Efficacy endpoints at Week 52 in PALACE 1 (value at timepoint, data as observed*). 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 (SD).
| 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 | 0.88 (0.64) | 0.93 (0.67) | 0.74 (0.65) | 0.95 (0.66) |
| SF-36v2 PF§ | 38.3 (11.1) | 39.4 (10.8) | 42.5 (10.6) | 38.7 (11.1) |
| SF-36v2 PCS§ | 38.9 (9.5) | 40.4 (9.4) | 43.0 (9.9) | 40.1 (9.6) |
| FACIT-Fatigue | 35.1 (10.3) | 32.5 (11.9) | 37.2 (10.6) | 33.3 (11.2) |
| 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 | 3.4 (1.2) | 3.9 (1.3) | 3.3 (1.2) | 3.6 (1.3) |
| DAS28, CRP, < 2.6 | 17/65 (26.2) | 11/60 (18.3) | 39/120 (32.5) | 30/129 (23.3) |
| CDAI, 0–76 | 14.0 (11.1) | 16.9 (12.1) | 13.2 (10.9) | 15.4 (11.9) |
| MASES, 0–13‡ | 3.5 (3.7) | 3.9 (3.9) | 1.9 (3.1) | 2.4 (3.2) |
| Dactylitis count, 0–20‖ | 1.8 (3.2) | 1.5 (2.8) | 0.9 (2.4) | 1.2 (2.0) |
| Swollen joint count, 0–76 | 4.5 (5.9) | 6.9 (8.7) | 4.4 (7.1) | 5.0 (7.3) |
| Tender joint count, 0–78 | 10.5 (13.8) | 12.8 (13.4) | 8.5 (11.1) | 12.1 (13.8) |
| CRP, mg/dl, normal range 0–0.5 | 0.69 (0.66) | 1.24 (2.76) | 0.68 (0.88) | 0.79 (1.15) |
| Patient global assessment, 0–100 VAS | 41.4 (24.9) | 46.7 (27.3) | 37.6 (24.5) | 40.6 (23.7) |
| Physician global assessment, 0–100 VAS | 25.0 (22.1) | 28.9 (24.4) | 22.5 (21.2) | 27.2 (23.3) |
| Patient assessment of pain, 0–100 VAS | 40.1 (24.4) | 43.6 (25.4) | 35.6 (23.2) | 39.1 (23.0) |
| 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.