Baseline and changes from baseline to weeks 14 and 104 in ASspiMRI-a score
| Golimumab | ||||
|---|---|---|---|---|
| MRI activity - ASspiMRI-a score | Placebo* (n=23) | 50 mg* (n=37) | 100 mg (n=38) | Combined (n=75) |
| Patients with baseline score and ≥1 post-baseline score to week 14 | 19 | 32 | 35 | 67 |
| Baseline ASspiMRI-a score=0 (no inflammation) | 2 (10.5%) | 1 (3.1%) | 8 (22.9%) | 9 (13.4%) |
| Baseline ASspiMRI-a score >0 | 17 (89.5%) | 31 (96.9%) | 27 (77.1%) | 58 (86.6%) |
| Patients with baseline score and ≥1 postbaseline score to week 104 | 10 | 32 | 35 | 67 |
| Baseline ASspiMRI-a score=0 (no inflammation) | 1 (10.0%) | 1 (3.1%) | 8 (22.9%) | 9 (13.4%) |
| Baseline ASspiMRI-a score >0 | 9 (90.0%) | 31 (96.9%) | 27 (77.1%) | 58 (86.6%) |
| Baseline | ||||
| Mean (SD) | 9.6 (9.5) | 9.3 (7.5) | 5.0 (5.6) | 7.1 (6.9) |
| Median (IQR) | 6.8 (1.4, 17.0) | 7.8 (3.5, 15.5) | 3.5 (1.5, 6.0) | 5.5 (2.0, 10.5) |
| Change from baseline to week 14 | ||||
| Mean (SD) | −2.5 (8.9) | −5.9 (7.1) | −3.2 (4.6) | −4.5 (6.1) |
| Median (IQR) | −0.5 (−4.5, 2.5) | −3.5 (10.8, –0.3) | −1.5 (−4.0, 0.0) | −2.5 (−7.5, 0.0) |
| ANOVA p value† | 0.047 | 0.14 | 0.041 | |
| Adjusted ANOVA p value‡ | 0.011 | 0.002 | 0.003 | |
| Percentage improvement from baseline to week 14 | ||||
| Mean (SD) | −11.5 (132.3) | 23.4 (210.1) | 48.5 (43.4) | 37.2 (143.9) |
| Median (IQR) | 1.8 (−26.3, 73.3) | 84.7 (32.5, 100.0) | 56.8 (0.0, 93.1) | 72.1 (0.0, 100.0) |
| ANOVA p value† | 0.032 | 0.025 | 0.013 | |
| Change from baseline to week 104§ | ||||
| Mean (SD) | −10.4 (10.5) | −7.1 (7.3) | −3.6 (5.7) | −5.3 (6.7) |
| Median (IQR) | −7.3 (−19.0, –1.5) | −5.3 (−12.8, –0.8) | −1.5 (−6.0, 0.0) | −4.0 (−9.5, 0.0) |
| Percentage improvement from baseline to week 104§ | ||||
| Mean (SD) | −67.4 (509.2) | 70.2 (52.4) | 14.9 (200.5) | 43.1 (146.4) |
| Median (IQR) | 79.0 (20.0, 100.0) | 98.4 (69.6, 100.0) | 77.8 (0.0, 100.0) | 87.5 (33.3, 100.0) |
| Patients with inflammation¶ at baseline and with week 14 data | 15 | 23 | 25 | 48 |
| No (%) of patients with minimal inflammation** at week 14 | 3 (20.0%) | 13 (56.5%) | 13 (52.0%) | 26 (54.2%) |
| p value vs placebo | 0.0205 | |||
| Patients with inflammation¶ at baseline and with week 104 data | 12 | 22 | 20 | 42 |
| No (%) of patients with minimal inflammation** at week 104 | 8 (66.7%) | 13 (59.1%) | 13 (65.0%) | 26 (61.9%) |
| p value vs placebo | 0.76 | |||
| Patients with no inflammation†† at baseline and with week 14 data | 2 | 1 | 8 | 9 |
| Patients with any inflammation‡‡ at week 14 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Patients with no inflammation†† at baseline and with week 104 data | 2 | 1 | 5 | 6 |
| Patients with any inflammation‡‡ at week 104 | 1 (50.0%) | 0 (0.0%) | 1 (20.0%) | 1 (16.7%) |
| p value vs placebo | 0.35 | |||
↵* At week 16, patients in the placebo and 50 mg groups with less than 20% improvement from baseline in both the total back pain and morning stiffness scores entered early escape. Patients in the placebo group received golimumab 50 mg and patients in the golimumab 50 mg group received golimumab 100 mg. Patients who were originally assigned to the golimumab 100 mg group were not eligible for dose adjustment.
↵† ANOVA on the van der Waerden normal scores comparing the active treatment groups versus placebo.
↵‡ ANOVA on the van der Waerden normal scores after adjusting for baseline ASspiMRI-a score because of the imbalance among the groups at baseline.
↵§ All patients were receiving golimumab from week 24 to week 104. Patients who entered early escape were included in their originally assigned treatment group without data imputation.
↵¶ ASspiMRI-a score>1.
↵** ASspiMRI-a score≤1.
↵†† ASspiMRI-a score=0.
↵‡‡ ASspiMRI-a score>0.
ANOVA, analysis of variance; ASspiMRI-a, ankylosing spondylitis spine magnetic resonance imaging activity.