Table 2

Summary of integrated analyses of change from baseline in total PsA-modified vdH-S score at wk 24; randomised patients

Ustekinumab
PlaceboCombined45 mg90 mg
Integrated data analysis of change from baseline to wk 24 in total vdH-S score in the PSUMMIT-1 and PSUMMIT-2 studies—Major 2° endpoint, n310617308309
 Mean±SD1.0±3.90.4±2.30.4±2.10.4±2.4
 Median (IQ range)0.0 (0.0, 1.0)0.0 (0.0. 0.5)0.0 (0.0, 0.5)0.0 (0.0, 0.5)
 p Value<0.0010.017<0.001
Integrated data analysis of patients with change in vdH-S score*, n271573289284
 Change ≤ SDC (2.01), n (%)227 (83.8)526 (91.8)265 (91.7)261 (91.9)
  p Value<0.0010.0050.004
 Change ≤ 0.0, n (%)162 (59.8)381 (66.5)185 (64.0)196 (69.0)
  p Value0.0610.3170.026
Integrated data analysis of patients with pencil-in-cup or gross osteolytic deformities among those with evaluations at baseline and wk 24*, n271575291284
 Reader 1, n (%)
  Baseline7 (2.6)22 (3.8)13 (4.5)9 (3.2)
  Wk 248 (3.0)22 (3.8)13 (4.5)9 (3.2)
 Reader 2, n (%)
  Baseline9 (3.3)15 (2.6)11 (3.8)4 (1.4)
  Wk 249 (3.3)17 (3.0)11 (3.8)6 (2.1)
  • *No missing data imputation rules were applied.

  • anti-TNF, anti-tumour necrosis factor α; PsA, psoriatic arthritis; SDC, smallest detectable change; vdH-S, van der Heijde-Sharp; wk, week.