Secondary outcomes at week 24: per-protocol population (n=489*)
| Apremilast | |||||
|---|---|---|---|---|---|
| Placebo n=165 | 20 mg BID n=163 | p Value vs placebo | 30 mg BID n=161 | p Value vs placebo | |
| ACR20, n† | 22 (13.3%) | 43 (26.4%) | 0.0032 | 59 (36.6%) | <0.0001 |
| ACR50, n† | 7 (4.2%) | 24 (14.7%) | 0.0013 | 32 (19.9%) | <0.0001 |
| ACR70, n† | 1 (0.6%) | 9 (5.5%) | 0.0102 | 17 (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) | 0.0295 | 5.1 (0.67) | 0.0001 |
| EULAR good/moderate response, n | 27 (16.4%) | 51 (31.3%) | 0.0016 | 71 (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, n | 4 (2.4%) | 19 (11.7%) | 0.0011 | 30 (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%) | 0.0439 | 41 (50.6%) | 0.0001 |
| PASI-75, n** | 3 (4.6%) | 13 (17.6%) | 0.0180 | 17 (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.