Table 1. Baseline clinical characteristics of the randomised participants.
| Baseline clinical characteristics | Enrolled participants (n = 39) |
Anakinra (n = 22) |
TNFi (n = 17) |
|---|---|---|---|
| Age, mean ± SD (years) | 62.72 ± 9.97 | 62.86 ± 9.70 | 62.53 ± 10.60 |
| Female, n (%) | 29 (74.4%) | 17 (77.2%) | 12 (70.6%) |
| RA clinical characteristics | |||
| RF, n (%) | 22 (56.4%) | 12 (54.5%) | 10 (45.4%) |
| ACPA, n (%) | 24 (61.5%) | 14 (63.6%) | 10 (58.8%) |
| RA duration (years), median (25%; 75%) |
2 (0.6; 5) | 2 (0.8; 5) | 1 (0.6; 5) |
| DAS28, mean ± SD | 5.54 ± 1.03 | 5.43 ± 1.18 | 5.70 ± 0.80 |
| SDAI, mean ± SD | 35.38 ± 22.66 | 34.98 ± 25.17 | 35.86 ± 19.68 |
| Physician global assessment, mean ± SD |
62.00 ± 19.28 | 62.00 ± 19.81 | 62.00 ± 19.17 |
| Patient global assessment, mean ± SD |
66.51 ± 20.99 | 63.95 ± 24.35 | 69.82 ± 15.73 |
| VAS, mean ± SD | 67.77 ± 26.47 | 66.86 ± 29.46 | 68.94 ± 22.86 |
| ESR (mm/h), mean ± SD | 32.79 ± 18.78 | 35.55 ± 19.13 | 29.24 ± 18.26 |
| CRP (mg/L), mean ± SD | 11.84 ± 9.67 | 12.66 ± 10.14 | 10.78 ± 9.23 |
| CCSs, n (%) | 26 (66.7%) | 13 (59.1%) | 13 (76.5%) |
| MTX, n (%) | 39 (100%) | 22 (100%) | 17 (100%) |
| HCQ, n (%) | 4 (10.3%) | 2 (9.1%) | 2 (11.8%) |
| SSZ, n (%) | 3 (7.7%) | 2 (9.1%) | 1 (5.9%) |
| Anakinra, n (%) | 22 (100%) | ||
| TNFi, n (%) | 17 (100%) | ||
| ADA, n (%) | 7 (41.2%) | ||
| CZP, n (%) | 3 (17.6%) | ||
| ETN, n (%) | 3 (17.6%) | ||
| IFX, n (%) | 2 (11.8%) | ||
| GOL, n (%) | 2 (11.8%) | ||
| T2D clinical characteristics | |||
| T2D duration (years), median (25%; 75%) |
1 (0.6; 2) | 0.7 (0.6; 1) | 2 (0.8; 3) |
| C peptide (mg/dL), mean ± SD |
2.66 ± 1.34 | 2.92 ± 1.42 | 2.32 ± 1.19 |
| HbA1c (%), mean ± SD | 7.77 ± 0.70 | 7.73 ± 0.67 | 7.83 ± 0.76 |
| FPG, mean ± SD | 139.13 ± 42.17 | 139.05 ± 50.09 | 139.25 ± 29.55 |
| Microalbuminuria (mg/L), mean ± SD | 10.88 ± 9.33 | 12.14 ± 11.93 | 8.15 ± 5.98 |
| Diabetic retinopathy, n (%) | 5 (12.8%) | 3 (13.6%) | 2 (11.8%) |
| BMI, mean ± SD | 27.93 ± 4.04 | 27.59 ± 4.49 | 28.37 ± 3.47 |
| Total cholesterol (mg/dL), mean ± SD |
190.52 ± 69.32 | 182.56 ± 65.12 | 195.52 ± 59.35 |
| Triglycerides (mg/dl), mean ± SD |
122.85 ± 54.59 | 123.78 ± 45.12 | 126.52 ± 49.09 |
| Oral antidiabetic drugs, n (%) | 29 (74.4%) | 18 (81.8%) | 11 (64.7%) |
| Insulin therapy, n (%) | 10 (25.6%) | 6 (27.3%) | 4 (23.5%) |
| Statins, n (%) | 5 (12.8%) | 3 (13.6%) | 2 (11.8%) |
| Comorbidities, n (%) | 30 (76.9%) | 18 (81.8%) | 12 (70.6%) |
Abbreviations: ACPA, anticyclic citrullinated peptide antibody; ADA, adalimumab; BMI, body mass index; CCS, corticosteroid; CRP, C-reactive protein; CZP, certolizumab pegol; DAS28, Disease Activity Score-28; ESR, erythrocyte sedimentation rate; ETN, etanercept; FPG, fasting plasma glucose; GOL, golimumab; HbA1c%, percentage of glycated haemoglobin; HCQ, hydroxychloroquine; IFX, infliximab; MTX, methotrexate; RA, rheumatoid arthritis; RF, rheumatoid factor; SDAI, simplified disease activity index; SSZ, sulfasalazine; T2D, type 2 diabetes; TNFi, tumour necrosis factor inhibitor; VAS, visual analogue scale