Table 1 Clinical efficacy measures over 2 years in intention-to-treat (ITT) analysis and per-protocol (PP) analysis
Variables | Year 2 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
ITT | PP | |||||||||
MTX (n = 69) | TwFH (n = 69) | TwFH vs MTX | TwFH + MTX (n = 69) | TwFH + MTX vs MTX | MTX (n = 14) | TwFH (n = 11) | TwFH vs MTX | TwFH + MTX (n = 22) | TwFH + MTX vs MTX | |
ACR20 response, n (%) | 38 (55.0%) | 51 (73.9%) | p < 0.001 | 50 (72.5%) | p = 0.034 | 8 (57.1%) | 10 (90.9%) | p < 0.001 | 14 (63.6%) | p = 0.163 |
ACR50 response, n (%) | 32 (46.4%) | 40 (58.0%) | p = 0.005 | 35 (50.7%) | p = 0.609 | 7 (50.0%) | 8 (72.7%) | p < 0.001 | 11 (50.0%) | p = 0.312 |
ACR70 response, n (%) | 15 (21.7%) | 24 (34.8%) | p = 0.001 | 20 (29.0%) | p = 0.328 | 4 (28.6%) | 4 (36.4%) | p = 0.013 | 7 (31.8%) | p = 0.346 |
cDAI response, n (%) | 39 (56.5%) | 50 (72.5%) | p = 0.001 | 37 (53.6%) | p = 0.732 | 8 (57.1%) | 9 (81.8%) | p < 0.001 | 15 (68.2%) | p = 0.110 |
EULAR good response, n (%) | 16 (23.2%) | 33 (47.8%) | p < 0.001 | 28 (40.6%) | p = 0.028 | 5 (35.7%) | 7 (63.6%) | p < 0.001 | 9 (40.9%) | p = 0.259 |
EULAR good to moderate response, n (%) | 50 (72.5%) | 57 (82.6%) | p = 0.002 | 59 (85.5%) | p = 0.060 | 12 (85.7%) | 10 (90.9%) | p = 0.003 | 21 (95.5%) | p = 0.072 |
DAS28 remission, n (%) | 12 (17.4%) | 30 (43.5%) | p < 0.001 | 24 (34.8%) | p = 0.020 | 4 (28.6%) | 7 (63.6%) | p < 0.001 | 7 (31.8%) | p = 0.346 |
DAS28 remission and LDA, n (%) | 18 (26.1%) | 33 (47.8%) | p < 0.001 | 28 (40.6%) | p = 0.071 | 5 (35.7%) | 7 (63.6%) | p < 0.001 | 8 (36.4%) | p = 0.784 |