Table 3.
Change in fatigue as measured by FACIT-Fatigue^ in RA RCTs
| RCT (N=13) |
Agent / Active comparator |
Interval (wks) |
Active Arm(s)- Mean change from baseline (SD,- not provided) |
Placebo/MtTX* Arm- Mean change from baseline (SD) |
P value |
|---|---|---|---|---|---|
| Phase IV | |||||
| Gabay C, 2013 | Tocilizumab 8/ | 24 | 11.40 (−) | - | 0.08 |
| Adalimumab | 8.90 (−) | ||||
| Phase III | |||||
| Strand V, 2012 | Ada*+Mtx*/ | 104 | 14.60 (−) | 13.5 (−) | <0.001 |
| Adalimumab/ | 14.60 (−) | 0.900 | |||
| Bingham C, 2014 | Golimumab iv | 24 | 7.96 (10.8) | 2.54 (10.2) | <0.001 |
| Genovese M, 2012 | Golimumabsc | 24 | 7.23 (8.6) | 2.16 (9.5) | <0.001 |
| Butgereit F, 2013 | MR-Prednisone | 12 | 3.80 (−) | 1.6 (−) | 0.003 |
| Yazici Y, 2012 | Tocilizumab 8 | 24 | 8.43 (−) | 5.89 (−) | <0.001 |
| Strand V, 2012 | Tocilizumab 8 | 24 | 8.83 (−) | 4.22 (−) | 0.015 |
| Tocilizumab 4 | 6.66 (−) | NS | |||
| Lee EB, 2014 | Tofacitininb | 24 | not provided | not provided | |
| Kremer J, 2013 | Tofacitininb 10 | 24 | 3.15** (1.27, 5.02) | - | |
| Tofacitinib 5 | 2.85** (0.95, 4.74) | ||||
| Fleischman RM, 2012 | Tofacitininb 10 | 12 | 8.00 (−) | 2.80 (−) | <0.001 |
| Tofacitinib 5 | 6.70 (−) | ||||
| Phase IIB | |||||
| Weinblatt M, 2013 | Fostamatinib 150 | 24 | 5.70 (1.0) | 4.50 (0.9) | NS |
| Fostamatinib 100 | 7.40 (1.0) | <0.050 | |||
| Kremer J, 2012 | Tofacitinib | no improvement data not shown | data not shown | ||
| Fleischman RM, 2012 | Tofacitinib 5/ | improvement vs placebo data not shown | NS | ||
| Tofacitinib 10/ | <0.001 | ||||
| Tofacitinib 15/ | NS | ||||
| Adalimumab | NS | ||||
^
Higher scores reflect less fatigue, clinically meaningful change is ≥4 points (84)
*
Methotrexate, Adalimumab
**
Difference from placebo (95%CI)