Table 1

Demographics and baseline clinical disease characteristics

TIL 200 mg
Q4W (n=78)
TIL 200 mg
Q12W (n=79)
TIL 100 mg
Q12W (n=77)
TIL 20→200 mg
Q12W (n=78)
PBO Q4W→TIL 200 mg
Q12W (n=79)
Demographics
Age, years50.1±13.349.3±11.249.2±11.947.2±13.448.1±13.3
Female, n (%)46 (59.0)37 (46.8)47 (61.0)41 (52.6)44 (55.7)
Race, n (%)
 White76 (97.4)78 (98.7)75 (97.4)75 (96.2)74 (93.7)
 Black or African American001 (1.3)1 (1.3)3 (3.8)
 Other2 (2.6)1 (1.3)1 (1.3)2 (2.6)2 (2.5)
Weight, kg85.1±19.787.2±19.583.7±18.985.2±18.185.3±20.2
BMI, kg/m230.1±6.530.2±6.529.5±6.829.4±5.229.5±6.0
Baseline disease characteristics
Duration of PsA, years7.5±8.56.2±7.27.0±6.66.6±6.76.3±6.1
Prior anti-TNFα therapy, n (%)*18 (22.8)17 (21.8)19 (23.8)19 (24.4)18 (23.7)
Concomitant antirheumatic medications, n (%)
 Methotrexate†44 (56.4)47 (59.5)49 (63.6)42 (53.8)47 (59.5)
  Dose, mg16.5±5.315.0±3.814.3±4.816.7±5.516.9±5.0
 Leflunomide2 (2.6)3 (3.8)2 (2.6)5 (6.4)3 (3.8)
 Leflunomide+prednisone/prednisolone00001 (1.3)
 Sulfasalazine001 (1.3)00
 Prednisolone01 (1.3)01 (1.3)0
 Sulfasalazine+leflunomide01 (1.3)000
Swollen joint count10.4±7.410.0±8.011.0±8.29.4±6.411.8±9.8
Tender joint count16.6±11.919.5±13.921.3±14.819.0±13.019.7±14.7
PtGA57.8±18.361.1±20.760.3±20.261.9±17.465.2±18.1
PGA54.0±16.155.4±16.257.3±17.359.4±14.459.5±15.6
Patient pain assessment55.4±19.159.6±23.559.2±22.160.9±19.764.2±20.4
HAQ-DI score1.0±0.61.0±0.61.0±0.71.1±0.61.2±0.6
hsCRP, mg/dL7.8±18.610.5±14.410.6±20.010.7±14.013.0±20.8
DAS28-CRP <3.2, n (%)6 (7.7)6 (7.6)4 (5.2)1 (1.3)6 (7.6)
DAPSA39.2±20.242.6±22.145.3±22.441.8±17.845.7±23.5
PASDAS5.2±0.865.2±0.785.3±0.895.3±0.855.4±0.89
LEI‡3.1±1.72.8±1.73.2±1.83.1±1.72.8±1.8
LDI‡32.8±32.961.3±73.593.8±146.571.4±118.599.6±170.7
BSA, (%)§11.9±16.09.0±12.413.1±16.010.4±14.18.2±12.2
BSA ≥3%, n (%)§53 (67.9)44 (55.7)55 (71.4)41 (52.6)42 (53.2)
PASI¶7.6±9.86.2±7.48.8±9.56.6±7.05.0±6.5
PsAID score5.1±1.85.3±2.15.5±2.15.6±1.95.7±1.6
  • Shown for randomised patients who received ≥1 dose of study drug; data shown as mean±SD unless otherwise noted.

  • *For prior anti-TNFα therapy, total patients analysed (N)=79, 78, 80, 78 and 76 for TIL 200 mg Q4W, TIL 200 mg Q12W, TIL 100 mg, TIL 20 mg and PBO, respectively.

  • †Patients receiving weekly oral methotrexate at baseline. No patients received concomitant methotrexate in combination with prednisone or prednisolone.

  • ‡For patients with baseline scores ≥1; N=48, 43, 51, 55 and 43 for LEI; N=27, 21, 21, 19 and 25 for LDI.

  • §Body surface area with psoriasis lesions; BSA ≥3% indicates active psoriasis.

  • ¶For analysis of baseline PASI, all patients were analysed, regardless of % BSA involved; N=75, 79, 76, 75 and 75 for TIL 200 mg Q4W, TIL 200 mg Q12W, TIL 100 mg, TIL 20 mg and PBO.

  • BMI, body mass index; BSA, body surface area; DAS28-CRP, Disease Activity Score in 28 joints with C reactive protein; HAQ-DI, Health Assessment Questionnaire-Disability Index; hsCRP, high sensitivity C reactive protein; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; PASI, Psoriasis Area and Severity Index; PBO, placebo; PGA, physician global assessment of disease activity; PsA, psoriatic arthritis; PsAID, PsA impact of disease; PtGA, patient global assessment of disease activity; Q4W, every 4 weeks; Q12W, every 12 weeks; TIL, tildrakizumab; TNF, tumour necrosis factor.