PROa | PBOc | Tofacitinib | Tofacitinib | Adalimumab |
---|---|---|---|---|
% of pts reporting improvements ≥MCIDb | n=46 | 5 mg BID | 10 mg BID | 40 mg Q2W |
[MCID values] | n=127 | n=134 | n=125 | |
PtGA | -12.48 | -28.63*** | -29.02*** | -26.00** |
% pts reporting ≥MCID [-10] | 62.37 | 70.11 | 72.38 | 70.56 |
Pain (VAS) | -16.34 | -30.68*** | -31.38*** | -27.25** |
% pts reporting ≥MCID [-10] | 64.52 | 72.41 | 74.59 | 69.27 |
Physical function (HAQ-DI) | -0.33 | -0.66*** | -0.68*** | -0.57** |
% pts reporting ≥MCID [-22] | 56.99 | 71.84* | 77.35** | 74.44* |
HR-QoL (SF-36) | ||||
Physical Component Score | 4.72 | 8.52** | 8.81*** | 7.25* |
% pts reporting ≥MCID [2.5] | 72.04 | 68.21 | 70.00 | 71.51 |
Mental Component Score | 0.89 | 5.51** | 6.00*** | 3.93* |
% pts reporting ≥MCID [2.5] | 30.11 | 58.38*** | 59.44*** | 51.96** |
Fatigue (FACIT-F) | 1.92 | 6.99*** | 7.85*** | 6.47** |
% pts reporting ≥MCID [4] | 45.65 | 57.23 | 67.40** | 55.56 |
Sleep (MOS Sleep Scale; overall sleep) | -4.14 | -12.47** | -12.13** | -10.26* |
aFull analysis set, longitudinal model; bFull analysis set, no imputation; cPBO patients with ≥20% improvement in TJC and SJC at Month 3 who were not advanced to tofacitinib until Month 6; CI, confidence interval; MCID, minimum clinically important difference, *p<0.05, **p<0.001, ***p<0.0001 vs PBO.