Table 2

Secondary outcomes at week 24: per-protocol population (n=489*)

20 mg BID
p Value vs
30 mg BID
p Value vs placebo
ACR20, n†22 (13.3%)43 (26.4%)0.003259 (36.6%)<0.0001
ACR50, n†7 (4.2%)24 (14.7%)0.001332 (19.9%)<0.0001
ACR70, n†1 (0.6%)9 (5.5%)0.010217 (10.6%)0.0001
HAQ-DI (0–3), LS mean change (SE)−0.08 (0.04)−0.21 (0.04)0.0092−0.26 (0.04)0.0004
SF-36v2 PF score, LS mean change (SE)‡1.5 (0.67)3.5 (0.68)0.02955.1 (0.67)0.0001
EULAR good/moderate response, n27 (16.4%)51 (31.3%)0.001671 (44.1%)<0.0001
DAS-28 (CRP), LS mean change (SE)−0.20 (0.09)−0.66 (0.09)0.0002−0.91 (0.09)<0.0001
DAS-28 (CRP) <2.6, n4 (2.4%)19 (11.7%)0.001130 (18.6%)<0.0001
CDAI (0–76), LS mean change (SE)−3.1 (0.97)−7.6 (0.96)0.0010−9.6 (0.95)<0.0001
Patient assessment of pain (0–100 mm VAS), LS mean change (SE)−4.1 (1.8)−11.3 (1.8)0.0045−14.8 (1.8)<0.0001
Swollen joint count (0–76), LS mean change (SE)−1.4 (0.63)−4.1 (0.63)0.0023−5.1 (0.63)<0.0001
Tender joint count (0–78), LS mean change (SE)−0.91 (1.01)−5.0 (1.0)0.0035−7.8 (1.0)<0.0001
Patient Global Assessment (0–100 mm VAS), LS mean change (SE)−2.1 (1.9)−8.0 (1.9)0.0285−12.1 (1.9)0.0002
Physician Global Assessment (0–100 mm VAS), LS mean change (SE)−6.7 (1.9)−14.4 (1.9)0.0040−19.1 (1.9)<0.0001
CRP (mg/dL, normal range <0.5), LS mean change (SE)0.17 (0.09)−0.02 (0.09)0.1321−0.05 (0.09)0.0713
MASES (0–13),§ LS mean change (SE)−0.8 (0.31)−1.6 (0.30)0.0678−1.7 (0.29)0.0334
Dactylitis severity score (0–20),¶ LS mean change (SE)−1.3 (0.27)−2.0 (0.30)0.0710−1.8 (0.27)0.1753
PASI-50, n**12 (18.5%)25 (33.8%)0.043941 (50.6%)0.0001
PASI-75, n**3 (4.6%)13 (17.6%)0.018017 (21.0%)0.0040
  • Imputation methods included non-responder imputation for categorical endpoints that involve joint counts and last observation carried forward for all continuous endpoints and categorical endpoints that do not involve joint counts.

  • *The n reflects the number of randomised patients in the per-protocol population; actual number of patients available for each endpoint may vary.

  • †Patients who escaped early, discontinued early or did not have sufficient data for ACR response determination were counted as non-responders.

  • ‡Increase in score from baseline indicates improvement.

  • §Examined among patients who had enthesitis at baseline and ≥1 post-baseline value at or prior to week 24 (placebo: n=96; apremilast 20 mg BID: n=100; apremilast 30 mg BID: n=107).

  • ¶Examined among patients who had dactylitis at baseline and ≥1 post-baseline value at or prior to week 24; each digit on the patient's hand and feet was assessed for presence (score=1) or absence (score=0) of dactylitis. The dactylitis score was the sum of the individual assessments for all 20 digits (placebo: n=64; apremilast 20 mg BID: n=56; apremilast 30 mg BID: n=65).

  • **Examined among patients who had body surface area ≥3% at baseline (placebo: n=65; apremilast 20 mg BID: n=74; apremilast 30 mg BID: n=81).

  • ACR20/50/70, 20%/50%/70% improvement in modified American College of Rheumatology response criteria; CDAI, Clinical Disease Activity Index; CRP, C-reactive protein; DAS-28 (CRP), 28-joint Disease Activity Score (using CRP as acute-phase reactant); EULAR, European League Against Rheumatism; HAQ-DI, Health Assessment Questionnaire–Disability Index; LS, least-squares; MASES, Maastricht Ankylosing Spondylitis Enthesitis Score; PASI-50/75, 50%/75% reduction from baseline Psoriasis Area and Severity Index score; SF-36v2 PF, 36-Item Short-Form Health Survey Physical Functioning domain; VAS, visual analogue scale.