Improvements in ASDAS, health-related quality of life, and productivity through Week 104a. Data presented as n (%) or mean ± SD.
| Placebo, n = 78 | Golimumab | |||
|---|---|---|---|---|
| 50 mg, n = 138 | 100 mg, n = 140 | Combined, n = 278 | ||
| Improvement in ASDAS | ||||
| Week 14 | 0.4 ± 0.9 | 1.5 ± 1.2*** | 1.6 ± 1.2*** | 1.6 ± 1.2*** |
| Week 24 | 0.3 ± 1.0 | 1.6 ± 1.2*** | 1.7 ± 1.3*** | 1.6 ± 1.3*** |
| Week 52 | 2.1 ± 1.1 | 1.9 ± 1.1 | 1.9 ± 1.2 | 1.9 ± 1.2 |
| Week 104 | 2.3 ± 1.0 | 2.1 ± 1.1 | 2.0 ± 1.2 | 2.0 ± 1.1 |
| SF-36 PCS | ||||
| Week 14 | ||||
| Change from baseline | 3.0 ± 7.2 | 8.8 ± 9.6*** | 8.9 ± 9.8*** | 8.8 ± 9.7*** |
| Patients with score ≥ 50 | 1/78 (1.3) | 21/133 (15.8)*** | 28/137 (20.4)*** | 49/270 (18.1)*** |
| Patients with MCID | 26/78 (33.3) | 82/133 (61.7)*** | 85/136 (62.5)*** | 167/269 (62.1)*** |
| Week 24 | ||||
| Change from baseline | 2.8 ± 8.1 | 9.6 ± 10.6*** | 9.2 ± 10.3*** | 9.4 ± 10.5*** |
| Patients with score ≥ 50 | 2/75 (2.7) | 31/131 (23.7)*** | 32/137 (23.4)*** | 63/268 (23.5)*** |
| Patients with MCID | 27/75 (36.0) | 87/130 (66.9)*** | 84/136 (61.8)*** | 171/266 (64.3)*** |
| Week 52 | ||||
| Change from baseline | 13.2 ± 9.1 | 11.4 ± 10.8 | 11.4 ± 8.8 | 11.4 ± 9.8 |
| Patients with score ≥ 50 | 16/70 (22.9) | 32/119 (26.9) | 36/129 (27.9) | 68/248 (27.4) |
| Patients with MCID | 56/70 (80.0) | 83/119 (69.7) | 97/128 (75.8) | 180/247 (72.9) |
| Week 104 | ||||
| Change from baseline | 14.5 ± 8.6 | 13.3 ± 11.2 | 12.4 ± 9.4 | 12.8 ± 10.3 |
| Patients with score ≥ 50 | 20/65 (30.8) | 37/105 (35.2) | 38/118 (32.2) | 75/223 (33.6) |
| Patients with MCID | 55/65 (84.6) | 82/105 (78.1) | 93/117 (79.5) | 175/222 (78.8) |
| SF-36 MCS | ||||
| Week 14 | ||||
| Change from baseline | −0.4 ± 8.3 | 2.6 ± 8.5* | 4.8 ± 10.4*** | 3.7 ± 9.5*** |
| Patients with score ≥ 50 | 36/78 (46.2) | 65/133 (48.9) | 67/137 (48.9) | 132/270 (48.9) |
| Patients with MCID | 21/78 (26.9) | 50/133 (37.6) | 63/136 (46.3)** | 113/269 (42.0)** |
| Week 24 | ||||
| Change from baseline | 0.7 ± 9.5 | 2.3 ± 8.3 | 5.7 ± 10.1*** | 4.0 ± 9.4*** |
| Patients with score ≥ 50 | 37/75 (49.3) | 67/131 (51.1) | 72/137 (52.6) | 139/268 (51.9) |
| Patients with MCID | 22/75 (29.3) | 42/130 (32.3) | 69/136 (50.7)** | 111/266 (41.7) |
| Week 52 | ||||
| Change from baseline | 4.0 ± 10.2 | 3.3 ± 8.3 | 5.3 ± 11.5 | 4.4 ± 10.1 |
| Patients with score ≥ 50 | 42/70 (60.0) | 65/119 (54.6) | 65/129 (50.4) | 130/248 (52.4) |
| Patients with MCID | 29/70 (41.4) | 46/119 (38.7) | 63/128 (49.2) | 109/247 (44.1) |
| Week 104 | ||||
| Change from baseline | 3.7 ± 10.3 | 3.5 ± 9.5 | 7.0 ± 10.7 | 5.4 ± 10.3 |
| Patients with score ≥ 50 | 38/65 (58.5) | 61/105 (58.1) | 72/118 (61.0) | 133/223 (59.6) |
| Patients with MCID | 27/65 (41.5) | 42/105 (40.0) | 65/117 (55.6) | 107/222 (48.2) |
| Improvement in the effect of disease on productivity | ||||
| Week 16 | 0.4 ± 2.7 | 2.8 ± 3.0*** | 2.9 ± 2.9*** | 2.8 ± 3.0*** |
| Week 24 | 0.4 ± 3.0 | 2.7 ± 3.1*** | 2.9 ± 3.0*** | 2.8 ± 3.0*** |
| Week 52 | 3.5 ± 3.0 | 3.4 ± 3.1 | 3.7 ± 3.0 | 3.6 ± 3.1 |
| Week 104 | 3.9 ± 3.0 | 3.8 ± 3.2 | 4.1 ± 2.9 | 4.0 ± 3.0 |
↵* p < 0.05;
↵** p < 0.01;
↵*** p ≤ 0.001.
↵a All patients who were randomized to placebo switched to golimumab at Week 16 (early escape) or Week 24 (prespecified crossover). ASDAS: Ankylosing Spondylitis Disease Activity Score; SF-36 PCS/MCS: Medical Outcomes Study Short Form-36 physical component summary/mental component summary; MCID: minimal clinically important difference.