Summary of efficacy and concomitant medication use at week 256 by randomised treatment group
| Golimumab | |||
|---|---|---|---|
| Placebo* | 50 mg† | 100 mg‡ | |
| Number of randomised patients | 113 | 146 | 146 |
| Radiographic efficacy at week 256 (among patients with SHS at weeks 0, 104, and 256) | |||
| CHANGE in modified SHS | |||
| Total score, N= | 73 | 93 | 101 |
| 0.3±3.8 | 0.3±4.2 | 0.1±2.7 | |
| 0.0 (−0.5, 0.5) | 0.0 (−0.5, 1.0) | 0.0 (0.0, 1.0) | |
| MTX use at baseline, N= | 43 | 48 | 52 |
| 0.0±2.2 | −0.3±4.8 | −0.3±3.4 | |
| 0.0 (−1.0, 1.0) | 0.0 (−1.5, 0.5) | 0.0 (−0.5, 0.5) | |
| No MTX use at baseline, N= | 30 | 45 | 49 |
| 0.7±5.4 | 0.9±3.3 | 0.4±1.8 | |
| 0.0 (0.0, 0.5) | 0.0 (0.0, 1.5) | 0.0 (0.0, 1.0) | |
| Erosion score, N= | 73 | 93 | 101 |
| −0.1±3.1 | −0.03±2.8 | −0.3±1.9 | |
| 0.0 (−0.5, 0.0) | 0.0 (−0.5, 0.5) | 0.0 (0.0, 0.5) | |
| Joint space narrowing score, N= | 73 | 94 | 101 |
| 0.4±1.4 | 0.3±1.9 | 0.4±1.4 | |
| 0.0 (0.0, 0.5) | 0.0 (0.0, 0.5) | 0.0 (0.0, 0.5) | |
| Pts with change in total PsA-modified SHS ≤0 (%) | 46/73 (63.0) | 58/93 (62.4) | 66/101 (65.3) |
| Clinical efficacy at week 256 (intent-to-treat analysis by randomised treatment group) | |||
| DAS28-CRP, N = | 113 | 146 | 146 |
| Baseline score | 4.9±1.0 | 5.0±1.1 | 4.9±1.1 |
| Week 256 score | 3.0±1.4 | 2.8±1.2 | 2.8±1.2 |
| DAS28-CRP responder (good/moderate) (%) | 85 (75.2) | 122 (83.6) | 124 (84.9) |
| % improvement in DAS28-CRP score 12 weeks after DE among pts who had not achieved a DAS28-CRP score < 2.6 before DE§ | – | – | N=47 18.0±21.2% |
| Enthesitis, ¶ N = | 88 | 109 | 115 |
| Baseline score | 5.0±4.1 | 5.7±4.0 | 6.1±4.1 |
| Week 256 score | 2.4±4.0 | 1.9±3.3 | 2.0±3.4 |
| Dactylitis,** N = | 38 | 50 | 49 |
| Baseline score | 3.1±2.1 | 6.3±6.1 | 5.4±6.7 |
| Week 256 score | 1.2±2.3 | 1.3±4.9 | 0.8±2.1 |
| HAQ-DI, N= | 113 | 146 | 146 |
| Baseline score | 1.0±0.5 | 1.0±0.6 | 1.1±0.6 |
| Week 256 score | 0.7±0.6 | 0.6±0.6 | 0.6±0.6 |
| Pts with HAQ-DI improvement ≥0.3 units | 59 (52.2%) | 79 (54.1%) | 85 (58.2%) |
| PASI,†† N= | 79 | 109 | 108 |
| Baseline score | 8.4±7.4 | 9.8±8.6 | 11.1±9.5 |
| Week 256 score | 3.0±5.8 | 2.7±4.5 | 2.2±3.9 |
| % improvement in PASI score 12 weeks after DE among pts without PASI75 response before DE§ | – | – | n=16 44.3±35.4% |
| NAPSI,‡‡ N= | 83 | 95 | 109 |
| Baseline score | 4.4±2.2 | 4.7±2.2 | 4.6±2.1 |
| Week 256 score | 1.1±1.9 | 1.7±2.5 | 1.1±1.8 |
| SF-36 PCS score, N= | 113 | 146 | 146 |
| Score | 40.1±11.4 | 41.8±11.6 | 41.0±11.1 |
| Improvement from baseline | 8.1±10.9 | 8.8±11.1 | 8.2±11.0 |
| SF-36 MCS score, N= | 113 | 146 | 146 |
| Score | 50.9±10.1 | 49.5±10.4 | 49.6±10.6 |
| Improvement from baseline | 3.3±11.1 | 4.2±11.8 | 4.5±11.2 |
| Concomitant medication use at wk256 | |||
| MTX (%) | 46 (40.7) | 59 (40.4) | 73 (50.0) |
| Dose (prednisone equivalent mg/week) | 15.2±4.6 | 13.6±4.6 | 14.2±4.5 |
| Oral corticosteroids (%) | 16 (14.2) | 17 (11.6) | 21 (14.4) |
| Prednisone-equivalent dose (mg/day) | 6.1±2.1 | 7.5±2.9 | 7.5±8.2 |
| NSAIDs (%) | 68 (60.2) | 93 (63.7) | 98 (67.1) |
Data shown are mean±SD, median (IQR) or number (%) of patients at week 256, unless otherwise specified.
*Includes patients who were initially randomised to placebo and later early escaped at week 16 or crossed over at week 24 to receive golimumab 50 mg, with the possibility after the week-52 database lock to increase the golimumab dose to 100 mg and also to decrease the golimumab dose from 100 mg to 50 mg.
†Includes patients who were initially randomised to golimumab 50 mg and later early escaped at week 16 or dose escalated after the week-52 database lock to receive golimumab 100 mg, with the possibility to decrease the dose from 100 mg to 50 mg after the week-52 database lock.
‡Includes patients randomised to receive golimumab 100 mg at week 0, with the possibility to decrease the golimumab dose from 100 mg to 50 mg after the week-52 database lock.
§Dose-escalation analyses used data from week 0 to 256, that is, from blinded and open-label portions of the study, from patients who had ≥12 weeks of follow-up after dose escalation.
¶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, C-reactive protein-based, 28-joint-count Disease Activity Score; HAQ-DI, Health Assessment Questionnaire Disability Index; DE, dose escalation from golimumab 50 mg q4w to golimumab 100 mg q4w; MCS, mental component summary; MTX, methotrexate; NAPSI, Nail Psoriasis Activity Index; NSAIDs, nonsteroidal anti-inflammatory drugs; PASI, Psoriasis Area and Severity Index; PCS, physical component summary; PsA, psoriatic arthritis; SF-36, 36-item short-form health survey, SHS, Sharp/van der Heijde score.