Table 1

Patient demographics and other baseline characteristics (full analysis set)

CharacteristicBrodalumab 210 mg
N=80
Placebo
N=79
Sex, male—n (%)66 (82.5)61 (77.2)
Mean age (SD)—years36.6 (11.4)38.3 (10.8)
Mean BMI (SD)—kg/m225.1 (4.2)25.4 (4.1)
Disease subpopulations— n (%)
 AS63 (78.8)62 (78.5)
 nr-axSpA17 (21.3)16 (20.3)
 Missing*01 (1.3)
Disease duration of axSpA†—n7575
 Mean (SD)—years7.1 (7.7)6.5 (6.5)
 Range—years0.1–33.90.1–26.8
Region—n (%)
 Japan15 (18.8)15 (19.0)
 Korea22 (27.5)22 (27.8)
 Taiwan43 (53.8)42 (53.2)
Spondyloarthritis features—n (%)
 Inflammatory back pain79 (98.8)79 (100.0)
 Arthritis25 (31.3)35 (44.3)
 Enthesitis (heel)18 (22.5)19 (24.1)
 Uveitis16 (20.0)11 (13.9)
 Dactylitis2 (2.5)4 (5.1)
 Psoriasis6 (7.5)5 (6.3)
 Good response to NSAIDs25 (31.3)31 (39.2)
 Family history of spondyloarthritis21 (26.3)31 (39.2)
 HLA-B27 positive68 (85.0)65 (82.3)
 Elevated CRP‡49 (61.3)46 (58.2)
Prior anti-TNF therapy—n (%)16 (20.0)17 (21.5)
 Adalimumab4 (5.0)4 (5.1)
 Certolizumab pegol4 (5.0)3 (3.8)
 Etanercept6 (7.5)5 (6.3)
 Golimumab02 (2.5)
 Infliximab2 (2.5)3 (3.8)
Prior anti-IL-12/23 therapy—n (%)00
CRP level at screening, mean (SD)—mg/dL1.22 (1.45)1.15 (1.19)
ASDAS-CRP score, mean (SD)2.660 (0.615)2.716 (0.652)
BASFI score, mean (SD)3.7 (2.3)3.5 (2.5)
BASDAI score, mean (SD)6.2 (1.4)6.4 (1.6)
BASMI score, mean (SD)2.3 (1.7)2.9 (1.9)
  • *The patient was initially randomised to the nr-axSpA subgroup at enrolment based on HLA-B-positive results observed on flow cytometry analysis at a local laboratory. However, based on HLA-B-negative results identified later using PCR-SBT at the central lab, the patient was excluded from the nr-axSpA subpopulation.

  • †Time from diagnosis to study enrolment.

  • ‡CRP above ULN (0.5 mg/dL).

  • AS, ankylosing spondylitis; ASDAS, Ankylosing Spondylitis Disease Activity Score; axSpA, axial spondyloarthritis; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BASMI, Bath Ankylosing Spondylitis Metrology Index; BMI, body mass index; CRP, C-reactive protein; HLA, human leucocyte antigen; IL, interleukin; nr-axSpA, non-radiographic axSpA; NSAID, non-steroidal anti-inflammatory drug; PCR-SBT, PCR-sequenced based typing; TNF, tumour necrosis factor; ULN, upper limit of normal.