Efficacy measures through week 104 by early escape status: observed data presented without imputation
| Placebo → golimumab 50 mg (group 1) | Golimumab 50 mg (group 2) | Golimumab 100 mg (group 3) | ||||
|---|---|---|---|---|---|---|
| Early escape (week 16–104)* | Crossover (week 24–104)† | 50 mg only‡ | Early escape (week 16–104) 50 mg →100 mg* | 100 mg only‡ | 100 mg → 100 mg* | |
| Randomised patients (n) | 41 | 35 | 113 | 25 | 107 | 33 |
| ASAS20 | ||||||
| Week 28 | 23/40 (57.5) | 26/35 (74.3) | 85/102 (83.3) | 6/25 (24.0) | 78/100 (78.0) | 3/32 (9.4) |
| Week 52 | 25/34 (73.5) | 29/34 (85.3) | 85/98 (86.7) | 9/21 (42.9) | 86/99 (86.9) | 10/28 (35.7) |
| Week 104 | 24/31 (77.4) | 28/31 (90.3) | 77/90 (85.6) | 7/16 (43.8) | 77/93 (82.8) | 14/25 (56.0) |
| ASAS40 | ||||||
| Week 28 | 15/40 (37.5) | 21/35 (60.0) | 66/102 (64.7) | 3/25 (12.0) | 70/100 (70.0) | 2/32 (6.3) |
| Week 52 | 19/34 (55.9) | 27/34 (79.4) | 73/98 (74.5) | 2/21 (9.5) | 73/99 (73.7) | 8/28 (28.6) |
| Week 104 | 21/31 (67.7) | 28/31 (90.3) | 74/90 (82.2) | 5/16 (31.3) | 64/93 (68.8) | 7/25 (28.0) |
| BASDAI50 | ||||||
| Week 28 | 17/41 (41.5) | 21/35 (60.0) | 65/103 (63.1) | 3/25 (12.0) | 66/100 (66.0) | 1/32 (3.1) |
| Week 52 | 17/35 (48.6) | 27/34 (79.4) | 70/99 (70.7) | 1/21 (4.8) | 76/99 (76.8) | 6/29 (20.7) |
| Week 104 | 21/33 (63.6) | 27/32 (84.4) | 72/91 (79.1) | 5/16 (31.3) | 65/93 (69.9) | 6/25 (24.0) |
| Change in BASDAI§ | ||||||
| Week 28 | −2.4±2.49 | −3.3±2.47 | −3.8±2.15 | −0.8±1.88 | −3.9±2.41 | −0.5±1.55 |
| Week 52 | −3.4±2.60 | −4.4±2.02 | −4.0±2.09 | −1.3±1.58 | −4.4±2.24 | −1.3±1.96 |
| Week 104 | −3.6±2.25 | −4.6±2.42 | −4.2±2.19 | −2.0±2.33 | −4.4±2.25 | −1.8±1.93 |
| Change in BASFI§ | ||||||
| Week 28 | −1.5±2.86 | −1.5±2.30 | −2.4±2.12 | −0.3±1.52 | −2.5±2.26 | 0.6±2.48 |
| Week 52 | −3.0±3.07 | −2.3±2.24 | −2.5±2.12 | −0.9±1.59 | −2.9±2.14 | −0.5±2.63 |
| Week 104 | −3.2±3.20 | −2.6±2.23 | −2.7±2.07 | −1.7±2.19 | −2.9±2.21 | −1.2±2.64 |
| Change in BASMI§ | ||||||
| Week 52 | −0.7±0.87 | −0.8±0.90 | −0.7±0.90 | −0.4±0.79 | −0.7±0.88 | 0.0±1.07 |
| Week 76 | −0.7±0.96 | −0.7±0.94 | −0.8±0.78 | −0.4±0.92 | −0.7±0.88 | −0.2±0.92 |
| Week 104 | −0.6±1.04 | −0.8±0.95 | −0.8±0.79 | −0.4±0.98 | −0.8±0.96 | −0.3±0.86 |
| Change in SF-36 PCS¶ | ||||||
| Week 52 | 12.3±8.78 | 14.1±9.40 | 12.8±10.63 | 4.8±8.96 | 13.0±8.14 | 5.4±8.62 |
| Week 76 | 12.7±10.87 | 15.2±8.65 | 13.4±10.70 | 7.3±10.82 | 13.5±8.73 | 6.6±7.49 |
| Week 104 | 13.6±7.80 | 15.5±9.32 | 14.2±11.28 | 7.6±8.83 | 13.9±9.28 | 6.5±7.77 |
| Change in SF-36 MCS¶ | ||||||
| Week 52 | 4.3±11.51 | 3.7±8.80 | 3.7±7.90 | 1.8±9.80 | 6.4±11.75 | 1.3±9.93 |
| Week 76 | 3.9±12.27 | 3.9±9.12 | 2.9±9.00 | 1.2±8.58 | 7.3±10.81 | 2.8±11.26 |
| Week 104 | 5.2±10.94 | 2.0±9.55 | 3.8±8.75 | 1.5±13.82 | 7.6±10.86 | 5.0±9.86 |
Values are mean±SD change from baseline for continuous outcomes or n (%) of patients achieving the end point for dichotomous outcomes.
↵* Patients in these groups met the early escape criteria at week 16.
↵† Patients in this group did not discontinue study agent prior to week 24 and crossed over at week 24.
↵‡ Patients in these groups did not meet the early escape criteria at week 16.
↵§ Negative change indicates improvement.
↵¶ Positive change indicates improvement.
ASAS, Assessment in SpondyloArthritis international Society; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BASMI, Bath Ankylosing Spondylitis Metrology Index; MCS, mental component summary; PCS, physical component summary; SF-36, 36-item Short-Form health survey.