Table 4.
Double-blind studies examining SF-36 and FACIT-F
| Study | Treatment Dose | Baseline FACIT-F | Changes in FACIT-F from baseline | P-value | Baseline SF-36 scores
|
Changes from baseline
|
||||
|---|---|---|---|---|---|---|---|---|---|---|
| Physical | Mental | Physical | P-value | Mental | P-value | |||||
| Genovese et al1 | TCZ 8.00 mg/kg | NA | 8.0 | P < 0.0001 (>MCID) | NA | NA | 8.9 | P < 0.0001 | 5.3 | P < 0.0001 |
| Placebo + DMARDS | NA | 3.6 | NA | NA | NA | 4.1 | P < 0.0001 | 2.3 | P < 0.0001 | |
| Smolen et al2 | TCZ 4.00 mg/kg | 27.0 | 7.3 | P = 0.0063 (>MCID) | 31.5 | 40.1 | 9.7 | P < 0.0010 | 5.7 | P = 0.0394 |
| TCZ 8.00 mg/kg | 27.7 | 8.6 | P < 0.0001 (>MCID) | 32.1 | 40.9 | 9.5 | P < 0.0010 | 7.3 | P = 0.0012 | |
| Control | 26.7 | 4.0 | NA | 32.3 | 39.1 | 5.0 | NA | 2.7 | NA | |
Abbreviations: SF-36, Short Form 36; FACIT, Functional Assessment of Chronic Illness Therapy; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; TCZ, tocilizumab; MTX, methotrexate; DMARD, disease-modifying antirheumatic drug; MCID, minimal clinically important difference.