Table 1

Demographics and baseline characteristics

VariablesSecukinumabPlaceboTotal
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 (%)
 Caucasian28 (100)11 (79)39 (93)
 Other0 (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)
 MTX12 (50)6 (46)18 (49)
 Leflunomide6 (25)1 (8)7 (19)
 Chloroquine1 (4)1 (3)
 SSZ2 (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)
 Intramuscular1 (8)1 (3)
 Oral7 (29)2 (15)9 (24)
 Topical1 (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.