalation to 8 mg/kg was effective in TCZ 4 mg/kg IR | 43 |
| ACT-RAY (Phase IIIb) | MTX-IR | RCT (International) | 2 years | 556 | TCZ (8) monotherapy TCZ (8) + MTX |
TCZ monotherapy was not inferior to combined therapy with MTX | 53–55 |
| ACT-SURE (Phase IIIb) | DMARDs-IR or aTNF-IR | Observational open-label (International) | 6 months | 1681 | TCZ (8) monotherapy TCZ (8) + DMARDs |
TCZ monotherapy was not inferior to combined therapy with DMARDs | 56,57 |
| ACT-STAR | aTNF-IR | Observational open-label (USA) | 24 weeks | 886 | TCZ (4/8) + DMARDs TCZ (8) + DMARDs TCZ (8) monotherapy |
TCZ monotherapy was not inferior to combined therapy with DMARDs | 58,59 |
| DREAM | Remission after TCZ monotherapy | Retrospective cohort (Japan) | 12 weeks | 187 | Cessation of TCZ | Cessation of TCZ was possible | 61 |
| RESTORE | Recurrence after TCZ cessation | Retrospective cohort (Japan) | 12 weeks | 187 | Retreatment of TCZ | Retreatment with TCZ was acceptable | 62 |
Abbreviations: MTX, methotrexate; TCZ, tocilizumab; IR, inadequate response; DMARDs, disease modifying antirheumatic drugs; aTNF, TNF inhibitor; PBO, placebo; ACR20, ACR criteria for 20% improvement; TCZ (8), 8 mg/kg TCZ every 4 weeks; TCZ (4), 4 mg/kg TCZ every 4 weeks.