Table 2

Outcomes at week 16 comparing apremilast and placebo

Sentinel* jointsAll joints
Placebo
(n=105)
Apremilast
(n=203)
Difference (95% CI)Placebo
(n=105)
Apremilast
(n=203)
Difference (95% CI)
cDAPSA REM/LDA, n (%)54 (51.8)143 (70.2)18.6%
(7.0 to 30.2)
p=0.0017
40 (38.0)122 (60.3)22.5%
(10.7 to 34.3)
p=0.0004†
SJC≤1, n (%)72 (69.0)150 (74.0)5.1
(−5.8 to 16.0)
p=0.3539
43 (41.5)117 (57.9)16.4
(4.7 to 28.0)
p=0.0068†
TJC≤1, n (%)47 (44.4)134 (66.2)22.1
(10.4 to 33.7)
p=0.0003†
17 (16.7)77 (38.0)21.4
(11.6 to 31.2)
p=0.0002†
PtGA VAS≤20, n (%)20 (19.1)62 (30.4)11.8%
(1.7 to 22.0)
p=0.0286†
Patient pain VAS≤15, n (%)14 (13.1)60 (29.4)16.3%
(6.9 to 25.8)
p=0.0022†
PsAID-12, LS mean (SE) change from baseline−0.4 (0.2)−1.5 (0.2)−1.0
(−1.5 to −0.6)
p<0.0001†
PASDAS good/moderate response, n (%)45 (42.7)122 (59.9)17.7%
(5.7 to 29.7)
p=0.0043†
42 (39.8)120 (59.3)20.0%
(8.1 to 32.0)
p=0.0014†
  • FAS. The number of responders was rounded based on the value given by multiple imputations.

  • *Sentinel joints are defined as joints affected at baseline.

  • †Nominal p value.

  • cDAPSA, Clinical Disease Activity in Psoriatic Arthritis; CI, confidence interval; csDMARD, conventional synthetic disease-modifying antirheumatic drug; FAS, full analysis set; LDA, low disease activity; LS, least squares; MDA, minimal disease activity; PASDAS, PsA Disease Activity Score; PsAID-12, Psoriatic Arthritis Impact of Disease; PtGA, Patient Global Assessment of disease activity; REM, remission; SE, standard error; SJC, swollen joint count; TJC, tender joint count; VAS, Visual Analogue Scale.