Patient demographics and baseline disease characteristics by baseline body mass index (BMI) category (pooled data from OPAL Broaden and OPAL Beyond)
| Baseline BMI category | ||||
| <25 kg/m2 (underweight/normal) N=161 (22.7%) | ≥25–<30 kg/m2 (overweight) N=238 (33.5%) | ≥30–<35 kg/m2 (class 1 obesity) N=186 (26.2%) | ≥35 kg/m2 (class 2 and 3 obesity) N=125 (17.6%) | |
| Patient demographics | ||||
| Age, years, mean (SD) | 44.5 (12.9) | 50.0 (11.8) | 50.5 (11.7) | 51.2 (11.3) |
| Female, n (%) | 101 (62.7) | 118 (49.6) | 92 (49.5) | 82 (65.6) |
| White, n (%) | 149 (92.5) | 224 (94.1) | 175 (94.1) | 121 (96.8) |
| BMI, kg/m2, mean (SD) | 22.5 (1.7) | 27.5 (1.4) | 32.3 (1.4) | 39.6 (4.1) |
| Weight, kg, n (%) | ||||
| <60 | 55 (34.2) | 0 | 1 (0.5) | 1 (0.8) |
| ≥60–<90 | 104 (64.6) | 202 (84.9) | 78 (41.9) | 11 (8.8) |
| ≥90 | 2 (1.2) | 36 (15.1) | 107 (57.5) | 113 (90.4) |
| Waist circumference, cm, mean (SD)* | 81.0 (9.0) | 95.2 (10.5) | 106.0 (9.3) | 118.0 (13.2) |
| Metabolic syndrome, n (%)† | 7 (4.3) | 85 (35.7) | 107 (57.5) | 95 (76.0) |
| Never smoked, n (%) | 110 (68.3) | 147 (61.8) | 108 (58.1) | 72 (57.6) |
| Baseline disease characteristics | ||||
| PsA duration, years, mean (SD) | 8.1 (7.7) | 8.0 (7.8) | 8.5 (7.1) | 7.3 (6.3) |
| HAQ-DI, mean (SD) | 1.1 (0.7) | 1.1 (0.7) | 1.2 (0.6) | 1.5 (0.7) |
| SF-36v2 PCS score, mean (SD) | 36.5 (8.7) | 35.3 (8.5) | 34.2 (7.9) | 30.8 (8.2) |
| SF-36v2 MCS score, mean (SD) | 38.6 (11.4) | 41.9 (11.7) | 39.9 (11.8) | 39.3 (12.6) |
| FACIT-F total score, mean (SD) | 27.5 (10.7) | 28.9 (10.8) | 27.3 (10.1) | 24.1 (11.8) |
| CRP mg/L, mean (SD) | 14.2 (27.5) | 10.6 (18.8) | 9.9 (17.3) | 14.4 (19.2) |
| >2.87 mg/L, n (%)‡ | 79 (49.1) | 143 (60.1) | 117 (62.9) | 105 (84.0) |
| PASI, mean (SD) | 9.2 (8.5) | 9.7 (8.3) | 10.4 (9.5) | 10.1 (8.1) |
| BSA ≥3%, n (%) | 113 (70.2) | 162 (68.1) | 125 (67.2) | 81 (64.8) |
| SJC, mean (SD) | 9.9 (7.7) | 12.1 (9.6) | 11.7 (9.6) | 14.7 (11.5) |
| TJC, mean (SD) | 18.5 (13.0) | 21.0 (14.2) | 20.7 (13.6) | 26.4 (16.8) |
| DSS, mean (SD) (N1)§ | 8.7 (7.7) (82) | 8.9 (8.7) (133) | 7.2 (6.5) (88) | 9.6 (9.5) (70) |
| LEI, mean (SD) (N2)¶ | 2.6 (1.4) (101) | 2.9 (1.6) (160) | 3.1 (1.7) (123) | 3.2 (1.7) (95) |
| Number of prior bDMARDs, n (%) | ||||
| 0 | 70 (43.5) | 114 (47.9) | 79 (42.5) | 42 (33.6) |
| 1 | 55 (34.2) | 79 (33.2) | 59 (31.7) | 53 (42.4) |
| ≥2 | 36 (22.4) | 45 (18.9) | 48 (25.8) | 30 (24.0) |
| Corticosteroid use at baseline, n (%) | 35 (21.7) | 47 (19.7) | 40 (21.5) | 31 (24.8) |
| NSAID use at baseline, n (%) | 91 (56.5) | 135 (56.7) | 96 (51.6) | 70 (56.0) |
| Concomitant methotrexate, n (%) | 122 (75.8) | 202 (84.9) | 139 (74.7) | 93 (74.4) |
| Dose, mg/week, mean (SD) | 15.3 (4.2) | 14.8 (4.3) | 14.8 (4.6) | 15.3 (4.2) |
| ≤15 mg/week, n (%) | 79 (49.1) | 140 (58.8) | 91 (48.9) | 61 (48.8) |
| >15 mg/week, n (%) | 43 (26.7) | 62 (26.1) | 48 (25.8) | 23 (25.6) |
*Baseline waist circumference data were unavailable for one patient in the <25 kg/m2 category and three patients in the ≥25–<30 kg/m2 category.
†A patient was classified as having baseline metabolic syndrome if any three of the five metabolic syndrome risk factors at baseline were satisfied: hypertension (systolic ≥130 mm Hg and/or diastolic ≥85 mm Hg and/or concomitant antihypertensive medication), elevated triglycerides (≥150 mg/dL, 1.7 mmol/L and/or concomitant lipid-lowering medication), reduced high-density lipoprotein cholesterol (<40 mg/dL, 1.0 mmol/L in males; <50 mg/dL, 1.3 mmol/L in females), elevated waist circumference (population-specific and country-specific definitions) and elevated fasting glucose levels (≥100 mg/dL and/or concomitant anti-diabetic medication).45
‡Elevated level of CRP defined as >2.87 mg/L.
§Assessed only in patients with baseline DSS >0.
¶Assessed only in patients with baseline LEI >0.
bDMARD, biological disease-modifying antirheumatic drug; BSA, body surface area; CRP, C-reactive protein; DSS, Dactylitis Severity Score; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; HAQ-DI, Health Assessment Questionnaire-Disability Index; LEI, Leeds Enthesitis Index; MCS, Mental Component Summary; N, number of patients randomised and treated; N1, number of patients with baseline DSS >0; N2, number of patients with baseline LEI >0; NSAID, non-steroidal anti-inflammatory drug; PASI, Psoriasis Area and Severity Index; PCS, Physical Component Summary; PsA, psoriatic arthritis; SF-36v2, Short Form-36 Health Survey version 2; SJC, swollen joint count; TJC, tender joint count.