PRO measures, Least Squares Mean change from baseline (unless noted)
| Wk 24 | Wk 52 | |||||
|---|---|---|---|---|---|---|
| MTX (N=210) | Bari 4 mg (N=159) | Bari 4 mg + MTX (N=215) | MTX (N=210) | Bari 4 mg (N=159) | Bari 4 mg + MTX (N=215) | |
| Physical function (HAQ-DI) [% with MCID ≥0.22] | −0.72 [70] | −1.00*** [81*] | −0.95*** [79*] | −0.66 [57] | −0.88** [68*] | −0.94*** [72***] |
| PtGDA | −30.5 | −41.1*** | −39.9*** | −29.0 | −40.4*** | −42.6*** |
| Pt Assessment of Pain | −30.0 | −40.8*** | −41.2*** | −30.7 | −40.3*** | −43.4*** |
| Fatigue (FACIT-F) [% with MCID ≥3.56] | 8.9 [65] | 13.3*** [76*] | 12.2*** [71] | 8.9 [54] | 11.7** [62] | 12.6*** [62] |
| QoL: SF-36 PCS [% with MCID ≥5]; | 10.0 [62]; | 13.8*** [71]; | 13.6*** [74*]; | 11.1 [48]; | 13.0 [65**]; | 14.5*** [65***]; |
| MCS [% with MCID ≥5] | 3.8 [32] | 5.4 [41] | 4.7 [41] | 3.5 [29] | 5.1 [33] | 5.3 [37] |
MCID, minimum clinically important difference; M/PCS, mental/physical component score; VAS, visual analog scale; *p≤0.05, **p≤0.01, ***p≤0.001 vs. MTX.