Baseline patient characteristics and concomitant medication use
Golimumab | |||
---|---|---|---|
Placebo | 50 mg | 100 mg | |
No. of patients randomised | 113 | 146 | 146 |
Male | 69 (61%) | 89 (61%) | 86 (59%) |
Caucasian | 110 (97%) | 141 (97%) | 142 (97%) |
Age (years) | 47.0±10.6 | 45.7±10.7 | 48.2±10.9 |
PsA duration (years) | 7.6±7.9 | 7.2±6.8 | 7.7±7.8 |
Number of swollen joints (0–66) | 13.4±9.8 | 14.1±11.4 | 12.0±8.5 |
Number of tender joints (0–68) | 21.9±14.7 | 24.0±17.1 | 22.5±15.7 |
CRP (mg/dl) | 1.3±1.6 | 1.3±1.6 | 1.4±1.8 |
DAS28 using CRP | 4.9±1.0 | 5.0±1.1 | 4.9±1.1 |
PsA-modified SHS of hands and feet (0–528) | 16.3±26.7 | 23.0±35.3 | 20.4±35.7 |
Patients receiving MTX | 24.4±35.4 | 28.9±42.7 | 28.9±42.6 |
Patients not receiving MTX | 12.0±15.3 | 19.1±26.1 | 18.1±25.9 |
Patients with dactylitis | 38 (34%) | 50 (34%) | 49 (34%) |
Dactylitis score (1–60) | 3.1±2.1 | 6.3±6.1 | 5.4±6.7 |
Patients with enthesitis | 88 (78%) | 109 (75%) | 115 (79%) |
PsA-modified MASES score (1–15) | 5.0±4.1 | 5.7±4.0 | 6.1±4.1 |
Patients with ≥3% BSA | 79 (70%) | 109 (75%) | 108 (74%) |
BSA (%) | 14.7±15.7 | 16.2±17.7 | 17.7±18.3 |
PASI score (0–72) | 8.4±7.4 | 9.8±8.6 | 11.1±9.5 |
HAQ score (0–3) | 1.0±0.5 | 1.0±0.6 | 1.1±0.6 |
Patients with fingernail involvement | 83 (74%) | 95 (65%) | 109 (75%) |
NAPSI score (1–8) of target fingernail | 4.4±2.2 | 4.7±2.2 | 4.6±2.1 |
Patients receiving MTX | 54 (48%) | 71 (49%) | 69 (47%) |
Dose (mg/week) | 15.0±4.4 | 14.8±4.7 | 15.5±5.1 |
Patients receiving oral corticosteroids | 19 (17%) | 19 (13%) | 27 (19%) |
Dose (mg/day) | 5.8±1.7 | 7.6±2.4 | 6.0±2.2 |
Patients receiving NSAIDs | 88 (78%) | 110 (75%) | 110 (75%) |
Values are mean±SD or n (%) unless otherwise noted.
BSA, body surface area; CRP, C reactive protein; DAS28, Disease Activity Score employing 28-joint count; 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; SHS, Sharp/van der Heijde score.