Summary of efficacy and concomitant medication use at week 104 by randomised treatment group
| Golimumab | |||
|---|---|---|---|
| Placebo* | 50 mg† | 100 mg‡ | |
| No. of patients randomised | 113 | 146 | 146 |
| RADIOGRAPHIC RESPONSES | |||
| Change in PsA-modified SHS§ | |||
| Total score, N= | 87 | 117 | 128 |
| 0.08±3.19 | −0.39±2.04 | −0.32±1.87 | |
| 0.0 (−0.5, 0.5) | 0.0 (−0.9, 0.0) | 0.0 (−0.5, 0.0) | |
| MTX use at baseline, N= | 51 | 61 | 63 |
| −0.24±2.09 | −0.78±1.76 | −0.65±2.15 | |
| 0.0 (−0.5, 0.5) | 0.0 (−1.0, 0.0) | 0.0 (−1.0, 0.0) | |
| No MTX use at baseline, N= | 36 | 56 | 65 |
| 0.53±4.30 | 0.03±2.25 | 0.00±1.51 | |
| 0.0 (−0.5, 0.3) | 0.0 (−0.5, 0.5) | 0.0 (0.0, 0.0) | |
| Erosion score, N= | 85 | 114 | 125 |
| 0.06±2.89 | −0.39±1.49 | −0.38±1.33 | |
| 0.0 (−0.5, 0.0) | 0.0 (−0.5, 0.0) | 0.0 (−0.5, 0.0) | |
| Joint space narrowing score, N= | 85 | 114 | 125 |
| 0.02±0.60 | 0.01±0.84 | −0.02±0.73 | |
| 0.0 (0.0, 0.0) | 0.0 (0.0, 0.0) | 0.0 (0.0, 0.0) | |
| Changes in PsA-modified SHS from weeks 52 to 104, N= | 87 | 116 | 127 |
| −0.03±1.59 | −0.10±1.00 | 0.02±0.71 | |
| 0.0 (0.0, 0.0) | 0.0 (0.0, 0.0) | 0.0 (0.0, 0.0) | |
| Pts with change in PsA-modified SHS>SDC, N= | 85 | 114 | 125 |
| 7 (8.2%) | 5 (4.4%) | 5 (4.0%) | |
| Pts with change in total PsA-modified SHS≤0, N= | 85 | 114 | 125 |
| 62 (72.9%) | 88 (77.2%) | 96 (76.8%) | |
| CLINICAL RESPONSES DAS28-CRP score | |||
| 3.1±1.3 | 2.9±1.3 | 2.8±1.2 | |
| 2.9 (2.0, 4.1) | 2.6 (1.8, 3.7) | 2.6 (1.7, 3.6) | |
| DAS28-CRP responders (good or moderate), n (%) | 87 (77.0%) | 126 (86.3%) | 125 (85.6%) |
| Enthesitis—PsA-modified MASES score,¶ N = | 88 | 109 | 115 |
| Score | 2.9±3.8 | 2.4±3.6 | 2.6±3.9 |
| 1.0 (0.0, 5.0) | 0.0 (0.0, 4.0) | 1.0 (0.0, 4.0) | |
| % Improvement from baseline | 40.4±92.7% | 59.5±70.0% | 56.0±72.7% |
| 64.0% | 100.0% | 90.9% | |
| (7.9, 100.0)% | (33.3, 100.0)% | (42.9, 100.0)% | |
| Dactylitis,** N= | 38 | 50 | 49 |
| Score | 1.1±2.4 | 1.3±4.1 | 0.8±2.4 |
| 0.0 (0.0, 1.0) | 0.0 (0.0, 0.0) | 0.0 (0.0, 0.0) | |
| % Improvement from baseline | 67.4±69.3% | 83.0±36.4% | 85.3±38.5% |
| 100.0% | 100.0% | 100.0% | |
| (75.0, 100.0)% | (100.0, 100.0) % | (100.0, 100.0) % | |
| HAQ | |||
| Score | 0.7±0.7 | 0.6±0.6 | 0.6±0.6 |
| 0.5 (0.0, 1.0) | 0.4 (0.0, 1.0) | 0.5 (0.0, 1.0) | |
| Pts with HAQ improvement ≥ 0.3 units | 61 (54.0%) | 77 (52.7%) | 86 (58.9%) |
| PASI,†† N= | 79 | 109 | 108 |
| Score | 3.0±5.8 | 2.5±4.1 | 1.9±2.7 |
| 1.2 (0.1, 2.8) | 1.4 (0.0, 2.8) | 1.1 (0.0, 2.6) | |
| NAPSI,‡‡ N= | 83 | 95 | 109 |
| Score | 1.5±1.9 | 2.0±2.6 | 1.3±1.9 |
| 1.0 (0.0, 3.0) | 1.0 (0.0, 4.0) | 0.0 (0.0, 2.0) | |
| % Improvement from baseline | 61.8±48.8% | 60.6±48.3% | 69.7±50.1% |
| 80.0% | 75.0% | 100.0% | |
| (33.3,100.0)% | (33.3,100.0)% | (50.0,100.0)% | |
| Concomitant medication use at week 104 | |||
| MTX | 53 (46.9%) | 63 (43.2%) | 68 (46.6%) |
| Dose (mg/week) | 14.2±4.9 | 13.7±4.6 | 14.9±5.0 |
| Oral corticosteroids | 17 (15.0%) | 18 (12.3%) | 24 (16.4%) |
| Dose (mg/day) | 5.8±1.7 | 7.1±3.0 | 6.6±4.3 |
| NSAIDs | 80 (70.8%) | 98 (67.1%) | 102 (69.9%) |
| Improvement from prior to → 12 weeks after dose escalation | Patients with dose escalation and ≥12 weeks of follow-up (n=33) | ||
| DAS28-CRP | |||
| Score (12 weeks after dose escalation) | 3.0±1.0 / 3.1 (2.3, 3.8) | ||
| % Improvement | 2.4±37.2% /6.3 (−12.2, 28.0)% | ||
| PASI†† | |||
| Score (12 weeks after dose escalation) | 1.9±3.0 / 0.4 (0.0, 2.8) | ||
| % Improvement | 32.5±38.8% / 22.2 (0.0, 70.0)% | ||
Data shown are mean±SD and median (IQR) or number (%) of patients at week 104, unless otherwise specified.
*Includes patients who early escaped at week 16 or crossed over at week 24 to receive golimumab 50 mg with the possibility to dose escalate after the week-52 database lock to receive golimumab 100 mg.
†Includes patients who early escaped at week 16 or dose escalated after the week-52 database lock to receive golimumab 100 mg.
‡Includes patients randomised to receive golimumab 100 mg at week 0. Patients in this group did not change study treatment.
§Includes patients who had baseline and at least one total PsA-modified SHS after week 52. Data derived from Reading Session 2.
¶Among patients with enthesitis at baseline.
**Among patients with dactylitis at baseline.
††Among patients with ≥3% BSA involvement at baseline.
‡‡Among patients with nail involvement at baseline.
BSA, body surface area; DAS28-CRP, Disease Activity Score employing 28-joint count and C reactive protein; HAQ, Health Assessment Questionnaire; MASES, Maastricht Ankylosing Spondylitis Enthesitis Score; MTX, methotrexate; NAPSI, Nail Psoriasis Severity Index; NSAIDs, non-steroidal anti-inflammatory drugs; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; SDC, smallest detectable change (=1.79); SHS, Sharp/van der Heijde score.