Efficacy endpoints at Week 52*. The n reflects the no. patients who completed 52 weeks; actual no. patients available for each endpoint may vary. Values are n/m (%) or mean change (SD) unless otherwise specified.
| Characteristics | Placebo/Apremilast 20 mg BID, n = 63 | Placebo/Apremilast 30 mg BID, n = 56 | Apremilast 20 mg BID, n = 124 | Apremilast 30 mg BID, n = 130 |
|---|---|---|---|---|
| ACR20 | 34/64 (53.1) | 30/60 (50.0) | 75/119 (63.0) | 71/130 (54.6) |
| ACR50 | 16/63 (25.4) | 17/61 (27.9) | 29/117 (24.8) | 32/130 (24.6) |
| ACR70 | 3/62 (4.8) | 9/61 (14.8) | 18/117 (15.4) | 18/130 (13.8) |
| HAQ-DI, 0–3 | −0.27 (0.56) | −0.29 (0.59) | −0.37 (0.48) | −0.32 (0.55) |
| SF-36v2 PF§ | 4.5 (8.9) | 4.6 (10.0) | 7.0 (9.4) | 5.7 (9.0) |
| SF-36v2 PCS§ | 4.6 (7.7) | 5.6 (8.2) | 7.8 (8.8) | 6.5 (8.7) |
| FACIT-Fatigue | 4.3 (8.2) | 4.2 (11.7) | 4.3 (8.5) | 3.7 (9.1) |
| EULAR good/moderate response | 53/64 (82.8) | 42/60 (70.0) | 90/120 (75.0) | 96/129 (74.4) |
| mPsARC response | 45/61 (73.8) | 42/59 (71.2) | 93/120 (77.5) | 95/129 (73.6) |
| DAS28, CRP | −1.5 (1.1) | −1.2 (1.3) | −1.4 (1.1) | −1.3 (1.1) |
| DAS28, CRP, < 2.6 | 17/65 (26.2) | 11/60 (18.3) | 39/120 (32.5) | 30/129 (23.3) |
| CDAI, 0–76 | −15.0 (11.1) | −14.0 (14.9) | −15.4 (13.0) | −14.5 (12.0) |
| MASES, 0–13, median % change‡ | −50.0 | −40.0 | −100.0 | −66.7 |
| Dactylitis count, 0–20, median % change‖ | −100.0 | −100.0 | −100.0 | −100.0 |
| Swollen joint count, 0–76, median % change | −81.0 | −66.7 | −78.8 | −77.8 |
| Tender joint count, 0–78, median % change | −63.6 | −56.1 | −69.2 | −62.5 |
| CRP, normal range 0–0.5, mg/dl, median % change | −30.4 | −5.5 | −8.2 | −16.2 |
| Patient global assessment, 0–100 VAS, median % change | −38.5 | −22.1 | −36.8 | −28.6 |
| Physician global assessment, 0–100 VAS, median % change | −70.9 | −58.8 | −66.7 | −61.7 |
| Patient assessment of pain, 0–100 VAS, median % change | −33.6 | −37.9 | −35.6 | −30.9 |
| PASI-50¶ | 11/25 (44.0) | 11/27 (40.7) | 28/53 (52.8) | 41/68 (60.3) |
| PASI-75¶ | 4/25 (16.0) | 6/27 (22.2) | 13/53 (24.5) | 25/68 (36.8) |
↵* Data as observed. Based on patients randomized to apremilast, placebo/apremilast 20 mg BID and placebo/apremilast 30 mg BID groups include patients who were randomized to placebo at baseline and re-randomized to apremilast 20 mg BID and apremilast 30 mg BID, respectively, at weeks 16 or 24; apremilast 20 mg BID and apremilast 30 mg BID groups include patients randomized to the respective regimen at baseline.
↵§ Increase indicates improvement.
↵‡ Examined among patients with enthesitis at baseline and having data at Week 52 (placebo/apremilast 20 mg BID: n = 36; placebo/apremilast 30 mg BID: n = 36; apremilast 20 mg BID: n = 69; apremilast 30 mg BID: n = 89).
↵‖ Examined among patients with dactylitis at baseline and having data at Week 52 (placebo/apremilast 20 mg BID: n = 23; placebo/apremilast 30 mg BID: n = 26; apremilast 20 mg BID: n = 48; apremilast 30 mg BID: n = 49).
↵¶ Examined among patients with psoriasis involving body surface area ≥ 3% at baseline. n/m: number of responders/number of patients with sufficient data for evaluation. ACR20/50/70: 20%/50%/70% improvement in modified American College of Rheumatology response criteria; HAQ-DI: Health Assessment Questionnaire–Disability Index; SF-36v2 PF: Medical Outcomes Study Short Form-36 health survey version 2 Physical Functioning domain; PCS: physical component summary score; FACIT-Fatigue: Functional Assessment of Chronic Illness Therapy-Fatigue; EULAR: European League Against Rheumatism; mPsARC: modified psoriatic arthritis response criteria; DAS28: 28-joint Disease Activity Score (using CRP as acute-phase reactant); CRP: C-reactive protein; CDAI: Clinical Disease Activity Index; MASES: Maastricht Ankylosing Spondylitis Enthesitis Score; VAS: visual analog scale; PASI-50/75: 50%/75% reduction from baseline Psoriasis Area and Severity Index score.