Clinical responses at week 24 and week 54
| Week 24 | Week 54 | |||||
|---|---|---|---|---|---|---|
| Responses | Placebo | Infliximab 5 mg/kg | p Value | Placebo/infliximab* | Randomised infliximab† | |
| *This group includes patients who were randomised to placebo and received infliximab, starting at either week 16 or 24; †this group includes patients who were randomised to infliximab 5 mg/kg and either received infliximab 5 mg/kg throughout the study or escalated the dose to 10 mg/kg at week 38 and 46; ‡values are change or improvement from baseline; §values are means (standard deviation). | ||||||
| ACR, American College of Rheumatology; BSA, body surface area; CRP, C reactive protein; HAQ, Health Assessment Questionnaire; PASI, Psoriasis Area and Severity Index; PsARC, Psoriatic Arthritis Response Criteria; SF-36, Short Form-36; VAS, visual analogue scale. | ||||||
| Number of patients | 100 | 100 | 83 | 90 | ||
| ACR response‡ | ||||||
| 20% Improvement (%) | 16.0 | 54.0 | <0.001 | 61.4 | 58.9 | |
| 50% Improvement (%) | 4.0 | 41.0 | <0.001 | 43.4 | 36.7 | |
| 70% Improvement (%) | 2.0 | 27.0 | <0.001 | 25.3 | 22.2 | |
| Achieving PsARC (%) | 32.0 | 70.0 | <0.001 | 81.9 | 74.4 | |
| Percentage improvement in individual ACR components‡, § | ||||||
| Number of swollen joints | 23.5 (39.8) | 58.0 (45.3) | <0.001 | 57.5 (62.5) | 59.6 (54.9) | |
| Number of tender joints | 14.9 (36.5) | 54.1 (45.2) | <0.001 | 54.8 (53.0) | 52.0 (46.8) | |
| CRP | −7.0 (55.0) | 34.7 (67.5) | <0.001 | 16.6 (108.2) | 8.3 (136.4) | |
| Physician’s global assessment of disease activity (VAS) | 18.0 (55.9) | 57.3 (46.8) | <0.001 | 66.5 (46.1) | 62.6 (39.7) | |
| Patient’s global assessment of disease activity (VAS) | 7.2 (45.4) | 35.1 (74.4) | <0.001 | 45.9 (56.8) | 31.3 (78.6) | |
| Patient’s assessment of pain (VAS) | −10.0 (114.2) | 37.4 (54.2) | <0.001 | 48.9 (53.3) | 38.9 (63.6) | |
| HAQ disability index | −19.4 (102.8) | 46.0 (42.5) | <0.001 | 35.5 (103.7) | 41.2 (89.4) | |
| Absolute values for individual ACR components§ | ||||||
| Number of swollen joints (0–66) | 11.7 (9.7) | 5.6 (6.9) | <0.001 | 6.7 (9.5) | 5.1 (7.3 | |
| Number of tender joints (0–68) | 21.1 (13.4) | 12.5 (15.1) | <0.001 | 11.9 (15.0) | 13.0 (15.7) | |
| CRP (mg/l) | 22 (32)) | 7 (8) | <0.001 | 10 (16) | 10 (15) | |
| Physician’s global assessment of disease activity (VAS; 0–10 cm) | 4.5 (2.4) | 2.2 (2.2) | <0.001 | 1.9 (2.2) | 2.0 (2.3) | |
| Patient’s global assessment of disease activity (VAS; 0–10 cm) | 5.0 (2.5) | 3.0 (2.5) | <0.001 | 2.8 (2.7) | 3.0 (2.6) | |
| Patient’s assessment of pain (VAS; 0–10 cm) | 5.2 (2.6) | 3.1 (2.6) | <0.001 | 2.7 (2.7) | 3.1 (2.7) | |
| HAQ Disability Index (0–3) | 1.1 (0.7) | 0.7 (0.7) | <0.001 | 0.7 (0.8) | 0.6 (0.7) | |
| Percentage improvement in duration of morning stiffness§ | −152.0 (882.6) | 43.1 (103.9) | <0.001 | 29.0 (330.7) | 12.4 (281.5) | |
| Patients with at least one digit with dactylitis (%) | 34.0 | 11.8 | <0.001 | 14.8 | 12.2 | |
| Patients with enthesopathy (%) | 37.2 | 20.4 | 0.002 | 19.8 | 18.9 | |
| PASI response‡ | ||||||
| Patients with ⩾3% BSA affected with psoriasis (baseline), n | 87 | 83 | 73 | 72 | ||
| ⩾50% Improvement (%) | 8.0 | 74.7 | <0.001 | 79.5 | 69.4 | |
| ⩾75% Improvement (%) | 1.1 | 60.2 | <0.001 | 60.3 | 50.0 | |
| ⩾90% Improvement (%) | 0.0 | 38.6 | <0.001 | 42.5 | 41.7 | |
| Percentage improvement in target lesion score‡, § | −1.0 (40.1) | 64.2 (43.9) | <0.001 | 70.3 (38.1) | 53.6 (50.4) | |
| Change in SF-36, n‡, § | 92 | 93 | 82 | 84 | ||
| Physical component | 1.3 (8.2) | 7.7 (9.8) | 0.001 | 10.7 (10.4) | 8.8 (10.6) | |
| Mental component | 0.4 (11.6) | 3.9 (11.9) | 0.047 | 2.8 (10.3) | 3.7 (9.5) | |