Table 1A

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

FUStudy% of patients fulfilling ACR20% of patients fulfilling ACR50% of patients fulfilling ACR70HAQ-decrease from baseline (%)Comment
TCZ combination therapy
16 weeksCHARISMA33 7 arms, escalating doses of TCZ monotherapy (2 vs 4 vs 8 mg/kg) versus each dose in combination with MTX74/4153/2937/16MTX-IR
Results for 8 mg/kg combination therapy versus MTX
24 weeksOPTION40 PL/TCZ 4/TCZ 8 mg/kg26/48/5911/31/442/12/2221/33/34MTX-IR
TOWARD41 PL/TCZ 8 mg/kg25/619/383/2113/33*MTX/DMARD-IR†
RADIATE42 PL/TCZ 4/TCZ 8 mg/kg10/30/504/17/291/5/120/18/23Anti-TNF-IR
ROSE43 PL vs TCZ 8 mg/kg11/30DMARD-IR†
52 weeksLITHE44‡ PL/TCZ 4/TCZ 8 mg/kg25/47/56*10/29/36*4/16/20*26/35/39*MTX-IR
TCZ monotherapy
12 weeksJapanese34 PL/TCZ 4 vs 8 mg/kg11/57/782/26/400/20/16DMARD-IR
16 weeksCHARISMA 7 arms, escalating doses of TCZ monotherapy (2 vs 4 vs 8 mg/kg) versus each dose in combination with MTX63/4141/2916/16MTX-IR
Results for 8 mg/kg monotherapy vs MTX
24 weeksAMBITION45 MTX/TCZ 8 mg/kg53/7034/4415/2833/44
ACT-RAY46 47 TCZ 8 mg/kg/TCZ 8 mg/kg+MTX70/7240/4625/2533/33*,§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/kg25/8011/496/3025/50*MTX-IR
ADACTA,49 TCZ 8 mg/kg/ adalimumab 40 mg65/4947/2833/18n.a.Adalimumab monotherapy
52 weeksSAMURAI50 DMARDs/TCZ 8 mg/kg34/7813/646/4410/50*DMARD-IR
Other IL-6 or IL-6R inhibitors (phase II; week 12)
12 weeksAnti-IL-6R
Sarilumab20 51 PL/150 mg46/72n.a.n.a.n.a.
Anti-IL-6
BMS94542919 PL/active36/82¶15/506/4329/39
Sirukumab17 PL/active30/63¶3/27n.a.n.a.
Olokizumab18n.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.