Demographics and baseline characteristics
| Variables | Secukinumab | Placebo | Total |
|---|---|---|---|
| Safety analysis set* | (n=28) | (n=14) | (n=42) |
| Female, n (%) | 19 (68) | 8 (57) | 27 (64) |
| Age (years), mean (SD) | 46.7 (11.3) | 47.6 (8.1) | 47.0 (10.2) |
| Predominant race, n (%) | |||
| Caucasian | 28 (100) | 11 (79) | 39 (93) |
| Other | 0 (0.0) | 3 (21) | 3 (7) |
| BMI (kg/m2), mean (SD) | 31.9 (8.1) | 27.5 (4.9) | 30.4 (7.5) |
| Efficacy analysis set* | (n=24) | (n=13) | (n=37) |
| Tender joint count, mean (SD) | 23.5 (19.4) | 22.6 (11.0) | 23.2 (16.8) |
| Swollen joint count, mean (SD) | 8.3 (5.6) | 9.5 (5.4) | 8.7 (5.5) |
| CRP (mg/l), median (min–max) | 4.9 (0.3–43) | 6.2 (1.3–39.7) | 5 (0.3–43) |
| ESR (mm/h), median (min–max) | 23.0 (2–64) | 14.0 (5–75) | 22.0 (2–75) |
| DAS28, mean (SD) | 4.8 (1.2) | 4.8 (1.2) | 4.8 (1.2) |
| LDI basic, mean (SD) | 2.7 (2.32) | 1.6 (2.34) | 2.2 (2.30) |
| MASES, mean (SD) | 3.0 (4.1) | 3.4 (2.3) | 3.1 (3.6) |
| SPARCC, mean (SD) | 4.4 (5.06) | 6.1 (4.41) | 5.0 (4.84) |
| PASI, mean (SD) | 3.5 (4.20) | 2.4 (2.13) | 3.1 (3.62) |
| PsA duration (years), mean (SD) | 6.3 (6.8) | 5.4 (3.8) | 6.0 (5.9) |
| Oligoarticular, n (%) | 10 (42) | 4 (31) | 14 (38) |
| Polyarticular, n (%) | 13 (54) | 9 (69) | 22 (59) |
| Distal interphalangeal joint predominant, n (%) | 1 (4) | 0 (0) | 1 (3) |
| Co-existing psoriasis, n (%) | 23 (96) | 11 (85) | 34 (92) |
| Concomitant DMARDs, n (%) | 13 (54) | 6 (46) | 19 (51) |
| MTX | 12 (50) | 6 (46) | 18 (49) |
| Leflunomide | 6 (25) | 1 (8) | 7 (19) |
| Chloroquine | 1 (4) | – | 1 (3) |
| SSZ | 2 (8) | – | 2 (5) |
| Concomitant NSAID, n (%) | 18 (75) | 1 (8) | 19 (51) |
| Concomitant steroid, n (%) | 8 (33) | 2 (15) | 10 (27) |
| Intra-articular† | 2 (8) | – | 2 (5) |
| Intramuscular | – | 1 (8) | 1 (3) |
| Oral | 7 (29) | 2 (15) | 9 (24) |
| Topical | 1 (4%) | – | 1 (3) |
| Prior TNFα inhibitor, n (%) | 10 (42) | 3 (23) | 13 (35) |
*The efficacy analysis set consisted of all patients who received the allocated treatment; the safety analysis set consisted of all patients who received at least one dose of the study medication regardless of treatment assignment; tender and swollen joint counts were based on 68 and 66 joints, respectively.
†Protocol violations.
BMI, body mass index; CRP, C reactive protein; DAS, disease activity score; DMARD, disease-modifying antirheumatic drug; ESR, erythrocyte sedimentation rate; LDI, Leeds Dactylitis Index; MASES, Maastricht Ankylosing Spondylitis Enthesitis Score; MTX, methotrexate; NSAID, non-steroidal anti-inflammatory drug; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; SPARCC, Spondyloarthritis Research Consortium of Canada; SSZ, sulphasalazine; TNF, tumour necrosis factor.