Baseline characteristics of the population included in the study.
| ADA (n=18) | IFX (n=22) | Total (n=40) | P value | |
| Age, years±SD | 47.7±10.20 | 45.73±11.88 | 46.75±10.70 | 0.635 |
| Sex (n, %) | ||||
| Male | 13 (72.22) | 15 (68.18) | 28 (70.0) | NS |
| Female | 5 (27.78) | 7 (31.82) | 12 (30.0) | |
| Ethnicity (n, %) | ||||
| White | 16 (88.89) | 18 (81.82) | 34 (85.0) | NS |
| Black | 0 | 2 (9.09) | 2 (5.0) | |
| Other | 2 (11.11) | 2 (9.1) | 4 (10.0) | |
| Smoking status (n, %) | ||||
| Never smoked | 10 (55.55) | 14 (63.63) | 24 (60.0) | 0.016 |
| Ex-smoker | 3 (16.66) | 3 (13.63) | 6 (15.0) | |
| Current smoker | 5 (27.77) | 5 (22.72) | 10 (25.0= | |
| Comorbidities (n, %) | ||||
| Diabetes | 4 (22.22) | 4 (28.57) | 8 (20.0) | NS |
| Hypertension | 6 (33.33) | 6 (42.86) | 12 (30.0) | NS |
| Ischaemic heart disease | 3 (16.67) | 5 (35.71) | 8 (20.0) | NS |
| Dyslipidaemia | 6 (33.33) | 3 (21.43) | 9 (22.50) | NS |
| Disease activity according to BDCAF mean±SD | 7.39±3.03 | 7.41±2.48 | 7.4±2.2 | NS |
| Active disease manifestations at time of randomisation (n,%) | ||||
| Mucocutaneous | 18 (100) | 22 (100) | ||
| Ocular | 3 (16) | 3 (13) | ||
| Neurological | 1 (5) | 2 (9) | ||
| Pattern of major organ involvement (n,%) | ||||
| Ocular | ||||
| Bilateral | 2 (67) | - | ||
| Unilateral | 1 (33) | 3 (100) | ||
| Anterior | - | 1 (33) | ||
| Posterior | 3 (100) | 2 (67) | ||
| Neurological | ||||
| Meningoencephalitis with brainstem involvement | 1 (100) | 1 (50) | ||
| Cranial neuropathy | - | 1 (50) | ||
| Previous medications*n (%) | ||||
| Colchicine | 10 (55) | 12 (54) | 22 (55) | |
| GC | 9 (50) | 10 (45) | 19 (48) | |
| Topical GC | 5 (28) | 7 (32) | 12 (30) | |
| Criteria entry | ||||
| AZA failure | 12 (67) | 15 (68) | 17 (43) | |
| CyA failure | 6 (33) | 7 (32) | 13 (33) | |
| Concomitant treatment at the study entry (n, %) | ||||
| GC | 18 (100) | 12 (54.55) | 30 (75.0) | 0.003 |
| Colchicine | 14 (77.78) | 11 (50) | 25 (62.50) | NS |
| DMARDs† | 3 (17) | 4 (23) | 7 (17) | NS |
*Previous medications were defined as those used within 30 days before screening.
†DMARDs at the study entry were represented by: AZA3 in the ADA arm and methotrexate4 in the IFX arm
ADA, adalimumab; AZA, azathioprine; BDCAF, Behçet’s Disease Current Activity Form; CyA, cyclosporine; DMARD, disease-modifying antirheumatic drug; GC, glucocorticoids; IFX, infliximab ; NS, not significant.