ACR20, 50 and 70% response rates (% of patients fulfilling improvement criteria) and percentage of HAQ change from baseline or fulfilment of HAQ-MCID (reduction of more than 0.22) in different clinical trials of TCZ
| FU | Study | % of patients fulfilling ACR20 | % of patients fulfilling ACR50 | % of patients fulfilling ACR70 | HAQ-decrease from baseline (%) | Comment |
|---|---|---|---|---|---|---|
| TCZ combination therapy | ||||||
| 16 weeks | CHARISMA33 7 arms, escalating doses of TCZ monotherapy (2 vs 4 vs 8 mg/kg) versus each dose in combination with MTX | 74/41 | 53/29 | 37/16 | MTX-IR | |
| Results for 8 mg/kg combination therapy versus MTX | ||||||
| 24 weeks | OPTION40 PL/TCZ 4/TCZ 8 mg/kg | 26/48/59 | 11/31/44 | 2/12/22 | 21/33/34 | MTX-IR |
| TOWARD41 PL/TCZ 8 mg/kg | 25/61 | 9/38 | 3/21 | 13/33* | MTX/DMARD-IR† | |
| RADIATE42 PL/TCZ 4/TCZ 8 mg/kg | 10/30/50 | 4/17/29 | 1/5/12 | 0/18/23 | Anti-TNF-IR | |
| ROSE43 PL vs TCZ 8 mg/kg | 11/30 | DMARD-IR† | ||||
| 52 weeks | LITHE44‡ PL/TCZ 4/TCZ 8 mg/kg | 25/47/56* | 10/29/36* | 4/16/20* | 26/35/39* | MTX-IR |
| TCZ monotherapy | ||||||
| 12 weeks | Japanese34 PL/TCZ 4 vs 8 mg/kg | 11/57/78 | 2/26/40 | 0/20/16 | DMARD-IR | |
| 16 weeks | CHARISMA 7 arms, escalating doses of TCZ monotherapy (2 vs 4 vs 8 mg/kg) versus each dose in combination with MTX | 63/41 | 41/29 | 16/16 | MTX-IR | |
| Results for 8 mg/kg monotherapy vs MTX | ||||||
| 24 weeks | AMBITION45 MTX/TCZ 8 mg/kg | 53/70 | 34/44 | 15/28 | 33/44 | |
| ACT-RAY46 47 TCZ 8 mg/kg/TCZ 8 mg/kg+MTX | 70/72 | 40/46 | 25/25 | 33/33*,§ | MTX-IR, switch to vs adding TCZ; LDA and DAS28-REM were more frequent on combination than TCZ mono-therapy | |
| SATORI48 MTX/TCZ 8 mg/kg | 25/80 | 11/49 | 6/30 | 25/50* | MTX-IR | |
| ADACTA,49 TCZ 8 mg/kg/ adalimumab 40 mg | 65/49 | 47/28 | 33/18 | n.a. | Adalimumab monotherapy | |
| 52 weeks | SAMURAI50 DMARDs/TCZ 8 mg/kg | 34/78 | 13/64 | 6/44 | 10/50* | DMARD-IR |
| Other IL-6 or IL-6R inhibitors (phase II; week 12) | ||||||
| 12 weeks | Anti-IL-6R | |||||
| Sarilumab20 51 PL/150 mg | 46/72 | n.a. | n.a. | n.a. | ||
| Anti-IL-6 | ||||||
| BMS94542919 PL/active | 36/82¶ | 15/50 | 6/43 | 29/39 | ||
| Sirukumab17 PL/active | 30/63¶ | 3/27 | n.a. | n.a. | ||
| Olokizumab18 | n.a. | n.a. | n.a. | n.a. | ||
*Estimated values using baseline data and approximate values from respective curves, since exact data not provided in the publications.
†DMARDs aside from MTX: sulfasalazine, leflunomide, antimalarials and other.
‡1 year data.
§Differences between groups in ACT-RAY not significant; all other studies showed significant differences from control; where studied, 4 mg/kg dose was also significantly different from control; details see individual publications.
¶Highest response rate among several arms.
ACR, American College of Rheumatology; DMARDs, disease modifying antirheumatic drugs; DAS-28, disease activity score using 28 joint counts; FU, weeks of follow-up; HAQ, Health Assessment questionnaire disability index; IR, insufficient response; LDA, low disease activity; MCID, minimally clinically important difference; MTX, methotrexate; n.a., not available; PL, placebo; TCZ, tocilizumab; TNF, tumour necrosis factor; for trial acronyms see respective publications.