Table 2

Efficacy outcomes change from baseline to week 12 and 24, for both treatment arms

Efficacy outcomes12 Weeks24 Weeks
Median change
GLM+MTX
Median change
PLB+MTX
P valueMedian change
GLM+MTX
Median change
PLB+MTX
P value
Dactylitis
 DSS-3.5-10.004-5-20.026
 DSS response
 DSS 20, n (%)19/20 (95)12/23 (52.2)0.00219/20 (95.0)16/22 (72.7)0.096
  DSS 50, n (%)17/20 (85)7/23 (30.4)0.00117/20 (85.0)09/22 (40.9)0.005
  DSS 70, n (%)7/20 (35)5/23 (21.7)0.49712/20 (60.0)4/22 (18.2)0.010
 Dactylitis remission (DSS=0), n (%)2/20 (10)4/23 (17.4)0.676/20 (30.0)4/22 (18.1)0.477
 LDI-58.6-34.60.169-69.4-31.10.042
 LDI response
  LDI 20, n (%)19/19 (100.0)18/23 (78.3)0.05319/19 (100.0)16/22 (72.7)0.023
  LDI 50, n (%)17/19 (89.5)13/23 (56.5)0.03719/19 (100.0)15/22 (68.2)0.001
  LDI 70, n (%)16/19 (84.1)9/23 (39.1)0.00418/19 (94.7)9/22 (40.9)0.011
Enthesitis
 Enthesitis-0.500.512-100.224
 LEI000.752000.953
 SPARCC-0.500.589-100.216
 Enthesitis remission (LEI=0), n (%)9/11 (81.8)10/12 (83.3)11/11 (100.0)9/11 (90.0)0.476
Peripheral joints
 Tender joints (68)-5.5-20.026-7.5-50.077
 Swollen joints (66)-6.5-20.006-7-40.060
Psoriasis
 PASI-2.4-0.60.027-2.2-1.10.130
 BSA-7-0.50.097-5.8-2.50.337
 Target NAPSI-200.044-1.500.027
Patient-reported and physician-reported outcomes
 PGA for arthritis activity (0–100 mm)-20-12.50.874-34-16.50.190
 PGA for psoriasis activity (0–100 mm)-30-100.846-10-90.860
Physical function
 HAQ-DI-0.5-0.1250.163-0.375-0.1880.414
Health-related quality of life
 DLQI-2-0.50.101-2.5-10.161
Composite indices of disease activity
 DAS28 4v-1.67-0.830.004-1.72-1.150.013
 DAPSA-17.05-9.320.012-21.62-12.880.039
 PASDAS-2.7-1.390.001-3.27-1.760.008
 CPDAI-2-20.312-6-30.292
Response indices
 ACR
  ACR 20, n (%)17/17 (100.0)9/19 (47.4)0.00115/16 (93.8)12/19 (63.2)0.047
  ACR 50, n (%)11/19 (57.9)5/21 (23.8)0.05212/17 (70.6)7/21 (33.3)0.049
  ACR 70, n (%)6/20 (30.0)1/22 (4.5)0.0418/19 (42.1)5/22 (22.7)0.313
 MDA, n (%)10/18 (55.6)3/23 (13.0)0.00611/16 (68.8)9/21 (42.9)0.185
 PsARC, n (%)16/20 (80.0)13/23 (56.5)0.11917/20 (85.0)16/22 (72.7)0.460
 PsAJAI, n (%)16/18 (88.9)14/22 (63.6)0.08216/17 (94.1)16/21 (76.2)0.197
 PASI
  PASI 50, n (%)16/20 (80.0)10/22 (45.5)0.02917/20 (85.0)12/20 (60.0)0.155
  PASI 70, n (%)10/20 (50.0)8/22 (36.4)0.53412/20 (60.0)9/20 (45.0)0.527
  PASI 90, n (%)5/20 (25.0)4/22 (18.2)0.7145/20 (25.0)8/20 (40.0)0.501
  • ACR, American College of Rheumatology; BSA, body surface area; CPDAI, Composite Psoriatic Disease Activity Index; DAPSA, Disease Activity in Psoriatic Arthritis; DAS28 v4, Disease Activity Score four variables; DLQI, Dermatology Life Quality Index; DSS, Dactylitis Severity Score; GLM, golimumab; HAQ-DI, Health Assessment Questionnaire Disability Index; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; MDA, minimal disease activity; MTX, methotrexate; NAPSI, Nail Psoriasis Severity Index; PASDAS, Psoriatic Arthritis Disease Activity Score; PASI, Psoriasis Area and Severity Index; PGA, patient global assessment; PhGA, physician global assessment; PLB, placebo; PsAJAI, Psoriatic Arthritis Joint Activity Index; PsARC, Psoriatic Arthritis Response Criteria; SPARCC, Spondyloarthritis Research Consortium of Canada Enthesitis Index.p<0.05.