Table 3 Summary of efficacy outcomes at week 12 with subgroup analysis according to previous treatment failure
Parameter | PP OCs | ITT LOCF | ||||
|---|---|---|---|---|---|---|
All patients | Resistance to anti-TNFα | Resistance to MTX | All patients | Resistance to anti-TNFα | Resistance to MTX | |
ACRa | (n = 27) | (n = 14) | (n = 23) | (n = 39) | (n = 19) | (n = 32) |
ACR20 | 15/27 (55.6%) | 8/14 (57.1%) | 14/23 (60.9%) | 21/39 (53.8%) | 10/19 (52.6%) | 17/32 (53.1%) |
ACR50 | 9/27 (33.3%) | 4/14 (28.6%) | 9/23 (39.1%) | 10/39 (25.6%) | 4/19 (21.1%) | 9/32 (28.1%) |
ACR70 | 3/27 (11.1%) | 1/14 (7.1%) | 3/23 (13.0%) | 3/39 (7.7%) | 1/19 (5.3%) | 3/32 (9.4%) |
ACRn | ||||||
Mean ± SD | 31.6 ± 33.5 | 28.1 ± 32.1 | 36.6 ± 31.6 | 23.0 ± 37.5 | 18.7 ± 36.8 | 24.1 ± 38.8 |
Median | 42.9 | 44.3 | 46.9 | 25.7 | 20.6 | 32.7 |
Range | -40.0–87.5 | -40.0–72.2 | -40.0–87.5 | -62.5–87.5 | -62.5–72.2 | -62.5–87.5 |
CRP | (n = 28) | (n = 14) | (n = 23) | (n = 35) | (n = 17) | (n = 29) |
Improvement > 50% | 14/28 (50.0%) | 7/14 (50.0%) | 12/23 (52.2%) | 19/35 (54.3%) | 9/17 (52.9%) | 16/29 (55.2%) |
25% < improvement ≤ 50% | 3/28 (10.7%) | 1/14 (7.1%) | 2/23 (8.7%) | 4/35 (11.4%) | 2/17 (11.8%) | 3/29 (10.3%) |
0% ≤ improvement ≤ 25% | 5/28 (17.9%) | 1/14 (7.1%) | 3/23 (13.0%) | 5/35 (14.3%) | 1/17 (5.9%) | 3/29 (10.3%) |
Stability | 3/28 (11%) | 3/14 (21%) | 3/23 (13%) | 3/35 (9%) | 3/17 (18%) | 3/29 (10%) |
Deterioration | 3/28 (11%) | 2/14 (14%) | 3/23 (13%) | 4/35 (11%) | 2/17 (12%) | 4/29 (14%) |
DAS28 | (n = 24) | (n = 13) | (n = 20) | (n = 34) | (n = 18) | (n = 28) |
Mean ± SD | 4.6 ± 1.3 | 5.1 ± 1.2 | 4.6 ± 1.4 | 4.8 ± 1.5 | 5.2 ± 1.1 | 4.8 ± 1.5 |
ΔDAS28 | 2.0 | 1.8 | 2.1 | 1.7 | 1.7 | 1.8 |
Range | 0.5–7.0 | 3.3–7.0 | 0.5–7.0 | 0.5–7.0 | 3.3–7.0 | 0.5–7.0 |
DAS28 < 2.6 | 1/24 (4.2%) | 0/28 (0%) | 1/20 (5.0%) | 2/34 (5.9%) | 0/18 (0%) | 2/28 (7.1%) |
DAS28 ≤ 3.2 | 1/24 (4.2%) | 0/28 (0%) | 1/20 (5.0%) | 2/34 (5.9%) | 0/18 (0%) | 2/28 (7.1%) |