Table 4 Efficacy outcomesa from the extension phase of the study: weeks 12 to 82 (intention-to-treat population)
Parameter | W12 | W24 | W36 | W48 | W60 | W72 | W84 |
|---|---|---|---|---|---|---|---|
ACR, number (percentage) of patients | n = 27 | n = 7 | n = 9 | n = 8 | n = 8 | n = 9 | n = 8 |
ACR20b | 15 (56%) | 6 (86%) | 7 (78%) | 5 (63%) | 6 (75%) | 6 (67%) | 7 (88%) |
ACR50b | 9 (33%) | 2 (27%) | 4 (44%) | 3 (38%) | 6 (75%) | 3 (33%) | 5 (63%) |
ACR70 | 3 (11%) | 1 (14%) | 2 (22%) | 1 (13%) | 3 (38%) | 2 (22%) | 2 (25%) |
ACR90 | 0 (0%) | 0 (0%) | 1 (11%) | 0 (0%) | 2 (25%) | 1 (11%) | 1 (13%) |
ACRn | n = 27 | n = 7 | n = 9 | n = 8 | n = 8 | n = 9 | n = 8 |
Mean ± SD | 31.6 ± 33.5 | 36.0 ± 29.0 | 45.9 ± 32.3 | 30.9 ± 36.7 | 58.3 ± 31.4 | 35.6 ± 41.3 | 50.9 ± 38.0 |
Median | 42.9 | 40.7 | 45.5 | 40.0 | 64.9 | 39.7 | 55.0 |
Range | -40.0–87.5 | -16.7–73.0 | -3.8–93.3 | -20.0–70.9 | 10.0–93.3 | -27.8–97.4 | -17.6–98.8 |
CRP, number (percentage) of patients | n = 28 | n = 7 | n = 12 | n = 9 | n = 7 | n = 9 | n = 8 |
Improvement > 50% | 14 (50%) | 5 (71%) | 9 (75%) | 6 (67%) | 3 (43%) | 6 (68%) | 5 (63%) |
25% < improvement ≤ 50% | 3 (11%) | 0 (0%) | 1 (8%) | 0 (0%) | 3 (43%) | 1 (11%) | 1 (13%) |
0% < improvement ≤ 25% | 5 (18%) | 1 (14%) | 1 (8%) | 1 (11%) | 1 (14%) | 1 (11%) | 1 (13%) |
Stable | 3 (11%) | 1 (14%) | 1 (8%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
Deterioration | 3 (11%) | 0 (0%) | 0 (0%) | 2 (22%) | 0 (0%) | 1 (11%) | 1 (13%) |
DAS28 | n = 24 | n = 4 | n = 5 | n = 6 | n = 7 | n = 7 | n = 4 |
Mean ± SD | 4.6 ± 1.3 | 5.2 ± 1.7 | 4.4 ± 1.9 | 4.7 ± 2.1 | 3.3 ± 1.5 | 3.5 ± 1.5 | 3.1 ± 1.6 |
Median | 4.4 | 4.9 | 4.1 | 4.4 | 2.6 | 3.0 | 2.5 |
Range | 0.5–7.0 | 3.6–7.5 | 2.3–7.5 | 2.7–8.7 | 1.7–5.3 | 1.6–6.1 | 1.9–5.5 |
DAS28 < 2.6, number (percentage) of patients | 1 (4%) | 0 (0%) | 1 (20%) | 0 (0%) | 4 (57%) | 1 (14%) | 2 (50%) |
DAS28 ≤ 3.2, number (percentage) of patients | 1 (4%) | 0 (0%) | 1 (20%) | 2 (33%) | 4 (57%) | 4 (57%) | 3 (75%) |